CALCITONIN SALMON Drug Interactions: What You Need to Know

INTERACTIONS No formal drug interaction studies have been performed with Calcitonin Salmon Nasal Solution. 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 )

Hypersensitivity to calcitonin-salmon or any of the excipients. Reactions have included anaphylactic shock, anaphylaxis, bronchospasm, and swelling of the tongue or throat [see Warnings and Precautions ( 5.1 ) ]. Hypersensitivity to calcitonin-salmon or any of the excipients (4 )

AND PRECAUTIONS

• 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., bronchospasm, swelling of the tongue or throat, anaphylactic shock, and death due to anaphylaxis. Appropriate medical support and monitoring measures should be readily available when calcitonin-salmon injection is administered. If anaphylaxis or other severe hypersensitivity/allergic reactions occur, initiate appropriate treatment <span class="opacity-50 text-xs">[see Contraindications ( 4) ]</span>. For patients with suspected hypersensitivity to calcitonin-salmon, skin testing should be considered prior to treatment utilizing a dilute, sterile solution of calcitonin-salmon injection. Healthcare providers may wish to refer patients who require skin testing to an allergist.A detailed skin testing protocol is available from the Dr. Reddy’s Laboratories Inc.

Medical

Service team.

5.2 Hypocalcemia Hypocalcemia associated with tetany (i.e., muscle cramps, twitching) and seizure activity has been reported with calcitonin-salmon injection therapy. Hypocalcemia must be corrected before initiating therapy. Other disorders affecting mineral metabolism (such as vitamin D deficiency) should also be effectively treated. In patients at risk for hypocalcemia, provisions for parenteral calcium administration should be available during the first several administrations of calcitonin­ salmon and serum calcium and symptoms of hypocalcemia should be monitored. Use of calcitonin-salmon injection for the treatment of Paget’s disease or postmenopausal osteoporosis is recommended in conjunction with an adequate intake of calcium and vitamin D <span class="opacity-50 text-xs">[see Dosage and Administration ( 2.5) ]</span>.

5.3 Malignancy In a meta-analysis of 21 randomized, controlled clinical trials with calcitonin-salmon (nasal spray or investigational oral formulations), the overall incidence of malignancies reported was higher among calcitonin-salmon-treated patients (4.1%) compared with placebo-treated patients (2.9%). This suggests an increased risk of malignancies in calcitonin-salmon-treated patients compared to placebo-treated patients. It is not possible to exclude an increased risk when calcitonin-salmon is administered long-term subcutaneously, intramuscularly, or intravenously. The benefits for the individual patient should be carefully considered against possible risks <span class="opacity-50 text-xs">[see Adverse Reactions ( 6.1 )]</span>.

5.4 Antibody Formation Circulating antibodies to calcitonin-salmon have been reported with calcitonin-salmon injection. The possibility of antibody formation should be considered in any patient with an initial response to calcitonin-salmon injection who later stops responding to treatment <span class="opacity-50 text-xs">[see Adverse Reactions ( 6.3 )]</span>.

5.5 Urine Sediment Abnormalities Coarse granular casts and casts containing renal tubular epithelial cells were reported in young adult volunteers at bed rest who were given injectable calcitonin-salmon to study the effect of immobilization on osteoporosis. There was no other evidence of renal abnormality and the urine sediment normalized after calcitonin-salmon was stopped. Periodic examinations of urine sediment should be considered.

5.1 Hypersensitivity Reactions Serious hypersensitivity reactions have been reported in patients receiving calcitonin-salmon injection, e.g., bronchospasm, swelling of the tongue or throat, anaphylactic shock, and death due to anaphylaxis. Appropriate medical support and monitoring measures should be readily available when calcitonin-salmon injection is administered. If anaphylaxis or other severe hypersensitivity/allergic reactions occur, initiate appropriate treatment <span class="opacity-50 text-xs">[see Contraindications ( 4) ]</span>. For patients with suspected hypersensitivity to calcitonin-salmon, skin testing should be considered prior to treatment utilizing a dilute, sterile solution of calcitonin-salmon injection. Healthcare providers may wish to refer patients who require skin testing to an allergist.A detailed skin testing protocol is available from the Dr. Reddy’s Laboratories Inc.

Medical

Service team.

5.2 Hypocalcemia Hypocalcemia associated with tetany (i.e., muscle cramps, twitching) and seizure activity has been reported with calcitonin-salmon injection therapy. Hypocalcemia must be corrected before initiating therapy. Other disorders affecting mineral metabolism (such as vitamin D deficiency) should also be effectively treated. In patients at risk for hypocalcemia, provisions for parenteral calcium administration should be available during the first several administrations of calcitonin­ salmon and serum calcium and symptoms of hypocalcemia should be monitored. Use of calcitonin-salmon injection for the treatment of Paget’s disease or postmenopausal osteoporosis is recommended in conjunction with an adequate intake of calcium and vitamin D <span class="opacity-50 text-xs">[see Dosage and Administration ( 2.5) ]</span>.

5.3 Malignancy In a meta-analysis of 21 randomized, controlled clinical trials with calcitonin-salmon (nasal spray or investigational oral formulations), the overall incidence of malignancies reported was higher among calcitonin-salmon-treated patients (4.1%) compared with placebo-treated patients (2.9%). This suggests an increased risk of malignancies in calcitonin-salmon-treated patients compared to placebo-treated patients. It is not possible to exclude an increased risk when calcitonin-salmon is administered long-term subcutaneously, intramuscularly, or intravenously. The benefits for the individual patient should be carefully considered against possible risks <span class="opacity-50 text-xs">[see Adverse Reactions ( 6.1 )]</span>.

5.4 Antibody Formation Circulating antibodies to calcitonin-salmon have been reported with calcitonin-salmon injection. The possibility of antibody formation should be considered in any patient with an initial response to calcitonin-salmon injection who later stops responding to treatment <span class="opacity-50 text-xs">[see Adverse Reactions ( 6.3 )]</span>.

5.5 Urine Sediment Abnormalities Coarse granular casts and casts containing renal tubular epithelial cells were reported in young adult volunteers at bed rest who were given injectable calcitonin-salmon to study the effect of immobilization on osteoporosis. There was no other evidence of renal abnormality and the urine sediment normalized after calcitonin-salmon was stopped. Periodic examinations of urine sediment should be considered.