Axitinib (Inlyta), a tyrosine kinase inhibitor that prevents angiogenesis, tumor growth, and cancer progression, has been approved to treat advanced renal cell cancer in patients who haven't responded to other drug therapy. Unlike many chemotherapeutic drugs, axitinib is taken orally. It's taken twice daily, with or without food. In a single randomized, open-label, multicenter clinical trial of 723 patients whose renal cancer had progressed after they'd received therapy with a different antineoplastic drug, axitinib was found to be effective in slowing disease progression.

Axitinib's label carries warnings that it can cause hypertensive crisis, arterial and venous thrombotic events, hemorrhagic events (including fatal ones), gastrointestinal perforation and fistula (which can be fatal), hypothyroidism requiring thyroid replacement therapy, reversible posterior leukoencephalopathy syndrome, proteinuria, liver enzyme elevations, impaired wound healing, and (because of its ability to prevent angiogenesis) fetal harm.

The most common adverse effects (occurring in 20% or more of patients) include diarrhea, hypertension, fatigue, anorexia, nausea, dysphonia (loss of voice), palmar-plantar erythrodysesthesia (commonly referred to as hand-foot syndrome, in which small amounts of drug leak out of capillaries in the palms and feet, producing redness, tenderness, and peeling), weight loss, vomiting, weakness, and constipation.

Axitinib is metabolized by the cytochrome P-450 (CYP) isoenzyme CYP3A4/5. Other drugs that are strong inhibitors of CYP3A4/5 will increase the plasma level of axitinib and should be avoided if possible. If such drugs must be used, a reduced dose of axitinib is required. Grapefruit juice should be avoided, too, because it will increase the circulating level of axitinib, increasing the risk of adverse effects.

Preexisting hypertension should be well controlled before a patient begins axitinib therapy. Patient education should include the importance of checking blood pressure regularly while one is receiving the drug. Patients should be made aware of the symptoms that may suggest a thromboembolic event or hypothyroidism. They should also be instructed to notify their prescriber immediately if they have a bleeding episode; persistent or severe abdominal pain; or any neurologic worsening (headache, seizure, lethargy, confusion, blindness, or other neurologic or visual disturbances) that could indicate reversible posterior leukoencephalopathy syndrome. Nurses should instruct both men and women to use birth control while they're receiving axitinib to prevent fetal injury.

For axitinib's complete prescribing information, go to http://1.usa.gov/wLvlFY.