Classes
DEA Class; Rx
Common Brand Names; Miacalcin
- Calcium Metabolism Modifiers
Description
Peptide hormone secreted by the C cells in the thyroid gland; binds directly to a receptor on the osteoclast surface to inhibit bone resorption; lowers serum calcium
Synthetic salmon calcitonin is more potent and longer-acting than human calcitonin
Due to lower efficacy vs. other agents, not routinely used in Paget’s disease or postmenopausal osteoporosis; indicated in regimens for hypercalcemic emergencies
Indications
Contraindications
Hypersensitivity to calcitonin-salmon
Adverse Effects
- Rhinitis (12%)
- Arthralgia (4%)
- Back pain (5%)
- Expistaxis (4%)
- Injection site reactions (10%)
- Nausea (10%)
- Headache (3%)
- Flushing of face or hands (2-5%)
- Abdominal pain
- Possible allergic reactions
- Appetite decreased
- Edema of feet
- Eye pain
- Feverish sensation
- Nausea
- Nocturia
- Possible local irritative effects in the respiratory tract
- Salty taste
- Tremors
Warnings
Serious hypersensitivity reactions, including fatal anaphylaxis, reported; consider skin testing prior to treatment
Hypocalcemia must be corrected before initiating therapy; also correct and treat other disorders affecting mineral metabolism (such as vitamin D deficiency); in patients at risk for hypocalcemia, provisions for parenteral calcium administration should be available during first several administrations of calcitonin salmon and serum calcium and symptoms of hypocalcemia should be monitored
Use of injection for treatment of Paget’s disease or postmenopausal osteoporosis recommended in conjunction with adequate intake of calcium and vitamin D
Overall incidence of malignancies reported to be higher in clinical trials among calcitonin-salmon-treated patients; this suggests increased risk of malignancies in calcitonin-salmon-treated patients compared to placebo-treated patients; not possible to exclude increased risk when calcitonin-salmon administered long-term subcutaneously, intramuscularly, or intravenously; benefits for individual patients should be carefully considered against possible risks
Circulating antibodies reported with treatment; consider possibility of antibody formation in any patient with an initial response to injection who later stops responding to treatment
Coarse granular casts and casts containing renal tubular epithelial cells reported in young adult volunteers at bed rest given injectable calcitonin-salmon to study effect of immobilization on osteoporosis; no other evidence of renal abnormality reported; urine sediment normalized after therapy was stopped; consider performing periodic examinations of urine sediment
Pregnancy and Lactation
Miacalcin nasal spray is not indicated for use in females of reproductive potential; there are no data with use of in pregnant women
Nasal spray is not indicated for use in females of reproductive potential; there is no information on presence in human milk
Maximum Dosage
200 International Units/day intranasally for osteoporosis; 100 International Units IM or subcutaneously for most indications; for acute hypercalcemia, up to 32 international units/kg/day IM or subcutaneously.
200 International Units/day intranasally for osteoporosis; 100 International Units IM or subcutaneously for most indications; for acute hypercalcemia, up to 32 international units/kg/day IM or subcutaneously.
Safety and efficacy have not been established; off-label use reported for selected conditions.
Safety and efficacy have not been established; off-label use reported for selected conditions.
Safety and efficacy have not been established.
How supplied
Calcitonin salmon
injectable solution
- 200 IU/mL
nasal spray
- 200 IU/actuation