CALCITONIN-SALMON

The absolute bioavailability of calcitonin salmon is approximately 66% and 71% after intramuscular or subcutaneous injection, respectively. After subcutaneous administration, peak plasma levels are reached in approximately 23 minutes. The terminal half-life is approximately 58 minutes for intramuscular administration and 59 to 64 minutes for subcutaneous administration. The apparent volume of distribution is 0.15 L/kg to 0.3 L/kg.

14.1 Paget’s Disease of Bone The trials used for the basis of approval for calcitonin salmon injection for treatment of Paget’s disease of bone were conducted in patients with moderate to severe disease characterized by polyostotic involvement with elevated serum alkaline phosphatase and urinary hydroxyproline excretion. In open-label clinical trials of several months to two years duration with historical controls, biochemical abnormalities were substantially improved (more than 30% reduction) in about 2/3 of patients studied and bone pain was improved in a similar fraction. A small number of ...

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 A...

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 (5.1) ] . Hypersensitivity to calcitonin salmon or any of the excipients. ( 4 )

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...

7 DRUG INTERACTIONS 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 con...