MIACALCIC

What it is

Miacalcic is calcitonin salmon, available as a solution for injection containing 50 or 100 I.U. per millilitre. It is presented as a clear, colourless solution, practically free of visible foreign particles. Miacalcic may be administered subcutaneously, intramuscularly or intravenously; local and systemic tolerance is generally good with all three routes of administration at recommended dosages.

Approved indications

— Active Paget's disease in patients who do not respond to alternative treatments or for whom such treatments are not suitable. — Hypercalcaemia.

Dosing overview

Due to the association between occurrence of malignancies and long-term calcitonin use, the treatment duration in all indications should be limited to the shortest period of time possible and using the lowest effective dose.

Key safety warnings

Being a polypeptide, calcitonin salmon may give rise in rare cases to localised or generalised hypersensitivity reactions, including allergic-type reactions and single cases of anaphylactic shock. It is advisable to perform a scratch or intradermal skin test to determine sensitivity before administration, as calcitonin is a protein, using a 1 in 100 dilution. Meta-analyses of randomised controlled trials conducted in patients with osteoarthritis and osteoporosis have shown that long-term calcitonin salmon use is associated with a small but statistically significant increase in the incidence of malignancies compared to placebo, with an absolute rate of occurrence varying between 0.7% and 2.36%. Patients in these trials were treated with oral or intranasal formulations however it cannot be excluded that an increased risk also applies when calcitonin is administered subcutaneously, intramuscularly or intravenously. Gastrointestinal disorder may include nausea, abdominal pain, diarrhoea and vomiting and is usually a transient, dose-related phenomenon, and occurs more frequently after intravenous than intramuscular or subcutaneous administration.

Contraindications

Pregnancy and lactation. Hypersensitivity to calcitonin salmon or to any of the excipients in the formulation.

PBS listing

Miacalcic injection 100 I.U. in 1 mL is listed on the PBS with authority required restriction, with an ex-manufacturer price of A$35.41.

Regulatory history

Miacalcic calcitonin salmon 50 I.U./1 mL injection ampoule (ARTG 13364) and 100 I.U./1 mL injection ampoule (ARTG 13363) were first listed on the ARTG on 21 August 1991.