Salmon calcitonin

Identification

Summary

Salmon calcitonin is a synthetic peptide form of calcitonin used to inhibit bone resorption in the treatment of hypercalcemia, osteoporosis, and Paget's disease.

Brand Names
Calcimar, Fortical, Miacalcin
Generic Name
Salmon calcitonin
DrugBank Accession Number
DB00017
Background

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

Type
Biotech
Groups
Approved, Investigational
Biologic Classification
Protein Based Therapies
Hormones
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
  • Calcitonina salmón sintética
  • Recombinant salmon calcitonin
  • Salmon calcitonin
External IDs
  • SMC-021
  • SMC021

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.

Pharmacology
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Associated Conditions
Contraindications & Blackbox Warnings
Contraindications
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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
Humans
Absorption

Salmon calcitonin is rapidly absorbed with bioavailability of 71% following subcutaneous injection and 66% following intramuscular injection in humans. 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

Protein binding is about 30 to 40%.

Metabolism

Salmon calcitonin primarily undergoes degradation in the kidneys to form pharmacologically inactive metabolites. 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

Adverse Effects
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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.

Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
DrugInteraction
AbacavirSalmon calcitonin may decrease the excretion rate of Abacavir which could result in a higher serum level.
AcalabrutinibThe therapeutic efficacy of Salmon calcitonin can be decreased when used in combination with Acalabrutinib.
AcebutololThe risk or severity of adverse effects can be increased when Acebutolol is combined with Salmon calcitonin.
AceclofenacAceclofenac may decrease the excretion rate of Salmon calcitonin which could result in a higher serum level.
AcemetacinAcemetacin may decrease the excretion rate of Salmon calcitonin which could result in a higher serum level.
AcetaminophenSalmon calcitonin may decrease the excretion rate of Acetaminophen which could result in a higher serum level.
AcetazolamideAcetazolamide may increase the excretion rate of Salmon calcitonin which could result in a lower serum level and potentially a reduction in efficacy.
AcetohexamideThe therapeutic efficacy of Acetohexamide can be decreased when used in combination with Salmon calcitonin.
Acetylsalicylic acidAcetylsalicylic acid may decrease the excretion rate of Salmon calcitonin which could result in a higher serum level.
AclidiniumSalmon calcitonin may decrease the excretion rate of Aclidinium which could result in a higher serum level.
Interactions
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Food Interactions
  • Administer calcium supplement. Individuals who are taking salmon calcitonin for the treatment of postmenopausal osteoporosis should ingest at least 1000mg of elemental calcium daily (by food or through supplementation).
  • Administer vitamin supplements. Individuals who are taking salmon calcitonin for the treatment of postmenopausal osteoporosis should take at least 400 international units of vitamin D daily.

Products

Products
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International/Other Brands
Calcimar
Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
CalcimarSolution200 unit / mLIntramuscular; SubcutaneousSanofi Aventis1983-12-31Not applicableCanada flag
Calcitonin (salmon) Injection, BPSolution200 unit / mLIntramuscular; SubcutaneousStrides Pharma Canada IncNot applicableNot applicableCanada flag
Caltine Inj 100 Unit/ml (1ml Amp)Liquid100 unit / mLIntramuscular; SubcutaneousFerring Pharmaceuticals1993-12-312014-07-25Canada flag
Caltine Inj 100unit/ml (0.5ml Amp)Liquid100 unit / mLIntramuscular; SubcutaneousFerring Pharmaceuticals1993-12-312002-01-30Canada flag
ForcaltoninInjection, solution100 IUIntramuscular; Intravenous; SubcutaneousUnigene Laboratories Inc.2016-09-082008-11-20EU flag
ForticalSpray, metered2200 [iU]/1mLNasalUpsher-Smith Laboratories, Inc.2005-08-122018-12-04US flag
ForticalSpray, metered2200 [iU]/1mLNasalPhysicians Total Care, Inc.2005-12-30Not applicableUS flag
MiacalcinInjection, solution200.0 [iU]/1.0mLIntramuscular; SubcutaneousNovartis1986-07-032017-02-28US flag
MiacalcinInjection, solution200 [USP'U]/1mLIntramuscular; SubcutaneousMylan Institutional LLC2016-09-16Not applicableUS flag
MiacalcinSpray, metered200 [iU]/1NasalPhysicians Total Care, Inc.1995-08-012010-06-30US flag
Generic Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
Apo-calcitonin InjectableLiquid200 unit / mLIntramuscular; SubcutaneousApotex Corporation2003-05-012013-08-02Canada flag
Apo-calcitonin Nasal SpraySolution200 unit / sprayNasalApotex Corporation2003-09-122013-10-01Canada flag
Calcitonin SalmonSpray, metered200 [iU]/1NasalApotex Corp.2008-12-09Not applicableUS flag
Calcitonin SalmonInjection, solution200 [USP'U]/1mLIntramuscular; SubcutaneousLeucadia Pharmaceuticals2021-05-14Not applicableUS flag
Calcitonin SalmonSpray, metered200 [iU]/1NasalSandoz1995-08-01Not applicableUS flag
Calcitonin SalmonSpray, metered200 [iU]/0.09mLNasalbryant ranch prepack2009-06-08Not applicableUS flag
Calcitonin SalmonSpray, metered200 [iU]/0.09mLNasalPar Pharmaceutical, Inc.2009-06-08Not applicableUS flag
Calcitonin SalmonSpray, metered200 [iU]/0.09mLNasalPhysicians Total Care, Inc.2011-12-09Not applicableUS flag
Pro-calcitonin - 200Solution200 unit / sprayNasalPro Doc Limitee2008-07-042011-07-27Canada flag
Sandoz-calcitonin NSLiquid200 unit / sprayNasalSandoz Canada Incorporated2004-12-012013-10-01Canada flag

