Identification

Name
Salmon Calcitonin
Accession Number
DB00017  (BTD00025, BIOD00025)
Type
Biotech
Groups
Approved, Investigational
Biologic Classification
Protein Based Therapies
Hormones
Description

Synthetic peptide, 32 residues long formulated as a nasal spray.

Protein structure
Db00017
Protein chemical formula
C145H240N44O48S2
Protein average weight
3431.853 Da
Sequences
>DB00017 sequence
CSNLSTCVLGKLSQELHKLQTYPRTNTGSGTP
Download FASTA Format
Synonyms
  • Calcitonin (Salmon Synthetic)
  • Calcitonin Salmon
  • Calcitonin salmon recombinant
  • Calcitonin-salmon
  • Calcitonin, salmon
  • Recombinant salmon calcitonin
  • Salmon calcitonin
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
Calcimar Solution Inj 200unit/mlSolution200 unitIntramuscular; SubcutaneousSanofi Aventis1983-12-31Not applicableCanada
Calcitonin (salmon) Injection, BPSolution200 unitIntramuscular; SubcutaneousMylan PharmaceuticalsNot applicableNot applicableCanada
Calcitonin SalmonSpray, metered200 [iU]/1NasalSandoz1995-08-01Not applicableUs
Caltine Inj 100 Unit/ml (1ml Amp)Liquid100 unitIntramuscular; SubcutaneousFerring Pharmaceuticals1993-12-312014-07-25Canada
Caltine Inj 100unit/ml (0.5ml Amp)Liquid100 unitIntramuscular; SubcutaneousFerring Pharmaceuticals1993-12-312002-01-30Canada
ForticalSpray, metered2200 [iU]/mLNasalUpsher Smith Laboratories2005-08-12Not applicableUs
ForticalSpray, metered2200 [iU]/mLNasalPhysicians Total Care, Inc.2005-12-30Not applicableUs
MiacalcinInjection, solution200 [iU]/mLIntramuscular; SubcutaneousMylan Institutional2016-09-16Not applicableUs
MiacalcinSpray, metered200 [iU]/1NasalNovartis1995-08-012017-04-14Us
MiacalcinInjection, solution200 [iU]/mLIntramuscular; SubcutaneousNovartis1986-07-032017-02-28Us
Generic Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
Apo-calcitonin InjectableLiquid200 unitIntramuscular; SubcutaneousApotex Corporation2003-05-012013-08-02Canada
Apo-calcitonin Nasal SpraySolution200 unitNasalApotex Corporation2003-09-122013-10-01Canada
Calcitonin SalmonSpray, metered200 [iU]/.09mLNasalPhysicians Total Care, Inc.2011-12-09Not applicableUs
Calcitonin SalmonSpray, metered200 [iU]/1NasalApotex Corporation2008-12-09Not applicableUs
Calcitonin SalmonSpray, metered200 [iU]/.09mLNasalPar Pharmaceutical2009-06-08Not applicableUs
Unapproved/Other Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
ForcaltoninInjection, solution100 IUIntramuscular; Intravenous; SubcutaneousUnigene Laboratories Inc.1999-01-11Not applicableEu
International/Other Brands
Calcimar
Categories
UNII
7SFC6U2VI5
CAS number
47931-85-1

Pharmacology

Indication

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.

Structured Indications
Pharmacodynamics

Calcitonin inhibits bone resorption by osteoclasts (bone remodeling cells) and promotes bone formation by osteoblasts. This leads to a net increase in bone mass and a reduction in plasma calcium levels. It also promotes the renal excretion of ions such as calcium, phosphate, sodium, magnesium, and potassium by decreasing tubular reabsorption. In consequence, there is an increase in the jejunal secretion of water, sodium, potassium, and chloride.

