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 REACTIONS
The most common (≥20%) adverse reactions are diarrhea, hypertension, fatigue, decreased appetite, nausea, dysphonia, palmar-plantar erythrodysesthesia (hand-foot) syndrome, weight decreased, vomiting, asthenia, and constipation. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
• Avoid strong CYP3A4/5 inhibitors. If unavoidable, reduce the INLYTA dose. (2.2, 7.1)
• Avoid strong CYP3A4/5 inducers. (7.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling
Revised: 01/2012
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FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
2.2 Dose Modification Guidelines
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypertension and Hypertensive Crisis
5.2 Arterial Thromboembolic Events
5.3 Venous Thromboembolic Events
5.4 Hemorrhage
5.5 Gastrointestinal Perforation and Fistula Formation
5.6 Thyroid Dysfunction
5.7 Wound Healing Complications
5.8 Reversible Posterior Leukoencephalopathy Syndrome
5.9 Proteinuria
5.10 Elevation of Liver E |
