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INLYTA® (axitinib)
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INLYTA® Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
1.1 First-Line Advanced Renal Cell Carcinoma
INLYTA in combination with avelumab is indicated for the first-line treatment of...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
...
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Dosage Forms and Strengths
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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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Hypertension
In a controlled clinical study with INLYTA for the treatment of patients with RCC, hypertension was reported in 145/359...
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Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed elsewhere in the labeling [see Warnings and Precautions (5)]:
- Hypertension...
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Drug Interactions
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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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on findings in...
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Overdosage
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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Description
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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Clinical Pharmacology
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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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies have not been conducted with axitinib.
Axitinib was...
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Clinical Studies
14 CLINICAL STUDIES
14.1 First-Line Advanced RCC
INLYTA in Combination with Avelumab...
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How Supplied/Storage and Handling
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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Medication Guide
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Hypertension...
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