MIACALCIC 100 IU/ML (CALCITONIN) – SOLUTION FOR INJECTION

Prescription Medicine

Dosage Form: Solution for injection.

Routes of Administration:

• Intramuscular (IM) injection.
• Subcutaneous (SC) injection.
• Intravenous (IV) injection or infusion, when indicated.

Pack Size: 5 ampoules, each containing 1 mL (100 IU).

Product Overview

Miacalcic contains calcitonin, a hormone that helps regulate calcium metabolism and maintain bone health. It works primarily by inhibiting the activity of osteoclasts, the cells responsible for bone breakdown, thereby reducing bone resorption and helping lower elevated blood calcium levels.

Calcitonin also has an important role in regulating calcium and phosphate balance in the body.

Indications and Therapeutic Uses

Miacalcic may be prescribed for the following conditions, depending on the locally approved product information:

1. Hypercalcaemia: Helps reduce abnormally elevated blood calcium levels, including hypercalcaemia associated with malignancy.
2. Paget's Disease of Bone: Helps reduce excessive bone resorption and bone turnover in patients with Paget's disease who cannot use, or do not respond adequately to, alternative treatments.
3. Acute Bone Loss Due to Immobilization: May help prevent acute bone loss following sudden immobilization, such as in patients with recent osteoporotic fractures, where this indication is approved.
4. Bone Pain Associated with Osteolysis or Osteopenia: May help relieve bone pain associated with certain conditions involving increased bone resorption.
5. Selected Osteoporosis Cases: Some product registrations include use in osteoporosis when alternative treatments are unsuitable; however, injectable calcitonin is not considered routine first-line osteoporosis treatment.

Mechanism of Action

Calcitonin is a naturally occurring hormone produced by the thyroid gland. Salmon calcitonin acts on specific receptors on osteoclasts, inhibiting their activity and reducing bone resorption.

Its main pharmacological effects include:

• Inhibition of Osteoclast Activity: Reduces the breakdown of bone tissue.
• Reduction of Blood Calcium: Helps lower elevated serum calcium levels by decreasing calcium release from bones.
• Regulation of Bone Turnover: Reduces excessive bone resorption in conditions associated with increased osteoclastic activity.
• Renal Effects: Can increase the urinary excretion of calcium and phosphate.

Dosage and Administration

Miacalcic 100 IU/mL is administered by a healthcare professional through one of the following routes:

• Intramuscular (IM) injection.
• Subcutaneous (SC) injection.
• Slow intravenous (IV) injection or intravenous infusion, depending on the indication.

Dosage depends on the condition being treated:

Important: The dose, route, frequency, and duration must be determined by the treating physician. Serum calcium levels and clinical response should be monitored during treatment.

Possible Side Effects

Miacalcic may cause some adverse reactions, including:

Common or relatively frequent effects:

• Nausea and vomiting.
• Facial flushing or a sensation of warmth.
• Dizziness.
• Mild abdominal discomfort.
• Injection-site pain, redness, or swelling.

Other clinically important adverse effects:

• Hypocalcaemia (low blood calcium levels).
• Muscle cramps, tingling, or numbness.
• Hypersensitivity reactions, including serious allergic reactions.
• Development of antibodies against calcitonin, potentially reducing treatment response.

Long-term calcitonin exposure has also been associated with a possible increased risk of malignancy in clinical trial analyses. Treatment should therefore be restricted to the shortest appropriate duration and periodically reassessed.

Contraindications

Miacalcic should not be used in patients with:

• Known hypersensitivity or allergy to calcitonin (salmon) or any of the product's ingredients.
• Uncorrected hypocalcaemia, which must be addressed before treatment begins.

Warnings and Precautions

• Calcium Monitoring: Serum calcium levels should be monitored, particularly in patients at risk of hypocalcaemia.
• Vitamin D and Calcium: Adequate calcium and vitamin D intake should be ensured when clinically indicated.
• Allergic Reactions: Patients with a history of fish or salmon allergy may require particular assessment before treatment.
• Renal Impairment: Use cautiously in patients with impaired kidney function.
• Long-Term Use: Avoid prolonged treatment unless clearly justified by the expected clinical benefit.
• Pregnancy and Breastfeeding: Use only when specifically recommended by a physician, following an assessment of potential risks and benefits.

Drug Interactions

• Lithium: Calcitonin may reduce serum lithium concentrations, potentially affecting its therapeutic effect.
• Other calcium-lowering medications: May increase the risk of hypocalcaemia.
• Vitamin D and calcium supplements: May be required to maintain appropriate mineral balance, depending on the patient's condition.

The treating physician should review all concomitant medications before starting treatment.

Storage Conditions

• Store in a refrigerator at 2°C–8°C.
• Do not freeze.
• Protect from inappropriate storage conditions and excessive heat.
• Do not use the solution if it appears discoloured or contains visible particles.
• Keep out of reach of children.

Follow the specific manufacturer's package leaflet for handling and storage instructions.

Available Pack

MIACALCIC 100 IU/mL

1. U.S. National Library of Medicine – DailyMed: Official prescribing information for Calcitonin Salmon Injection. DailyMed – Calcitonin Salmon Injection.
2. New Zealand Medicines and Medical Devices Safety Authority (Medsafe): Miacalcic 100 IU Data Sheet. Miacalcic – Official Data Sheet.
3. Australian Commission on Safety and Quality in Health Care: Miacalcic product information. Miacalcic – Medicine Information.
4. Singapore National Drug Formulary: Miacalcic Injection 100 IU/mL. Singapore National Drug Formulary.
5. Saudi Food and Drug Authority (SFDA): Registered Miacalcic 100 IU/mL product information. SFDA – Miacalcic Registration.
6. U.S. National Library of Medicine – DailyMed: Hypocalcaemia, malignancy risk, and hypersensitivity precautions. Calcitonin Salmon – Safety Information.

Patient Disclaimer

This information is intended for educational purposes only and should not replace professional medical advice, diagnosis, or treatment. Miacalcic is a prescription medication and should only be used under the supervision of a qualified healthcare professional.

Dosage and duration of treatment must be determined by the treating physician according to the patient's medical condition and laboratory results. Patients should not self-administer this medication or discontinue treatment without medical advice.

This product is not intended to diagnose, treat, cure, or prevent any disease without appropriate medical supervision.