| DB00001 | Lepirudin | For the treatment of heparin-induced thrombocytopenia |
| DB00002 | Cetuximab | Cetuximab, used in combination with irinotecan, is indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy. Cetuximab administered as a single agent is indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma in patients who are intolerant to irinotecan-based chemotherapy. |
| DB00003 | Dornase alfa | Used as adjunct therapy in the treatment of cystic fibrosis. |
| DB00004 | Denileukin diftitox | For treatment of cutaneous T-cell lymphoma |
| DB00005 | Etanercept | Etanercept is indicated for the treatment of moderately to severely active rheumatoid arthritis in adults and chronic moderate to severe plaque psoriasis in adults. It is also used to manage signs and symptoms of polyarticular idiopathic arthritis in those aged 4 to 17 after insufficient response to one or more disease-modifying anti-rheumatic drugs. Etanercept is also used to improve psoriatic arthritis and ankylosing spondylitis. |
| DB00006 | Bivalirudin | For treatment of heparin-induced thrombocytopenia and for the prevention of thrombosis. Bivalirudin is indicated for use in patients undergoing percutaneous coronary intervention (PCI), in patients at moderate to high risk acute coronary syndromes due to unstable angina or non-ST segment elevation in whom a PCI is planned. |
| DB00007 | Leuprolide | For treatment of prostate cancer, endometriosis, uterine fibroids and premature puberty |
| DB00008 | Peginterferon alfa-2a | Peginterferon alfa-2a is indicated for the treatment of HCV in combination with other antiviral drugs in patients over 5 years of age with compensated liver disease [FDA Label]. May be used as a monotherapy in patients with contraindications to or significant intolerance to other anti-viral therapies.
Peginterferon alfa-2a is also indicated as a monotherapy for adult patients with HBeAg positive and HBeAg negative chronic hepatitis B infection who have
compensated liver disease and evidence of viral replication and liver inflammation [FDA Label]. |
| DB00009 | Alteplase | For management of acute myocardial infarction, acute ischemic strok and for lysis of acute pulmonary emboli |
| DB00010 | Sermorelin | For the treatment of dwarfism, prevention of HIV-induced weight loss |
| DB00011 | Interferon alfa-n1 | For treatment of venereal or genital warts caused by the Human Papiloma Virus |
| DB00012 | Darbepoetin alfa | For the treatment of anemia (from renal transplants or certain HIV treatment) |
| DB00013 | Urokinase | Urokinase can be used for the treatment of pulminary embolism, coronary artery thrombosis, IV catheter clearance, and venous and arterial blood clots. |
| DB00014 | Goserelin | Used to treat hormone-sensitive cancers of the breast (in pre- and peri- menopausal women) and prostate, and some benign gynaecological disorders (endometriosis, uterine fibroids and endometrial thinning). In addition, goserelin is used in assisted reproduction and in the treatment of precocious puberty. |
| DB00015 | Reteplase | For lysis of acute pulmonary emboli, intracoronary emboli and management of myocardial infarction |
| DB00016 | Erythropoietin | Indicated in adult and paediatric patients for the:
- treatment of anemia due to Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis.
- treatment of anemia due to zidovudine in patients with HIV-infection.
- treatment of anemia due to the effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
- reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery. |
| DB00017 | Salmon Calcitonin | Used in the treatment of symptomatic Paget's disease for patients unresponsive to alternate treatments or intolerant to such treatments. In addition, it is used in emergency situations when serum calcium levels must be decreased quickly until the underlying condition is identified. It can also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or corticosteroids, or other agents. Calcitonin can be used in patients with azotemia and cases where intravenous fluids would be contraindicated due to limited cardiac reserves. Also for the treatment of post-menopausal osteoporosis in women more than 5 years post-menopause. |
| DB00018 | Interferon alfa-n3 | For the intralesional treatment of refractory or recurring external condylomata acuminata. |
| DB00019 | Pegfilgrastim | Pegfilgrastim is indicated for use in patients receiving myelosuppressive chemotherapy for non-myeloid malignancies to reduce the incidence of infection. It is also indicated to increase in patients with acute myelosuppresive radiation exposure. |
| DB00020 | Sargramostim | For the treatment of cancer and bone marrow transplant |
| DB00022 | Peginterferon alfa-2b | Peginterferon alfa-2b is indicated for the treatment of HCV in combination with [DB00811] and a NS3/4A protease inhibitor for genotype 1 or without a NS3/4A protease inhibitor for genotypes 2-6 [FDA Label]. May be used as a monotherapy in patients with contraindications to or significant intolerance to other anti-viral therapies.
|
| DB00025 | Antihemophilic factor, human recombinant | For the treatment of hemophilia A, von Willebrand disease and Factor XIII deficiency. |
| DB00026 | Anakinra | For the treatment of adult rheumatoid arthritis and treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID). |
| DB00027 | Gramicidin D | For treatment of skin lesions, surface wounds and eye infections. |
| DB00028 | Immune Globulin Human | IVIg is used in the treatment of immunodeficiencies, as well as autoimmune and inflammatory disorders. These indications includes idiopathic thrombocytopenic purpura, Kawasaki disease, hypogammaglobulinemia, B cell chronic lymphocytic leukemia, bone marrow transplant complications, Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy (CIDP), multiple sclerosis, rheumatoid arthritis, myesthenia gravis, Wiskott–Aldrich syndrome and inflammatory skin diseases. |
| DB00029 | Anistreplase | For lysis of acute pulmonary emboli, intracoronary emboli and management of myocardial infarction |
| DB00031 | Tenecteplase | For treatment of myocardial infarction and lysis of intracoronary emboli |
| DB00033 | Interferon gamma-1b | Interferon gamma-1b is used for the treatment of Chronic granulomatous disease and Osteopetrosis. |
| DB00034 | Interferon Alfa-2a, Recombinant | For the treatment of chronic hepatitis C, hairy cell leukemia, AIDS-related Kaposi's sarcoma, and chronic myelogenous leukemia. Also for the treatment of oral warts arising from HIV infection. |
| DB00035 | Desmopressin | - Indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void (intranasal).
- Indicated as antidiuretic replacement therapy in the management of central cranial diabetes insipidus and for management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region (intranasal/parenteral).
- Indicated for patients with hemophilia A with factor VIII coagulant activity levels greater than 5% or mild to moderate classic von Willebrand's Disease (Type I) with factor VIII levels greater than 5% during surgical procedures and postoperatively to maintain hemostasis (parenteral). |
| DB00036 | Coagulation factor VIIa Recombinant Human | For treatment of hemorrhagic complications in hemophilia A and B |
| DB00038 | Oprelvekin | Increases reduced platelet levels due to chemotherapy |
| DB00039 | Palifermin | For treatment of oral mucositis associated with chemotherapy and radiation therapy. |
| DB00040 | Glucagon | For treatment of severe hypoglycemia, also used in gastrointestinal imaging |
| DB00041 | Aldesleukin | For treatment of adults with metastatic renal cell carcinoma. |
| DB00042 | Botulinum Toxin Type B | For the treatment of patients with cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia. |
| DB00043 | Omalizumab | This drug is an anti-IgE antibody indicated for:
1. Moderate to severe persistent asthma in patients 6 years of age and older
with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids [FDA label]
2. Chronic idiopathic urticaria in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment [FDA label] |
| DB00050 | Cetrorelix | For the inhibition of premature LH surges in women undergoing controlled ovarian stimulation |
| DB00051 | Adalimumab | The following are conditions for which adalimumab has been indicated [F2118], [FDA label], [L4805], [A40001], [A40002], [L4806].
Rheumatoid Arthritis (Moderate to Severe)
Juvenile Idiopathic Arthritis (Moderately to Severely Active)
Psoriatic Arthritis (Active)
Ankylosing Spondylitis (Active)
Crohn’s Disease (Moderately to Severely Active)
Ulcerative Colitis (Moderately to Severely Active)
Plaque Psoriasis (Moderate to Severe Chronic)
Non-infectious Intermediate, Posterior and Panuveitis
Hidradenitis Suppurativa (Moderate to Severe)
Pyoderma Gangrenosum (off-label)
|
| DB00054 | Abciximab | Abciximab is indicated as an adjunct to percutaneous coronary intervention for the prevention of cardiac ischemic complications in patients undergoing percutaneous coronary intervention and in patients with unstable angina not responding to conventional medical therapy when percutaneous coronary intervention is planned within 24 hours. Abciximab is intended for use with aspirin and heparin and has been studied only in that setting. |
| DB00055 | Drotrecogin alfa | For reduction of mortality in patients with severe sepsis. |
| DB00056 | Gemtuzumab ozogamicin | Indicated for the treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for other cytotoxic chemotherapy. Indicated for the treatment of patients aged 2 years and older with CD33-positive AML who have experienced a relapse or who have not responded to initial treatment (refractory). |
| DB00057 | Indium In-111 satumomab pendetide | For diagnosis of extrahepatic malignant cancers |
| DB00058 | Alpha-1-proteinase inhibitor | For chronic augmentation and maintenance therapy in individuals with alpha1-proteinase inhibitor (A1-PI) deficiency and clinical evidence of emphysema. |
| DB00060 | Interferon beta-1a | For treatment of relapsing/remitting multiple sclerosis, also for condyloma acuminatum |
| DB00062 | Human Serum Albumin | Albuminex solution is indicated for adults and children for hypovolemia, ascites, hypoalbuminemia including from burns, acute nephrosis, acute respiratory distress syndrome and cardipulmonary bypass [F229]. |
| DB00065 | Infliximab | * Indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult or pediatric (≥ 6 years of age) patients with moderately to severely active **Crohn’s disease** who have had an inadequate response to conventional therapy
* Indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing **Crohn’s disease**.
* Indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult or pediatric (≥ 6 years of age) patients with moderately to severely active **ulcerative colitis** who have had an inadequate response to conventional therapy.
* Indicated for, in combination with methotrexate, reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active **rheumatoid arthritis**.
* Indicated for reducing signs and symptoms in patients with active **ankylosing spondylitis**.
* Indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with **psoriatic arthritis**.
* Indicated for the treatment of adult patients with chronic severe (i.e., extensive and/or disabling) **plaque psoriasis** who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. |
| DB00066 | Follitropin | In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). |
| DB00067 | Vasopressin | For the treatment of enuresis, polyuria, diabetes insipidus, polydipsia and oesophageal varices with bleeding |
| DB00068 | Interferon beta-1b | Interferon beta-1b is a drug used for the treatment of relapsing/remitting multiple sclerosis. It has been shown to slow the advance of the disease as well as to decrease the frequency of attacks. |
| DB00069 | Interferon alfacon-1 | For the treatment of hairy cell leukemia, malignant melanoma, and AIDS-related Kaposi's sarcoma |
| DB00071 | Insulin Pork | For the treatment of type I and II diabetes mellitus. |
| DB00072 | Trastuzumab | Indicated for treatment of early stage HER2-positive breast cancer, or metastatic breast cancer that substantially overexpress HER2. |
| DB00073 | Rituximab | Rituximab is indicated in the following conditions [FDA label]:
**Non–Hodgkin’s Lymphoma (NHL)**
**Chronic Lymphocytic Leukemia (CLL)**
**Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA**
**Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA)**
**Moderate to severe Pemphigus Vulgaris (PV) in adult patients**
The biosimilar (approved in November 2018), _Truxima_, is indicated For the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy [L4808]. |
| DB00074 | Basiliximab | For prophylactic treatment of kidney transplant rejection |
| DB00075 | Muromonab | For treatment of organ transplant recipients, prevention of organ rejection |
| DB00078 | Ibritumomab tiuxetan | For treatment of non-Hodgkin's lymphoma |
| DB00081 | Tositumomab | For treatment of non-Hodgkin's lymphoma (CD20 positive, follicular) |
| DB00083 | Botulinum toxin type A | For the treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia. Also for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents and for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and above. Also used cosmetically to temporarily improve the appearance of moderate-to-severe frown lines between the eyebrows (glabellar lines) as well as for the treatment of excessive underarm sweating. |
| DB00086 | Streptokinase | For the treatment of acute evolving transmural myocardial infarction, pulmonary embolism, deep vein thrombosis, arterial thrombosis or emolism and occlusion of arteriovenous cannulae |
| DB00087 | Alemtuzumab | Alemtuzumab (Campath) is a monoclonal antibody therapy used for treatment of B-cell chronic lymphocytic leukemia. |
| DB00089 | Capromab pendetide | For diagnosis of prostate cancer and detection of intra-pelvic metastases. |
| DB00092 | Alefacept | As an immunosuppressive drug, Alefacept can be used for treatment of moderate to severe chronic plaque psoriasis |
| DB00093 | Felypressin | For use as an alternative to adrenaline as a localising agent, provided that local ischaemia is not essential. |
| DB00095 | Efalizumab | For the treatment of adult patients with moderate to severe chronic plaque psoriasis, who are candidates for phototherapy or systemic therapy. |
| DB00098 | Antithymocyte immunoglobulin (rabbit) | For prevention of renal transplant rejection |
| DB00099 | Filgrastim | This drug is a leucocyte growth factor [FDA label] indicated to:
Decrease the incidence of infection‚ as manifested by febrile neutropenia‚
in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever [FDA label].
Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment in patients with acute myeloid leukemia (AML) [FDA label]
Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) [FDA label]
Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis [FDA label]
Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia [FDA label].
Neupogen is approved for treatment of patients with radiation-induced myelosuppression following a radiological/nuclear incident [L3739]. |
| DB00102 | Becaplermin | For topical treatment of skin ulcers (from diabetes) |
| DB00103 | Agalsidase beta | For treatment of Fabry's disease (alpha-galactosidase A deficiency) |
| DB00105 | Interferon alfa-2b | For the treatment of hairy cell leukemia, malignant melanoma, and AIDS-related Kaposi's sarcoma. |
| DB00108 | Natalizumab | For treatment of multiple sclerosis. |
| DB00109 | Enfuvirtide | Enfuvirtide is an antiretroviral drug used in combination therapy for the treatment of HIV-1/AIDS. |
| DB00110 | Palivizumab | For prophylaxis of respiratory diseases casued by respiratory syncytial virus. |
| DB00111 | Daclizumab | Zenapax is a humanized monoclonal antibody used for prevention of renal transplant rejection |
| DB00112 | Bevacizumab | As part of combination therapy for metastatic colorectal cancer and HER2-negative metastatic breast cancer. |
| DB00113 | Technetium Tc-99m arcitumomab | For imaging colorectal tumors |
| DB00155 | L-Citrulline | Used for nutritional supplementation, also for treating dietary shortage or imbalance. |
| DB00183 | Pentagastrin | Used as a diagnostic aid for evaluation of gastric acid secretory function |
| DB00556 | Perflutren | Used as an ultrasound contrast imaging in cardiology and radiology. |
| DB00644 | Gonadorelin | For evaluating the functional capacity and response of the gonadotropes of the anterior pituitary also for evaluating residual gonadotropic function of the pituitary following removal of a pituitary tumor by surgery and/or irradiation. |
| DB00666 | Nafarelin | For treatment of central precocious puberty (true precocious puberty, GnRH-dependent precocious precocity, complete isosexual precocity) in children of both sexes and for the treatment of endometriosis. |
| DB00781 | Polymyxin B sulfate | For treatment of infections of the urinary tract, meninges, and blood stream, caused by susceptible strains of Pseudomonas aeruginosa. |
| DB00803 | Colistin | For the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli, particularly Pseudomonas aeruginosa. |
| DB00855 | Aminolevulinic acid | Aminolevulinic acid plus blue light illumination using a blue light photodynamic therapy illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses of the face or scalp. |
| DB01111 | Colistimethate | For the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli, particularly _Pseudomonas aeruginosa_. |
| DB01229 | Paclitaxel | Used in the treatment of Kaposi's sarcoma and cancer of the lung, ovarian, and breast. Abraxane® is specfically indicated for the treatment of metastatic breast cancer and locally advanced or metastatic non-small cell lung cancer. |
| DB01257 | Eculizumab | For the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. |
| DB01269 | Panitumumab | For the treatment of EGFR-expressing, metastatic colorectal carcinoma that is refractory to fluoropyrimidine-, oxaliplatin-, and irinotecan- containing chemotherapy regimens. |
| DB01270 | Ranibizumab | For the treatment of patients with macular edema after retinal vein occlusion, age-related macular degeneration (wet), and diabetic macular edema.
|
| DB01277 | Mecasermin | For the long-term treatment of growth failure in pediatric patients with Primary IGFD or with GH gene deletion who have developed neutralizing antibodies to GH. It is not indicated to treat Secondary IGFD resulting from GH deficiency, malnutrition, hypothyroidism or other causes; it is not a substitute for GH therapy. |
| DB01278 | Pramlintide | For the treatment of type 1 and type 2 diabetes mellitus as an adjunct to preprandial insulin therapy in patients without adequate glycemic control of insulin therapy. |
| DB01279 | Galsulfase | For the treatment of adults and children with Mucopolysaccharidosis VI. |
| DB01281 | Abatacept | For the management of the signs and symptoms of moderate-to-severe active rheumatoid arthritis, inducing major clinical response, slowing the progression of structural damage, and improving physical function in adult patients. It is indicated both as a monotherapy and for use in combination with a continued regimen of DMARDs (not including TNF antagonists). Also used for the management of the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in children. |
| DB01284 | Tetracosactide | For use as a diagnostic agent in the screening of patients presumed to have adrenocortical insufficiency. |
| DB01285 | Corticotropin | For use as a diagnostic agent in the screening of patients presumed to have adrenocortical insufficiency. |
| DB01309 | Insulin Glulisine | For the treatment of Type 1 and 2 diabetes mellitus. Should be used in regimens including a long-acting or basal insulin analogue unless it is used in a continuous infusion pump. May be used with oral antidiabetic agents. |
| DB01373 | Calcium | Calcium plays a vital role in the anatomy, physiology and biochemistry of organisms and of the cell, particularly in signal transduction pathways. It is vital in cell signaling, muscular contractions, bone health, and signalling cascades. |
| DB01584 | Thyroglobulin | For the treatment of hypothyroidism (deficiency in the production of thyroid hormone). |
| DB01853 | Bacteriochlorophyll A | Not Available |
| DB02137 | Molybdenum Cofactor | Not Available |
| DB02261 | Platelet Activating Factor | Not Available |
| DB02638 | Terlipressin | Commonly used to stop bleeding of varices in the food pipe (oesophagus). |
| DB04894 | Vapreotide | For the treatment of esophageal variceal bleeding in patients with cirrhotic liver disease and has also shown efficacy in the treatment of patients with AIDS-related diarrhea. |
| DB04899 | Nesiritide | For the intravenous treatment of patients with acutely decompensated congestive heart failure who have dyspnea at rest or with minimal activity. |
| DB04900 | Thymalfasin | Indicated as an adjuvant for influenza vaccine in elderly patients and as an adjuvant for both influenza and hepatitis B vaccines in chronic hemodialysis patients who failed to achieve adequate antibody titers from previous immunization. |
| DB04901 | Galiximab | Investigated for use/treatment in lymphoma (non-hodgkin's), psoriasis and psoriatic disorders, bone metastases, multiple myeloma, prostate cancer, and rheumatoid arthritis. |
| DB04914 | G17DT | Intended for the treatment of various forms of cancer. |
| DB04921 | Dirucotide | For the treatment of multiple sclerosis (MS). |
| DB04925 | Desmoteplase | Investigated for use/treatment in cerebral ischemia and strokes. |
| DB04931 | Afamelanotide | Investigated for use/treatment in actinic keratosis, keratoses, skin cell studies, and skin infections/disorders. |
| DB04949 | Pexelizumab | For the treatment of inflammation during cardiac surgery. |
| DB04956 | Afelimomab | Investigated for use/treatment in sepsis and septicemia. |
| DB04958 | Epratuzumab | Investigated for use/treatment in leukemia (lymphoid), lymphoma (non-hodgkin's), and systemic lupus erythematosus. |
| DB04962 | Bectumomab | Investigated for use/treatment in lymphoma (non-hodgkin's). |
| DB04964 | Oregovomab | Investigated for use/treatment in ovarian cancer. |
| DB04985 | Tigapotide | For the treatment of late stage Hormone Refractory Prostate Cancer (HRPC) for which no effective therapy currently exists.
|
| DB04988 | IGN311 | Intended for the treatment of various forms of cancer. |
| DB05006 | Adecatumumab | Investigated for use/treatment in breast cancer and prostate cancer. |
| DB05029 | Lancovutide | Investigated for use/treatment in cystic fibrosis and eye disorders/infections. |
| DB05032 | REV131 | Investigated for use/treatment in allergic reaction, allergic rhinitis, and cataracts. |
| DB05084 | Abaloparatide | Investigated for use/treatment in postmenopausal osteoporosis to reduce vertebral and/or non-vertebral fractures. |
| DB05097 | Labetuzumab | Labetuzumab is a humanized monoclonal antibody used to treat cancer. Retrieved from "http://en.wikipedia.org/wiki/Labetuzumab" |
| DB05098 | Leptin | Investigated for use/treatment in lipodystrophy and obesity. |
| DB05101 | Matuzumab | Investigated for use/treatment in cervical dysplasia/cancer, colorectal cancer, gastric cancer, and lung cancer. |
| DB05111 | Fontolizumab | Investigated for use/treatment in crohn's disease and psoriasis and psoriatic disorders. |
| DB05115 | NN344 | Investigated for use/treatment in diabetes mellitus type 1 and 2. |
| DB05136 | Bavituximab | Investigated for use/treatment in breast cancer, cancer/tumors (unspecified), HIV infection, hepatitis (viral, C), and solid tumors. |
| DB05139 | CR002 | Investigated for use/treatment in nephropathy. |
| DB05155 | CR665 | Investigated for use/treatment in pain (acute or chronic). |
| DB05160 | Topsalysin | Investigated for use/treatment in benign prostatic hyperplasia, cancer/tumors (unspecified), prostate cancer, prostate disorders, and solid tumors. |
| DB05161 | Elafin | Investigated for use/treatment in inflammatory disorders (unspecified). |
| DB05209 | Rozrolimupab | Investigated for use/treatment in thrombocytopenia. |
| DB05258 | Natural alpha interferon | Investigated for use/treatment in hepatitis (viral, C), leukemia (lymphoid), leukemia (myeloid), leukemia (unspecified), and melanoma. |
| DB05259 | Glatiramer | For reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis. |
| DB05276 | Hepatitis B Immune Globulin | Investigated for use/treatment in hepatitis (viral, B), liver transplant surgery, and pediatric indications. |
| DB05299 | keyhole limpet hemocyanin | Investigated for use/treatment in bladder cancer and solid tumors. |
| DB05305 | Cintredekin Besudotox | Investigated for use/treatment in brain cancer. |
| DB05319 | Oportuzumab monatox | Investigated for use/treatment in bladder cancer and head and neck cancer. |
| DB05332 | Romiplostim | Treatment of chronic immune thrombocytopenic purpura. |
| DB05336 | Obiltoxaximab | Investigated for use/treatment in anthrax exposure, bacterial infection, crohn's disease, and graft versus host disease. |
| DB05344 | Ciliary neurotrophic factor | Investigated for use/treatment in eye disorders/infections, macular degeneration, and retinal disorders (unspecified). |
| DB05394 | Corticorelin | Investigated for use/treatment in brain cancer and neurologic disorders. |
| DB05396 | Albinterferon Alfa-2B | Investigated for use/treatment in hepatitis (viral, C). |
| DB05405 | XTL-001 | Investigated for use/treatment in hepatitis (viral, B). |
| DB05413 | Tifuvirtide | Investigated for use/treatment in acquired immune deficiency syndrome (AIDS) and aids-related infections and HIV infection. |
| DB05437 | RIGScan CR49 | Investigated for use/treatment in colorectal cancer and solid tumors. |
| DB05446 | LJP 1082 | Investigated for use/treatment in autoimmune diseases, strokes, and thrombosis. |
| DB05459 | Briakinumab | Investigated for use/treatment in autoimmune diseases, crohn's disease, multiple sclerosis, psoriasis and psoriatic disorders, and rheumatoid arthritis. |
| DB05496 | Otelixizumab | Investigated for use/treatment in diabetes mellitus type 1, pediatric indications, and psoriasis and psoriatic disorders. |
| DB05550 | Iratumumab | Investigated for use/treatment in lymphoma (unspecified). |
| DB05555 | Enokizumab | Investigated for use/treatment in asthma. |
| DB05578 | Ramucirumab | For use in advanced gastric or gastro-esophageal junction adenocarcinoma as a single agent or in combination with paclitaxel after prior fluoropyrimidine- or platinum-containing chemotherapy. |
| DB05595 | Farletuzumab | Investigated for use/treatment in ovarian cancer. |
| DB05599 | Fibroblast growth factor-1 | Investigated for use/treatment in coronary artery disease and peripheral vascular disease. |
| DB05656 | Veltuzumab | Investigated for use/treatment in lymphoma (non-hodgkin's). |
| DB05679 | Ustekinumab | Ustekinumab is indicated for management of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy; or is used alone or in conjunction with methotrexate for the management of active psoriatic arthritis in adults. The FDA approved the use of ustekinumab in September 2016 for the treatment of moderate to severe Crohn's disease. The use of ustekinumab may improve short term clinical response but not clinical remission in moderate to severe Crohn's disease. |
| DB05718 | Maxy-G34 | Investigated for use/treatment in adverse effects (chemotherapy) and neutropenics. |
| DB05773 | Trastuzumab emtansine | Used in HER2-positive, metastatic breast cancer patients who have already used taxane and/or trastuzumab for metastatic disease or had their cancer recur within 6 months of adjuvant treatment.
