MIACALCIN (calcitonin salmon) injection, solution. %PDF-1.4 endobj Possibility of hypocalcemic tetany following parenteral administration; have calcium injection readily available, particularly during first several doses of parenteral calcitonin. 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 . Use calcitonin salmon injection exactly as directed. 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. was insufficient regarding room- temperature stability and pharma- . Patients in these trials were treated with oral or intra-nasal formulations however it is likely that an increased risk also applies when calcitonin is administered subcutaneously, intramuscularly or intravenously especially for long-term use, as systemic exposure to calcitonin in such patients is expected to be higher than for other formulations. Advise patients to record number of doses used and to discard the bottle after 30 doses. It is not known whether calcitonin crosses the blood-brain barrier or if it distributes into breast milk. Stability Storage Parenteral Injection. If the solution is discolored or contains particles, do not use it, and call your pharmacist. Decreases in bone resorption as judged by a reduction in urinary hydroxyproline and deoxypyridinoline are observed following calcitonin treatment in both normal volunteers and patients with bone-related disorders, including Paget's disease and osteoporosis. cool to room temperature. Talk with the doctor. The dose of lithium may require adjustment. Sub-Q injection preferred for patient self-administration. 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. 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 Although smaller ulcers often heal without withdrawal of calcitonin nasal spray, the medication should be discontinued temporarily until healing occurs. Store in a refrigerator (2C-8C). Mix thoroughly.Discard 0.9 mL of the diluted test injection and administer the remaining 0.1 mL intracutaneously on the flexor surface of the forearm.Development of mild erythema or wheal within 15 minutes indicates a positive reaction and calcitonin-salmon should not be administered. Rapidly absorbed by nasal mucosa; bioavailability of intranasal dose relative to IM dose is approximately 3%. /Parent 2 0 R Dihydrotachysterol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Qf Ml@DEHb!(`HPb0dFJ|yygs{. Therefore, a nasal examination should be performed prior to the start of treatment with nasal calcitonin and at anytime nasal complaints occur. [27980] [52559] [57624]Calcitonin is a hypocalcemic hormone whose effects are generally opposite those of parathyroid hormone (PTH). V5U?f1&&A(EgRM:BI>[:c]Y~Gtf]. Important Limitations of Use: Due to the possible association between malignancy and calcitonin salmon use, the need for continued therapy should be re-evaluated on a periodic basis. Peak plasma concentrations are attained within the first hour of administration. In addition to adequate intake of calcium/vitamin D and other lifestyle modifications (e.g., exercise, avoidance of excessive alcohol and tobacco use), experts recommend that pharmacologic therapy for osteoporosis be considered in postmenopausal women with high risk of fractures (generally those who have experienced a previous hip or vertebral fracture or who have low BMD); pharmacologic therapy also may be considered in postmenopausal women with low bone mass, although there is less evidence supporting overall fracture risk reduction in such patients. Such reactions should be differentiated from generalised or local flushing, which are common non-allergic effects of calcitonin (see section 4.8). 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%. 19 0 obj Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. The risk for hypocalcemia and other disturbances of mineral metabolism may increase during coadministration. Adverse nasal effects (i.e., rhinitis, irritation, congestion) reported more frequently in patients >65 years of age receiving calcitonin nasal spray. An increased risk of hypocalcemia was seen in clinical trials involving patients with renal dysfunction. - Bone Resorption Inhibitors /Length 18 0 R After subcutaneous administration, peak plasma levels are reached in about 23 minutes. Miacalcin Injection is indicated for the treatment of postmenopausal osteoporosis in females greater than 5 years postmenopause with low bone mass relative to healthy premenopausal females. 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. Salmon calcitonin may be administered at bedtime to reduce the incidence of nausea or vomiting which may occur, especially at the initiation of therapy. Have blood work checked as you have been told by the doctor. 3R `j[~ : w! Effect not reported by other investigators. Secretion of calcitonin is regulated by serum calcium; high serum calcium increases the release of calcitonin. 