Categories

ATC Codes
H05BA01 — Calcitonin (salmon synthetic)
Drug Categories
Chemical TaxonomyProvided by Classyfire
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
Affected organisms
  • Humans and other mammals

Chemical Identifiers

UNII
7SFC6U2VI5
CAS number
47931-85-1

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
UniProt
P01263
Genbank
Y00765
KEGG Drug
D00249
KEGG Compound
C06865
PubChem Substance
46506061
RxNav
36118
Therapeutic Targets Database
DAP001302
PharmGKB
PA448715
RxList
RxList Drug Page
Wikipedia
Calcitonin

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4CompletedPreventionAnalgesia1
4CompletedTreatmentForearm Fractures1
4CompletedTreatmentHypothyroidism1
4RecruitingDiagnosticHypercalcemia / Primary Hyperparathyroidism1
4RecruitingTreatmentPelvic Ring Fractures1
4TerminatedTreatmentPain / Rib Fractures1
4WithdrawnTreatmentFibromyalgia1
3CompletedTreatmentOsteoarthritis (OA)1
3CompletedTreatmentOsteoporosis2
3CompletedTreatmentPostmenopausal1

Pharmacoeconomics

Manufacturers
  • Sanofi aventis us llc
  • Astrazeneca lp
  • Novartis pharmaceuticals corp
  • Apotex inc
  • Par pharmaceutical inc
  • Upsher smith laboratories inc
Packagers
  • Apotex Inc.
  • Novartis AG
  • Par Pharmaceuticals
  • Sandoz
  • Upsher Smith Laboratories
Dosage Forms
FormRouteStrength
LiquidIntramuscular; Subcutaneous200 unit / mL
SolutionIntramuscular; Subcutaneous200 unit / mL
Injection, solution
PowderNot applicable1 g/1g
Spray, meteredNasal200 [iU]/0.09mL
Injection, solutionIntramuscular; Intravenous; Subcutaneous
SprayNasal100 U.I.
SprayNasal50 U.I.
Solution100 IU/1ml
Solution50 IU/1ml
LiquidIntramuscular; Subcutaneous100 unit / mL
Injection, solutionIntramuscular; Intravenous; Subcutaneous100 IU
Spray, meteredNasal2200 [iU]/1mL
InjectionIntramuscular; Subcutaneous
SprayNasal
Injection, solution100 IU/1ml
Injection, solution50 IU/1ml
Injection, solutionIntramuscular; Subcutaneous
Spray, meteredNasal
Injection, solutionIntramuscular200 [iU]/1mL
Injection, solutionIntramuscular; Subcutaneous200 [USP'U]/1mL
Injection, solutionIntramuscular; Subcutaneous200.0 [iU]/1.0mL
Spray, meteredNasal200 [iU]/1
LiquidIntramuscular; Intravenous; Subcutaneous200 unit / mL
SprayNasal200 unit / act
SprayNasal200 IU/1dose
SolutionNasal200 unit / spray
LiquidNasal200 unit / spray
Solution; sprayNasal200 IU/1dose
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)Region
US5733569No1998-03-312015-03-31US flag
US6440392No2002-08-272021-02-02US flag
USRE43580No2012-08-142021-02-02US flag
USRE40812No2009-06-302021-02-02US flag

Properties

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

Targets

Drugtargets
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Kind
Protein
Organism
Humans
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. [Article]
  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. [Article]
  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. [Article]
  4. Chen X, Ji ZL, Chen YZ: TTD: Therapeutic Target Database. Nucleic Acids Res. 2002 Jan 1;30(1):412-5. [Article]

Drug created on June 13, 2005 13:24 / Updated on July 24, 2021 14:58