Miacalcin
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Miacalcin injection is indicated for the treatment of symptomatic Paget’s disease of bone in patients with moderate to severe disease characterized by polyostotic involvement with elevated serum alkaline phosphatase and urinary hydroxyproline excretion. There is no evidence that the prophylactic use of calcitonin-salmon is beneficial in asymptomatic patients. Miacalcin injection should be used only in patients who do not respond to alternative treatments or for whom such treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies).
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. It may also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or corticosteroids, or other agents.
Miacalcin injection is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. The evidence of efficacy for calcitonin-salmon injection is based on increases in total body calcium observed in clinical trials. Fracture reduction efficacy has not been demonstrated. Miacalcin injection should be reserved for patients for whom alternative treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies).
Due to the possible association between malignancy and calcitonin-salmon use, the need for continued therapy should be re-evaluated on a periodic basis [see Warnings and Precautions (5.3)].
History
There is currently no drug history available for this drug.
Other Information
Calcitonin is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland in mammals and by the ultimobranchial gland of birds and fish.
Miacalcin (calcitonin-salmon) injection, synthetic is a synthetic polypeptide of 32 amino acids in the same linear sequence that is found in calcitonin of salmon origin. This is shown by the following graphic formula:
Sources
Miacalcin Manufacturers
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Sebela Pharmaceuticals Inc.
![Miacalcin (Calcitonin Salmon) Injection, Solution [Sebela Pharmaceuticals Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Miacalcin | Dolgencorp, Llc
moisten face with water. Apply product with wet fingertips and massage over face. Rinse well and pat dry. avoid contact with the eyes. If contact occurs, flush thoroughly with water. -
Novartis Pharmaceuticals Corporation
Miacalcin | Novartis Pharmaceuticals Corporation
2.1 Paget’s Disease of BoneThe recommended dose of Miacalcin injection for treatment of symptomatic Paget's disease of bone is 100 International Units (0.5 mL) per day administered subcutaneously or intramuscularly.
2.2 HypercalcemiaThe recommended starting dose of Miacalcin injection for early treatment of hypercalcemia is 4 International Units/kg body weight every 12 hours by subcutaneous or intramuscular injection. If the response to this dose is not satisfactory after one or two days, the dose may be increased to 8 International Units/kg every 12 hours. If the response remains unsatisfactory after two more days, the dose may be further increased to a maximum of 8 International Units/kg every 6 hours.
2.3 Postmenopausal OsteoporosisThe recommended dose of Miacalcin injection for treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause is 100 International Units (0.5 mL) per day administered subcutaneously or intramuscularly. The minimum effective dose of Miacalcin injection for the prevention of vertebral bone mineral density loss has not been established.
2.4 Preparation and AdministrationVisually inspect Miacalcin vials. Miacalcin injection is a clear, colorless, solution. If the solution is not clear and colorless, or contains any particles, or if the vial is damaged, do not administer the solution.
If the volume of Miacalcin injection to be injected exceeds 2 mL, intramuscular injection is preferable and the total dose should be distributed across multiple sites of injection.
Instruct patients to use sterile injection technique when administering Miacalcin injection, and to dispose of needles properly.
2.5 Recommendations for Calcium and Vitamin D SupplementationPatients who use Miacalcin injection for treatment of postmenopausal osteoporosis should receive adequate calcium (at least 1000 mg elemental calcium per day) and vitamin D (at least 400 International Units per day).
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Novartis Pharmaceuticals Corporation
Miacalcin | Novartis Pharmaceuticals Corporation
2.1 Basic Dosing InformationThe recommended dose of Miacalcin nasal spray is 1 spray (200 International Units) per day administered intranasally, alternating nostrils daily.
2.2 Priming (Activation) of PumpUnopened Miacalcin nasal spray should be stored in the refrigerator. Before using the first dose of Miacalcin nasal spray, the patient should wait until it has reached room temperature. To prime the pump before it is used for the first time, the bottle should be held upright and the two white side arms of the pump depressed toward the bottle, repeat until a full spray is released. The pump is primed once the first full spray is emitted. To administer, the nozzle should first be carefully placed into the nostril while the patient’s head is in the upright position, then the pump should be firmly depressed toward the bottle. The pump should not be primed before each daily dose.
2.3 Recommendations for Calcium and Vitamin D SupplementationPatients who use Miacalcin nasal spray should receive adequate calcium (at least 1000 mg elemental calcium per day) and vitamin D (at least 400 International Units per day).
![Miacalcin (Calcitonin Salmon) Injection, Solution [Novartis Pharmaceuticals Corporation]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f9d5a587-e2bc-4001-987d-9b04731303cb&name=miacalcin-injectable-02.jpg)
![Miacalcin (Calcitonin Salmon) Spray, Metered [Novartis Pharmaceuticals Corporation]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e147226d-7bf3-4f72-959b-8abd6464fbcd&name=miacalcin-nasal-spray-0B.jpg)
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