|
| DB05777 | Thrombomodulin Alfa | Investigated for use/treatment in blood preservative, blood (blood forming organ disorders, unspecified), sepsis and septicemia, and thrombosis. |
| DB05793 | PRO-542 | Investigated for use/treatment in acquired immune deficiency syndrome (AIDS) and aids-related infections, HIV infection, and pediatric indications. |
| DB05797 | TNX-901 | Investigated for use/treatment in allergic reaction. |
| DB05819 | NBI-6024 | Investigated for use/treatment in diabetes mellitus type 1 and pediatric indications. |
| DB05833 | lymphotoxin beta receptor | Investigated for use/treatment in autoimmune diseases. |
| DB05875 | substance P | Investigated for use/treatment in acute respiratory distress syndrome (ARDS) and viral infection. |
| DB05889 | Inotuzumab ozogamicin | Indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). |
| DB05892 | RI 624 | Investigated for use/treatment in pain (acute or chronic). |
| DB05915 | MYO-029 | Investigated for use/treatment in muscular dystrophy. |
| DB05931 | Pegdinetanib | Investigated for use/treatment in cancer/tumors (unspecified) and macular degeneration. |
| DB05934 | CTCE-0214 | Investigated for use/treatment in adverse effects (chemotherapy), blood (blood forming organ disorders, unspecified), cancer/tumors (unspecified), neutropenics, and vascular diseases. |
| DB05941 | Leronlimab | Investigated for use/treatment in HIV infection. |
| DB05996 | Glembatumumab vedotin | Investigated for use/treatment in melanoma. |
| DB06043 | Olaratumab | Olaratumab is indicated, in combination with doxorubicin, for the treatment of adult patients with advanced or mestastatic soft tissue sarcoma (STS) with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery. |
| DB06049 | IPH 2101 | Investigated for use/treatment in leukemia (myeloid) and multiple myeloma. |
| DB06081 | Caplacizumab | Capacizumab is approved for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP) in conjunction with plasma exchange and immunosuppression in patients 18 years or older.[A174634, L5302]
aTTP is a rare autoimmune condition presented by a disruption of blood clotting order which is translated into systemic microvascular thrombosis leading to profound thrombocytopenia, hemolytic anemia and organ ischemia. It is caused by the production of autoantibodies against ADAMTS-13 which is the protein in charge of cleaving the von-Wilebrand factor. The lack of this process produces the generation of ultra large von Wilebrand multimers that bind to platelets and form microthrombi and causing thromboembolic complications.[A174649]
Previously, capacizumab was under review for the prevention of thrombosis in high-risk patients with acute coronary syndrome undergoing percutaneous coronary intervention but this indication was withdrawn.[A174634] |
| DB06101 | IMC-1C11 | Investigated for use/treatment in cancer/tumors (unspecified). |
| DB06116 | Eldelumab | Investigated for use/treatment in ulcerative colitis. |
| DB06138 | IRL-1620 | Investigated for use/treatment in cancer/tumors (unspecified). |
| DB06162 | Lumiliximab | Investigated for use/treatment in asthma and leukemia (lymphoid). |
| DB06168 | Canakinumab | Used in patients 4 years of age and older to treat Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS), which are both part of the Cryopyrin-Associated Periodic Syndromes (CAPS) as well as for patients 2 years of age and older to treat systemic juvenile idiopathic arthritis (SJIA). |
| DB06186 | Ipilimumab | Ipilimumab is approved for different conditions such as:
* Treatment of unresectable or metastatic melanoma in patients 12 years and older.
* Adjuvant treatment of patients with cutaneous melanoma with the pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy.[FDA label]
In combination with [nivolumab], ipilimumab is approved for:
* Treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma
* Treatment of 12 years and older patients with MSI-H/dMMR metastatic colorectal cancer with progression after treatment with fluoropyrimidine, oxaliplatin, and irinotecan.[FDA label] |
| DB06192 | Nimotuzumab | Investigated for use/treatment in head and neck cancer, brain cancer, pediatric indications, pancreatic cancer, lung cancer, and colorectal cancer. |
| DB06196 | Icatibant | Approved for use in acute attacks of hereditary angioedema (HAE). Investigated for use/treatment in angioedema, liver disease, and burns and burn infections. |
| DB06241 | Clenoliximab | Investigated for use/treatment in rheumatoid arthritis. |
| DB06244 | Trafermin | Investigated for use/treatment in coronary artery disease, peripheral vascular disease, periodontal disease, bone fractures, entero-related fistulae, and diabetic foot ulcers. |
| DB06245 | Lanoteplase | Investigated for use/treatment in myocardial infarction. |
| DB06260 | Aviptadil | Not Available |
| DB06273 | Tocilizumab | Indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). It is also indicated for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) and active systemic juvenile idiopathic arthritis (SJIA) in patients 2 years of age and older. |
| DB06310 | Motavizumab | Investigated for use/treatment in viral infection and pediatric indications. |
| DB06317 | Elotuzumab | Indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies. |
| DB06323 | AZX-100 | Investigated for use/treatment in scar tissue. |
| DB06342 | Coltuximab ravtansine | Investigated for use/treatment in lymphoma (non-hodgkin's). |
| DB06343 | Teprotumumab | Investigated for use/treatment in solid tumors. |
| DB06360 | Lucatumumab | Investigated for use/treatment in leukemia (lymphoid), multiple myeloma, and lymphoma (unspecified). |
| DB06366 | Pertuzumab | Pertuzumab is indicated for use in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. |
| DB06371 | Siplizumab | Investigated for use/treatment in psoriasis and psoriatic disorders, transplant (rejection), graft versus host disease, lymphoma (unspecified), and leukemia (unspecified). |
| DB06372 | Rilonacept | Rilonacept is currently used in the treatment of cryopyrin-associated periodic syndrome. In May 2012, an advisory panel for the FDA voted 11-0 against the use of Rilonacept for the treatment of gout. |
| DB06379 | Calcitonin gene-related peptide | Investigated for use/treatment in myocardial infarction, heart disease, and asthma. |
| DB06399 | Atacicept | Investigated for use/treatment in autoimmune diseases, systemic lupus erythematosus, rheumatoid arthritis, multiple myeloma, lymphoma (non-hodgkin's), and leukemia (lymphoid). |
| DB06404 | Human C1-esterase inhibitor | For routine prophylaxis against angioedema attacks in adolescent and adult patients with Hereditary Angioedema (HAE). |
| DB06434 | Repifermin | Investigated for use/treatment in bone marrow transplant, ulcers, and inflammatory bowel disease. |
| DB06467 | Apolizumab | Investigated for use/treatment in lymphoma (non-hodgkin's), leukemia (lymphoid), and solid tumors. |
| DB06493 | Velafermin | Investigated for use/treatment in adverse effects (chemotherapy). |
| DB06495 | Onercept | Investigated for use/treatment in psoriasis and psoriatic disorders and crohn's disease. |
| DB06534 | Thrombopoietin | Investigated for use/treatment in thrombocytopenia. |
| DB06549 | Labradimil | Investigated for use/treatment in brain cancer and pediatric indications. |
| DB06550 | Bivatuzumab | Investigated for use/treatment in cancer/tumors (unspecified) and head and neck cancer. |
| DB06557 | Lerdelimumab | Investigated for use/treatment in glaucoma and cataracts. |
| DB06562 | Emfilermin | Investigated for use/treatment in adverse effects (chemotherapy), reproductive health, and infertility. |
| DB06576 | Baminercept | Investigated for use/treatment in rheumatoid arthritis. |
| DB06584 | TG4010 | Investigated for use/treatment in breast cancer, renal cell carcinoma, prostate cancer, and lung cancer. |
| DB06599 | Lexatumumab | Investigated for use/treatment in cancer/tumors (unspecified). |
| DB06602 | Reslizumab | Indicated for the add-on maintenance treatment of patients with severe asthma aged 18 years and older with an eosinophilic phenotype. |
| DB06606 | Teplizumab | Investigated for use/treatment in diabetes mellitus type 1. |
| DB06607 | Catumaxomab | For use in the management of malignant ascites tumours via intraperitoneal infusion where standard therapy is not available or feasible [FDA Label]. |
| DB06611 | Pegsunercept | Investigated for use/treatment in rheumatoid arthritis. |
| DB06612 | Mepolizumab | Mepolizumab is indicated for add-on maintenance treatment of severe eosinophilic asthma, as identified by blood eosinophils greater than or equal to 150 cells/μl at initiation of treatment or blood eosinophils greater than or equal to 300 cells/μl in the past 12 months, in patients aged 12 years and older. Mepolizumab has been shown to reduce exacerbations of asthma in patients with an exacerbation history |
| DB06643 | Denosumab | Prolia is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture. It reduces the incidence of vertebral, nonvertebral, and hip fractures. Prolia is also indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. It can also be used in men with osteoporosis at high risk for fracture or in men receiving androgen deprivation therapy for nonmetastatic prostate cancer to increase bone mass. Xgeva is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors. |
| DB06647 | Volociximab | Investigated for use/treatment in solid tumors, renal cell carcinoma, melanoma, pancreatic cancer, lung cancer, and ovarian cancer. |
| DB06650 | Ofatumumab | Ofatumumab is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab. |
| DB06655 | Liraglutide | For use in/treatment of diabetes mellitus type 2. |
| DB06663 | Pasireotide | For the treatment of Cushing’s disease, specifically for those patients whom pituitary surgery has not been curative or is not an option. |
| DB06674 | Golimumab | Used in adults (i) as an adjunct to methotrexate treatment in patients with moderate to severe active rheumatoid arthritis (RA), (ii) alone or as an adjunct to methotrexate treatment in patients with active psoriatic arthritis (PsA), (iii) as a single agent in patients with active ankylosing spondylitis (AS), and (iv) as a single agent in patients with moderate to severe ulcerative colitis (UC) who require chronic steroids or have experienced intolerance or only a partial response to previous medications. |
| DB06679 | Amediplase | Investigated for use/treatment in myocardial infarction and thrombosis. |
| DB06681 | Belatacept | For prophylaxis of organ rejection. It is also used concomitantly with basiliximumab for induction therapy, mycophenolate, and corticosteriods in kidney transplant recepients that are seropositive for the Epstein-Barr virus. |
| DB06692 | Aprotinin | For prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at an increased risk for blood loss and blood transfusion. |
| DB06719 | Buserelin | Buserelin may be used in the treatment of hormone-responsive cancers such as prostate cancer or breast cancer, estrogen-dependent conditions (such as endometriosis or uterine fibroids), and in assisted reproduction. |
| DB06763 | Saralasin | Not Available |
| DB06785 | Ganirelix | For the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation. |
| DB06788 | Histrelin | As the product Supprelin LA (FDA), histrelin is indicated for the treatment of children with central precocious puberty (CPP). As the product Vantas (FDA), histrelin is indicated for the palliative treatment of advanced prostate cancer. |
| DB06791 | Lanreotide | Lanreotide is a somatostatin analog approved for treatment of neuroendocrine tumours and acromegaly. (2) |
| DB06825 | Triptorelin | Triptorelin is indicated for the palliative treatment of advanced prostate cancer. |
| DB08856 | DADLE | Not Available |
| DB08861 | DPDPE | Not Available |
| DB08869 | Tesamorelin | Tesamorelin acetate is a synthetic analogue of human hypothalamic Growth Hormone Releasing Factor (hGRF) indicated to induce and maintain a reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. |
| DB08870 | Brentuximab vedotin | Seattle Genetics Announced FDA Approval of ADCETRIS® (Brentuximab Vedotin) in combination with chemotherapy for adults with previously untreated stage III or IV Classical Hodgkin Lymphoma in March 2018 [L1737, L1739].
Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates [FDA label], [L1737].
Systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen [FDA label]. |
| DB08879 | Belimumab | Adjunct treatment for auto-antibody-positive active systemic lupus erythematosus. |
| DB08885 | Aflibercept | The opthalmic agent is used for the treatment of neovascular (wet) age-related mascular degeneration (AMD) and macular edema following central retinal vein occulsion (CRVO). The systemic injection, known as ziv-aflibercept, in combination with 5-fluorouracil, leucovorin, irinotecan-(FOLFIRI), is for the treatment of metastatic colorectal cancer that is resistant to or progressed following treatment with oxaliplatin. |
| DB08900 | Teduglutide | Treatment of short bowel syndrome (SBS), malabsorption associated with the removal of the intestine, in adults patients who are dependent on parenteral support. |
| DB08902 | Raxibacumab | Raxibacumab is indicated for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. |
| DB08904 | Certolizumab pegol | Reducing signs and symptoms of Crohn's disease and treatment of moderately to severely active rheumatoid arthritis (RA). |
| DB08935 | Obinutuzumab | Obinutuzumab is used as a combination treatment with chlorambucil to treat patients with untreated chronic lymphocytic leukemia. |
| DB09029 | Secukinumab | For the treatment of moderate to severe plaque psoriasis in patients that are candidates for systemic therapy or phototherapy. |
| DB09033 | Vedolizumab | Vedolizumab is indicated for adult patients with moderately to severely active UC or CD who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids. |
| DB09035 | Nivolumab | Nivolumab is indicated as a single agent for the treatment of:
* BRAF V600 wild-type unresectable or metastatic melanoma.
* BRAF V600 mutation-positive unresectable or metastatic melanoma.
* metastatic non-small cell lung cancer and progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on disease-specific FDA therapy.
* advanced renal cell carcinoma with prior anti-angiogenic therapy.
* classical Hodgkin lymphoma in adults that has relapsed or progressed after autologous hematopoietic stem cell transplantation and brentuximab vedotin or 3 or more lines of systemic therapy that includes autologous hematopoietic stem cell transplantation.
* recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy.
* locally advanced or metastatic urothelial carcinoma with disease progression during or after platinum-containing chemotherapy or disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
* microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer in patients 12 years or older that progressed following treatment with fluoropyrimidine, oxaliplatin and irinotecan.
* hepatocellular carcinoma previously treated with sorafenib.[FDA label]
In combination with [ipilimumab], nivolumab is indicated for the treatment of:
* unresectable or metastatic melanoma.
* melanoma with lymph node involvement or metastatic disease that has gone through complete resection.
* intermediate or poor risk, previously untreated advanced renal cell carcinoma.
* microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer in patients 12 years or older that progressed following treatment with fluoropyrimidine, oxaliplatin and irinotecan.[FDA label] |
| DB09036 | Siltuximab | Siltuximab is indicated for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. Siltuximab did not bind to virally produced IL-6 in a nonclinical study and was therefore not studied in patients with MCD who are HIV or HHV-8 positive. |
| DB09037 | Pembrolizumab | Pembrolizumab is indicated for the treatment of:
-Patients with unresectable or metastatic melanoma.[FDA label]
-As a single therapy, pembrolizumab is indicated for first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have high PD-L1 expression [(Tumor Proportion Score (TPS) ≥50%)] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.[F137]
-As a single therapy, pembrolizumab is indicated for first-line treatment of patients with metastatic non-small cell lung cancer whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to treatment.[F137]
The following indications present the status of accelerated approval based on tumor response rate and durability of the response and thus, the approval of this indications are contingent upon verification and description of clinical benefit in confirmatory trials.
-Patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS > 1) as determined by an FDA-approved test.[L2955]
-In combination with pemetrexed and carboplatin, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer.[F137]
-Patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy.[F137]
-Treatment of adults and pediatric patients with refractory classical Hodgkin lymphoma or who have relapsed after 3 or more prior lines of therapy.[F137]
-Treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma or who have relapsed after 2 or more prior lines of therapy.[F137]
-Treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.[F137]
-Patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy.[F137]
-Treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient with solid tumors that have progressed following previous treatment and colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.[F137]
-Patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (CPS >1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy.[F137] |
| DB09043 | Albiglutide | Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. |
| DB09045 | Dulaglutide | Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. |
| DB09046 | Metreleptin | Metreleptin is indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. |
| DB09052 | Blinatumomab | Indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). |
| DB09067 | Corticorelin ovine triflutate | Corticorelin is indicated for use in differentiating pituitary and ectopic production of ACTH in patients with ACTH-dependent Cushing's syndrome. |
| DB09077 | Dinutuximab | Dinutuximab is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. Despite a high clinical response seen after first-line treatment, the complete eradication of neuroblastoma is rarely achieved and the majority of patients with advanced disease suffer a relapse. Current strategies for treatment include immunotherapy with drugs such as dinutuximab to target surviving neuroblastoma cells and to prevent relapse. |
| DB09099 | Somatostatin | For the symptomatic treatment of acute bleeding from esophageal varices. Other treatment options for long-term management of the condition may be considered if necessary, once initial control has been established. |
| DB09103 | Ancestim | Ancestim, in combination with filgrastim, is indicated for the setting of autologous peripheral blood progenitor cell transplantation in patients at risk of poor peripheral blood progenitor cell mobilisation.[L1090] The use of ancestim with filgrastim will generate a sustained increase in the number of peripheral blood progenitor cells capable of engraftment. It is used for mobilization of progenitor cells from the bone marrow to the peripheral blood with or withouth mobilizing chemotherapy. The harvested progenitor cells can be used for transplant following myelosuppressive or myeloablative therapies.[L1089] |
| DB09105 | Asfotase Alfa | Indicated for the treatment of patients with perinatal/infantile and juvenile onset hypophosphatasia (HPP). |
| DB09107 | Methoxy polyethylene glycol-epoetin beta | For the treatment of patients with anaemia associated with chronic kidney disease. Not a substitute for RBC transfusion if immediate correction of anemia is required. |
| DB09109 | Turoctocog alfa | Turoctocog alfa is indicated for the treatment and prophylaxis of bleedings in patients presenting hemophilia A.[L1105] The treatment with turoctocog alfa is related with its use to control bleeding episodes or as a perioperative management.[L1106] Hemophilia A is a hereditary hemorrhagic disorder generated by the congenital deficit of the coagulation factor VIII. This disease is manifested as excessive spontaneous or trauma-driven bleeding. The coagulation factor VIII is a robust initiator of thrombin which is later required for the generation of fibrin to form a platelet plug and its gene is expressed in the X chromosome.[A31505] |
| DB09122 | Peginterferon beta-1a | For the treatment of patients with relapsing forms of multiple sclerosis. |
| DB09126 | Chorionic Gonadotropin (Human) | For the treatment of prepubertal cryptorchidism (not due to anatomical obstruction), for the treatment of selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males and for the induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pretreated with human menotropins. |
| DB09141 | Protamine sulfate | Protamine sulfate is usually administered to reverse the large dose of heparin administered during certain surgeries, especially heart surgery. |
| DB09221 | Polaprezinc | Peptic ulcer disease, dyspepsia [L1308]. |
| DB09222 | Fibrinogen Human | For the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. |
| DB09264 | Idarucizumab | For use in patients treated with Dabigatran when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures and in life-threatening or uncontrolled bleeding. |
| DB09302 | Alirocumab | Alirocumab is indicated as an adjunct to diet and maximally tolerated statin therapy in adults who require additional LDL-cholesterol (LDL-C) lowering due to heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease. |
| DB09303 | Evolocumab | For the treatment of heterozygous/homozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease in patients on maximum tolerated statin therapy requiring additional LDL-cholesterol lowering. |
| DB09312 | Antilymphocyte immunoglobulin (horse) | For prevention of renal transplant rejection and for the treatment of aplastic anemia. |
| DB09331 | Daratumumab | For the treatment of patients with multiple myeloma who have received at least three prior lines of therapy (a proteasome inhibitor (PI) and an immunomodulatory agent) or who are double-refractory to a PI and an immunomodulatory agent. This indication was approved by accelerated approval based on response rate. |
| DB09349 | Gastric intrinsic factor | Intrinsic factor is not currently available in any FDA or Health Canada approved products. However, it is currently in the marketed (but unapproved) product Hematogen in combination with cyanocobalamin (synthetic Vitamin B12), ferrous fumarate, and ascorbic acid for the treatment of anemias responsive to oral iron therapy. |
| DB09421 | Protirelin | Not Available |
| DB09527 | Secretin porcine | Not Available |
| DB09559 | Necitumumab | Necitumumab is approved for use in combination with cisplatin and gemcitabine as a first-line treatment for metastatic squamous non-small cell lung cancer (NSCLC). It is not indicated for treatment of non-squamous NSCLC. |
| DB10516 | Casein | Not Available |
| DB10789 | Bordetella pertussis pertactin antigen | Not Available |
| DB11095 | Desirudin | Indicated as prophylaxis of deep vein thrombosis for patients undergoing hip replacement surgery. |
| DB11209 | Iron protein succinylate | Not Available |
| DB11242 | Gelatin | Gelatin is used for weight loss and for treating osteoarthritis, rheumatoid arthritis, and brittle bones (osteoporosis). Some people also use it for strengthening bones, joints, and fingernails. Gelatin is also used for improving hair condition and to shorten the recovery after exercise and sports-related injury [L2113]. Gelatin is used in preparations of foods, cosmetics, and medicine [L2113].
Plasma volume expander in hypovolaemic shock [L2115]. Haemostatic [L2115].
Gelatin-based hydrogels are being used in drug delivery and tissue engineering because they are able to promote cell adhesion and proliferation. In addition, these hydrogels can be used as wound dressings because of their attractive fluid absorbance properties. Manufacturing technologies such as ultraviolet stereolithography and two-photon polymerization can be used to prepare structures containing photosensitive gelatin-based hydrogels [L2111]. |
| DB11298 | Thioredoxin | Not Available |
| DB11300 | Thrombin | Bovine thrombin is a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (like suture, ligature, or cautery) is ineffective or impractical [FDA Label]. Additionally, topical bovine thrombin can also be used in combination with an absorbable gelatin sponge, USP [FDA Label]. |
| DB11311 | Prothrombin | For use in the emergency reversal of coagulation factor deficiency in patients receiving vitamin K antagonist therapy. Prothrombin is administered as part of a cocktail containing several coagulation factors. |
| DB11312 | Protein C | Protein C Concentrate is indicated for pediatric and adult patients with severe congenital Protein C deficiency for the prevention and treatment of venous thrombosis and purpura fulminans. |
| DB11330 | Factor IX Complex (Human) | Factor IX Complex is indicated for the prevention and control of hemorrhagic episodes in hemophilia B patients. It is also indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding or who require rapid reversal of therapy. |
| DB11510 | Deslorelin | Not Available |
| DB11569 | Ixekizumab | Ixekizumab is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. |
| DB11595 | Atezolizumab | For the treatment of patients with locally advanced or metastatic urothelial carcinoma who: 1) have disease progression during or following platinum-containing chemotherapy, and 2) have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. |
| DB11598 | Antithrombin III human | Antithrombin III human is a human antithrombin (AT) indicated in patients with hereditary antithrombin deficiency for the treatment and prevention of thromboembolism and prevention of peri-operative and peri-partum thromboembolism |
| DB11621 | Human Varicella-Zoster Immune Globulin | Indicated for preventing and reducing the severity of chicken pox (varicella zoster virus) infections in high risk individuals within 4 days of exposure to varicella zoster virus. |
| DB11624 | Epoetin delta | Not Available |
| DB11631 | Eptotermin Alfa | Not Available |
| DB11639 | Dibotermin alfa | - indicated for the treatment of acute tibia fractures in adults, as an adjunct to standard care using open fracture reduction and intramedullary unreamed nail fixation [FDA Label].
- indicated for single-level lumbar interbody spine fusion as a substitute for autogenous bone graft in adults with degenerative disc disease who have had at least 6 months of non-operative treatment for this condition [L1391]. |
| DB11646 | Conatumumab | Not Available |
| DB11653 | Bremelanotide | Not Available |
| DB11657 | Tabalumab | Not Available |
| DB11668 | Rusalatide acetate | Not Available |
| DB11680 | Ficlatuzumab | Not Available |
| DB11685 | Figitumumab | Not Available |
| DB11690 | Vonapanitase | Not Available |
| DB11695 | Carnosine | Not Available |
| DB11700 | Setmelanotide | Not Available |
| DB11714 | Durvalumab | Durvalumab is indicated for patients with urothelial carcinoma, such as urinary bladder, urethra or ureter cancer. Patients with prolonged disease progression due to failed platinum-based chemotherapy such as cisplatin and carboplatin are most likely to benefit from durvalumab treatment. Its clinical effectiveness is especially enhanced in PD-L1-positive patient groups [A19123]. |
