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 do blood tests while you use Calcitonin Salmon 2.1 Basic Dosing Information 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 of lithium See the end of this leaflet for a complete list of Nasal Solution 8.5 Geriatric Use may require adjustment. o 2.3 Recommendations for Calcium and Vitamin D 10 OVERDOSAGE ingredients in Calcitonin Salmon Nasal Solution. prescribe calcium and vitamin D to help pre- Supplementation 11 DESCRIPTION 8 USE IN SPECIFIC POPULATIONS vent low calcium levels in your blood while you 3 DOSAGE FORMS AND STRENGTHS What should I tell my healthcare provider before 12 CLINICAL PHARMACOLOGY 8.1 Pregnancy use Calcitonin Salmon Nasal Solution 4 CONTRAINDICATIONS 12.1 Mechanism of Action Pregnancy Category C: using Calcitonin Salmon Nasal Solution? Before 5 WARNINGS AND PRECAUTIONS 12.2 Pharmacodynamics Risk Summary you use Calcitonin Salmon Nasal Solution, tell Take your calcium and vitamin D as your healthcare 5.1 Hypersensitivity Reactions 12.3 Pharmacokinetics There are no adequate and well-controlled studies in pregnant women. Calcitonin Salmon Nasal Solution should be used during pregnancy only if the potential benefit your healthcare provider if you: provider tells you to. 5.2 Hypocalcemia 13 NONCLINICAL TOXICOLOGY 5.3 Nasal Adverse Reactions justifies the use as compared with potential risks to the patient and fetus. Based on 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility animal data, Calcitonin Salmon Nasal Solution is predicted to have low probability of • have any other medical conditions • nose irritation Calcitonin Salmon 5.4 Malignancy 14 CLINICAL STUDIES increasing the risk of adverse developmental outcomes above background risk. Nasal Solution, USP 5.5 Antibody Formation • have low calcium levels in your blood Irritation of your nose can happen while you are 16 HOW SUPPLIED/STORAGE AND HANDLING Animal Data (Calcitonin Salmon Nasal Spray) 5.6 Urine Sediment Abnormalities 17 PATIENT COUNSELING INFORMATION Calcitonin-salmon has been shown to cause a decrease in fetal birth weights in rabbits • are pregnant or plan to become pregnant. It is not using Calcitonin Salmon Nasal Solution, especially 06/16 6 ADVERSE REACTIONS when given by subcutaneous injection in doses 4 to 18 times the parenteral dose (of R 2 known if Calcitonin Salmon Nasal Solution can if you are over 65 years of age. Call your healthcare 6.1 Clinical Trials Experience *Sections or subsections omitted from the full prescribing informa- 54 International Units/m ) and 70 to 278 times the intranasal dose recommended for tion are not listed. human use based on body surface area. No embryo/fetal toxicities related to Calcitonin harm your unborn baby. provider right way if you have any of these symp- Salmon Nasal Solution were reported from maternal subcutaneous daily doses in rats toms of nose irritation up to 80 International Units/kg/day from gestation day 6 to 15. • are breastfeeding or plan to breastfeed. It is not FULL PRESCRIBING INFORMATION 5.5 Antibody Formation o crusting Circulating antibodies to calcitonin-salmon have been reported with Calcitonin Salmon 8.3 Nursing Mothers known if Calcitonin Salmon Nasal Solution passes o It is not known whether this drug is excreted in human milk. No studies have been dryness 1 INDICATIONS AND USAGE Nasal Solution. The possibility of antibody formation should be considered in any patient into your breast milk. You and your healthcare 010161-06 with an initial response to Calcitonin Salmon Nasal Solution who later stops responding conducted to assess the impact of Calcitonin Salmon Nasal Solution on milk production o 1.1 Treatment of Postmenopausal Osteoporosis in humans, its presence in human breast milk, or its effects on the breast-fed child. redness or swelling to treatment [see ADVERSE REACTIONS (6.3)]. provider should decide if you will use Calcitonin o Calcitonin Salmon Nasal Solution is indicated for the treatment of postmenopausal oste- Because many drugs are excreted in human milk, caution should be exercised when nose sores (ulcers) oporosis in women greater than 5 years postmenopause. Fracture reduction efficacy 5.6 Urine Sediment Abnormalities Calcitonin Salmon Nasal Solution is administered to a nursing woman. Calcitonin has Salmon Nasal Solution or breastfeed. o has not been demonstrated. Calcitonin Salmon Nasal Solution should be reserved for Coarse granular casts and casts containing renal tubular epithelial cells were reported been shown to inhibit lactation in rats. nose bleeds patients for whom alternative treatments are not suitable (e.g., patients for whom other in young adult volunteers at bed rest who were given injectable calcitonin-salmon therapies are contraindicated or for patients who are intolerant or unwilling to use other to study the effect of immobilization on osteoporosis. There was no other evidence 8.4 Pediatric Use Tell your healthcare provider about all the Your healthcare provider may stop your treatment therapies). of renal abnormality and the urine sediment normalized after calcitonin-salmon was Safety and effectiveness in pediatric patients have not been established. medicines you take, including prescription and with Calcitonin Salmon Nasal Solution until your 1.2 Important Limitations of Use stopped. Periodic examinations of urine sediment should be considered. Urine sedi- 8.5 Geriatric Use • Due to the possible association between malignancy and calcitonin-salmon use, ment abnormalities have not been reported in ambulatory volunteers treated with cal- In a multi-centered, double-blind, randomized clinical study of calcitonin salmon nasal over-the-counter medicines, vitamins, and herbal nose irritation symptoms go away. citonin salmon nasal spray. the need for continued therapy should be re-evaluated on a periodic basis [see spray, 279 patients were less than 65 years old, while 467 patients were 65 to 74 years supplements. • risk of cancer WARNINGS AND PRECAUTIONS (5.4)]. 