Mianin®
Calcitonin
ampoule
Hypercalcemia (injection): Adjunctive therapy for hypercalcemia. May be used in hypercalcemic emergencies when a rapid decrease in serum calcium is required or until more specific treatment of underlying disease is accomplished.
Osteoporosis, postmenopausal (intranasal or injection): Treatment of osteoporosis in females more than 5 years post-menopause.
Paget disease (injection): Treatment of symptomatic Paget disease of bone (osteitis deformans) in patients who are nonresponsive or intolerant to alternative therapy.
Mechanism of Action:
Peptide sequence similar to human calcitonin; functionally antagonizes the effects of parathyroid hormone. Directly inhibits osteoclastic bone resorption; promotes the renal excretion of calcium, phosphate, sodium, magnesium, and potassium by decreasing tubular reabsorption; increases the jejunal secretion of water, sodium, potassium, and chloride.
Method of Administration:
Hypercalcemia: IM, SUBQ: Initial: 4 units/kg every 12 hours; if response is unsatisfactory after 24 to 48 hours, may increase to 8 units/kg every 12 hours; if response remains unsatisfactory after an additional 48 hours, may increase to a maximum dose of 8 units/kg every 6 hours. Hypocalcemic effect of calcitonin diminishes after 24 to 48 hours.
Osteoporosis, postmenopausal, fracture risk reduction (labeled use) or osteoporotic vertebral fracture pain relief (off-label use): Note: May be used to reduce pain associated with acute osteoporotic vertebral fractures; switch to a more effective agent (eg, a bisphosphonate) once pain has abated. IM, SUBQ: 100 units once daily.
Paget disease (alternative agent): IM, SUBQ: 100 units daily. Lower maintenance dosages (eg, 50 units 3 times/week) may be sufficient.
Notes
Hypersensitivity to calcitonin salmon or any component of the formulation
Interactions:
Lithium: Calcitonin may decrease the serum concentration of Lithium. Risk C: Monitor therapy
Sincalide: Drugs that Affect Gallbladder Function may diminish the therapeutic effect of Sincalide. Management: Consider discontinuing drugs that may affect gallbladder motility prior to the use of sincalide to stimulate gallbladder contraction. Risk D: Consider therapy modification
Zoledronic Acid: Calcitonin may enhance the hypocalcemic effect of Zoledronic Acid. Risk C: Monitor therapy
Pregnancy and Lactation:
Information related to the use of calcitonin in pregnancy is limited.
Calcitonin is endogenous to breast milk in lactating females.
Warning and Precaution:
- Hypersensitivity reactions: Salmon-derived products: Anaphylactic shock, anaphylaxis, bronchospasm, and swelling of the tongue or throat have been reported; have epinephrine immediately available for a possible hypersensitivity reaction. A skin test should be performed prior to initiating therapy of calcitonin salmon in patients with suspected sensitivity; a detailed skin testing protocol is available from the manufacturer.
- Hypocalcemia: Hypocalcemia with tetany and seizure activity has been reported. Hypocalcemia and other disorders affecting mineral metabolism (eg, vitamin D deficiency) should be corrected before initiating therapy; monitor serum calcium and symptoms of hypocalcemia during therapy. Administer in conjunction with calcium and vitamin D when treating Paget disease or postmenopausal osteoporosis.
- Malignancy: Analyses of randomized controlled trials (in osteoporosis and osteoarthritis) using the nasal spray and oral formulations have demonstrated a statistically significant increase in the risk of the development of cancer in calcitonin-treated patients (compared to placebo). The risk for malignancies is associated with long-term use of calcitonin (trials ranged from 6 months to 5 years in duration). Periodically reassess continued use of calcitonin therapy, carefully considering the risks versus benefits. Similar risk for other routes (subcutaneous, IM, IV) cannot be ruled out.
Adverse Reactions:
Immunologic: Antibody development (injection: ~50%; nasal spray: 69%; drug efficacy can be affected)
Respiratory: Rhinitis (12%)
Storage:
Store in 2-8ºC and protect from light and freezing.