|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.|
|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]|
|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)
|DB00072||Trastuzumab||For treatment of early stage HER2-positive breast cancer, or metastatic breast cancer that substantially overexpress HER2.|
|DB00108||Natalizumab||For treatment of multiple sclerosis.|
|DB00110||Palivizumab||For prophylaxis of respiratory diseases casued by respiratory syncytial virus.|
|DB00112||Bevacizumab||As part of combination therapy for metastatic colorectal cancer and HER2-negative metastatic breast cancer.|
|DB01270||Ranibizumab||For the treatment of patients with macular edema after retinal vein occlusion, age-related macular degeneration (wet), and diabetic macular edema.
|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.|
|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.|
|DB08904||Certolizumab pegol||Reducing signs and symptoms of Crohn's disease and treatment of moderately to severely active rheumatoid arthritis (RA). |
|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]|
|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]|
|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.|
|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.|
|DB11988||Ocrelizumab||Indicated for the treatment of adult patients with relapsing or primary progressive forms of multiple sclerosis [FDA Label].|
|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] |
|DB14042||Galcanezumab||Galcanezumab is a humanized monoclonal antibody that is indicated for migraine prophylaxis in adults by binding endogenous human calcitonin gene-related peptide (CGRP) [A33112, FDA Label].|