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Uses

Paget’s Disease of Bone

Treatment of Paget’s disease of bone. 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).

Hypercalcemia

Early treatment of hypercalcemic emergencies (with other appropriate agents) when a rapid decrease in serum calcium concentration is required.

Postmenopausal Osteoporosis

Treatment of postmenopausal osteoporosis in women >5 years postmenopause; use supplemental calcium and/or vitamin D concomitantly if daily dietary intake is considered inadequate.

Corticosteroid-induced Osteoporosis

Has been used in the treatment of corticosteroid-induced osteoporosis† in patients receiving long-term corticosteroid therapy. 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.

Not recommended for prevention of bone loss in patients just beginning corticosteroid therapy; efficacy not established for this indication.

Dosage and Administration

General

Paget’s Disease of Bone

• Monitor by periodic determinations of serum alkaline phosphatase and urinary hydroxyproline excretion as well as evaluation of symptoms.
• Investigate possibility of antibody formation in any patient who shows initial response but subsequently relapses.

Postmenopausal Osteoporosis

• Monitor BMD.

Administration

Administer by sub-Q or IM injection (Paget’s disease of bone, hypercalcemia, postmenopausal osteoporosis) or intranasally (postmenopausal osteoporosis).

IM Administration

IM injection preferred when injection volume >2 mL.

Use multiple sites of injection when volume >2 mL.

Sub-Q Administration

Sub-Q injection preferred for patient self-administration.

Intranasal Administration

Administer once daily (as a single spray in 1 nostril) using metered-dose spray pump supplied by manufacturer. Alternate nostrils daily.

Allow solution to reach room temperature before priming pump and administering first dose.

Prime pump before first dose; do not prime before each dose.

Miacalcin^®: To prime pump, hold bottle upright and depress the 2 white side arms of pump toward the bottle until full spray is produced.

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.

Administer dose by placing nozzle in nostril with head in upright position and firmly depressing pump toward bottle.

Discard spray pump after 30 actuations, since the correct drug dose per actuation cannot be assured if used for additional doses.

Dosage

Activity of calcitonin salmon expressed in terms of International Units (units).

Intranasal spray pumps deliver 0.09 mL of solution per actuation; each 0.09-mL spray delivers 200-unit dose.

Adults

Paget’s Disease of Bone

Sub-Q or IM

Initial dosage: 100 units (0.5 mL) daily.

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.

Dosage >100 units daily usually does not produce an improved response in patients who relapse while receiving calcitonin.

Hypercalcemia

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.

Postmenopausal Osteoporosis

Sub-Q or IM

Minimum effective dosage not established; 100 units every other day may be effective in preserving vertebral BMD.

Intranasal

200 units (1 spray) daily.

Prescribing Limits

Adults

Hypercalcemia

Sub-Q or IM

Maximum 8 units/kg every 6 hours.