VA Class: HS900
CAS Number: 47931-85-1
Brands: Fortical, Miacalcin
Polypeptide hormone secreted by parafollicular cells (C cells) of thyroid gland; acts predominantly on bone to lower serum calcium concentration and inhibit bone resorption.125
Uses for Calcitonin
Paget’s Disease of Bone
Treatment of Paget’s disease of bone.125 Consider treatment with calcitonin or a bisphosphonate (e.g., alendronate, etidronate, pamidronate, risedronate) in patients with biochemical markers suggestive of an increase in bone remodeling, those who are symptomatic, and those at risk for future complications from their disease (e.g., those with pagetic lesions in weight-bearing regions or adjacent to joints).143
Early treatment of hypercalcemic emergencies (with other appropriate agents) when a rapid decrease in serum calcium concentration is required.125
Has been used in the treatment of corticosteroid-induced osteoporosis† in patients receiving long-term corticosteroid therapy.126 Considered second-line therapy for patients with low bone mineral density (BMD) during corticosteroid therapy, particularly when bisphosphonate (e.g., alendronate, risedronate) is contraindicated or not tolerated or when such patients refuse bisphosphonate therapy.126
Not recommended for prevention of bone loss in patients just beginning corticosteroid therapy; efficacy not established for this indication.126
Calcitonin Dosage and Administration
Paget’s Disease of Bone
Monitor by periodic determinations of serum alkaline phosphatase and urinary hydroxyproline excretion as well as evaluation of symptoms.125
Investigate possibility of antibody formation in any patient who shows initial response but subsequently relapses.125
IM injection preferred when injection volume >2 mL.125
Use multiple sites of injection when volume >2 mL.125
Sub-Q injection preferred for patient self-administration.125
Miacalcin: To prime pump, hold bottle upright and depress the 2 white side arms of pump toward the bottle until full spray is produced.127
Fortical: To prime pump, hold bottle upright and depress the 2 white side arms of pump toward the bottle at least 5 times until full spray is produced.145
Discard spray pump after 30 actuations, since the correct drug dose per actuation cannot be assured if used for additional doses.127
Paget’s Disease of Bone
Sub-Q or IM
Initial dosage: 100 units (0.5 mL) daily.125
Maintenance: 50 units (0.25 mL) daily or every other day; higher dosage (100 units daily) appropriate in patients with serious deformity or neurologic involvement.125
Sub-Q or IM
Initially, 4 units/kg every 12 hours; may increase dosage after 1 or 2 days (if response not adequate) to 8 units/kg every 12 hours; may further increase dosage after 2 days (if response not adequate) to 8 units/kg every 6 hours.125
Sub-Q or IM
Minimum effective dosage not established; 100 units every other day may be effective in preserving vertebral BMD.125
Sub-Q or IM
Maximum 8 units/kg every 6 hours.125
Cautions for Calcitonin
Serious allergic reactions (bronchospasm, swelling of tongue or throat, anaphylactic shock, at least 1 death due to anaphylaxis) reported in patients receiving calcitonin injection.125 127 145 Differentiate hypersensitivity reactions from generalized flushing and hypotension.125
Coarse granular casts and casts containing renal tubular epithelial cells reported in some young adult volunteers at bedrest who received parenteral calcitonin in a study of its effect on immobilization osteoporosis.34 125 Clcr not altered and proteinuria not reported; urine sediment returned to normal within 4 days following drug discontinuance.34 125 Effect not reported by other investigators.125 127
In patients with Paget’s disease, carefully evaluate radiographic evidence of marked progression of pagetic lesions to rule out osteogenic sarcoma (since frequency is increased in patients with Paget’s disease).125
Discontinue nasal spray if severe ulceration of nasal mucosa (i.e., ulcers >1.5 mm in diameter or penetrating below the mucosa, ulcers associated with heavy bleeding) occurs.127 145 For smaller ulcers, interrupt therapy until healing occurs.127 145