| DB11715 | Bapineuzumab | Not Available |
| DB11724 | Bombesin | Not Available |
| DB11746 | Onartuzumab | Not Available |
| DB11756 | Solanezumab | Not Available |
| DB11767 | Sarilumab | Indicated for modere to severe reactive RA in adult patients who are irresponsive, respond inadequately or present intolerance to disease-modifying anti-rheumatic drugs (DMARDs) or tumor necrosis factor (TNF) antagonists. It is indicated to be used in combination with methotrexate (MTX) or as a monotherapy when there is intolerance to MTX or MTX administration is inappropriate. |
| DB11771 | Tremelimumab | Not Available |
| DB11776 | Brodalumab | Brodalumab has been approved for the treatment of psoriasis vulgaris, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma. |
| DB11788 | Neuropeptide Y | Not Available |
| DB11803 | Sirukumab | Not Available |
| DB11826 | Lampalizumab | Not Available |
| DB11834 | Guselkumab | Indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. |
| DB11840 | Dalotuzumab | Not Available |
| DB11842 | Angiotensin II | Angiotensin II is a vasoconstrictor indicated for increasing blood pressure in adults with septic or other distributive shock [FDA Label]. |
| DB11849 | Emibetuzumab | Not Available |
| DB11856 | Ligelizumab | Not Available |
| DB11857 | Seribantumab | Not Available |
| DB11862 | Landogrozumab | Not Available |
| DB11866 | Romosozumab | Not Available |
| DB11945 | Avelumab | Indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). |
| DB11955 | Avotermin | Not Available |
| DB11959 | Crenezumab | Not Available |
| DB11972 | Rilotumumab | Not Available |
| DB11975 | TAK-448 | Not Available |
| DB11976 | Anifrolumab | Not Available |
| DB11988 | Ocrelizumab | Indicated for the treatment of adult patients with relapsing or primary progressive forms of multiple sclerosis [FDA Label]. |
| DB11997 | Interleukin-7 | Not Available |
| DB12003 | Thymosin beta-4 | Not Available |
| DB12034 | Gantenerumab | Not Available |
| DB12038 | Ulinastatin | Not Available |
| DB12053 | Visilizumab | Not Available |
| DB12056 | Trebananib | Not Available |
| DB12075 | Nagrestipen | Not Available |
| DB12088 | TT-232 | Not Available |
| DB12089 | Lorvotuzumab mertansine | Not Available |
| DB12090 | Patritumab | Not Available |
| DB12102 | Fulranumab | Not Available |
| DB12104 | Tarextumab | Not Available |
| DB12118 | Sotatercept | Not Available |
| DB12119 | Gevokizumab | Not Available |
| DB12126 | Bradykinin | Not Available |
| DB12132 | Vanutide cridificar | Not Available |
| DB12142 | Duligotuzumab | Not Available |
| DB12159 | Dupilumab | Dupilumab is a monoclonal antibody designed for the treatment of atopic diseases such as eczema. |
| DB12169 | Tralokinumab | Not Available |
| DB12182 | Binetrakin | Not Available |
| DB12189 | Etrolizumab | Not Available |
| DB12205 | Ganitumab | Not Available |
| DB12213 | Etaracizumab | Not Available |
| DB12240 | Polatuzumab Vedotin | Not Available |
| DB12246 | Inclacumab | Not Available |
| DB12250 | Cixutumumab | Not Available |
| DB12261 | Ascrinvacumab | Not Available |
| DB12274 | Aducanumab | Not Available |
| DB12330 | Blisibimod | Not Available |
| DB12335 | Tanezumab | Not Available |
| DB12349 | Dulanermin | Not Available |
| DB12363 | Dusigitumab | Not Available |
| DB12396 | Fresolimumab | Not Available |
| DB12409 | Vatreptacog alfa | Not Available |
| DB12431 | Muplestim | Not Available |
| DB12456 | Bococizumab | Not Available |
| DB12460 | Conbercept | Not Available |
| DB12489 | Mirvetuximab Soravtansine | Not Available |
| DB12495 | Selepressin | Not Available |
| DB12498 | Mogamulizumab | For the intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. This approval provides a new treatment option for patients with MF and is the first FDA approval of a drug specifically for Sézary Syndrome [FDA label]. |
| DB12525 | Molgramostim | Not Available |
| DB12530 | Inebilizumab | Not Available |
| DB12534 | Mavrilimumab | Not Available |
| DB12560 | Blosozumab | Not Available |
| DB12568 | Tecemotide | Not Available |
| DB12584 | Bimagrumab | Not Available |
| DB12589 | Dacetuzumab | Investigated for use/treatment in lymphoma (non-hodgkin's) and multiple myeloma. |
| DB12602 | Pentetreotide | Not Available |
| DB12609 | Tovetumab | Not Available |
| DB12616 | Sprifermin | Not Available |
| DB12620 | Nerve Growth Factor | Not Available |
| DB12652 | Endothelin-1 | Not Available |
| DB12684 | Aviscumine | Not Available |
| DB12698 | Ibalizumab | Indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in highly treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen [FDA label].
The approval of Trogarzo was supported by a clinical trial of 40 treatment-experienced adults with MDR HIV-1 infection who persistently had elevated levels of HIV RNA in their blood despite heavy antiretroviral therapy. The majority of study patients had previously been treated with ≥10 antiretroviral medications [L1554]. |
| DB12699 | Balugrastim | Not Available |
| DB12701 | Intetumumab | Not Available |
| DB12718 | Carlumab | Not Available |
| DB12726 | Monteplase | Not Available |
| DB12732 | Firategrast | Not Available |
| DB12734 | Demcizumab | Not Available |
| DB12738 | Tiplimotide | Not Available |
| DB12755 | Zoptarelin doxorubicin | Not Available |
| DB12775 | Abituzumab | Not Available |
| DB12777 | Somatoprim | Not Available |
| DB12807 | Naptumomab Estafenatox | Not Available |
| DB12815 | Crotedumab | Not Available |
| DB12820 | Concizumab | Not Available |
| DB12822 | Pancreatic Polypeptide | Not Available |
| DB12826 | Depatuxizumab | Not Available |
| DB12835 | Olipudase alfa | Not Available |
| DB12844 | Rontalizumab | Not Available |
| DB12845 | Amatuximab | Not Available |
| DB12849 | Clazakizumab | Not Available |
| DB12880 | Interleukin-10 | Not Available |
| DB12891 | Ozanezumab | Not Available |
| DB12893 | Sacituzumab govitecan | Not Available |
| DB12909 | Factor XIII (human) | Factor XIII (Human), available as the commercially available product Corifact, is approved by the Food and Drug Administration for routine prophylactic treatment and peri-operative management of surgical bleeding in adult and pediatric patients with congenital FXIII deficiency [FDA Label]. |
| DB12938 | Isoxaflutole | Not Available |
| DB12943 | Milatuzumab | Not Available |
| DB12976 | Robatumumab | Not Available |
| DB13033 | Urocortin-2 | Not Available |
| DB13045 | Racotumomab | Not Available |
| DB13127 | Olokizumab | Not Available |
| DB13133 | Von Willebrand Factor Human | The vWF and Factor VIII complex is indicated for the prevention of excessive bleeding during and after minor and major surgery in adult and pediatric von Willebrand disease patients. It is also indicated for the on-demand treatment and control of bleeding episodes.[L1880] The von Willebrand disease is an inherited disorder characterized by the deficiency or misfunction of the von Willebrand factor (vWF). Due to this deficiency, the blood cannot clot properly and the patients that present this disease are prone to prolonged or excessive bleeding. There are three types of this disease, and type 3 is an autosomal recessive inherited disorder marked by very low or absent levels of vWF.[L1867] |
| DB13144 | Lenograstim | The drug is used to reduce the risk of life-threatening infection in patients with neutropenia, particularly after cytotoxic chemotherapy.
Lenograstim is indicated as a treatment to reduce the duration of neutropenia and the severity of infections in patients with non-myeloid malignancy who have undergone autologous or allogeneic bone marrow transplantation, or treatment with established cytotoxic chemotherapy and in addition to reduce the incidence of infection associated with established cytotoxic chemotherapy.
Lenograstim is also indicated to mobilise peripheral blood progenitor cells (PBPCs) with Lenograstim alone, or after myelosuppressive chemotherapy, in order to accelerate haematopoietic recovery by infusion of such cells, after myelosuppressive or myeloablative therapy. Lenograstim is also indicated to accelerate the engraftment of these cells after their reinfusion.
GRANOCYTE is also indicated for the treatment of severe chronic neutropenia including congenital agranulocytosis (Kostmann's syndrome). |
| DB13148 | Coagulation factor X human | Indicated in adults and children (aged 12 years and above) with hereditary Factor X deficiency for on-demand treatment and control of bleeding episodes, or for perioperative management of bleeding in patients with mild hereditary Factor X deficiency [FDA Label]. |
| DB13149 | Protein S human | For use in the emergency reversal of coagulation factor deficiency in patients recieving vitamin K antagonist therapy [FDA Label]. Protein S is administered as part of a cocktail containing several other coagulation factors. |
| DB13150 | Coagulation factor VII human | May be administered in cases of uncontrolled bleeding. Factor VII alone can be used in the treatment of congenital hemophilia A or B, acquired hemophilia, congenital factor VII deficiency, and Glanzmann's thrombasthenia. Off label use in the treatment of refractory bleeding after cardiac surgery and warfarin related intracerebral hemorrhage. Brands for human factor VII are currently only in combination with other vitamin K coagulation factors and can be used to reverse vitamin K antagonist activity in patients with acute major bleeds or for urgent surgery/invasive procedures. |
| DB13192 | Antihemophilic factor human | The human antihemophilic factor is indicated for the cases of hemophilia A, also known as classical hemophilia for the prevention and control of hemorrhagic episodes.[L1055] If surgery is needed in patients with hemophilia A there is a need of correction of the clotting abnormality. In this cases, the human antihemophilic factor may be administered followed by intermittent maintenance doses.[L1053] The hemophilia A is characterized by the deficiency of the coagulation factor VIII that results in prolonged blood flow after injury or surgery as well as recurrent bleeding.[T56] |
| DB13200 | Lipegfilgrastim | Indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) [L2441]. |
| DB13201 | Trenonacog alfa | Not Available |
| DB13257 | Ferrous sulfate anhydrous | For the prevention and treatment of iron deficiency anemia [L2252].
|
| DB13375 | Edrecolomab | Not Available |
| DB13646 | Saruplase | Not Available |
| DB13864 | Hemoglobin crosfumaril | Not Available |
| DB13886 | Human cytomegalovirus immune globulin | It is used to prevent cytomegalovirus (CMV) disease after organ transplant [L2225].
Cytomegalovirus Immune Globulin Intravenous (Human) is indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas, and heart [FDA label].
