Calcitonin Salmon Nasal Spray)
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HIGHLIGHTS OF PRESCRIBING INFORMATION delivers 200 International Units of calcitonin-salmon (3) Table 2: Risk Difference for Malignancies in Calcitonin-Salmon Treated Patients Compared with Placebo-Treated Patients PHARMACIST : DETACH HERE What are the possible side effects of Calcitonin These highlights do not include all the information needed ——————— CONTRAINDICATIONS ————————— Risk Difference1 95% Confidence Salmon Nasal Solution? Hypersensitivity to calcitonin-salmon or any of the excipients (4) Patients Malignancies 2 to use Calcitonin Salmon Nasal Solution, USP (Calcitonin (%) Interval (%) Patient Information Calcitonin Salmon Nasal Solution may cause Salmon Nasal Spray) safely and effectively. —————— WARNINGS AND PRECAUTIONS —————— All (nasal spray + oral) All 1.0 (0.3, 1.6) Excluding basal serious side effects, including: See full prescribing information for Calcitonin Salmon Nasal • Serious hypersensitivity reactions including anaphylactic shock All (nasal spray + oral) cell carcinoma 0.5 (-0.1, 1.2) Calcitonin Salmon Nasal Solution, USP Solution, USP (Calcitonin Salmon Nasal Spray). have been reported. Consider skin testing prior to treatment All (nasal spray only) All 1.4 (0.3, 2.6) • allergic reactions in patients with suspected hypersensitivity to calcitonin-salmon (Calcitonin Salmon Nasal Spray) Calcitonin Salmon Nasal Solution, USP (Calcitonin Salmon All (nasal spray only) Excluding basal 0.8 (-0.2, 1.8) Some people have had an allergic reaction when (5.1) cell carcinoma Read this Patient Information before you start using Nasal Spray), for intranasal use (Synthetic Origin) • Hypocalcemia has been reported. Ensure adequate intake of 1 The overall adjusted risk difference is the difference between the percentage using Calcitonin Salmon Nasal Solution. Some of patients who had any malignancy (or malignancy excluding basal cell Calcitonin Salmon Nasal Solution and each time Initial U.S. Approval: 1975 calcium and vitamin D (5.2) carcinoma) in calcitonin-salmon and placebo treatment groups, using the reactions may be serious and can be life threaten- ———————— RECENT MAJOR CHANGES —————— • Nasal adverse reactions, including severe ulceration can occur. Mantel-Haenszel (MH) fixed-effect method. A risk difference of 0 is suggestive you get a refill. There may be new information. This ing. Call your healthcare provider or go to the near- Periodic nasal examinations are recommended (5.3) of no difference in malignancy risks between the treatment groups. information does not take the place of talking to your Indications and Usage (1.2) 03/2014 2 The corresponding 95% confidence interval for the overall adjusted risk differ- est hospital emergency room right away if you have Warnings and Precautions (5.4) 03/2014 • Malignancy: A meta-analysis of 21 clinical trials suggests an increased risk of overall malignancies in calcitonin-salmon- ence also based on MH fixed-effect method. healthcare provider about your medical condition or any of these symptoms of an allergic reaction. ——————— INDICATIONS AND USAGE ——————— treated patients (5.4, 6.1) 6.2 Postmarketing Experience your treatment. o Calcitonin Salmon Nasal Solution is a calcitonin, indicated for Because postmarketing adverse reactions are reported voluntarily from a population of trouble breathing • Circulating antibodies to calcitonin-salmon may develop, and uncertain size, it is not always possible to reliably estimate their frequency or establish o swelling of your face, throat or tongue the treatment of postmenopausal osteoporosis in women greater may cause loss of response to treatment (5.5) a causal relationship to drug exposure. What is Calcitonin Salmon Nasal Solution? than 5 years postmenopause when alternative treatments are not o fast heartbeat The following adverse reactions have been reported during post-approval use of Calcitonin Salmon Nasal Solution is a prescription suitable. Fracture reduction efficacy has not been demonstrated. ——————— ADVERSE REACTIONS ————————— o Most common adverse reactions (3% or greater) are rhinitis, Calcitonin Salmon Nasal Solution. chest pain (1.1) medicine used to treat osteoporosis in women more o epistaxis and other nasal symptoms, back pain, arthralgia, and • Allergic/Hypersensitivity Reactions: Serious allergic reactions have been reported than 5 years after menopause. Calcitonin Salmon feel dizzy or faint Limitations of Use: headache (6) in patients receiving Calcitonin Salmon Nasal Solution, including anaphylaxis and • Due to the possible association between malignancy and cal- anaphylactic shock. Nasal Solution should be used for women who can- If you might be allergic to calcitonin-salmon, your citonin-salmon use, the need for continued therapy should be To