Experience with calcitonin in children with juvenile Paget’s disease is very limited; the relationship between this disorder and adult Paget’s disease is not established.125
Common Adverse Effects
Interactions for Calcitonin
With IM or sub-Q administration, 15 minutes.c
Reduction in serum calcium concentration in patients with hypercalcemia evident within about 2 hours after first injection.125
Clinical and/or biochemical effects in Paget’s disease may not be evident for several months.125
With IM or sub-Q administration, 8–24 hours.c
Reduction in serum calcium concentration in patients with hypercalcemia persists for about 6–8 hours after single injection.125
Appears to be rapidly metabolized to smaller inactive fragments in kidney, blood, and peripheral tissues.125
Excreted in urine as metabolites.125
Miacalcinbottle in use: 15–30°C, in upright position for up to 35 days.127
Fortical bottle in use: 20–25°C, in upright position for up to 30 days.145
Actions and Spectrum
Commercially available as calcitonin salmon.125 127 145 Prepared synthetically or using recombinant DNA technology; contains the 32 amino acids in the same linear sequence as occurs in natural calcitonin of salmon origin.125 127 145 Calcitonin salmon prepared by recombinant DNA technology is structurally identical to calcitonin salmon produced by chemical synthesis.145
In most patients with Paget’s disease, causes a decrease in the rate of bone turnover with a resultant decrease in elevated serum alkaline phosphatase concentrations and urinary hydroxyproline excretion.125 These changes appear to correspond to changes toward more normal bone formation.125
Advice to Patients
If patient or caregiver is to administer parenteral calcitonin, provide careful instructions on proper administration methods, including aseptic technique.125
For patients using calcitonin nasal spray, provide careful instruction on storage, pump assembly, priming of pump, and administration.127 145 Advise patients to record number of doses used and to discard the bottle after 30 doses.127
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
200 units/metered spray
Fortical (recombinant DNA origin)
Miacalcin (synthetic; with phenol 5 mg/mL)
AHFS DI Essentials. © Copyright, 2004-2016, Selected Revisions May 1, 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
8. Mundy GR, Raisz LG. Calcitonin: background and uses. Drug Ther. 1975; 5:38-42.
20. Crosbie WA, Woodhouse NJY. Effect of salmon calcitonin treatment on bone turnover, cardiac output and oxygen transport in patients with Paget’s disease. Clin Sci Mol Med. 1974; 48:5-6P.
21. Hamilton CR Jr. Effects of synthetic salmon calcitonin in patients with Paget’s disease of bone. Am J Med. 1974; 56:315-22. [IDIS 46922] [PubMed 4855941]
22. DeRose J, Singer FR, Avramides A et al. Response of Paget’s disease to porcine and salmon calcitonins—effects on long-term treatment. Am J Med. 1974; 56:858-66. [IDIS 44624] [PubMed 4857531]
24. Kanis JA, Horn DB, Scott RDM et al. Treatment of Paget’s disease of bone with synthetic salmon calcitonin. Br Med J. 1974; 3:727-31. [IDIS 49113] [PubMed 4472416]
33. Singer FR, Aldred JP, Neer RM et al. An evaluation of antibodies and clinical resistance to salmon calcitonin. J Clin Invest. 1972; 51:2331-8. [IDIS 28595] [PubMed 4674133]
34. Hantman DA, Donaldson CL, Hulley SB. Abnormal urinary sediment during therapy with synthetic salmon calcitonin. J Clin Endocrinol Metab. 1971; 33:564-6. [IDIS 21062] [PubMed 5106277]
98. Ciba Pharmaceutical Company. Cibacalcin (calcitonin human for injection) prescribing information. Summit, NJ; 1988 Feb.
99. Rorer. Calcimar (calcitonin salmon injection) prescribing information. Fort Washington, PA; 1989 Jun.
100. Hosking DJ. Paget’s disease of bone: an update on management. Drugs. 1985; 30:156-73. [IDIS 203548] [PubMed 3928323]
101. Austin LA, Heath HH III. Calcitonin: physiology and pathophysiology. N Engl J Med. 1981; 304:269-78. [IDIS 126649] [PubMed 7003392]
102. Deftos LJ, First BP. Calcitonin as a drug. Ann Intern Med. 1981; 95:192-7. [IDIS 135887] [PubMed 7258871]
103. Johl A, Rittel W. Chemistry of human calcitonin. In: Caniggia A, ed. Proceedings of the International Workshop on Human Calcitonin of Stresa. April 24, 1982:9-22.
