S
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 Enzymes
5.11 Hepatic Impairment
5.12 Pregnancy
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
7.1 CYP3A4/5 Inhibitors
7.2 CYP3A4/5 Inducers
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Hypertension
17.2 Arterial/Venous Thromboembolic Events
17.3 Hemorrhage
17.4 Gastrointestinal Disorders
17.5 Abnormal Thyroid Function
17.6 Wound Healing Complications
17.7 Reversible Posterior Leukoencephalopathy Syndrome
17.8 Pregnancy
17.9 Concomitant Medications
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
INLYTA is indicated for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
The recommended starting oral dose of INLYTA is 5 mg twice daily. Administer INLYTA doses approximately 12 hours apart with or without food [see Clinical Pharmacol