In transplants of these organs other than the kidney from CMV seropositive donors into seronegative recipients, prophylactic CMV-IGIV should be considered in combination with ganciclovir [FDA label]. |
| DB13923 | Emicizumab | The main function of Emicizumab is the prevention of bleeding episodes. Thus, Emicizumab is approved for the routine prophylaxis to prevent or reduce the frequency of bleeding episodes of adult and pediatric patients with hemophilia A with or without Factor VIII inhibitors.[L4657]
Hemophilia A is a deficiency of coagulation Factor VIII which causes a serious bleeding disorder. The standard treatment is done with the administration of recombinant or serum-deriver Factor VIII which induces the formation of anti-factor VIII alloantibodies (Factor VIII inhibitors) and renders the standard treatment ineffective.[A31286] |
| DB13928 | Semaglutide | Semaglutide is indicated to improve glycemic control in adults with type 2 diabetes mellitus as an adjunct of diet and exercise. The approved therapeutic doses are 0.5 mg and 1 mg.[L1068] Diabetes mellitus type 2 is a long-term metabolic disorder characterized by high blood sugar, insulin resistance and lack of insulin. Its onset is determined by the loss ability of beta cells to respond to an increased plasma glucose. This disease is predominantly caused by lifestyle factors like overweight and obesity. The key feature on type 2 diabetes is the presence of insulin resistance which reduced the capacity of insulin to exert its functions at normal at any given concentration. The secretion of insulin is stimulated by the action of incretins in the gut like glucagon-like peptide 1, which also delays gastric emptying and induces satiety, and glucose-dependent insulinotropic polypeptide.[T59] |
| DB13933 | Nonacog beta pegol | Nonacog beta pegol is indicated for the use in adults and children with hemophilia B for control and prevention of bleeding episodes, routine prophylaxis and perioperative management.[L1100] In the EMA approval, it is also indicated for on-demand treatment of bleeding episodes.[L1099] Hemophilia B is characterized by a deficiency in the coagulation factor IX which results in prolonged oozing after injuries and delayed or recurring bleeding prior wound healing. Hemophilia B patients present more frequent bleeding episodes during childhood and adolescence than in adulthood.[T56] |
| DB13968 | Plasma protein fraction (human) | PPFh is used as a replacement therapy in patients with complex deficiencies of coagulation factors such as coagulopathy. It is also used as a substitution therapy in emergency cases of factor deficiencies, for rapid reversal of the effects of oral anticoagulants or in dangerous hemorrhages during fibrinolytic therapy. PPFh can be used in therapeutic plasma exchange procedures including thrombotic thrombocytopenic purpura.[L2264]
PPFh can be used in the treatment of shock where there is a predominant loss of plasma fluids and not red blood cells.[L2261] |
| DB13976 | Sulesomab | Not Available |
| DB13979 | Besilesomab | Besilesomab is radiolabelled with sodium pertechnetate (Tc99m) solution to develop technetium (Tc99m) besilesomab solution. This solution is indicated in adults for scintigraphic imaging - in conjunction with other appropriate imaging modalities, when possible - in determining the location of inflammation/infection in peripheral bone in adults with suspected osteomyelitis [FDA Label]. When utilized as such, this medicinal product is for diagnostic use only [FDA Label]. |
| DB13999 | Moroctocog alfa | Moroctocog Alfa is approved by Health Canada for the control and prevention of hemorrhagic episodes and for routine and surgical prophylaxis in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia).
Moroctocog Alfa is also approved by the European Medicines Agency for the treatment and prophylaxis of bleeding in patients with Haemophilia A (congenital factor VIII deficiency). |
| DB14004 | Tildrakizumab | Moderate-severe plaque psoriasis [L1858], [FDA label]. |
| DB14027 | Taspoglutide | Not Available |
| DB14039 | Erenumab | Erenumab is indicated for the preventative treatment of migraine in adults [FDA Label]. |
| DB14041 | Fremanezumab | The ongoing trials for fremanezumab are for episodic and chronic migraine prevention and also for cluster headache [A33114]. |
| DB14131 | Basic Fibroblast Growth Factor | Basic Fibroblast Growth Factor is not currently approved for any FDA or Health Canada approved indications. |
| DB14145 | Nepidermin | Not Available |
| DB14211 | Fanolesomab | Not Available |
| DB14472 | Insulin-like growth factor II | Not Available |
| DB14473 | Beroctocog alfa | Not Available |
| DB09532 | Secretin human | Indicated for the stimulation of:
- pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction [FDA Label].
- gastrin secretion to aid in the diagnosis of gastrinoma [FDA Label].
- pancreatic secretions to facilitate the identification of the ampulla of Vater and accessory papilla during endoscopic retrograde cholangiopancreatography (ERCP) [FDA Label]. |
| DB14562 | Andexanet alfa | Andexanet alfa is indicated for patients treated with [rivaroxaban] and [apixaban], when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding [L3725]. Andexxa has not been shown to be effective for, and is not indicated for, the treatment of bleeding related to any Factor Xa inhibitors other than apixaban and rivaroxaban [L3725]. |
| DB14597 | Lanadelumab | Lanadelumab is indicated for the prophylaxis treatment to prevent attacks in patients 12 years and older with hereditary angioedema.[L4537]
The hereditary angioedema (HEA) is an autosomal dominant disorder resulted from the presence of C1 deficiency. Some reports have indicated a high prevalence of cases that result from spontaneous mutations which can be inherited. This condition is manifested by attacks of subcutaneous or submucosal edema in the face, larynx, GI tract, limbs or genitalia. From all the types of attacks, the most serious is the laryngeal as it can compromise the airway. The rest of the attacks are accompanied by pain and considerable dysfunction.[A38679] |
| DB09329 | Antihemophilic Factor (Recombinant), PEGylated | For the management of hemophilia A (congenital factor VIII deficiency) [FDA label], [A32064].
This medication is a human antihemophilic factor indicated in adolescent and adult patients (12 years and older) with hemophilia A (congenital factor VIII deficiency). It is also used for on-demand treatment and control of bleeding and routine prophylaxis of bleeding episodes. It is not indicated for the treatment of von Willebrand disease [FDA label]. |
| DB14642 | Lypressin | Not Available |
| DB12688 | Moxetumomab Pasudotox | MxP is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies including treatment with a purine nucleoside analog. The use of this drug is not recommended in patients with severe renal impairment (CrCl < 29 ml/min).[L4568]
HCL is an uncommon type of lymphocytic leukemia that starts in B cells or B lymphocytes. It is characterized by an accumulation of abnormal B lymphocytes. HCL is called "hairy" as it produces hair-like projections in the surface of the cancer cells. A usual symptom in people having HCL is the presence of splenomegaly and less often hepatomegaly.[A38877] |
| DB14712 | Elapegademase | Elapegademase is approved for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients.[L4654] This condition was previously treated by the use of pegamedase bovine as part of an enzyme replacement therapy.[L4655]
ADA-SCID is a genetically inherited disorder that is very rare and characterized by a deficiency in the adenosine deaminase enzyme. The patients suffering from this disease often present a compromised immune system. This condition is characterized by very low levels of white blood cells and immunoglobulin levels which results in severe and recurring infections.[L4656] |
| DB11835 | Indium In-111 pentetreotide | Not Available |
| DB11914 | Lebrikizumab | Not Available |
| DB12023 | Benralizumab | Benralizumab is indicated as a maintenance treatment of patients 12 years or older with severe asthma and an eosinophilic phenotype.[L1020] The pathology of severe asthma with eosinophilic phenotype is also denotated as TH2-high phenotype. The patients with this phenotype are characterized by the expression of IL-5 and IL-13, airway hyperresponsiveness, responsiveness to inhaled corticosteroids, high serum IgE and eosinophilia in blood and airway. In the TH2-high phenotype, IL-5 presents a central role as it is responsible for eosinophil differentiation, survival, activation and migration to the lungs.[A31295] |
| DB12202 | Zalutumumab | Not Available |
| DB12520 | Plozalizumab | Not Available |
| DB12773 | Sifalimumab | Not Available |
| DB14724 | Emapalumab | Emapalumab is indicated for the treatment of pediatric and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance to conventional HLH therapy.[L4840]
The HLH condition is a hyperinflammatory status characterized by the overwhelming activation of normal T lymphocytes and macrophages which can lead to disturbances in the hematology profile and even death. As part of the condition profile, there have been reports proving a massive overexpression of interferon-gamma which is thought to drive the immune hyperactivation leading to organ failure.[A38676] This condition is usually developed and present the symptomatic profile within the first months or years of life. These symptoms consist of fever, enlarged liver or spleen and a lower number of blood cells.[L4840] |
| DB06651 | DiaPep 277 | Investigated for use/treatment in diabetes mellitus type 1, autoimmune diseases, and diabetes mellitus type 2. |