openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings and cautions
5 WARNINGS 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 Miacalcin 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 Miacalcin injection is administered. If anaphylaxis or other severe hypersensitivity/allergic reactions occur, initiate appropriate treatment [see Contraindications (4) ] . For patients with suspected hypersensitivity to calcitonin salmon, skin testing should be considered prior to treatment utilizing a dilute, sterile solution of Miacalcin injection. Healthcare providers may wish to refer patients who require skin testing to an allergist. A detailed skin testing protocol is available from the Mylan Pharmaceuticals Inc. Product Safety Department. 5.2 Hypocalcemia Hypocalcemia associated with tetany (i.e., muscle cramps, twitching) and seizure activity has been reported with Miacalcin 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 Miacalcin injection for the treatment of Paget’s disease or postmenopausal osteoporosis is recommended in conjunction with an adequate intake of calcium and vitamin D [see Dosage and Administration (2.5) ] . 5.3 Malignancy In a meta-analysis of 21 randomized, controlled clinical trials with calcitonin salmon (nasal spray or investigational oral formulations)...
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
6 ADVERSE REACTIONS 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 Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of calcitonin salmon injection was assessed in open-label trials several months to two years in duration. The most common adverse reactions are discussed below. Nausea Nausea with or without vomiting has been noted in about 10% of patients treated with calcitonin salmon. It is most evident when treatment is first initiated and tends to decrease or disappear with continued administration. Dermatologic Reactions Local inflammatory reactions at the site of subcutaneous or intramuscular injection have been reported in about 10% of patients. Flushing of face or hands occurred in about 2% to 5% of patients. Skin rashes and pruritus of the ear lobes have also been reported. Other Adverse Reactions Nocturia, feverish sensation, pain in the eyes, poor appetite, abdominal pain, pedal edema, and salty taste have been reported in patients treated with calcitonin salmon injection. Malignancy A meta-analysis of 21 randomized, controlled clinical trials with calcitonin salmon (nasal spray or investigational oral formulations) was conducted to assess the risk of malignancies in calcitonin salmon-treated patients compared to placebo-treated patients. The trials in the meta-analysis ranged in duration from 6 months to 5 years and included a total of 10883 patients (6151 treated with calcitonin salmon and 4732 treated with placebo). The overall incidence of malignancies reported in these 21 trials was higher among calcitonin salmon-treated patients (254/6151 or 4.1%) co...
adverse reactions table
Table 1: Risk Difference for Malignancies in Calcitonin Salmon-Treated Patients Compared with Placebo-Treated PatientsPatientsMalignanciesRisk DifferenceThe overall adjusted risk difference is the difference between the percentage of patients who had any malignancy (or malignancy excluding basal cell carcinoma) in calcitonin salmon and placebo treatment groups, using the Mantel-Haenszel (MH) fixed-effect method. A risk difference of 0 is suggestive of no difference in malignancy risks between the treatment groups. (%)95% Confidence IntervalThe corresponding 95% confidence interval for the overall adjusted risk difference also based on MH fixed-effect method. (%)All (nasal spray + oral)All1.0(0.3, 1.6)All (nasal spray + oral)Excluding basal cell carcinoma0.5(-0.1, 1.2)All (nasal spray only)All1.4(0.3, 2.6)All (nasal spray only)Excluding basal cell carcinoma0.8(-0.2, 1.8)