HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |
Did you find an answer to your question?
Yes
No
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our medical information is accurate, up to date, and scientifically balanced.
INLYTA®(axitinib)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our medical information is accurate, up to date, and scientifically balanced.
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...
Did you find an answer to your question?
Yes
No
Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
...
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed elsewhere in the labeling [see Warnings and Precautions (5)]:
- Hypertension...
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on findings in...
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies have not been conducted with axitinib.
Axitinib was...
Did you find an answer to your question?
Yes
No
Clinical Studies
14 CLINICAL STUDIES
14.1 First-Line Advanced RCC
INLYTA in Combination with Avelumab...
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
Medication Guide
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Hypertension...
Did you find an answer to your question?
Yes
No
Did you find an answer to your question?
Yes
No
Resources
Didn’t find what you were looking for? Contact us.
To interact with the Medical Information Digital Assistant click here.
Contact Pfizer Medical Information to speak with a professional regarding your medical question on a Pfizer prescription product: (800) 438-1985
Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.