Miacalcin

MIACALCIN- calcitonin salmon injection, solution
Mylan Institutional LLC

1 INDICATIONS AND USAGE

1.1 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).

1.2 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.

1.3 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).

1.4 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 (5.3)].

2 DOSAGE AND ADMINISTRATION

2.1 Paget’s Disease of Bone

The recommended dose of Miacalcin injection for treatment of symptomatic Paget’s disease of bone is 100 USP Units (0.5 mL) per day administered subcutaneously or intramuscularly.

2.2 Hypercalcemia

The recommended starting dose of Miacalcin injection for early treatment of hypercalcemia is 4 USP 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 USP 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 USP Units/kg every 6 hours.

2.3 Postmenopausal Osteoporosis

The recommended dose of Miacalcin injection for treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause is 100 USP 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 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.

2.5 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).

3 DOSAGE FORMS AND STRENGTHS

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.

4 CONTRAINDICATIONS

Hypersensitivity to calcitonin salmon or any of the excipients. Reactions have included anaphylaxis with death, bronchospasm, and swelling of the tongue or throat [see Warnings and Precautions (5.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Serious hypersensitivity reactions have been reported in patients receiving Miacalcin injection, e.g., bronchospasm, swelling of the tongue or throat, anaphylactic shock, and death due to anaphylaxis. Appropriate medical support and monitoring measures should be readily available when Miacalcin injection is administered. If anaphylaxis or other severe hypersensitivity/allergic reactions occur, initiate appropriate treatment [see Contraindications (4)].

For patients with suspected hypersensitivity to calcitonin salmon, skin testing should be considered prior to treatment utilizing a dilute, sterile solution of Miacalcin injection. Healthcare providers may wish to refer patients who require skin testing to an allergist. A detailed skin testing protocol is available from the Mylan Pharmaceuticals Inc. Product Safety Department.

5.2 Hypocalcemia

Hypocalcemia associated with tetany (i.e., muscle cramps, twitching) and seizure activity has been reported with Miacalcin injection therapy. Hypocalcemia must be corrected before initiating therapy. Other disorders affecting mineral metabolism (such as vitamin D deficiency) should also be effectively treated. In patients at risk for hypocalcemia, provisions for parenteral calcium administration should be available during the first several administrations of calcitonin salmon and serum calcium and symptoms of hypocalcemia should be monitored. Use of Miacalcin injection for the treatment of Paget’s disease or postmenopausal osteoporosis is recommended in conjunction with an adequate intake of calcium and vitamin D [see Dosage and Administration (2.5)].

5.3 Malignancy

In a meta-analysis of 21 randomized, controlled clinical trials with calcitonin salmon (nasal spray or investigational oral formulations), the overall incidence of malignancies reported was higher among calcitonin salmon-treated patients (4.1%) compared with placebo-treated patients (2.9%). This suggests an increased risk of malignancies in calcitonin salmon-treated patients compared to placebo-treated patients. It is not possible to exclude an increased risk when calcitonin salmon is administered long-term subcutaneously, intramuscularly, or intravenously. The benefits for the individual patient should be carefully considered against possible risks [see Adverse Reactions (6.1)].

5.4 Antibody Formation

Circulating antibodies to calcitonin salmon have been reported with Miacalcin injection. The possibility of antibody formation should be considered in any patient with an initial response to Miacalcin injection who later stops responding to treatment [see Adverse Reactions (6.3)].

5.5 Urine Sediment Abnormalities

Coarse granular casts and casts containing renal tubular epithelial cells were reported in young adult volunteers at bed rest who were given injectable calcitonin salmon to study the effect of immobilization on osteoporosis. There was no other evidence of renal abnormality and the urine sediment normalized after calcitonin salmon was stopped. Periodic examinations of urine sediment should be considered.

6 ADVERSE REACTIONS

The following serious adverse reactions are discussed in greater detail in other sections of the label:

Hypersensitivity Reactions, including anaphylaxis [see Warnings and Precautions (5.1)]
Hypocalcemia [see Warnings and Precautions (5.2)]
Malignancy [see Warnings and Precautions (5.3)]
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