In a large multi-centered, double-blind, randomized clinical study of 942 patients using calcitonin-salmon nasal spray, geriatric patients age 65 to 74 years old accounted for 49.5% of patients and those aged 75 years or more accounted for 21%. &f;7m?T*'gc`SGss,QU! 2'8cq(=@ y@ Known hypersensitivity to calcitonin salmon. Irrigant Sterile (Monarch Pharmaceuticals), Peg-interferon alfa-2a vial prefilled syringe, Penicillin G benzathine injection suspension, Penicillin G benzathine and penicillin G procaine injection suspension, Pneumococcal 7-valent conjugate vaccine (diphtheria CRM, Proparacaine hydrochloride ophthalmic solution, Rabies immune globulin (human) solvent/detergent treated, Tetanus immune globulin human solvent/detergent treated. $E}kyhyRm333: }=#ve Miacalcin injection is available as a clear, colorless, sterile solution of synthetic calcitonin salmon, USP in individual 2 mL multi-dose vials containing 200 USP Units per mL. 10 0 obj Please see our, 2010comirnaty-covid-19-vaccine-mRNA-pfizer-4000140, 2010covid-19-bivalent-vaccine-mrna-moderna-4000319. For the treatment of hypercalcemia, calcium supplements should be avoided. %PDF-1.6 % (See Cautions.). Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Administer by sub-Q or IM injection (Paget disease of bone, hypercalcemia, postmenopausal osteoporosis) or intranasally (postmenopausal osteoporosis). By using this Site you agree to the following, By using this Site you agree to the following, Miacalcin injection prescribing information. Healthcare providers may wish to refer patients who require skin testing to an allergist. new primary malignancy / Delayed / 4.1-4.1bronchospasm / Rapid / 1.0-3.0stroke / Early / 0-1.0myocardial infarction / Delayed / 0-1.0hearing loss / Delayed / 0-1.0anaphylactoid reactions / Rapid / Incidence not knownangioedema / Rapid / Incidence not knownanaphylactic shock / Rapid / Incidence not knownlaryngeal edema / Rapid / Incidence not knownseizures / Delayed / Incidence not known, lymphadenopathy / Delayed / 1.0-3.0constipation / Delayed / 1.0-3.0depression / Delayed / 1.0-3.0hypertension / Early / 1.0-3.0angina / Early / 1.0-3.0cystitis / Delayed / 0-3.0conjunctivitis / Delayed / 1.0-3.0skin ulcer / Delayed / 0-1.0anemia / Delayed / 0-1.0dyspnea / Early / 0-1.0gastritis / Delayed / 0-1.0migraine / Early / 0-1.0palpitations / Early / 0-1.0sinus tachycardia / Rapid / 0-1.0bundle-branch block / Early / 0-1.0phlebitis / Rapid / 0-1.0cholelithiasis / Delayed / 0-1.0hepatitis / Delayed / 0-1.0hyperthyroidism / Delayed / 0-1.0goiter / Delayed / 0-1.0nephrolithiasis / Delayed / 0-1.0hematuria / Delayed / 0-1.0peripheral edema / Delayed / 0-1.0edema / Delayed / 0-1.0blurred vision / Early / 0-1.0antibody formation / Delayed / 10.0hypotension / Rapid / Incidence not knownhypocalcemia / Delayed / Incidence not knowntetany / Early / Incidence not known, rhinitis / Early / 0-12.0injection site reaction / Rapid / 10.0-10.0vomiting / Early / 1.8-10.0nausea / Early / 1.8-10.0flushing / Rapid / 0-5.0back pain / Delayed / 5.0-5.0arthralgia / Delayed / 3.8-3.8epistaxis / Delayed / 3.5-3.5headache / Early / 3.2-3.2rash / Early / 1.0-3.0infection / Delayed / 1.0-3.0sinusitis / Delayed / 1.0-3.0diarrhea / Early / 1.0-3.0abdominal pain / Early / 1.0-3.0dyspepsia / Early / 1.0-3.0dizziness / Early / 1.0-3.0paresthesias / Delayed / 1.0-3.0myalgia / Early / 1.0-3.0fatigue / Early / 1.0-3.0lacrimation / Early / 1.0-3.0alopecia / Delayed / 0-1.0pruritus / Rapid / 0-1.0parosmia / Delayed / 0-1.0nasal congestion / Early / 0-1.0sneezing / Early / 0-1.0cough / Delayed / 0-1.0pharyngitis / Delayed / 0-1.0appetite stimulation / Delayed / 0-1.0flatulence / Early / 0-1.0dysgeusia / Early / 0-1.0xerostomia / Early / 0-1.0weight gain / Delayed / 0-1.0agitation / Early / 0-1.0insomnia / Early / 0-1.0anorexia / Delayed / 0-1.0anxiety / Delayed / 0-1.0vertigo / Early / 0-1.0tremor / Early / 0-1.0diaphoresis / Early / 0-1.0fever / Early / 0-1.0tinnitus / Delayed / 0-1.0otalgia / Early / 0-1.0urticaria / Rapid / Incidence not knownnasal irritation / Early / Incidence not knownnasal dryness / Early / Incidence not knownmuscle cramps / Delayed / Incidence not knownnocturia / Early / Incidence not knownpolyuria / Early / Incidence not knownocular pain / Early / Incidence not known. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Secretion of calcitonin is regulated by serum calcium; high serum calcium increases the release of calcitonin. The stability of calcitonin salmon in calcitonin salmon nasal spray at elevated temperatures was studied. Aspirate prior to injection to avoid injection into a blood vessel. Treatment of Paget disease of bone. CONTRAINDICATIONS: Hypersensitivity to calcitonin salmon or any of the excipients. If your usual dose is one dose per day, use the missed dose if you remember it during the same day. Reactions have included anaphylaxis with death, bronchospasm, and swelling of the tongue or throat [see . For the treatment of hypercalcemia, vitamin D preparations should be avoided. Please enter a Recipient Address and/or check the Send me a copy checkbox. endobj Musculoskeletal and connective tissue disorders. This includes your doctors, nurses, pharmacists, and dentists. Store bottle in use at room temperature between 15C-30C (59F-86F) in an upright Based on animal data, calcitonin-salmon nasal spray is predicted to have a low probability of increasing the risk of adverse developmental outcomes above background risk. There is insufficient evidence to support the use of salmon calcitonin in conditions associated with paediatric osteoporosis. These changes appear to correspond to changes toward more normal bone formation. Duration of treatment should not normally exceed 3 months due to evidence of an increased risk of malignancies with long term calcitonin use. endstream endobj startxref The following symptoms are uncommon, but if you experience any of them, call your doctor immediately: hives skin rash itching difficulty breathing or swallowing swelling of the tongue or throat Calcitonin salmon may cause other side effects. Nausea, vomiting, flushing and dizziness are known to be dose dependent when calcitonin is administered parenterally. Miacalcin injection is indicated for the early treatment of hypercalcemic emergencies, along with other appropriate agents, when a rapid decrease in serum calcium is required, until more specific treatment of the underlying disease can be accomplished. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. Effect not reported by other investigators. As an example, you should spray into the left side on the first day, then into the right side on the second day, and back to the left side on the third day. - Bone Resorption Inhibitors [27980] [52559] [57624]Calcitonin is a hypocalcemic hormone whose effects are generally opposite those of parathyroid hormone (PTH). hbbd``b` Before using the first dose of Miacalcin nasal spray, the patient should wait until it has reached room temperature. Allow solution to reach room temperature before priming pump and administering first dose. Bioavailability following subcutaneous and intramuscular injection in humans is high and similar for the two routes of administration (71% and 66%, respectively). Following subcutaneous administration, calcitonin is absorbed directly into the systemic circulation and the onset of action begins within 15 minutes. Calcium Carbonate; Simethicone: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Initially, 4 units/kg every 12 hours; may increase dosage after 1 or 2 days (if response not adequate) to 8 units/kg every 12 hours; may further increase dosage after 2 days (if response not adequate) to 8 units/kg every 6 hours. Call your doctor if you have any unusual problems while taking this medication. /SA true Product Safety Department. << Healthcare providers may wish to refer patients who require skin testing to an allergist.Prepare testing solution in a tuberculin syringe by diluting 10 International Units (0.05 mL) of the calcitonin salmon injection to 1 mL with 0.9% Sodium Chloride injection. [57624]Miacalcin Nasal Spray Storage (or generic equivalent): After opening, store bottle in use at room temperature between 20 and 25 degrees C (68 and 77 degrees F) in an upright position, for up to 35 days. [ 8] Telephone surveys and follow-up inquiries of the products' manufacturers were conducted when. [0 /XYZ 69.5999999 If there is anything . Calcium Carbonate: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. V5U?f1&&A(EgRM:BI>[:c]Y~Gtf]. If patient or caregiver is to administer parenteral calcitonin, provide careful instructions on proper administration methods, including aseptic technique. For the treatment of hypercalcemia, calcium supplements should be avoided. For the treatment of hypercalcemia, calcium supplements should be avoided. Room-temperature storage of medications labeled for refrigeration | American Journal of Health-System Pharmacy | Oxford Academic Abstract. http://www.upandaway.org. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Hypocalcemia must be corrected before initiating therapy. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. In most patients with Paget disease, causes a decrease in the rate of bone turnover with a resultant decrease in elevated serum alkaline phosphatase concentrations and urinary hydroxyproline excretion. Allow to reach room temperature before intramuscular or subcutaneous use. Development of neutralising antibodies to calcitonin.1. Peak plasma concentrations are attained within the first hour of administration. Intranasal Nasal Solution. Do not freeze this medicine or shake the vials. /ExtGState << For the treatment of hypercalcemia, vitamin D preparations should be avoided. endobj Calcitonin may be considered for women who can not or will not take more effective agents; do not prescribe in early menopause as benefit/efficacy has not been observed within the first 5 years of menopause onset. Serious allergic-type reactions such as bronchospasm, swelling of the tongue and throat, anaphylactic shock. The actions of calcitonin on bone and its role in normal human bone physiology are still not completely elucidated, although calcitonin receptors have been discovered in osteoclasts and osteoblasts. It is usually used once a day or once every other day. tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. Periodic re-treatment may be considered in these patients, and should take into account the potential benefits and evidence of an increased risk of malignancies and long term calcitonin use (see section 4.4). Experience with the use of calcitonin in the elderly has shown no evidence of reduced tolerability or altered dosage requirements. 2007;64(16):1711-1715. Administer once daily (as a single spray in 1 nostril) using metered-dose spray pump supplied by manufacturer. Mylan Institutional LLC. /GSa 3 0 R Nausea/vomiting are less frequent when the injection is done in the evening and after meals. /Title ( T h e s e h i g h l i g h t s d o n o t i n c l u d e a l l t h e i n f o r m a t i o n n e e d e d t o u s e M I A C A L C I N I N J E C T I O N s a f e l y a n d e f f e c t i v e l y . Information on Miacalcin (calcitonin-salmon) Miacalcin, available as an injection and as a nasal spray, is a calcitonin-salmon medication used for the treatment of postmenopausal osteoporosis in . For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. The pharmacological properties of the synthetic and recombinant peptides have been demonstrated to be qualitatively and quantitatively equivalent. Store in a refrigerator (2C-8C). Salmon calcitonin may be administered at bedtime to reduce the incidence of nausea or vomiting which may occur, especially at the initiation of therapy. Patients must therefore be warned that these effects may occur, in which case they should not drive or use machines. Importance of women informing clinicians if they are or plan to become pregnant or to breast-feed. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Salmon calcitonin is rapidly absorbed. Fracture reduction efficacy has not been demonstrated. The risk for hypocalcemia and other disturbances of mineral metabolism may increase during coadministration. Periodic nasal examinations with visualization of the nasal mucosa, turbinates, septum, and mucosal blood vessels for any sign of nasal trauma are recommended for patients receiving intranasal calcitonin-salmon. Then, continue a regular dosing schedule of every other day from that point. [/Pattern /DeviceRGB] >> Start typing to retrieve search suggestions. 0 Such reactions should be differentiated from generalised or local flushing, which are common non-allergic effects of calcitonin (see section 4.8). Pharmacotherapeutic group: antiparathyroid hormone, ATC code: H05BA01 (calcitonin, salmon, synthetic). This branded product is no longer on the market. 354.719999 0] Importance of informing patients of other important precautionary information. Antibody Formation: Circulating antibodies to calcitonin salmon have been reported with Miacalcin injection. >> Miacalcin bottle in use: 15-30C, in upright position for up to 35 days. Talk with your doctor. $@D` J Vn)$ @bP1# H #O Duplication for commercial use must be authorized by ASHP. The duration of effect is 824 hours after subcutaneous administration. Guidelines recommend against calcitonin-salmon for the treatment of osteoporosis; the efficacy of calcitonin in preventing vertebral and non-vertebral fractures is not established, and the increase in bone mineral density observed is less than that reported for other agents (e.g., bisphosphonates). M I A C A L C I N \( c a l c i t o n i n s a l m o n \) i n j e c t i o n , s y n t h e t i c , f o r s u b c u t a n e o u s o r i n t r a m u s c u l a r u s e I n i t i a l U . CARLSBAD, Calif., May 20, 2021 /PRNewswire/ -- Leucadia Pharmaceuticals, a U.S. leader in generic injectables and the commercial arm of Custopharm, Inc., today announced . Due to evidence of an increased risk of malignancies and long term calcitonin use (see section 4.4), the treatment duration in all indications should be limited to the shortest period of time possible and using the minimum effective dose. [27980] [57624] The PROOF study indicates a potential reduction in new vertebral fractures with use. The dose may be reduced to 50 IU daily at the start of remobilisation. The possibility of antibody formation should be considered in any patient with an initial response to Miacalcin injection who later stops responding to treatment. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088). In addition, it appears to be quite beneficial in preventing bone loss after liver transplantation. In addition, salmon calcitonin could be administered by intravenous injection after previous rehydration. 3 In case of patients with high bone remodelling (Paget's disease and young patients) a transient decrease of calcemia may occur between the 4th and the 6th hour after administration, usually asymptomatic. [27980] [52559] [57624], Use calcitonin with caution during breast-feeding. Calcitonin also has activity outside the bone. Dihydrotachysterol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. >> Under exceptional circumstances, e.g. However, you should not flush this medication down the toilet. Remove the unopened bottle from the refrigerator and allow the spray to reach room temperature.Remove the protective cap.To prime the pump bottle, the bottle should be held upright and the 2 side arms of the pump depressed toward the bottle until a full spray is produced. Reduction in serum calcium concentration in patients with hypercalcemia persists for about 68 hours after single injection. Salmon calcitonin is devoid of embryotoxic, teratogenic and mutagenic potential. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Calcium Chloride: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Safety and efficacy not established; off-label use reported. Give with supplemental calcium and vitamin D if dietary intake is inadequate. Paricalcitol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Stability Storage Parenteral Injection. Serious hypersensitivity reactions have been reported in patients receiving calcitonin-salmon nasal spray (e.g., bronchospasm, swelling of the tongue or throat, anaphylaxis and anaphylactic shock). - Treatment of hypercalcemia of malignancy. If the solution is discolored or contains particles, do not use it, and call your pharmacist. Calcitonin 50 IU/ml solution for injection and infusion. Each bottle contains at least 30 doses. Vials of calcitonin salmon nasal spray (2200 IU/mL) were stored for three days at 25, 40, or 60 degrees C or for three days at the same temperatures followed by two weeks at 5 degrees C and two An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels. 1 Development of neutralising antibodies to calcitonin. MIA-2020-0001 V3. 123 0 obj <> endobj Hypersensitivity to calcitonin salmon or any of the excipients. Discontinue nasal spray if severe ulceration of nasal mucosa (i.e., ulcers >1.5 mm in diameter or penetrating below the mucosa, ulcers associated with heavy bleeding) occurs. Denosumab: (Moderate) Monitor serum calcium, phosphorus, and magnesium concentrations within 14 days of denosumab injection during concurrent treatment with calcimimetics such as calcitonin. Monitor serum calcium concentrations closely in patients with severe renal impairment (CrCl less than 30 mL/minute) or renal failure (and/or on dialysis) receiving calcimimetics. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. hb```M~ cc`aq@a/O(C" H82t*\S, j2UFMzCD(ztZh PZa0J i`1@ The effect of calcitonin may be monitored by measurement of suitable markers of bone remodelling, such as serum alkaline phosphatase or urinary hydroxyproline or deoxypyridinoline. Data regarding the recommended maximum duration that refrigerated medications available in hospital pharmacies may be stored safely at room t Appropriate medical support and monitoring measures should be readily available when Miacalcin injection is administered. Adverse reactions have been ranked under headings of frequency using the following convention: very common (1/10); common (1/100 to <1/10); uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). [27980] [52559] [57624]. Calcitonin is a human hormone that is also found in salmon. For the treatment of hypercalcemia, calcium supplements should be avoided. Calcitonin helps maintain calcium homeostasis. /Pattern << The analgesic effect appears to be evident for acute vertebral fractures due to osteoporosis; there is no sufficient evidence that the drug has effectiveness for pain due to prior fracture. Pharmacokinetic/pharmacodynamic relationship. A day or once every other day administer parenteral calcitonin, salmon, synthetic ) calcitonin in associated... 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