This oncology drug snapshot takes a look at axitinib (Inlyta) for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy.
Axitinib (Inlyta) for the treatment of advanced renal cell carcinoma after failure of one prior systemic therapy.
Starting Dose: 5 mg orally twice daily. Dose adjustments can be made based on individual safety and tolerability. Administration: Approximately 12 hours apart with or without food. Axitinib should be swallowed whole with a glass of water. Additional Notes: If a strong CYP3A4/5 inhibitor is required, or if patients have moderate hepatic impairment, decrease the axitinib dose by approximately half.
Category D; There are no adequate and well-controlled studies with axitinib in pregnant women. Axitinib can cause fetal harm when administered to a pregnant woman based on its mechanism of action. It is unknown whether axitinib is excreted in human milk, but because of the potential for adverse reactions, a decision should be made to discontinue nursing or the drug. The safety and efficacy of axitinib in pediatric patients have not been studied.
No dosage adjustment is required in elderly patients. Unknown whether axitinib is excreted in human milk, but because of the potential for adverse reactions, a decision should be made to discontinue nursing or the drug. No dedicated renal impairment trial for axitinib has been conducted. Caution should be used in patients with end-stage renal disease.
Blood pressure should be well-controlled prior to initiating axitinib. Arterial and venous thrombotic events have been observed and can be fatal. Hemorrhagic events, including fatal events, have been reported.
Cardiac failure has been observed and can be fatal. Gastrointestinal perforation and fistula, including death, have occurred. Hypothyroidism requiring thyroid hormone replacement has been reported.
Stop axitinib at least 24 hours prior to scheduled surgery. Reversible posterior leukoencephalopathy syndrome has been observed. Monitor for proteinuria before initiation of, and periodically throughout, treatment with axitinib.
Liver enzyme elevation has been observed during treatment with axitinib. The starting dose of axitinib should be decreased if used in patients with moderate hepatic impairment. Axitinib can cause fetal harm when administered to a pregnant woman based on its mechanism of action.
The most common (â¥ 20%) adverse reactions are diarrhea, hypertension, fatigue, decreased appetite, nausea, dysphonia, palmar-plantar erythrodysesthesia (hand-foot) syndrome, weight decreased, vomiting, asthenia, and constipation. Avoid strong CYP3A4/5 inhibitors. If unavoidable, reduce the axitinib dose. Avoid strong CYP3A4/5 inducers.
For more detailed prescribing information on axitinib, including clinical pharmacology, clinical study details, and patient counseling information, please review Pfizer’s product label.View product label here.