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
Treatment of postmenopausal osteoporosis in women >5 years postmenopause; use supplemental calcium and/or vitamin D concomitantly if daily dietary intake is considered inadequate.125 127 145
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
Monitor BMD.125 127 145
Administer by sub-Q or IM injection (Paget’s disease of bone, hypercalcemia, postmenopausal osteoporosis)125 or intranasally (postmenopausal osteoporosis).127 145
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
Administer once daily (as a single spray in 1 nostril) using metered-dose spray pump supplied by manufacturer.127 145 Alternate nostrils daily.127 145
Allow solution to reach room temperature before priming pump and administering first dose.127 145
Prime pump before first dose; do not prime before each dose.127 145
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
Administer dose by placing nozzle in nostril with head in upright position and firmly depressing pump toward bottle.127 145
Discard spray pump after 30 actuations, since the correct drug dose per actuation cannot be assured if used for additional doses.127
Activity of calcitonin salmon expressed in terms of International Units (units).125 127 145
Intranasal spray pumps deliver 0.09 mL of solution per actuation; each 0.09-mL spray delivers 200-unit dose.127 145
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
Dosage >100 units daily usually does not produce an improved response in patients who relapse while receiving calcitonin.101 105 109 110 111 112 125
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
200 units (1 spray) daily.127 145
Sub-Q or IM
Maximum 8 units/kg every 6 hours.125
Cautions for Calcitonin
Known hypersensitivity to calcitonin salmon.125 127 145
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
Allergic-type reactions also reported in patients receiving calcitonin nasal spray.127 145
Appropriate agents for treatment of hypersensitivity reactions should be readily available.125 127 145
For patients with suspected sensitivity to calcitonin, consider skin testing prior to initiating therapy.125 127 145
Possibility of hypocalcemic tetany following parenteral administration;8 111 125 have calcium injection readily available, particularly during first several doses of parenteral calcitonin.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
Periodic examinations of urine sediment are recommended in patients receiving long-term parenteral therapy.34 125 145
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
Periodic nasal examinations with visualization of nasal mucosa, turbinates, septum, and mucosal blood vessel status are recommended for patients receiving calcitonin nasal spray.127 145
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
Category C.125 127 145
Inhibits lactation in animals.125 127 145 Not known whether calcitonin is distributed into human milk.125 127 145 Use not recommended.125 127 145
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
Experience with calcitonin in children with idiopathic juvenile osteoporosis is very limited; the relationship between this disorder and postmenopausal osteoporosis is not established.127 145
Data are inadequate to support use of calcitonin in children.125 127 145
Adverse nasal effects (i.e., rhinitis, irritation, congestion) reported more frequently in patients >65 years of age receiving calcitonin nasal spray.127 145 Nasal effects described as mild.127 145
Common Adverse Effects
With parenteral therapy, nausea,125 118 vomiting,118 125 injection site reaction,125 flushing of the face, ears, hands, and feet.24 100 102 104 106 107 117 118 120 125
With intranasal therapy, rhinitis, nasal symptoms, back pain.127 145
Interactions for Calcitonin
Possible reduced antiresorptive response to calcitonin in patients with Paget’s disease previously treated with bisphosphonates.127 145
Destroyed in GI tract; administer parenterally or intranasally.125 127 145
Rapidly absorbed by nasal mucosa; bioavailability of intranasal dose relative to IM dose is approximately 3%.127 145
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
Not studied extensively.125 127 145
Apparently does not cross placenta.125 127 145
Appears to be rapidly metabolized to smaller inactive fragments in kidney, blood, and peripheral tissues.125
Excreted in urine as metabolites.125
<1 hour.114 127
Miacalcin and Fortical new unassembled bottles: 2–8°C; protect from freezing.127 145
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
Calcitonin salmon has same pharmacologic activity as calcitonin human, but calcitonin salmon is more potent and has longer duration of action.100 101 102 103 104 109 112 114 125 127 145
Acts predominantly on bone to lower serum calcium concentration;125 127 145 also has direct effects on kidneys and GI tract.125
Directly inhibits osteoclastic bone resorption, altering the function and/or number of osteoclasts.125 127 145
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
Advise patients using calcitonin nasal spray to notify their clinician if nasal irritation develops.127 145
Importance of women informing clinicians if they are or plan to become pregnant or to breast-feed.125 127 145
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.125 127 145
Importance of informing patients of other important precautionary information.125 127 145 (See Cautions.)
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 2017, Selected Revisions May 1, 2007. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
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