Mechanism of action

Calcitonin binds to the calcitonin receptor (found primarily in osteoclasts) which then enhances the production of vitamin D producing enzymes (25-hydroxyvitamine D-24-hydroxylase), leading to greater calcium retention and enhanced bone density. Binding of calcitonin to its receptor also activates adenylyl cyclase and the phosphatidyl-inositol-calcium pathway.

TargetActionsOrganism
UCalcitonin receptor
agonist
Human
Absorption

Salmon calcitonin is rapidly absorbed and eliminated. Bioavailability following subcutaneous and intramuscular injection in humans is high and similar for the two routes of administration (71% and 66%, respectively). Via the nasal route, the bioavailability varies between 3 to 5% relative to IM.

Volume of distribution

0.15 to 0.3 L/kg

Protein binding

30 to 40%

Metabolism

Salmon calcitonin is primarily and almost exclusively degraded in the kidneys, forming pharmacologically inactive fragments of the molecule. It is also metabolized in the blood and the peripheral tissue.

Route of elimination

Urine. Studies with injectable calcitonin show increases in the excretion of filtered phosphate, calcium, and sodium by decreasing their tubular reabsorption in the kidney.

Half life

Half-life elimination (terminal): I.M. 58 minutes; SubQ 59 to 64 minutes; Nasal: ~18 to 23 minutes

Clearance
Not Available
Toxicity

Salmon calcitonin was shown to inhibit lactation in animals and is not recommend in nursing mothers. While research in animals have shown a decrease in fetal weight, no studies have yet shown similar results in humans. It is recommended however to proceed carefully when administering salmon calcitonin to pregnant women and consider if the benefits outweigh the risks. Because of its protein nature, salmon calcitonin may provoke an allergy reaction (bronchospams and swelling of the tongue/throat) that can turn into a full-blown anaphylactic response. The manufacturer also reports an increase in the risk of malignancies from oral route (0.7%) to intranasal route (2.4%) compared to placebo. The same may apply to IV, IM and SC routes since the systemic exposure is higher in those cases. Nausea is noticeable in some patients but tends to decrease with continued administration. Rhinitis, headaches and back pain have also been reported among others.

Affected organisms
  • Humans and other mammals
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
DrugInteractionDrug group
LithiumThe serum concentration of Lithium can be decreased when it is combined with Salmon Calcitonin.Approved
Zoledronic acidSalmon Calcitonin may increase the hypocalcemic activities of Zoledronic acid.Approved
Food Interactions
Not Available

References

Synthesis Reference

Marcos C. Poblet, Berta P. Obiols, Gemma J. Farres, "Procedure for preparing salmon calcitonin." U.S. Patent US5527881, issued October, 1991.

US5527881
General References
Not Available
External Links
UniProt
P01263
Genbank
Y00765
KEGG Drug
D00249
KEGG Compound
C06865
PubChem Substance
46506061
Therapeutic Targets Database
DAP001302
PharmGKB
PA448715
RxList
RxList Drug Page
Wikipedia
Calcitonin
ATC Codes
H05BA01 — Calcitonin (salmon synthetic)
AHFS Codes
  • 68:24.00 — Parathyroid

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
1CompletedTreatmentOsteoarthritis (OA)1
1CompletedTreatmentPostmenopausal Osteoporosis (PMO)1
2CompletedBasic ScienceBone destruction1
2TerminatedTreatmentOsteoarthritis (OA)1
3CompletedTreatmentOsteoporosis, Post-Menopausal1
3CompletedTreatmentPostmenopausal Osteoporosis (PMO)2
3CompletedTreatmentBone destruction1
3CompletedTreatmentOne to five years postmenopausal1
3TerminatedTreatmentOsteoarthritis (OA)1
4CompletedTreatmentForearm Fractures1
4WithdrawnTreatmentFibromyalgia1
Not AvailableCompletedTreatmentHypophosphatemic Rickets, X Linked Dominant1