104. MacIntyre I, Evans IMA, Hobitz HHG et al. Chemistry, physiology, and therapeutic applications of calcitonin. Arthritis Rheum. 1980; 23:1139-47. [IDIS 125985] [PubMed 7191707]
105. Martin TJ. Treatment of Paget’s disease with the calcitonins. Aust N Z J Med. 1979; 9:36-43. [PubMed 287441]
106. Evans RA. Treatment of Paget’s disease of bone. Med J Aust. 1983; 1:159-62. [IDIS 170428] [PubMed 6405139]
107. Grunstein HS, Clifton-Bligh P, Posen S. Paget’s disease of bone: experiences with 100 patients treated with salmon calcitonin. Med J Aust. 1981; 2:278-80. [IDIS 140934] [PubMed 7300759]
108. Avioli LV. Calcitonin therapy for bone disease and hypercalcemia. Arch Intern Med. 1982; 142:2076-9. [IDIS 160957] [PubMed 7138154]
109. Hosking DJ. Paget’s disease of bone. BMJ. 1981; 283:686-8. [IDIS 137977] [PubMed 6793126]
110. Scuro LA, Lo Cascio V, Adami S. Therapeutic use of human calcitonin in patients with Paget’s disease resistant to heterologous calcitonins. In: Caniggia A, ed. Proceedings of the International Workshop on Human Calcitonin of Stresa. April 24, 1982:181-91.
111. Singer FR, Fredericks RS, Minkin C. Salmon calcitonin therapy for Paget’s disease of bone: the problem of acquired clinical resistance. Arthritis Rheum. 1980; 23:1148-54. [IDIS 125986] [PubMed 7000081]
112. Rojanasathit S, Rosenberg E, Haddad JG Jr. Paget’s bone disease: response to human calcitonin in patients resistant to salmon calcitonin. Lancet. 1974; 2:1412-5. [PubMed 4140329]
113. Bucht E, Arver S, Sjoberg HE et al. Heterogeneity of immunoreactive calcitonin in human milk. Acta Endocrinol. 1983; 103:572-6. [PubMed 6613498]
114. Huwyler R, Born W, Ohnhaus EE et al. Plasma kinetics and urinary excretion of exogenous human and salmon calcitonin in man. Am J Physiol. 1979; 236:E15-9. [PubMed 571211]
115. Dietrich FM, Macarol V, Dambacher MA et al. Immunology of synthetic human calcitonin. In: Caniggia A, ed. Proceedings of the International Workshop on Human Calcitonin of Stresa. April 24, 1982:57-67.
116. Dietrich FM, Fischer JA, Bijvoet OL. Formation of antibodies to synthetic human calcitonin during treatment of Paget’s disease. Acta Endocrinol. 1979; 92:468-76. [PubMed 517048]
117. Gennari C, Passeri M, Chierichetti SM et al. Side-effects of synthetic salmon and human calcitonin. Lancet. 1983; 1:594-5. [IDIS 167942] [PubMed 6131289]
118. Melick RA. Treatment of Paget’s disease of bone. Med J Aust. 1985; 143:394-7. [IDIS 209837] [PubMed 2932626]
119. Woodhouse NJY, Crosbie WA, Mohamedally SM. Cardiac output in Paget’s disease: response to long-term salmon calcitonin therapy. Br Med J. 1975; 4:680. [IDIS 60265] [PubMed 1203720]
120. Castells S, Colbert C, Chakrabarti C et al. Therapy of osteogenesis imperfecta with synthetic salmon calcitonin. J Pediatr. 1979; 95(5 Part 1):807-11. [IDIS 107604] [PubMed 573785]
121. Jowsey J, Riggs BL, Kelly PJ et al. Calcium and salmon calcitonin in treatment of postmenopausal osteoporosis. J Clin Endocrinol Metab. 1978; 47:633-9. [IDIS 116584] [PubMed 263316]
122. Gruber HE, Ivey JL, Baylink DJ et al. Long-term calcitonin therapy in postmenopausal osteoporosis. Metabolism. 1984; 33:295-303. [PubMed 6423929]
123. Avramides A, Flores A, DeRose J et al. Paget’s disease of the bone: observations after cessation of long-term synthetic salmon calcitonin treatment. J Clin Endocrinol Metab. 1976; 42:459-63. [PubMed 1254686]
124. Evans IMA, Banks L, Doyle FH et al. Paget’s disease of bone—the effect of stopping long-term human calcitonin and recommendations for future treatment. Metab Dis Relat Res. 1980; 2:87-92.
