Calcitonin (injection)

Calcitonin (injection)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Turky Alkathery, M.D. [2]

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Overview

Calcitonin (injection) is a calcitonin receptor agonist that is FDA approved for the treatment of Paget's disease of bone, hypercalcemia, and postmenopausal osteoporosis. Common adverse reactions include flushing, injection site reaction, nausea, arthralgia, epistaxis, rhinitis, and sinusitis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

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.

Dosage

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).

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Calcitonin in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Calcitonin in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Safety and effectiveness in pediatric patients have not been established.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Calcitonin in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Calcitonin in pediatric patients.

Contraindications

There is limited information regarding Calcitonin (injection) Contraindications in the drug label.

Warnings

There is limited information regarding Calcitonin (injection) Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Calcitonin (injection) Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Calcitonin (injection) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Calcitonin (injection) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Calcitonin (injection) in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Calcitonin (injection) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Calcitonin (injection) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Calcitonin (injection) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Calcitonin (injection) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Calcitonin (injection) in geriatric settings.

Gender

There is no FDA guidance on the use of Calcitonin (injection) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Calcitonin (injection) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Calcitonin (injection) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Calcitonin (injection) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Calcitonin (injection) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Calcitonin (injection) in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Calcitonin (injection) Administration in the drug label.

Monitoring

There is limited information regarding Calcitonin (injection) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Calcitonin (injection) and IV administrations.

Overdosage

There is limited information regarding Calcitonin (injection) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Calcitonin (injection) Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Calcitonin (injection) Mechanism of Action in the drug label.

Structure

There is limited information regarding Calcitonin (injection) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Calcitonin (injection) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Calcitonin (injection) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Calcitonin (injection) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Calcitonin (injection) Clinical Studies in the drug label.

How Supplied

There is limited information regarding Calcitonin (injection) How Supplied in the drug label.

Storage

There is limited information regarding Calcitonin (injection) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Calcitonin (injection) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Calcitonin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Calcitonin (injection) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Calcitonin (injection) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.