Axinix 1

At therapeutic plasma concentrations, axitinib blocks several receptor tyrosine kinases, including vascular endothelial growth factor receptors (VEGFR)-1, VEGFR-2 and VEGFR-3. These receptors are linked to pathologic angiogenesis, tumor growth and the progression of cancer. In laboratory studies and in mouse models, axitinib stopped VEGF-mediated endothelial cell proliferation and survival. It also slowed tumor growth and reduced phosphorylation of VEGFR-2 in tumor xenograft mouse models.

Pregnancy Category D. Axitinib can harm an unborn baby when given to a pregnant woman, and this is based on how the medicine works. There are no adequate, well-controlled studies of axitinib in pregnant women. In developmental toxicity studies in mice, axitinib was teratogenic, embryotoxic and fetotoxic, even at maternal exposures lower than the human exposure at the recommended clinical dose.

Women who could become pregnant should be advised to avoid pregnancy while taking axitinib. If the medicine is used during pregnancy, or if a patient becomes pregnant while taking it, she should be told about the potential hazard to the fetus.

Nursing Mothers: It is not known whether axitinib is excreted in human milk. Many drugs pass into human milk, and axitinib could cause serious adverse reactions in nursing infants. So a decision should be made either to stop nursing or to stop the drug, taking into account how important the drug is to the mother.

Strong CYP3A4/5 inhibitors

Avoid using strong CYP3A4/5 inhibitors together with Axitinib. Examples are Ketoconazole, Itraconazole, Clarithromycin, Atazanavir, Indinavir, Nefazodone, Nelfinavir, Ritonavir, Saquinavir, Telithromycin and Voriconazole. It's recommended to choose another medicine that has no or minimal CYP3A4/5 inhibition potential. Axitinib dose adjustment has not been studied in patients receiving strong CYP3A4/5 inhibitors. But if a strong inhibitor must be given at the same time, the Axitinib dose should be cut by approximately half. This reduction is predicted to bring the Axitinib area under the plasma concentration vs time curve (AUC) back to the range seen without inhibitors. Later doses can then be raised or lowered depending on the individual patient's safety and tolerability. If the strong inhibitor is stopped, the Axitinib dose should go back (after 3 to 5 half-lives of the inhibitor) to the dose used before the inhibitor was started.

Hepatic impairment

Patients with mild hepatic impairment (Child-Pugh class A) need no adjustment to the starting dose of Axitinib. In patients with baseline moderate hepatic impairment (Child Pugh class B), the starting dose should be reduced by approximately half, based on the pharmacokinetic data. Later doses can be raised or lowered depending on individual safety and tolerability. Axitinib has not been studied in patients with severe hepatic impairment (Child-Pugh class C).

There is no specific treatment for Axitinib overdose. In a controlled clinical study in patients with RCC, 1 patient received a dose of 20 mg twice daily for 4 days by mistake and had dizziness (Grade 1). In a clinical dose finding study, subjects who started on 10 mg twice daily or 20 mg twice daily had adverse reactions, including hypertension, seizures associated with hypertension, and fatal hemoptysis. If an overdose is suspected, Axitinib should be withheld and supportive care started.

অ্যাক্সিটিনিব আলো ও আর্দ্রতা থেকে দূরে রাখুন এবং ২৫ ডিগ্রী সেঃ তাপমাত্রার নীচে থাকে এমন জায়গায় রাখুন। শিশুদের নাগালের বাইরে রাখুন।