report SUSPECTED ADVERSE REACTIONS, contact Par • Hypocalcemia: Hypocalcemia with paresthesia has been reported. Pharmaceutical at 1-800-828-9393 or FDA at 1-800-FDA-1088 • Body as a whole: facial or peripheral edema not use other treatments or who choose not to use healthcare provider should do a skin test before you re-evaluated on a periodic basis. (1.2, 5.4) • Cardiovascular: hypertension, vasodilatation, syncope, chest pain use Calcitonin Salmon Nasal Solution. • Calcitonin Salmon Nasal Solution has not been shown to or www.fda.gov/medwatch • Nervous system: dizziness, seizure, visual or hearing impairment, tinnitus other treatments for osteoporosis. increase bone mineral density in early postmenopausal women ———————— DRUG INTERACTIONS ———————— • Respiratory/Special Senses: cough, bronchospasm, dyspnea, loss of taste/smell It is not known if Calcitonin Salmon Nasal Solution • low calcium levels in your blood (hypocalcemia) (1.2) • Concomitant use of calcitonin-salmon and lithium may lead to • Skin: rash/dermatitis, pruritus, alopecia, increased sweating • Gastrointestinal: diarrhea lowers the chance of having bone fractures. Calcitonin Salmon Nasal Solution may lower the —————— DOSAGE AND ADMINISTRATION ————— a reduction in plasma lithium concentrations due to increased • Nervous system disorders: tremor urinary clearance of lithium. The dose of lithium may require calcium levels in your blood. If you have low blood • For intranasal use only: one spray (200 International Units) per 6.3 Immunogenicity Calcitonin Salmon Nasal Solution has not been day, alternating nostrils daily (2.1) adjustment (7) Consistent with the potentially immunogenic properties of medicinal products containing calcium before you start using Calcitonin Salmon • Prior to first use, allow the bottle to reach room temperature and —————— USE IN SPECIFIC POPULATIONS —————— peptides, administration of Calcitonin Salmon Nasal Solution may trigger the develop- shown to be effective in women less than 5 years Nasal Solution, it may get worse during treatment. ment of anti-calcitonin antibodies. In a two-year Calcitonin Salmon Nasal Solution clini- prime the pump (2.2) • There are no data to support use in children (8.4) cal study that evaluated immunogenicity, a measurable antibody titer was found in 69% after menopause. Your low blood calcium must be treated before you • Ensure adequate calcium and vitamin D intake (2.3) • Nasal reactions are more common in elderly patients (8.5) of patients treated with Calcitonin Salmon Nasal Solution and 3% of placebo-treated patients. Antibody formation may be associated with a loss of response to treatment It is not known if Calcitonin Salmon Nasal Solution use Calcitonin Salmon Nasal Solution. Most peo- ————— DOSAGE FORMS AND STRENGTHS ————— See 17 for PATIENT COUNSELING INFORMATION and FDA [see WARNINGS AND PRECAUTIONS (5.5)]. ple with low blood calcium levels do not have symp- Nasal Spray: 2200 International Units per mL of calcitonin-salmon approved patient labeling is safe and effective in children under 18 years of The incidence of antibody formation is highly dependent on the sensitivity and specificity toms, but some people may have symptoms. Call in a 3.7 mL fill glass bottle with screw-on pump. Each actuation Revised: 06/2016 of the assay. Additionally, the observed incidence of a positive antibody test result may age. be influenced by several factors, including assaym ethodology, sample handling, timing your healthcare provider right away if you have any of sample collection, concomitant medications, and underlying disease. For these rea- Who should not use Calcitonin Salmon Nasal of these symptoms of low blood calcium: FULL PRESCRIBING INFORMATION: CONTENTS* 6.2 Post Marketing Experience sons, comparison of antibodies to Calcitonin Salmon Nasal Solution with the incidence o 6.3 Immunogenicity of antibodies to other calcitonin-containing products may be misleading. Solution? numbness or tingling in your fingers, toes, or 1 INDICATIONS AND USAGE 7 DRUG INTERACTIONS Do not use Calcitonin Salmon Nasal Solution if you: around your mouth 010161-06 7 DRUG INTERACTIONS 1.1 Treatment of Postmenopausal Osteoporosis 8 USE IN SPECIFIC POPULATIONS 1.2 Important Limitations of Use 8.1 Pregnancy No formal drug interaction studies have been performed with Calcitonin Salmon Nasal • are allergic to calcitonin-salmon or any of the Your healthcare provider should: 2 DOSAGE AND ADMINISTRATION 8.3 Nursing Mothers Solution. ingredients in Calcitonin Salmon Nasal Solution. o 2.1 Basic Dosing Information do blood tests while you use Calcitonin Salmon 8.4 Pediatric Use Concomitant use of calcitonin-salmon and lithium may lead to a reduction in plasma 2.2 Priming (Activation) of Pump lithium concentrations due to increased urinary clearance of lithium. The dose