Calcitonin salmon

Miacalcin synthetic injection is a calcitonin, indicated for the following conditions: • Treatment of symptomatic Paget’s disease of bone when alternative treatments are not suitable. • Treatment of hypercalcemia. • Treatment of postmenopausal osteoporosis when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated. Limitations of Use: • Due to the possible association between malignancy and calcitonin salmon use, the need for continued therapy should be re-evaluated on a periodic basis

Calcitonin salmon is a calcitonin receptor agonist. Calcitonin salmon acts primarily on bone, but direct renal effects and actions on the gastro-intestinal tract are also recognized. Calcitonin salmon appears to have actions essentially identical to calcitonins of mammalian origin, but its potency per mg is greater and it has a longer duration of action. The actions of calcitonin on bone and its role in normal human bone physiology are still not completely elucidated, although calcitonin receptors have been discovered in osteoclasts and osteoblasts.

• Symptomatic Paget’s disease of bone: 100 USP Units daily. Ensure adequate calcium and vitamin D intake. • Hypercalcemia: start with 4 USP Units/kg body weight every 12 hours. Increase to 8 USP Units/kg every 12 hours if no improvement in 1-2 days. Increase further to 8 USP Units/kg every 6 hours if no improvement after 2 more days. • Postmenopausal osteoporosis: 100 USP Units daily. Ensure adequate calcium and vitamin D intake

Hypersensitivity to calcitonin salmon or any of the excipients. Reactions have included anaphylaxis with death, bronchospasm, and swelling of the tongue or throat.

• Serious hypersensitivity reactions, including reports of fatal anaphylaxis have been reported. Consider skin testing prior to treatment in patients with suspected hypersensitivity to calcitonin salmon. • Hypocalcemia has been reported. Ensure adequate intake of calcium and vitamin D. • Malignancy: A meta-analysis of 21 clinical trials suggests an increased risk of overall malignancies in calcitonin salmon-treated patients. • Circulating antibodies to calcitonin salmon may develop, and may cause loss of response to treatment

The following serious adverse reactions are discussed in greater detail in other sections of the label: • Hypersensitivity Reactions, including anaphylaxis • Hypocalcemia • Malignancy Most common adverse reactions are nausea with or without vomiting (10%), injection site inflammation (10%), and flushing of the face or hands (2% to 5%)

No formal drug interaction studies have been performed with Miacalcin injection. Concomitant use of calcitonin salmon and lithium may lead to a reduction in plasma lithium concentrations due to increased urinary clearance of lithium. The dose of lithium may require adjustment. • Concomitant use of calcitonin salmon and lithium may lead to a reduction in plasma lithium concentrations due to increased urinary clearance of lithium. The dose of lithium may require adjustment

Store in a refrigerator between 2° to 8°C (36° to 46°F). Protect from freezing.