Pharmacoeconomics

Manufacturers
  • Sanofi aventis us llc
  • Astrazeneca lp
  • Novartis pharmaceuticals corp
  • Apotex inc
  • Par pharmaceutical inc
  • Upsher smith laboratories inc
Packagers
Dosage forms
FormRouteStrength
LiquidIntramuscular; Subcutaneous200 unit
SolutionNasal200 unit
SolutionIntramuscular; Subcutaneous200 unit
Spray, meteredNasal200 [iU]/.09mL
LiquidIntramuscular; Subcutaneous100 unit
Injection, solutionIntramuscular; Intravenous; Subcutaneous100 IU
Spray, meteredNasal2200 [iU]/mL
Injection, solutionIntramuscular200 [iU]/mL
Injection, solutionIntramuscular; Subcutaneous200 [iU]/mL
Spray, meteredNasal200 [iU]/1
LiquidIntramuscular; Intravenous; Subcutaneous200 unit
SprayNasal200 unit
LiquidNasal200 unit
Prices
Unit descriptionCostUnit
Miacalcin 200 unit/act Solution 3.7ml Bottle139.39USD bottle
Calcitonin (Salmon) 200 unit/act Solution 3.7ml Bottle123.28USD bottle
Miacalcin For Inj, 2 unit = 1 Box 2ml Vial63.59USD vial
Miacalcin 200 unit nasal spray44.68USD ml
Calcitonin-salmon 200 unit sp39.51USD ml
Fortical 200 unit nasal spray34.3USD ml
Miacalcin 200 unit/ml vial30.73USD ml
Calcimar 200 iu/ml29.94USD ml
Caltine 100 (100 Iu/Ml) 100 iu/ml8.81USD ml
DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only.
Patents
Patent NumberPediatric ExtensionApprovedExpires (estimated)
US5733569No1995-03-312015-03-31Us
US6440392No2001-02-022021-02-02Us
USRE43580No2001-02-022021-02-02Us
USRE40812No2001-02-022021-02-02Us

Properties

State
Liquid
Experimental Properties
PropertyValueSource
hydrophobicity-0.537Not Available
isoelectric point8.86Not Available

Taxonomy

Description
Not Available
Kingdom
Organic Compounds
Super Class
Organic Acids
Class
Carboxylic Acids and Derivatives
Sub Class
Amino Acids, Peptides, and Analogues
Direct Parent
Peptides
Alternative Parents
Not Available
Substituents
Not Available
Molecular Framework
Not Available
External Descriptors
Not Available

Targets

Kind
Protein
Organism
Human
Pharmacological action
Unknown
Actions
Agonist
General Function
Receptor activity
Specific Function
This is a receptor for calcitonin. The activity of this receptor is mediated by G proteins which activate adenylyl cyclase. The calcitonin receptor is thought to couple to the heterotrimeric guanos...
Gene Name
CALCR
Uniprot ID
P30988
Uniprot Name
Calcitonin receptor
Molecular Weight
59351.865 Da
References
  1. Bouizar Z, Fouchereau-Peron M, Taboulet J, Moukhtar MS, Milhaud G: Purification and characterization of calcitonin receptors in rat kidney membranes by covalent cross-linking techniques. Eur J Biochem. 1986 Feb 17;155(1):141-7. [PubMed:3004987]
  2. Stroop SD, Moore EE: Intracellular calcium increases mediated by a recombinant human calcitonin receptor. J Bone Miner Res. 1995 Apr;10(4):524-32. [PubMed:7610922]
  3. Sarkar A, Dickerson IM: Cloning, characterization, and expression of a calcitonin receptor from guinea pig brain. J Neurochem. 1997 Aug;69(2):455-64. [PubMed:9231703]
  4. Chen X, Ji ZL, Chen YZ: TTD: Therapeutic Target Database. Nucleic Acids Res. 2002 Jan 1;30(1):412-5. [PubMed:11752352]

Drug created on June 13, 2005 07:24 / Updated on November 19, 2017 20:34