6 ADVERSE REACTIONS old and 196 patients were 75 years old and older. Compared to subjects less than 65 years old, the incidence of nasal adverse reactions (rhinitis, irritation, erythema, and • Calcitonin Salmon Nasal Solution has not been shown to increase spinal bone min- excoriation) was higher in patients over the age of 65, particularly among those over the Especially tell your healthcare provider if you take: People who use calcitonin-salmon, the medicine eral density in early postmenopausal women. The following serious adverse reactions are discussed in greater detail in other sections of the label: age of 75. Other reported clinical experience has not identified differences in responses • lithium. Your healthcare provider may need in Calcitonin Salmon Nasal Solution, may have an 2 DOSAGE AND ADMINISTRATION • Hypersensitivity Reactions, including anaphylaxis [see WARNINGS AND between the elderly and younger patients, but greater sensitivity of some older individ- PRECAUTIONS (5.1)]. uals cannot be ruled out. to change your dose of lithium while you use increased risk of cancer. 2.1 Basic Dosing Information • Hypocalcemia [see WARNINGS AND PRECAUTIONS (5.2)]. The recommended dose of Calcitonin Salmon Nasal Solution is 1 spray (200 • Nasal Adverse Reactions [see WARNINGS AND PRECAUTIONS (5.3)]. 10 OVERDOSAGE Calcitonin Salmon Nasal Solution. • increase of certain cells (sediment) in your International Units) per day administered intranasally, alternating nostrils daily. • Malignancy [see WARNINGS AND PRECAUTIONS (5.4)]. The pharmacologic actions of Calcitonin Salmon Nasal Solution suggest that hypocal- urine 2.2 Priming (Activation) of Pump 6.1 Clinical Trials Experience cemic tetany could occur in overdose. Therefore, provisions for parenteral administra- Know the medicines you take. Keep a list of them Unopened Calcitonin Salmon Nasal Solution should be stored in the refrigerator. Before Because clinical trials are conducted under widely varying conditions, adverse reaction tion of calcium should be available for the treatment of overdose. to show your healthcare provider and pharmacist Your healthcare provider should test your urine using the first dose of Calcitonin Salmon Nasal Solution, the patient should wait until it rates observed in the clinical trials of a drug cannot be directly compared to rates in the Single doses of Calcitonin Salmon Nasal Solution up to 1600 International Units, doses often while you are using Calcitonin Salmon Nasal has reached room temperature. To prime the pump before it is used for the first time, clinical trials of another drug and may not reflect the rates observed in practice. when you get a new medicine. the bottle should be held upright and the two white side arms of the pump depressed up to 800 International Units per day for 3 days and chronic administration of doses up Solution. toward the bottle, repeat until a full spray is released. The pump is primed once the first The safety of Calcitonin Salmon Nasal Solution in the treatment of postmenopausal to 600 International Units per day have been studied without serious adverse effects. osteoporosis was assessed in 5 randomized, double-blind, placebo controlled trials that How should I use Calcitonin Salmon Nasal full spray is emitted. To administer, the nozzle should first be carefully placed into the 11 DESCRIPTION The most common side effects of Calcitonin nostril while the patient’s head is in the upright position, then the pump should be firmly enrolled postmenopausal women, aged 45 to 75 years. The duration of the trials ranged Solution? from 1 to 2 years. The incidence of adverse reactions reported in studies involving depressed toward the bottle. The pump should not be primed before each daily dose. Calcitonin is a polypeptide hormone secreted by the parafollicular cells of the thyroid Salmon Nasal Solution include: postmenopausal osteoporotic patients chronically exposed to Calcitonin Salmon Nasal gland in mammals and by the ultimobranchial gland of birds and fish. • For detailed instructions, see the Instructions 2.3 Recommendations for Calcium and Vitamin D Supplementation Solution (N=341) and to placebo nasal spray (N=131), and reported in greater than • back pain Patients who use Calcitonin Salmon Nasal Solution should receive adequate cal- 3% of Calcitonin Salmon Nasal Solution treated patients are presented in the following Calcitonin Salmon Nasal Solution is a synthetic polypeptide of 32 amino acids in the for Use at the end of this Patient Information • muscle aches cium (at least 1000 mg elemental calcium per day) and vitamin D (at least 400 table. Other than flushing, nausea, possible allergic reactions, and possible local irrita- same linear sequence that is found in calcitonin of salmon origin. This is shown by the leaflet. International Units per day). tive effects in the respiratory tract, a relationship to Calcitonin Salmon Nasal Solution following graphic formula: • headache has not been established. 3 DOSAGE FORMS AND STRENGTHS • Use Calcitonin Salmon Nasal Solution exactly as • runny nose your healthcare provider tells you to use it. Calcitonin Salmon Nasal Solution consists of one glass bottle and one screw-on pump. Table 1. Adverse Reactions Occurring in at Least 3% Of Postmenopausal These are not all the possible side effects of The bottle contains 3.7 mL of calcitonin-salmon clear solution at a concentration of 2200 Patients Treated with Calcitonin Salmon Nasal Solution • Do not use Calcitonin Salmon Nasal Solution International Units per mL. A primed pump delivers 0.09 mL (200 International Units) Calcitonin Salmon Placebo Nasal Spray Calcitonin Salmon Nasal Solution. For more infor- calcitonin-salmon per actuation. Nasal Solution until your healthcare provider shows you and you mation, ask your healthcare provider or pharmacist. 