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INLYTA®(axitinib)

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INLYTA® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

1.1 First-Line Advanced Renal Cell Carcinoma

INLYTA in combination with avelumab is...

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2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosing

...

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3 DOSAGE FORMS AND STRENGTHS

  • 1 mg tablets of INLYTA: red, film-coated, oval tablets, debossed with "Pfizer" on one side and "1 XNB" on the other side.
  • 5 mg tablets of INLYTA: red, film-coated, triangular tablets, debossed...
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4 CONTRAINDICATIONS

None.

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5 WARNINGS AND PRECAUTIONS

5.1 Hypertension and Hypertensive Crisis

In a controlled clinical study with INLYTA for the treatment of patients with RCC, hypertension...

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6 ADVERSE REACTIONS

The following clinically significant adverse reactions are discussed elsewhere in the labeling [see

6.1 Clinical Trials Experience

Because clinical trials...

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7 DRUG INTERACTIONS

7.1 CYP3A4/5 Inhibitors

Co-administration of ketoconazole, a strong inhibitor of CYP3A4/5, increased the plasma exposure of axitinib in healthy...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on findings in...

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10 OVERDOSAGE

There is no specific treatment for INLYTA overdose.

In a controlled clinical study with INLYTA for the treatment of patients with RCC, 1 patient inadvertently received a dose of 20 mg twice daily for 4...

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11 DESCRIPTION

INLYTA (axitinib) is a kinase inhibitor. Axitinib has the chemical name N-methyl-2-[3-((E)-2-pyridin-2-yl-vinyl)-1H-indazol-6-ylsulfanyl]-benzamide. The molecular formula is C22H18N4OS and the molecular weight...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Axitinib has been shown to inhibit receptor tyrosine kinases including vascular endothelial growth factor receptors...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies have not been conducted with axitinib.

Axitinib was...

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14 CLINICAL STUDIES

14.1 First-Line Advanced RCC

INLYTA in Combination with Avelumab...

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16 HOW SUPPLIED/STORAGE AND HANDLING

INLYTA tablets are supplied as follows:

  • 1 mg tablets are red film-coated, oval tablets debossed with "Pfizer" on one side and "1 XNB" on the other; available in bottles of 180...
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17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Hypertension...

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This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

...

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Resources

Pfizer Oncology Together
For questions regarding the Pfizer Oncology Together program, please call (877) 744-5675.
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