MIACALCIC INJECTION 100 IU/ML FOR INTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR USE

Product Information

Registration Status: Active

MIACALCIC INJECTION 100 IU/ML is approved to be sold in Singapore with effective from 1990-06-26. It is marketed by ZUELLIG PHARMA PTE LTD, with the registration number of SIN04735P.

This product contains Calcitonin 100 iu/ml in the form of INJECTION. It is approved for INTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR use.

This product is manufactured by NOVARTIS PHARMA AG NOVARTIS PHARMA AG in SWITZERLAND.

It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Description

Synthetic peptide, 32 residues long formulated as a nasal spray.

Indication

Used in the treatment of symptomatic Paget's disease for patients unresponsive to alternate treatments or intolerant to such treatments. In addition, it is used in emergency situations when serum calcium levels must be decreased quickly until the underlying condition is identified. It can also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or corticosteroids, or other agents. Calcitonin can be used in patients with azotemia and cases where intravenous fluids would be contraindicated due to limited cardiac reserves. Also for the treatment of post-menopausal osteoporosis in women more than 5 years post-menopause.

Mechanism of Action

Calcitonin binds to the calcitonin receptor (found primarily in osteoclasts) which then enhances the production of vitamin D producing enzymes (25-hydroxyvitamine D-24-hydroxylase), leading to greater calcium retention and enhanced bone density. Binding of calcitonin to its receptor also activates adenylyl cyclase and the phosphatidyl-inositol-calcium pathway.

Pharmacokinetics

Absorption: Salmon calcitonin is rapidly absorbed and eliminated. Bioavailability following subcutaneous and intramuscular injection in humans is high and similar for the two routes of administration (71% and 66%, respectively). Via the nasal route, the bioavailability varies between 3 to 5% relative to IM.
Distribution: 0.15 to 0.3 L/kg
Metabolism: Salmon calcitonin is primarily and almost exclusively degraded in the kidneys, forming pharmacologically inactive fragments of the molecule. It is also metabolized in the blood and the peripheral tissue.
Elimination

Toxicity

Salmon calcitonin was shown to inhibit lactation in animals and is not recommend in nursing mothers. While research in animals have shown a decrease in fetal weight, no studies have yet shown similar results in humans. It is recommended however to proceed carefully when administering salmon calcitonin to pregnant women and consider if the benefits outweigh the risks. Because of its protein nature, salmon calcitonin may provoke an allergy reaction (bronchospams and swelling of the tongue/throat) that can turn into a full-blown anaphylactic response. The manufacturer also reports an increase in the risk of malignancies from oral route (0.7%) to intranasal route (2.4%) compared to placebo. The same may apply to IV, IM and SC routes since the systemic exposure is higher in those cases. Nausea is noticeable in some patients but tends to decrease with continued administration. Rhinitis, headaches and back pain have also been reported among others.

Active Ingredient/Synonyms

Source of information: Drugbank (External Link). Last updated on: 3^rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.