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INLYTA® (axitinib)
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INLYTA® Quick Finder
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...
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
...
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...
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...
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed elsewhere in the labeling [see Warnings and Precautions (5)]:
- Hypertension...
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...
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on findings in...
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...
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...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Axitinib has been shown to inhibit receptor tyrosine kinases including vascular endothelial growth factor receptors...
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies have not been conducted with axitinib.
Axitinib was...
14 CLINICAL STUDIES
14.1 First-Line Advanced RCC
INLYTA in Combination with Avelumab...
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...
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Hypertension...
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