4 CONTRAINDICATIONS N = 341 N = 131 understand how to use it correctly. Adverse Reaction % of Patients % of Patients Tell your healthcare provider right away if you have Hypersensitivity to calcitonin-salmon or any of the excipients. Reactions have included • Use 1 spray of Calcitonin Salmon Nasal Solution, any side effect that bothers you or does not go away. anaphylactic shock, anaphylaxis, bronchospasm, and swelling of the tongue or throat [see Rhinitis 12 7 1 time each day, in 1 nostril (inside your nose). WARNINGS and PRECAUTIONS (5.1)]. Symptom of Nose† 11 16 o Call your doctor for medical advice about side 5 WARNINGS AND PRECAUTIONS Back Pain 5 2 Start with 1 spray in your left nostril on your Arthralgia 4 5 effects. You may report side effects to FDA at 5.1 Hypersensitivity Reactions It is provided in a 3.7 mL fill glass bottle as a solution for nasal administration. This is first day, followed by 1 spray in your right nos- Serious hypersensitivity reactions have been reported in patients receiving Calcitonin Epistaxis 4 5 sufficient medication for at least 30 doses. tril on the second day. 1-800-FDA-1088­ . Salmon Nasal Solution, e.g., bronchospasm, swelling of the tongue or throat, anaphy- Headache 3 5 Active Ingredient: calcitonin-salmon, 2200 International Units per mL (corresponding to o laxis and anaphylactic shock. Reports of serious hypersensitivity reactions with inject- † Symptom of nose includes: nasal crusts, dryness, redness or erythema, 200 International Units per 0.09 mL actuation). Continue to switch nostrils for your dose each How do I store Calcitonin Salmon Nasal able calcitonin-salmon have also been reported, including reports of death attributed nasal sores, irritation, itching, thick feeling, soreness, pallor, infection, to anaphylaxis. The usual provisions should be made for emergency treatment if such Inactive Ingredients: sodium chloride, chlorobutanol (possesses a characteristic odor), day. Solution? stenosis, runny/blocked, small wound, bleeding wound, tenderness, hydrochloric acid (added as necessary to adjust pH), purified water and nitrogen. a reaction occurs. Hypersensitivity reactions should be differentiated from generalized uncomfortable feeling and sore across bridge of nose. • Store open bottles of Calcitonin Salmon Nasal flushing and hypotension [see CONTRAINDICATIONS (4)]. The activity of Calcitonin Salmon Nasal Solution is stated in International Units • Your healthcare provider should check your nose Nasal Adverse Reactions: In all postmenopausal patients treated with Calcitonin based on bioassay in comparison with the International Reference Preparation of Solution at room temperature between 20°C to For patients with suspected hypersensitivity to calcitonin-salmon, skin testing should Salmon Nasal Solution , the most commonly reported nasal adverse reactions included before you start using Calcitonin Salmon Nasal be considered prior to treatment utilizing a dilute, sterile solution of a calcitonin-salmon calcitonin-salmon for Bioassay, distributed by the National Institute of Biological 25°C (68°F to 77°F) for 35 days. rhinitis (12%), epistaxis (4%), and sinusitis (2%). Smoking did not have a contributory Standards and Control, Holly Hill, London. Solution and often while you are using it. injectable product. Healthcare providers may wish to refer patients who require skin effect of the occurrence of nasal adverse reactions. testing to an allergist. A detailed skin testing protocol is available from the Drug Safety • Store unopened bottles of Calcitonin Salmon Adverse reactions reported in 1 to 3% of patients treated with Calcitonin Salmon Nasal 12 CLINICAL PHARMACOLOGY • Tell your healthcare provider if you start to have Department of Par Pharmaceutical at 1-800-828-9393. Nasal Solution in the refrigerator between 2°C to Solution include: influenza-like symptoms, erythematous rash, arthrosis, myalgia, 12.1 Mechanism of Action discomfort (irritation) in your nose that bothers you 5.2 Hypocalcemia sinusitis, upper respiratory tract infection, bronchospasm, abdominal pain, nausea, diz- 8°C (36°F to 46°F). Do not freeze. Hypocalcemia associated with tetany (i.e., muscle cramps, twitching) and seizure activ- Calcitonin-salmon is a calcitonin receptor agonist. Calcitonin-salmon acts primarily on ziness, paresthesia, abnormal lacrimation, conjunctivitis, lymphadenopathy, infection, bone, but direct renal effects and actions on the gastrointestinal tract are also recog- while you use Calcitonin Salmon Nasal Solution. ity has been reported with calcitonin therapy. Hypocalcemia must be corrected before and depression. • Store Calcitonin Salmon Nasal Solution bottles in initiating therapy with Calcitonin Salmon Nasal Solution. Other disorders affecting min- nized. Calcitonin-salmon appears to have actions essentially identical to calcitonins • Your healthcare provider should prescribe calcium eral metabolism (such as vitamin D deficiency) should also be effectively treated. In Malignancy of mammalian origin, but its potency per mg is greater and it has a longer duration of an upright position. patients with these conditions, serum calcium and symptoms of hypocalcemia should A meta-analysis of 21 randomized, controlled clinical trials with calcitonin-salmon (nasal action. and vitamin D to help prevent low calcium levels be monitored during therapy with Calcitonin Salmon Nasal Solution. Use of Calcitonin spray or investigational oral formulations) was conducted to assess the risk of malignan- The actions of calcitonin on bone and its role in normal human bone physiology are in your blood while you use Calcitonin Salmon • Safely throw away Calcitonin Salmon Nasal Salmon Nasal Solution is recommended in conjunction with an adequate intake of cal- cies in calcitonin-salmon treated patients compared to placebo-treated patients. The tri- still not completely elucidated, although calcitonin receptors have been discovered in Solution in the trash after you have used 30 doses cium and vitamin D [see DOSAGE AND ADMINISTRATION (2.3)]. als in the meta-analysis ranged in duration from 6 months to 5 years and included a total osteoclasts and osteoblasts. Nasal Solution. of 10883 patients (6151 treated with calcitonin-salmon and 4732 treated with placebo). (sprays). 