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
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
INLYTA is a kinase inhibitor indicated:
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
1 mg and 5 mg tablets (3)
WARNINGS AND PRECAUTIONS
Most common adverse reactions (≥20%) are:
INLYTA in combination with avelumab: diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain, and headache. (6.1)
INLYTA in combination with pembrolizumab: diarrhea, fatigue/asthenia, hypertension, hypothyroidism, decreased appetite, hepatotoxicity, palmar-plantar erythrodysesthesia, nausea, stomatitis/mucosal inflammation, dysphonia, rash, cough, and constipation. (6.1)
INLYTA as a single agent: 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.
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
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