Inlyta is an antineoplastic agent. Protein kinase inhibitors. Indications for use - treatment of advanced renal cell carcinoma in case the previous course of systemic treatment was ineffective.
1 coated tablet contains 5 mg axitinib;
auxiliary substances - microcrystalline cellulose lactose monohydrate, croscarmellose sodium; magnesium stearate Opadry® II red 32K15441 (HPMC 2910 / hypromellose 15cP, titanium dioxide (E 171), lactose monohydrate, triacetin; iron oxide red (E172)).
Hypersensitivity to axitinib or to any other component of the drug.
The recommended starting oral dose of Inlit is 5 mg twice a day. The intervals between doses of the drug Inlyta should be approximately 12:00; the drug can be used regardless of food intake. The tablets are swallowed whole with a glass of water.
Pregnant
Adequate studies with an appropriate level of control, studying the use of the drug Inlyta for the treatment of pregnant women, have not been carried out. Due to the peculiarities of the mechanism of action, the drug Inlyta can cause harmful effects on the fetus when this drug is prescribed to pregnant women.
Children
The safety and efficacy of using the drug Inlyta in children have not been studied.
Drivers
It is necessary to warn patients about the possibility of dizziness, drowsiness, visual impairment when using the drug Inlyta and recommend that they do not drive vehicles and do not work with mechanisms if these symptoms occur.
In a controlled clinical trial of Inlyta for the treatment of renal cell carcinoma, one patient inadvertently took 20 mg twice daily for 4 days and felt slightly dizzy.
In a clinical study to determine the dose of Inlyta, participants who received the drug in the initial doses of 10 or 20 mg twice a day experienced adverse reactions that included hypertension, convulsions associated with arterial hypertension, and fatal hemoptysis ...
The safety of using the drug Inlyta was assessed in the course of studies of the monotherapy regimen with the participation of 715 patients, of whom 537 had advanced renal cell carcinoma. The data presented in the section "Adverse reactions" relate to the use of the drug Inlyta in 359 patients with advanced renal cell carcinoma who participated in a randomized clinical study, where the drug Inlyta was compared with sorafenib.
Risks such as: arterial hypertension, arterial and venous thromboembolism, bleeding, heart failure, perforation of the digestive tract and fistula formation, thyroid dysfunction, difficult wound healing, posterior reverse leukoencephalopathy syndrome (PSL), proteinuria, increased liver enzymes, dysfunction liver and fetal developmental disorders.
Store at temperatures below 30 ° C out of reach of children.
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