5.3 Nasal Adverse Reactions The overall incidence of malignancies reported in these 21 trials was higher among 12.2 Pharmacodynamics • Take your calcium and vitamin D as your health- Adverse reactions related to the nose including rhinitis and epistaxis have been reported. calcitonin-salmon treated patients (254/6151 or 4.1%) compared with placebo-treated The information below, describing the clinical pharmacology of calcitonin, has been Development of mucosal alterations may occur. Therefore, periodic nasal examinations patients (137/4732 or 2.9%). Findings were similar when analyses were restricted to the derived from studies with injectable calcitonin-salmon. The mean bioavailability of cal- care provider tells you to. Keep Calcitonin Salmon Nasal Solution and all with visualization of the nasal mucosa, turbinates, septum and mucosal blood vessels 18 nasal spray only trials [calcitonin-salmon 122/2712 (4.5%); placebo 30/1309 (2.3%)]. citonin-salmon nasal spray is approximately 3% of the injectable calcitonin-salmon in other medicines out of the reach of children. are recommended prior to start of treatment with Calcitonin Salmon Nasal Solution, healthy subjects and, therefore, the conclusions concerning the clinical pharmacology • There are 30 doses (sprays) of Calcitonin Salmon periodically during the course of therapy, and at any time nasal symptoms occur. The meta-analysis results suggest an increased risk of overall malignancies in calci- of this preparation may be different. tonin-salmon treated patients compared to placebo-treated patients when all 21 trials Nasal Solution in each bottle. After 30 doses, General information about the safe and effective Calcitonin Salmon Nasal Solution should be discontinued if severe ulceration of the are included and when the analysis is restricted to the 18 nasal spray only trials (see Bone nasal mucosa occurs, as indicated by ulcers greater than 1.5 mm in diameter or pen- each spray may not give you the right amount use of Calcitonin Salmon Nasal Solution. Table 2). It is not possible to exclude an increased risk when calcitonin-salmon is admin- Single injections of calcitonin-salmon caused a marked transient inhibition of the ongo- etrating below the mucosa, or those associated with heavy bleeding. Although smaller ing bone resorptive process. With prolonged use, there is a persistent, smaller decrease ulcers often heal without withdrawal of Calcitonin Salmon Nasal Solution, medication istered by the subcutaneous, intramuscular, or intravenous route because these routes of medicine, even if the bottle is not completely Medicines are sometimes prescribed for purposes of administration were not investigated in the meta-analysis. The increased malignancy in the rate of bone resorption. Histologically, this is associated with a decreased number should be discontinued temporarily until healing occurs [see ADVERSE REACTIONS risk seen with the meta-analysis was heavily influenced by a single large 5-year trial, of osteoclasts and an apparent decrease in their resorptive activity. empty. Keep track of the number of doses of med- (6.1)]. other than those listed in a Patient Information leaf- which had an observed risk difference of 3.4% [95% CI (0.4%, 6.5%)]. Imbalances in In healthy adults, who have a relatively low rate of bone resorption, the administra- icine used from your bottle. let. Do not use Calcitonin Salmon Nasal Solution 5.4 Malignancy risks were still observed when analyses excluded basal cell carcinoma (see Table 2); tion of exogenous calcitonin-salmon results in decreases in serum calcium within the In a meta-analysis of 21 randomized, controlled clinical trials with calcitonin-salmon the data were not sufficient for further analyses by type of malignancy. A mechanism limits of the normal range. In healthy children and in patients whose bone resorp- • If you use too much Calcitonin Salmon Nasal for a condition for which it was not prescribed. Do (nasal spray or investigational oral formulations), the overall incidence of malignancies for these observations has not been identified. Although a definitive causal relation- tion is more rapid, decreases in serum calcium are more pronounced in response to not give Calcitonin Salmon Nasal Solution to other reported was higher among calcitonin-salmon treated patients (4.1%) compared with ship between calcitonin-salmon use and malignancies cannot be established from calcitonin-salmon. Solution, call your healthcare provider or go to the placebo treated patients (2.9%). This suggests an increased risk of malignancies in calci- this meta-analysis, the benefits for the individual patient should be carefully evaluated nearest hospital emergency room right away. people, even if they have the same symptoms you tonin-salmon treated patients compared to placebo treated patients. The benefits for the against all possible risks [see WARNINGS AND PRECAUTIONS (5.4)]. Kidney individual patient should be carefully considered against possible risks [see ADVERSE Studies with injectable calcitonin-salmon show increases in the excretion of filtered have. It may harm them. REACTIONS (6.1)]. phosphate, calcium, and sodium by decreasing their tubular reabsorption. Comparable studies have not been conducted with Calcitonin Salmon Nasal Solution. This Patient Information summarizes the most mist is so fine, you may not feel it Gastrointestinal Tract What should I tell my healthcare provider before using Calcitonin Salmon Nasal 5. Holding the bottle upright with your index finger on top of one of the Some evidence from studies with injectable preparations suggests that calcitonin-salmon Solution? Before you use Calcitonin Salmon Nasal Solution, tell your healthcare two side arms of the pump, gently remove the clear protective cap important information about Calcitonin Salmon inside your nose. Also, some med- may have effects on the gastrointestinal tract. Short-term administration of injectable provider if you: from the top of the nozzle. Nasal Solution. If you would like more information, ication may drip out of your nose. calcitonin-salmon results in marked transient decreases in the volume and acidity of • have any other medical conditions gastric juice and in the volume and the trypsin and amylase content of pancreatic juice. • have low calcium levels in your blood talk with your healthcare provider. You can ask your However, in either case, the med- Whether these effects continue to be elicited after each injection of calcitonin-salmon • are pregnant or plan to become pregnant. It is not known if Calcitonin Salmon Nasal during chronic therapy has not been investigated. These studies have not been con- Solution can harm your unborn baby. pharmacist or healthcare provider for information ication is absorbed. IMPORTANT: ducted with Calcitonin Salmon Nasal Solution. • are breastfeeding or plan to breastfeed. It is not known if Calcitonin Salmon Nasal about Calcitonin Salmon Nasal Solution that is writ- Do not “test” the spray unit or Calcium Homeostasis Solution passes into your breast milk. You and your healthcare provider should decide In two clinical studies designed to evaluate the pharmacodynamic response to calci- if you will use Calcitonin Salmon Nasal Solution or breastfeed. ten