125. Novartis. Miacalcin (calcitonin-salmon) injection, synthetic prescribing information. East Hanover, NJ; 2002 Jul.
126. American College of Rheumatology Ad Hoc Committee on Glucocorticoid-induced Osteoporosis. Recommendations for the prevention and treatment of gluococorticoid-induced osteoporosis: 2001 update. Arthritis Rheum. 2001; 44:1496-503. [IDIS 466759] [PubMed 11465699]
127. Novaritis. Miacalcin(calcitonin-salmon) nasal spray prescribing information. East Hanover, NJ: 2006 Jun.
128. Wood AJJ. Treatment of postmenopausal osteoporosis. N Engl J Med. 1998; 338:736-46. [IDIS 402219] [PubMed 9494151]
129. Committee on Educational Bulletins of the American College of Obstetricians and Gynecologists. ACOG Educational Bulletin: osteoporosis. Obstet Gynecol. 1998; 91:1-9. [IDIS 403501] [PubMed 9464711]
130. Heaney RP. Bone mass, bone loss, and osteoporosis prophylaxis. Ann Intern Med. 1998; 128:313-4. [IDIS 401677] [PubMed 9471936]
131. Seeman E. Osteoporosis: trials and tribulations. Am J Med. 1997; 103:74-89S. [PubMed 9236490]
132. European Foundation for Osteoporosis and Bone Disease, National Osteoporosis Foundation, and National Institute of Arthritis and Musculoskeletal and Skin Diseases. Consensus development conference: diagnosis, prophylaxis, and treatment of osteoporosis. Am J Med. 1993; 94:646-50. [IDIS 316087] [PubMed 8506892]
133. Osteoporosis Society of Canada Scientific Advisory Board. Clinical practice guidelines for diagnosis and mangement of osteoporosis. CMAJ. 1996; 155:1113-33. [IDIS 373678] [PubMed 8873639]
134. Standing Committee on the Scientific Evaluation of Dietary Reference Intakes of the Food and Nutrition Board, Institute of Medicine, National Academy of Sciences. Dietary reference intakes for calcium, phosphorus, magnesium, vitamin D, and fluoride. Washington, DC: National Academy Press; 1997. Prepublication Copy.
135. Anon. Drugs for the prevention and treatment of postmenopausal osteoporosis. Treatment Guidelines from the Medical Letter. 2002;1:13-18.
136. National Isteoporosis Foundation. Physician's guide to prevention and treatment of osteoporosis. Apr 2003. From the National Guideline Clearinghouse web site (). Accessed 2004 Dec 16.
137. U.S. Preventive Services Task Force. Postmenopausal hormone replacement therapy for primary prevention of chronic conditions: recommendations and rationale. Ann Intern Med/ 2002; 137-834-9.
138. Overgaard K, Hansen MA, Jensen SB et al. Effect of salcatonin given intranasally on bone mass and fracture rates in established osteoporosis: a dose-response study. BMJ. 1992; 305(6853):556-61. [IDIS 301735] [PubMed 1393035]
139. Overgaard K, Lindsay R, Christiansen C. Patient responsiveness to calcitonin salmon nasal spray: a subanalysis of a 2-year study. Clin Ther. 1995 Jul-Aug; 17(4):680-5.
140. Downs RW, Bell NH, Ettinger MP et al. Comparison of alendronate and intranasal calcitonin for treatment of osteoporosis in postmenopausal women. J Clin Endocrinol Metab. 2000; 85(5):1783-8. [IDIS 446990] [PubMed 10843152]
141. Chesnut CH, Silverman S, Andriano K et al. A randomized trial of nasal spray salmon calcitonin in postmenopausal women with established osteoporosis: the prevent recurrence of osteoporotic fractures study. PROOF Study Group. Am J Med. 2000; 109(4):267-76. [IDIS 453617] [PubMed 10996576]
142. Cummings SR, Bates D, Black DM. Clinical use of bone densitometry: scientific review. JAMA. 2002; 288(15):1889-97. [PubMed 12377088]
143. Schneider D, Hofmann MT, Peterson JA. Diagnosis and treatment of Paget’s disease of bone. Am Fam Physician. 2002; 65(10):2069-72. [IDIS 481523] [PubMed 12046775]
145. Upsher-Smith. Fortical (calcitonin-salmon [rDNA origin]) nasal spray prescribing information. Minneapolis, MN; 2006 Jun.
146. North American Menopause Society. Management of osteoporosis in postmenopausal women: 2006 position statement of the North American Menopause society. Menopause. 2006; 13:340-67. [PubMed 16735931]
c. AHFS drug information 2003. McEvoy GK, ed. Calcitonin. Bethesda, MD: American Society of Health-System Pharmacists; 2003: page 3039-42.