BIOCALCIN ® - Salmon calcitonin

BIOCALCIN ® is a salmon calcitonin drug

THERAPEUTIC GROUP: Drugs affecting bone metabolism

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Directions BIOCALCIN ® - Salmon calcitonin

BIOCALCIN ® is indicated for the treatment of hypercalcaemia associated with malignant tumors, hyperparathyroidism and calcium intoxication.

The same medicine is used in the treatment of osteoporosis and various types of syndromes such as Paget's disease and Sudeck's disease.

Mechanism of action BIOCALCIN ® - Salmon calcitonin

BIOCALCIN ® is a drug based on synthetic salmon calcitonin, obtained in the laboratory through recombinant DNA technology and therefore free of risks associated with common extraction procedures.

Injected parenterally it acts on the bone metabolism to be subsequently metabolized on the renal level and excreted through the urine.

This protein-based hormone, physiologically secreted by the parafollicular C cells of the thyroid, controls the normal bone metabolism in concert with the parathyroid hormone, acting at the intestinal level, reducing the absorption of this element introduced through the alimentation, at the renal level, increasing the phosphate reabsorption, promoting calcium excretion and inhibiting the activation of vitamin D, at the level of bone tissue, blocking the osteoriasorbent activity of osteoclasts.

The aforementioned actions, possible thanks to the interaction with specific cellular receptors, are accompanied by marked antalgic and anti-inflammatory activity, which justify its use in diseases such as Paget's disease.

Studies carried out and clinical efficacy

1. SALMON CALCITONIN BY INHALATION.

Different studies try to characterize the pharmacokinetic and clinical characteristics of the salmon calcitonin taken by inhalation. The main problem seems to be represented by proteases expressed at the level of the respiratory tract.

2. THE IMPORTANCE OF THE ORAL FORM OF CALCITONINA IN THE CLINICAL FUTURE PRACTICE

Experimental studies demonstrate the importance of new pharmaceutical formulations for salmon calcitonin in the treatment of chronic diseases such as osteoporosis. The limits related to the hormone's sensitivity to enzymatic digestion could be overcome by the design of new release methods, which can make therapy more effective.

3.CALCITHONIN IN THE TREATMENT OF OSTEOARTRITIC DISEASES

Treatment with salmon calcitonin has been shown to be effective in increasing the synthesis of proteoglycans and collagen in human cartilage. This property could be important in the treatment of osteoarthritic diseases.

Method of use and dosage

BIOCALCIN ®

Injectable intravenous, intramuscular and subcutaneous ampoules of 50 or 100 IU salmon synthetic calcitonin:

the administration of this drug should be carried out exclusively by medical specialists in the treatment of diseases of bone or systemic interest.

Usually the slow intravenous inoculation pathway is used in the treatment of hypercalcaemia, while osteoporosis and bone tissue disorders are treated by intramuscular or subcutaneous administration.

The dosages vary considerably from patient to patient based on his physio-pathological conditions.

Warnings BIOCALCIN ® - Salmon calcitonin

Treatment with BIOCALCIN ® must necessarily be defined and monitored by a specialist doctor, in order to minimize side effects and maximize therapeutic effects.

Particular attention should be paid to patients with reduced kidney function, liver disease and heart failure for whom periodic medical checks should be defined.

The control through skin test of any allergies to the active ingredient or to one of its excipients should be carried out before taking calcitonin in order to avoid the appearance of unpleasant and dangerous side effects.

Treatment with this hormone, especially when prolonged over time, could facilitate the appearance of anti-calcitonin antibodies, which can reduce the therapeutic efficacy of the treatment.

PREGNANCY AND BREASTFEEDING

The important metabolic effects of the drug and the absence of studies able to characterize the safety profile of calcitonin when taken during pregnancy, extend the contraindications also to the period of pregnancy and lactation.

Interactions

At the moment there are no pharmacokinetic studies that have demonstrated the presence of pharmacologically relevant interactions or that can significantly vary the pharmacological efficacy of BIOCALCIN ®

Contraindications BIOCALCIN ® - Salmon calcitonin

The use of BIOCALCIN ® is contraindicated in patients with hypersensitivity to the active substance or to one of its excipients.

Undesirable effects - Side effects

The use of BIOCALCIN ® can be associated with the appearance of side effects such as nausea, vomiting, diarrhea, vasomotor phenomena and tingling in the hands.

More rarely, the appearance of skin rash and allergic manifestations of various nature has been observed, for which it was necessary to suspend treatment.

Local reactions at the injection site have been observed in different patients.