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What is the drug CINACALCET

The drug contains the active substance cinacalcet, which belongs to the pharmacotherapy group antiparathyroid agent (to reduce the level of parathyroid hormone). Hyperparathyroidism is an endocrine disorder that develops with excessive release of parathyroid hormone (PTH). Calcium-sensitive receptors located on the surface of the main cells of the parathyroid glands are the main regulators of parathyroid hormone (PTH) secretion. Cinacalcet has a calcium mimetic effect that directly reduces the level of PTH, increasing the sensitivity of this receptor to extracellular calcium. A decrease in PTH is accompanied by a decrease in serum calcium.

Indications for use

Secondary hyperparathyroidism

Treatment of hyperparathyroidism in adult patients with end-stage renal failure (ESRD) undergoing dialysis.

CINACALCET may also be used as part of a combination therapy that includes phosphate and/or vitamin D binding agents.

Parathyroid carcinoma and primary HPT

Reduction of hypercalcaemia in adult patients with:

- cancer of the parathyroid glands;

- primary hyperparathyroidism, in which parathyroidectomy is indicated based on the results of assessing the concentration of calcium in the blood serum (according to the relevant treatment recommendations), but its implementation is not clinically justified or contraindicated.

Efficacy and safety studies

In accordance with current legislation, the drug has proven its effectiveness, safety and quality during state registration. For registration purposes, a bioequivalence study was conducted with the original (reference) medicinal product.