for health professionals. prime it before you use your daily tonin-salmon nasal spray, administration of calcitonin-salmon 100-1600 International dose because this will waste your Units to healthy volunteers resulted in rapid and sustained decreases within the normal Tell your healthcare provider about all the medicines you take, including prescrip- Priming a New Bottle For more information, call 1-800-828-9393. range for both total serum calcium and serum ionized calcium. Single doses of calci- tion and over-the-counter medicines, vitamins, and herbal supplements. medication. tonin-salmon greater than 400 International Units did not produce any further biological 6. To ensure proper delivery of medication, a newly opened and Especially tell your healthcare provider if you take: What are the ingredients in Calcitonin Salmon response to the drug. assembled bottle must be primed before you use it for the first Cleaning the Pump • lithium. Your healthcare provider may need to change your dose of lithium while you time. Nasal Solution? 12.3 Pharmacokinetics use Calcitonin Salmon Nasal Solution. The bioavailability of Calcitonin Salmon Nasal Solution relative to intramuscular admin- If your pharmacist assembled the unit for you, check to see if it Active Ingredients: calcitonin-salmon Once or twice a week, wipe the nozzle with a clean, istration in healthy volunteers is between 3 and 5%. Calcitonin Salmon Nasal Solution Know the medicines you take. Keep a list of them to show your healthcare provider and has already been primed by pumping the unit once. If a full spray is absorbed rapidly by the nasal mucosa with a mean T of about 13 minutes. The pharmacist when you get a new medicine. damp cloth. Dry the nozzle before replacing the max is emitted, the unit has already been primed. If no spray is emit- Inactive Ingredients: sodium chloride, chlorobuta- terminal half-life of calcitonin-salmon has been calculated to be around 18 minutes and How should I use Calcitonin Salmon Nasal Solution? ted, you must prime the unit. Holding the bottle upright with your dust cap. no evidence of accumulation was observed with multiple dosing. nol (possesses a characteristic odor), hydrochloric • For detailed instructions, see the Instructions for Use at the end of this Patient index and middle fingers on the two side arms of the pump, and Storing the Unit 13 NONCLINICAL TOXICOLOGY Information leaflet. your thumb on the bottom of the bottle, press the arms down fully acid (added as necessary to adjust pH), purified • Use Calcitonin Salmon Nasal Solution exactly as your healthcare provider tells you until you see a full spray. Now the nasal spray is ready for use. water and nitrogen. 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility to use it. 8. Holding the bottle with two fingers Carcinogenicity Do not re-prime the pump before each daily use because this under the two side arms of the The incidence of pituitary adenomas was increased in rats after one and two years of • Do not use Calcitonin Salmon Nasal Solution until your healthcare provider shows will waste your medication. subcutaneous exposure to synthetic calcitonin-salmon. The significance of this finding you and you understand how to use it correctly. Using the Medication How to Assemble and Use pump, gently replace the protec- to humans is unknown because pituitary adenomas are very common in rats as they • Use 1 spray of Calcitonin Salmon Nasal Solution, 1 time each day, in 1 nostril (inside tive cap on the nasal spray unit. age, the pituitary adenomas did not transform into metastatic tumors, there were no your nose). 7. The recommended dose of Calcitonin Salmon Nasal Solution is one Calcitonin Salmon Nasal Solution, USP other clear treatment-related neoplasms, and synthetic calcitonin-salmon related neo- o Start with 1 spray in your left nostril on your first day, followed by 1 spray in your spray once a day in one nostril. Be careful not to depress the plasms were not observed in mice after two years of dosing. right nostril on the second day. Keep your head upright and carefully place the nozzle in one nostril. pump while this is being done. Rat findings: o Continue to switch nostrils for your dose each day. The only clear neoplastic finding in rats dosed subcutaneously with synthetic calci- Tilt the bottle until it is in a straight line with the nasal passage. One Spray, Once a Day Your healthcare provider should check your nose before you start using Calcitonin Once the pump is primed, the unit tonin-salmon was an increase in the incidence of pituitary adenomas in male Fisher •  must be kept at room tempera- 344 rats and female Sprague Dawley rats after one year of dosing and male Sprague Salmon Nasal Solution and often while you are using it. Firmly press down on the pump once to spray the medication into BEFORE USING CALCITONIN SALMON NASAL Dawley rats dosed for one and two years. In female Sprague Dawley rats, the incidence • Tell your healthcare provider if you start to have discomfort (irritation) in your nose that your nose. It is not necessary to inhale while this is being done. ture between 20°C to 25°C (68°F of pituitary adenomas after two years was high in all treatment groups (between 80% bothers you while you use Calcitonin Salmon Nasal Solution. Please note: Because the mist is so fine, you may not feel it inside SOLUTION and 92% including the control groups) such that a treatment-related effect could not be • Your healthcare provider should prescribe calcium and vitamin D to help prevent low your nose. Also, some medication may drip out of your nose. to 77°F) in the upright position distinguished from natural background incidence. The lowest dose in male Sprague calcium levels in your blood while you use Calcitonin Salmon Nasal Solution. However, in either case, the medication is absorbed. IMPORTANT: This package contains one bottle of Calcitonin Dawley rats that developed an increased incidence of pituitary adenomas after two until the medication is finished. • Take your calcium and vitamin D as your healthcare provider tells you to. Do not “test” the spray unit or prime it before you use your daily Salmon Nasal Solution and one screw on pump. years of dosing (1.7 International Units/kg/day) is approximately 2 times the maximum dose because this will waste your medication. IMPORTANT