INLYTA (axitinib) tablet, film coated
[Pfizer Laboratories Div Pfizer Inc]
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use INLYTA safely and effectively. See full prescribing information for INLYTA.
INLYTA® (axitinib) tablets for oral administration
 Initial U.S. Approval: 2012
INDICATIONS AND USAGE
INLYTA is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma after failure of one prior systemic therapy. (1)
DOSAGE AND ADMINISTRATION
• The starting dose is 5 mg orally twice daily. Dose adjustments can be made based on individual safety and tolerability. (2.1, 2.2)
 • Administer INLYTA dose approximately 12 hours apart with or without food. (2.1)
 • INLYTA should be swallowed whole with a glass of water. (2.1)
 • If a strong CYP3A4/5 inhibitor is required, decrease the INLYTA dose by approximately half. (2.2)
 • For patients with moderate hepatic impairment, decrease the starting dose by approximately half. (2.2)
DOSAGE FORMS AND STRENGTHS
1 mg and 5 mg tablets (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
• Hypertension including hypertensive crisis has been observed. Blood pressure should be well-controlled prior to initiating INLYTA. Monitor for hypertension and treat as needed. For persistent hypertension despite use of anti-hypertensive medications, reduce the INLYTA dose. (5.1)
 • Arterial and venous thrombotic events have been observed and can be fatal. Use with caution in patients who are at increased risk for these events. (5.2, 5.3)
 • Hemorrhagic events, including fatal events, have been reported. INLYTA has not been studied in patients with evidence of untreated brain metastasis or recent active gastrointestinal bleeding and should not be used in those patients. (5.4)
 • Gastrointestinal perforation and fistula, including death, have occurred. Use with caution in patients at risk for gastrointestinal perforation or fistula. (5.5)
 •Hypothyroidism requiring thyroid hormone replacement has been reported. Monitor thyroid function before initiation of, and periodically throughout, treatment with INLYTA. (5.6)
 • Stop INLYTA at least 24 hours prior to scheduled surgery. (5.7)
 • Reversible Posterior Leukoencephalopathy Syndrome (RPLS) has been observed. Permanently discontinue INLYTA if signs or symptoms of RPLS occur. (5.8)
 • Monitor for proteinuria before initiation of, and periodically throughout, treatment with INLYTA. For moderate to severe proteinuria, reduce the dose or temporarily interrupt treatment with INLYTA. (5.9)
 • Liver enzyme elevation has been observed during treatment with INLYTA. Monitor ALT, AST and bilirubin before initiation of, and periodically throughout, treatment with INLYTA. (5.10)
 • The starting dose of INLYTA should be decreased if used in patients with moderate hepatic impairment. INLYTA has not been studied in patients with severe hepatic impairment. (2.2, 5.11)
 • INLYTA can cause fetal harm when administered to a pregnant woman based on its mechanism of action. Women of childbearing potential should be advised of the potential hazard to the fetus and to avoid becoming pregnant while receiving INLYTA. (5.12, 8.1)
ADVERSE REACTION