Axinix 5 Mg (Axitinib) – 60 Tablets

Pregnancy Category D. Axinix can cause fetal harm when administered to a pregnant woman base on its mechanism of action. There are no adequate and well-controlled studies in pregnant women using Axitinib. In developmental toxicity studies in mice, axitinib was teratogenic, embryotoxic and fetotoxic at maternal exposures that were lower than human exposures at the recommended clinical dose.

Women of childbearing potential should advised to avoid becoming pregnant while receiving Axinix . If this drug use during pregnancy, or if a patient becomes pregnant while receiving this drug, the patient apprise of the potential hazard to the fetus.

Nursing Mothers: It is not known whether Axinix excrete in human milk. Many drugs are excreted in human milk, and Axitinib could potentially cause serious adverse reactions in nursing infants. Therefore, you should decide whether to discontinue nursing or to stop using the drug. Consider the importance of Axitinib to the mother when making this decision.

Hepatic Impairment: The systemic exposure to Axinix higher in subjects with moderate hepatic impairment (Child-Pugh class B) compared to subjects with normal hepatic function. A dose decrease recommended when administering Axitinib to patients with moderate hepatic impairment (Child-Pugh class B). Axinix has not studied in patients with severe hepatic impairment (Child-Pugh class C).

Renal Impairment: No dedicated renal impairment trial for Axinix has conducted. Based on the population pharmacokinetic analyses, no significant difference in axitinib clearance observed in patients with pre-existing mild to severe renal impairment (15 mL/min ≤ ClCr < 89 mL/min). No starting dose adjustment need for patients with pre-existing mild to severe renal impairment. Caution should use in patients with end-stage renal disease (ClCr< 15 mL/min).

Pediatric Use: The safety and efficacy of Axinix in pediatric patients have not studied.