recommended intranasal dose in humans (200 International Units/day) based on body • There are 30 doses (sprays) of Calcitonin Salmon Nasal Solution in each bottle. After Important Facts About Your Medication: surface area conversion between rats and humans and a 20-fold conversion factor to 30 doses, each spray may not give you the right amount of medicine, even if the Cleaning the Pump • Do not refrigerate the unit between doses account for decreased clinical exposure via the intranasal route. The findings suggest bottle is not completely empty. Keep track of the number of doses of medicine used Once or twice a week, wipe the nozzle with a clean, damp cloth. Dry the nozzle before that calcitonin-salmon reduced the latency period for development of non-functioning from your bottle. replacing the dust cap. • The bottle contains the proper amount of medica- pituitary adenomas. • Do not store the unit on its side • If you use too much Calcitonin Salmon Nasal Solution, call your healthcare provider Storing the Unit tion — be aware that the entire bottle will not be Mouse findings: or go to the nearest hospital emergency room right away. 8. Holding the bottle with two fingers under the two side arms of the filled with liquid. Bottles left at room temperature (opened or No carcinogenicity potential was evident in male or female mice dosed subcutaneously What are the possible side effects of Calcitonin Salmon Nasal Solution? for two years with synthetic calcitonin-salmon at doses up to 800 International Units/kg/ pump, gently replace the protective cap on the nasal spray unit. Be • Before opening and assembling your medication unopened) for more than 35 days must be discarded. day. The 800 International Units/kg/day dose is approximately 390 times the maximum Calcitonin Salmon Nasal Solution may cause serious side effects, including: careful not to depress the pump while this is being done. Once the recommended intranasal dose in humans (200 International Units) based on scaling for • allergic reactions pump is primed, the unit must be kept at room temperature between bottle, keep it in your refrigerator between 2°C to Refrigerated bottles are good until the expiration body surface area and a 20-fold conversion factor to account for low clinical exposure Some people have had an allergic reaction when using Calcitonin Salmon Nasal 20°C to 25°C (68°F to 77°F) in the upright position until the medication 8°C (36°F to 46°F). Freezing is to be avoided. date stamped on the bottle and box. via the intranasal route. Solution. Some reactions may be serious and can be life threatening. Call your health- is finished. Mutagenesis care provider or go to the nearest hospital emergency room right away if you have any of • After opening and assembling a new medication Alternate Nostrils Daily Synthetic calcitonin-salmon tested negative for mutagenicity using Salmonella typh- these symptoms of an allergic reaction. imurium (5 strains) and Escherichia coli (2 strains), with and without rat liver metabolic o trouble breathing bottle, keep it at room temperature between 20°C The first day, start with one spray in the left nostril. activation, and was not clastogenic in a chromosome aberration test in Chinese Hamster o swelling of your face, throat or tongue to 25°C (68°F to 77°F) in an upright position. V79 cells. There was no evidence that calcitonin-salmon was clastogenic in the in vivo o fast heartbeat The next day, use one spray in the right nostril, and mouse micronucleus test. o chest pain IMPORTANT so on. Fertility o feel dizzy or faint • Do not refrigerate the unit between doses HOW TO USE CALCITONIN SALMON NASAL Effects of calcitonin-salmon on fertility have not been assessed in animals. If you might be allergic to calcitonin-salmon, your healthcare provider should do a skin • Do not store the unit on its side SOLUTION It is important to receive the correct daily amount of test before you use Calcitonin Salmon Nasal Solution. 14 CLINICAL STUDIES Bottles left at room temperature (opened or unopened) for more than 35 days must be calcium and vitamin D, as directed by your health- • low calcium levels in your blood (hypocalcemia) Putting the Nasal Spray Pump Unit Together Two randomized, placebo-controlled, two-year trials were conducted in 266 postmeno- discarded. care provider. Calcitonin Salmon Nasal Solution may lower the calcium levels in your blood. If you pausal women who were greater than 5 years postmenopause with spinal, forearm or Refrigerated bottles are good until the expiration date stamped on the bottle and box. 1. If your bottle and pump unit were already assem- femoral bone mineral density (BMD) at least one standard deviation below the normal have low blood calcium before you start using Calcitonin Salmon Nasal Solution, it may IMPORTANT value for healthy premenopausal women (T-score < -1). In both studies, a total of 144 get worse during treatment. Your low blood calcium must be treated before you use Alternate Nostrils Daily bled by your pharmacist, go to step 6. If not, patients received Calcitonin Salmon Nasal Solution 200 International Units or placebo Calcitonin Salmon Nasal Solution. Most people with low blood calcium levels do not remove the bottle from your refrigerator and allow • Use Calcitonin Salmon Nasal Solution daily. daily. The intent-to-treat population comprised 139 patients who had at least one fol- have symptoms, but some people may have symptoms. Call your healthcare provider The first day, start with one spray in the left nostril. The next day, use one spray in the low-up BMD measurement. In study 1, patients also received 500 mg daily calcium right away if you have any of these symptoms of low blood calcium: right nostril, and so on. it to reach room temperature before assembling. To ensure proper treatment, it is important to use supplements, while in study 2, patients received no calcium supplementation. The pri- o numbness or tingling in your fingers, toes, or around your mouth It is important to receive the correct daily amount of calcium and vitamin D, as directed mary endpoint for both studies was percent change in lumbar spine BMD at 2 years. by your healthcare provider. 