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). Following IM administration, calcitonin is absorbed directly into the systemic circulation and the onset of action begins within 15 minutes. AHFS DI Essentials. Other reported clinical experience with calcitonin-salmon injection or nasal sprays has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Miacalcin injection should be Glass or hard plastic IV containers should not be used. [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. IM injection preferred when injection volume >2 mL. endstream endobj 40 0 obj <>>> endobj 41 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text]>>/Rotate 0/TrimBox[0.0 0.0 585.0 783.0]/Type/Page>> endobj 42 0 obj <>stream Do not administer a double dose to make up for a missed one. Healthcare providers may wish to refer patients who require skin testing to an allergist. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. [0 /XYZ 69.5999999 Written by ASHP. Before priming the pump and using a new bottle, allow it to reach room temperature. $E}kyhyRm333: }=#ve [0 /XYZ 43.6799999 Calcitonin salmon prepared by recombinant DNA technology is structurally identical to calcitonin salmon produced by chemical synthesis. Keep all supplies in a clean, dry place and out of reach of children. Calcitonin is a is a peptide hormone secreted by the C-cells of the thyroid gland endogenously; calcitonin-salmon is a calcitonin receptor agonist. A p p r o v a l : 1 9 7 5) 200 International Units/day intranasally for osteoporosis; 100 International Units IM or subcutaneously for most indications; for acute hypercalcemia, up to 32 international units/kg/day IM or subcutaneously. [ ] DRUG INTERACTIONS: Concomitant use of calcitonin salmon and lithium may lead to a reduction in plasma lithium concentrations due to increased urinary clearance of lithium. American Society of Health-System Pharmacists, Inc. Disclaimer, U.S. Department of Health and Human Services. When sprayed into the nose, miacalcin is quickly absorbed into the blood stream. Pharmacotherapeutic group: antiparathyroid hormone, ATC code: H05BA01 (calcitonin, salmon, synthetic). 680.159999 0] Importance of informing patients of other important precautionary information. Remaining contents should be discarded. Denosumab: (Moderate) Monitor serum calcium, phosphorus, and magnesium concentrations within 14 days of denosumab injection during concurrent treatment with calcimimetics such as calcitonin. Hypersensitivity reactions should be differentiated from generalized flushing and hypotension. Cite this: Room-temperature Storage of Medications Labeled for Refrigeration-Medscape-Aug01,2007. Nausea/vomiting are less frequent when the injection is done in the evening and after meals. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. /SM 0.02 Healthcare providers may wish to refer patients who require skin testing to an allergist. For the treatment of hypercalcemia, calcium supplements should be avoided. Following subcutaneous administration, calcitonin is absorbed directly into the systemic circulation and the onset of action begins within 15 minutes. Victor Cohen,1,2 Samantha P. Jellinek,1 Leftherios Teperikidis,1 Elliot Berkovits,1 William M. Goldman 1,2 1Maimonides Medical Center, Brooklyn, NY 2Long Island University, Brooklyn, NY. Do not freeze this medicine or shake the vials. Treatment of postmenopausal osteoporosis in women >5 years postmenopause. For the treatment of hypercalcemia, calcium supplements should be avoided. Destroyed in GI tract; administer parenterally or intranasally. Glass or hard plastic IV containers should not be used. Calcitonin may cause fatigue, dizziness and visual disturbances (see section 4.8) which may impair the patient's reaction. From a microbiological point of view, this medicine should be used immediately after it has reached room temperature if it is to be injected or immediately after dilution in 0.9% w/v sodium chloride in soft PVC bags only, if it is to be infused. To comment please, Comments on Medscape are moderated and should be professional in tone and on topic. 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). 172.319999 0] 1. [52559] Per treatment guidelines for Paget's disease, the use of injectable calcitonin-salmon leads to partial radiographic healing of lytic lesions, but most patients do not achieve normalization of bone turnover, and thus calcitonin has limited use versus newer, more effective agents (i.e., bisphosphonates). [27980] [57624] The PROOF study indicates a potential reduction in new vertebral fractures with use. All Rights Reserved. Calcitonin-salmon injection is administered intramuscularly or subcutaneously. [0 /XYZ 69.5999999 If anaphylaxis or other severe hypersensitivity/allergic reactions occur, initiate appropriate treatment. 39 0 obj <> endobj /PCSp 4 0 R Elevate serum calcium concentrations and antagonize the effects of calcitonin effects of the calcitonin for this condition when volume! Doses used and to discard the bottle after 30 doses calcitonin ( section! C ] Y~Gtf ] 69.5999999 if anaphylaxis or other severe hypersensitivity/allergic reactions,. 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