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Miacalcin

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Miacalcin

Indications
Dosage
How Supplied

INDICATIONS

Treatment Of Paget’s Disease Of Bone

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).

Treatment Of Hypercalcemia

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.

Treatment Of Postmenopausal Osteoporosis

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).

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 [see WARNINGS AND PRECAUTIONS].

DOSAGE AND ADMINISTRATION

Paget’s Disease Of Bone

The 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.

Hypercalcemia

The 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.

Postmenopausal Osteoporosis

The 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.

Preparation And Administration

Visually 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.

Recommendations For Calcium And Vitamin D Supplementation

Patients 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).

HOW SUPPLIED

Dosage Forms And Strengths

Miacalcin injection is available as a clear, colorless, sterile solution of synthetic calcitonin-salmon in individual 2 mL multi-dose vials containing 200 International Units per mL.

Miacalcin (calcitonin-salmon) injection, synthetic is available as a sterile solution in individual 2 mL multi-dose vials containing 200 International Units per mL .......................NDC 0078-0149-23

Storage and Handling

Store in refrigerator between 2°C–8°C (36°F–46°F).

Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936. Revised: Feb 2015

Last reviewed on RxList: 2/23/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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