2. Keeping the bottle upright, unscrew the white your Calcitonin Salmon Nasal Solution daily even Calcitonin Salmon Nasal Solution increased lumbar vertebral BMD relative to placebo Your healthcare provider should: if you have no symptoms of postmenopausal in women with low bone mass who were greater than 5 years post menopause (see o do blood tests while you use Calcitonin Salmon Nasal Solution IMPORTANT cap. Table 3 below). o prescribe calcium and vitamin D to help prevent low calcium levels in your blood osteoporosis. while you use Calcitonin Salmon Nasal Solution • Use Calcitonin Salmon Nasal Solution daily. 3. Remove the pump from the plastic protection Table 3. Calcitonin Salmon Nasal Solution: Lumbar Spine Bone Mineral Density In Women Greater Than 5 years Take your calcium and vitamin D as your healthcare provider tells you to. To ensure proper treatment, it is important to use your Calcitonin Salmon Nasal Solution bag. What is the Correct Dose of Calcitonin Salmon Postmenopause With Low Bone Mass daily even if you have no symptoms of postmenopausal osteoporosis. Nasal Solution? • nose irritation 4. Holding the bottle upright, insert the nasal spray Lumbar Spine Bone Mineral Density, Irritation of your nose can happen while you are using Calcitonin Salmon Nasal Solution, What is the Correct Dose of Calcitonin Salmon Nasal Solution? A single spray of Calcitonin Salmon Nasal Solution, Mean Change from Baseline (in %) at Month 24 especially if you are over 65 years of age. Call your healthcare provider right way if you A single spray of Calcitonin Salmon Nasal Solution, USP contains one daily dose, which is pump unit into the bottle. Then turn the pump Study 1 Study 2 have any of these symptoms of nose irritation 200 International Units of calcitonin-salmon. The fine mist is actually 0.09 mL (milliliter) of o USP contains one daily dose, which is 200 (with calcium supplement) (no calcium supplement) crusting solution. Your bottle of Calcitonin Salmon Nasal Solution contains at least 30 doses. clockwise, and tighten it until it is securely fas- o dryness International Units of calcitonin-salmon. The fine mist n (ITT)=100 n (ITT) =39 Priming the pump as described in step 6 does not alter the total number of doses avail- o redness or swelling tened to the bottle. Calcitonin Salmon +1.56 +1.02 able in a bottle of Calcitonin Salmon Nasal Solution. The bottle need only be primed is actually 0.09 mL (milliliter) of solution. Your bot- Nasal Solution o nose sores (ulcers) o nose bleeds once after assembly. Do not reprime or “test spray” your bottle before you use your daily Note: Do not depress pump when it is not attached tle of Calcitonin Salmon Nasal Solution contains 200 IU NS Daily dose of Calcitonin Salmon Nasal Solution. This will waste your medication. Placebo +0.20 -1.85 Your healthcare provider may stop your treatment with Calcitonin Salmon Nasal to the bottle. at least 30 doses. Priming the pump as described Solution until your nose irritation symptoms go away. Please see your healthcare provider for complete product information for Calcitonin in step 6 does not alter the total number of doses Treatment +1.36 +2.87 Salmon Nasal Solution. 5. Holding the bottle upright with Difference • risk of cancer available in a bottle of Calcitonin Salmon Nasal p-value+ <0.05 <0.005 People who use calcitonin-salmon, the medicine in Calcitonin Salmon Nasal Solution, Call your doctor for medical advice about side effects. You may report side effects to your index finger on top of one of may have an increased risk of cancer. FDA at 1-800-FDA-1088. Solution. The bottle need only be primed once after ITT: Intent to Treat • increase of certain cells (sediment) in your urine Manufactured by: the two side arms of the pump, IU: International Units assembly. Do not reprime or “test spray” your bottle PAR PHARMACEUTICAL gently remove the clear protec- NS: nasal spray Your healthcare provider should test your urine often while you are using Calcitonin before you use your daily dose of Calcitonin Salmon Salmon Nasal Solution. Chestnut Ridge, NY 10977 tive cap from the top of the +p – values by parametric testing (2 – tailed 2-sample t-test) Nasal Solution. This will waste your medication. The most common side effects of Calcitonin Salmon Nasal Solution include: Revised: 06/2016 OS161-01-1-06 nozzle. No effects of calcitonin salmon nasal spray on cortical bone of the forearm or hip were • back pain Please see your healthcare provider for complete demonstrated. • muscle aches product information for Calcitonin Salmon Nasal In clinical studies of postmenopausal osteoporosis, bone biopsy and radial bone mass • headache assessments at baseline and after 26 months of daily injectable calcitonin-salmon indi- • runny nose Solution. cate that calcitonin therapy results in the formation of normal bone. These are not all the possible side effects of Calcitonin Salmon Nasal Solution. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side 16 HOW SUPPLIED/STORAGE AND HANDLING Tell your healthcare provider right away if you have any side effect that bothers you or Priming a New Bottle effects. You may report side effects to FDA at 16 HOW SUPPLIED does not go away. Available as a metered dose clear solution in a 3.7 mL fill clear glass bottle. It is avail- 1-800-FDA-1088. Call your doctor for medical advice about side effects. You may report side effects to able in a dosage strength of 200 International Units per activation (0.09 mL/spray). A 6. To ensure proper delivery of FDA at 1-­800-FDA-1088. screw-on pump is provided. The pump, following priming, will deliver 0.09 mL of solution. medication, a newly opened Manufactured by: Calcitonin Salmon Nasal Solution contains 2200 International Units/mL calcitonin-salmon How do I store Calcitonin Salmon Nasal Solution? and assembled bottle must be and is provided in an individual box containing one glass bottle and one screw-on pump • Store open bottles of Calcitonin Salmon Nasal Solution at room temperature between PAR PHARMACEUTICAL (NDC 49884-161-11). 20°C to 25°C (68°F to 77°F) for 35 days. primed before you use it for Chestnut Ridge, NY 10977 Storage and Handling • Store unopened bottles of Calcitonin Salmon Nasal Solution in the refrigerator between the first time. Store unopened bottle in refrigerator between 2°C to 8°C (36°F to 46°F). Freezing is 2°C to 8°C (36°F to 46°F). Do not freeze. to be avoided. If your pharmacist assembled • Store Calcitonin Salmon Nasal Solution bottles in an upright position. Revised: 06/2016 OS161-01-1-06 Store bottle in use at room temperature between 20°C to 25°C (68°F to 77°F) in an • Safely throw away Calcitonin Salmon Nasal Solution in the trash after you have used the unit for you, check to see if it upright position, for up to 35 days. Each bottle contains at least 30 doses. 30 doses (sprays). has already been primed by pump- Discard bottle after 30 doses. Keep Calcitonin Salmon Nasal Solution and all other medicines out of the reach ing the unit once. If a full spray is 17 PATIENT COUNSELING INFORMATION of children. General information about the safe and effective use of Calcitonin Salmon Nasal See FDA-approved patient labeling (Patient Information and Instructions for use). emitted, the unit has already been Solution. • Instruct patients on pump assembly, priming of the pump, and nasal introduction Medicines are sometimes prescribed for purposes other than those listed in a Patient primed. If no spray is emitted, of Calcitonin Salmon Nasal Solution. Although instructions for patients are sup- Information leaflet. Do not use Calcitonin Salmon Nasal Solution for a condition for plied with the individual bottle, procedures for use should be demonstrated to each you must prime the unit. Holding which it was not prescribed. Do not give Calcitonin Salmon Nasal Solution to other peo- patient [see DOSAGE AND ADMINISTRATION (2.2)]. Patients should notify their ple, even if they have the same symptoms you have. It may harm them. the bottle upright with your index healthcare provider if they develop significant nasal irritation [see WARNINGS AND and middle fingers on the two side PRECAUTIONS (5.3)]. This Patient Information summarizes the most important information about Calcitonin • Inform patients of the potential increase in risk of malignancy [see WARNINGS AND Salmon Nasal Solution. If you would like more information, talk with your healthcare arms of the pump, and your thumb PRECAUTIONS (5.4)]. provider. You can ask your pharmacist or healthcare provider for information about on the bottom of the bottle, press • Advise patients to maintain an adequate calcium (at least 1000 mg elemental calcium Calcitonin Salmon Nasal Solution that is written for health professionals. per day) and vitamin D (at least 400 International Units per day) intake [see DOSAGE For more information, call 1-800-828-9393. the arms down fully AND ADMINISTRATION (2.3)]. until you see What are the ingredients in Calcitonin Salmon Nasal Solution? Now the nasal spray • Instruct patients to seek emergency medical help or go to the nearest hospital emer- a full spray. gency room right away if they develop any signs or symptoms of a serious allergic Active Ingredients: calcitonin-salmon is ready for use. reaction. Inactive Ingredients: sodium chloride, chlorobutanol (possesses a characteristic odor), hydrochloric acid (added as necessary to adjust pH), purified water and nitrogen. • Advise patients how to correctly store unopened and opened product [see HOW Do not re-prime the pump SUPPLIED/STORAGE AND HANDLING (16)]. Advise patients that the bottle should be discarded after 30 doses, because after 30 doses, each spray may not deliver the How to Assemble and Use before each daily use because correct amount of medication even if the bottle is not completely empty. this will waste your medication. Calcitonin Salmon Nasal Solution, USP Patient Information Using the Medication Calcitonin Salmon Nasal Solution, USP One Spray, Once a Day (Calcitonin Salmon Nasal Spray) BEFORE USING CALCITONIN SALMON NASAL SOLUTION 7. The recommended dose of Calcit- Read this Patient Information before you start using Calcitonin Salmon Nasal Solution This package contains one bottle of Calcitonin Salmon Nasal Solution and one screw onin Salmon Nasal Solution is and each time you get a refill. There may be new information. This information does on pump. not take the place of talking to your healthcare provider about your medical condition Important Facts About Your Medication: one spray once a day in one or your treatment. • The bottle contains the proper amount of medication — be aware that the entire bottle nostril. What is Calcitonin Salmon Nasal Solution? will not be filled with liquid. Calcitonin Salmon Nasal Solution is a prescription medicine used to treat osteoporosis Keep your head upright and care- in women more than 5 years after menopause. Calcitonin Salmon Nasal Solution should • Before opening and assembling your medication bottle, keep it in your refrigerator be used for women who cannot use other treatments or who choose not to use other between 2°C to 8°C (36°F to 46°F). Freezing is to be avoided. fully place the nozzle in one nostril. treatments for osteoporosis. • After opening and assembling a new medication bottle, keep it at room temperature between 20°C to 25°C (68°F to 77°F) in an upright position. Tilt the bottle until it is in a straight It is not known if Calcitonin Salmon Nasal Solution lowers the chance of having bone line with the nasal passage. fractures. HOW TO USE CALCITONIN SALMON NASAL SOLUTION Calcitonin Salmon Nasal Solution has not been shown to be effective in women less Putting the Nasal Spray Pump Unit Together Firmly press down on the pump than 5 years after menopause. 1. If your bottle and pump unit were already assembled by your pharmacist, go to step 6. once to spray the medication It is not known if Calcitonin Salmon Nasal Solution is safe and effective in children under If not, remove the bottle from your refrigerator and allow it to reach room temperature 18 years of age. before assembling. into your nose. It is not neces- 2. Keeping the bottle upright, unscrew the white cap. Who should not use Calcitonin Salmon Nasal Solution? sary to inhale while this is being Do not use Calcitonin Salmon Nasal Solution if you: 3. Remove the pump from the plastic protection bag. done. Please note: Because the • are allergic to calcitonin-salmon or any of the ingredients in Calcitonin Salmon Nasal 4. Holding the bottle upright, insert the nasal spray pump unit into the bottle. Then turn Solution. See the end of this leaflet for a complete list of ingredients in Calcitonin the pump clockwise, and tighten it until it is securely fastened to the bottle. Salmon Nasal Solution. Note: Do not depress pump when it is not attached to the bottle.