Cinacalcet-Vista film-coated tablets 30 mg blister No. 28

Cinacalcet-Vista will provide treatment for secondary hyperparathyroidism in patients with end-stage renal disease who are on maintenance hemodialysis.

Composition

Active ingredient: cinacalcet, 1 film-coated tablet contains 30 mg of cinacalcet, equivalent to 33.06 mg of cinacalcet hydrochloride.

Excipients: corn starch, crospovidone, povidone, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate.

Shell: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, indigo aluminum lake, iron oxide yellow (E 172).

Contraindication

Hypersensitivity to the active substance or to any of the excipients listed in the composition section.

Method of application

The recommended starting dose for adults is 30 mg once daily.

Cinacalcet dose titration should be performed every 2-4 weeks to a maximum dose of 180 mg once daily, at which in patients on hemodialysis, the desired PTH concentration (PTH) is achieved in the range of 150-300 pg / ml (15 9-31.8 pmol / l), which is determined by the content of intact PTH (PTH content test).

PTH concentration should be determined no earlier than 12 hours after taking cinacalcet.

PTH levels should be measured 1-4 weeks after initiation of therapy or dose adjustment of cinacalcet. IPTH or biointact PTH (biPTH) levels can be used to measure PTH levels. Cinacalcet treatment does not alter the ratio of IPTH to biPTH.

Application features

Pregnant

There are no clinical data on the use of cinacalcet in pregnant women.

Animal studies do not indicate direct harmful effects with respect to pregnancy, childbirth, or postnatal development.

No embryo-fetal toxicity was reported in studies in pregnant animals, except for a decrease in fetal body weight at doses associated with maternal toxicity.

Therefore, cinacalcet should be used during pregnancy only if the expected benefit outweighs the potential risk to the fetus.

Drivers

Some side effects may affect the ability to drive and use machines.

Children

Cinacalcet is not intended for use in children and adolescents due to a lack of data on safety and efficacy.

Overdose

Titrated doses up to 300 mg once daily have been safely administered to patients on dialysis.

Overdose of cinacalcet may lead to hypocalcemia.

In the event of overdose, patients should be monitored for symptoms of hypocalcemia and treatment should be symptomatic and supportive.

Because cinacalcet is highly protein bound, hemodialysis is not an effective treatment for overdose.

Side effects

Based on available placebo-controlled studies in patients treated with cinacalcet, the most common adverse reactions were nausea and vomiting, which were mild to moderate in severity and, in most cases, transient. Discontinuation of therapy due to adverse reactions was primarily due to nausea and vomiting.

Storage conditions

Shelf life 3 years.

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.