Calcitonin salmon

Calcitonin salmon injection, synthetic is a calcitonin, indicated for the following conditions: Treatment of symptomatic Paget's disease of bone when alternative treatments are not suitable ( 1.1 ) Treatment of hypercalcemia ( 1.2 ) Treatment of postmenopausal osteoporosis when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated ( 1.3 ) 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 ( 1.4 , 5.3 ) 1.1 Treatment of Paget’s Disease of Bone Calcitonin salmon injection is indicated for the treatment of symptomatic Paget's disease o …

• 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 Paget’s Disease of Bone The recommended dose of Calcitonin salmon injection for treatment of symptomatic Paget's disease of bone is 100 USP Units (0.5 mL) per day administered subcutaneously or intramuscularly
• Hypercalcemia The recommended starting dose of Calcitonin salmon injection for early treatment of hypercalcemia is 4 USP Units/kg body weight every 12 hours by subcutaneous or intramuscular injection
• If the response to this dose is not satisfactory after one or two days, the dose may be increased to 8 USP Units/kg every 12 hours
• If the response remains unsatisfactory after two more days, the dose may be further increased to a maximum of 8 USP Units/kg every 6 hours
• Postmenopausal Osteoporosis The recommended dose of Calcitonin salmon injection for treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause is 100 USP Units (0.5 mL) per day administered subcutaneously or intramuscularly
• The minimum effective dose of Calcitonin salmon injection for the prevention of vertebral bone mineral density loss has not been established. …

Calcitonin salmon injection, USP, synthetic is available as a clear, colorless, sterile solution of synthetic calcitonin salmon, USP in individual 2 mL multiple-dose vials containing 200 USP Units per mL. Injection: 200 USP Units per mL sterile solution in 2 mL multiple-dose vials ( 3 )

• Safety and effectiveness
• In pediatric patients have not been established

Clinical studies of calcitonin salmon injection did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. …

• Instruct patients and other persons who may administer calcitonin salmon injection in sterile injection technique
• Also instruct patients to dispose of needles properly [see Dosage and Administration ]
• Inform patients of the potential increase in risk of malignancy [see Warnings and Precautions ]
• Advise patients with postmenopausal osteoporosis or Paget's disease of bone to maintain an adequate calcium (at least 1000 mg elemental calcium per day) and vitamin D (at least 400 International Units per day) intake [see Dosage and Administration ]. …

• Hypersensitivity to calcitonin salmon or any of the excipients
• Reactions have included anaphylaxis with death, bronchospasm, and swelling of the tongue or throat [see Warnings and Precautions ]
• Hypersensitivity to calcitonin salmon or any of the excipients

No formal drug interaction studies have been performed with calcitonin salmon 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 ( 7 )

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 ( 5.1 ) Hypocalcemia has been reported. Ensure adequate intake of calcium and vitamin D ( 5.2 ) Malignancy: A meta-analysis of 21 clinical trials suggests an increased risk of overall malignancies in calcitonin salmon-treated patients ( 5.3 , 6.1 ) Circulating antibodies to calcitonin salmon may develop, and may cause loss of response to treatment ( 5.4 ) 5.1 Hypersensitivity Reactions Serious hypersensitivity reactions have been reported in patients receiving calcitonin salmon injection, e.g., …

The following serious adverse reactions are discussed in greater detail in other sections of the label: Hypersensitivity Reactions, including anaphylaxis [see Warnings and Precautions ( 5.1 )] Hypocalcemia [see Warnings and Precautions ( 5.2 )] Malignancy [see Warnings and Precautions ( 5.3 )] 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%) ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . …

8.1 Pregnancy Risk Summary There are no studies with calcitonin salmon injection in pregnant women to inform a drug associated risk for birth defects or miscarriage. In an animal reproduction study, subcutaneous administration of calcitonin salmon to pregnant rabbits during organogenesis at 4-18 times the recommended parenteral human dose caused a decrease in fetal birth weights. …

The pharmacologic actions of calcitonin salmon injection suggest that hypocalcemic tetany could occur in overdose. Therefore, provisions for parenteral administration of calcium should be available for the treatment of overdose. A dose of calcitonin salmon l000 International Units subcutaneously may produce nausea and vomiting. Doses of 32 International Units per kg per day for 1 to 2 days demonstrate no other adverse effects. Data on chronic high-dose administration are insufficient to assess toxicity.

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