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INLYTA®Highlights (axitinib)

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, First-line advanced RCC (1.1)6/2020
Dosage and Administration, Recommended Dosing (2.1)6/2020
Dosage and Administration, Dose Modification Guidelines (2.2)6/2020
Warnings and Precautions, Risk of Impaired Wound Healing (5.8)1/2020
Warnings and Precautions, Hepatotoxicity (5.11)6/2020
Warnings and Precautions, Major Adverse Cardiovascular Events (MACE) (5.13)6/2020

INDICATIONS AND USAGE

INLYTA is a kinase inhibitor indicated:

  • in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). (1.1)
  • in combination with pembrolizumab, for the first-line treatment of patients with advanced RCC. (1.1)
  • as a single agent, for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. (1.2)

DOSAGE AND ADMINISTRATION

  • INLYTA 5 mg orally twice daily with avelumab 800 mg every 2 weeks. (2.1)
  • INLYTA 5 mg orally twice daily with pembrolizumab 200 mg every 3 weeks or 400 mg every 6 weeks. (2.1)
  • INLYTA as a single agent the starting dose is 5 mg orally twice daily. (2.1)
  • Dose adjustments can be made based on individual safety and tolerability. (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 and Hypertensive Crisis: 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 Thromboembolic Events: 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)
  • Hemorrhage: 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)
  • Cardiac Failure: Cardiac failure has been observed and can be fatal. Monitor for signs or symptoms of cardiac failure throughout treatment with INLYTA. (5.5)
  • Gastrointestinal Perforation and Fistula Formation: Gastrointestinal perforation and fistula, including death, have occurred. Use with caution in patients at risk for gastrointestinal perforation or fistula. (5.6)
  • Hypothyroidism: Hypothyroidism requiring thyroid hormone replacement has been reported. Monitor thyroid function before initiation of, and periodically throughout, treatment with INLYTA. (5.7)
  • Risk of Impaired Wound Healing: Withhold INLYTA for at least 2 days prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of INLYTA after resolution of wound healing complications has not been established. (5.8)
  • Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS has been observed. Permanently discontinue INLYTA if signs or symptoms of RPLS occur. (5.9)
  • Proteinuria: 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. (5.10)
  • Hepatotoxicity: Liver enzyme elevation has occurred during treatment with INLYTA as a single agent. Monitor ALT, AST and bilirubin before initiation of, and periodically throughout, treatment with INLYTA. When used in combination with avelumab or pembrolizumab, higher frequencies of Grade 3 and 4 ALT and AST elevation may occur. Consider more frequent monitoring of liver enzymes. Consider withholding INLYTA and/or avelumab or pembrolizumab, initiating corticosteroid therapy, and/or permanently discontinuing the combination for severe or life-threatening hepatotoxicity. (5.11)
  • Use in Patients with Hepatic Impairment: Decrease the starting dose of INLYTA if used in patients with moderate hepatic impairment. INLYTA has not been studied in patients with severe hepatic impairment. (2.2, 5.12)
  • Major adverse cardiovascular events (INLYTA in combination with avelumab): Optimize management of cardiovascular risk factors. Discontinue INLYTA in combination with avelumab for Grade 3–4 events. (5.13)
  • Embryo-Fetal Toxicity: INLYTA can cause fetal harm. Advise patients of the potential risk to the fetus and to use effective contraception. (5.14, 8.1, 8.3)

ADVERSE REACTIONS

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.

DRUG INTERACTIONS

  • Avoid strong CYP3A4/5 inhibitors. If unavoidable, reduce the INLYTA dose. (2.2, 7.1)
  • Avoid strong CYP3A4/5 inducers. (7.2)

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed. (8.2)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 6/2020

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You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch