Inlyta Tablet, Film Coated
Product Images NDC 0069-0145
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Inlyta (NDC 0069-0145). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Pfizer Laboratories Div Pfizer Inc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.
Figure 1 (Inlyta 02)
This is a table describing the effect of various inhibitors and inducers on the pharmacokinetics of a drug called INLYTA. The inhibitors and inducers include Ketoconazole, Rifampin and Rabeprazole among others. The table also describes the effect of hepatic impairment on the Cmax and AUC of INLYTA. The recommendations for dose adjustment based on fold change and 90% confidence interval are also provided.*
Figure 2 (Inlyta 03)
Figure 3 (Inlyta 04)
The text represents a chart that shows the overall survival percentage for two treatment arms, INLYTA + pembrolizumab and Sunitinib. There are 432 patients in the INLYTA + pembrolizumab arm, and the number at risk is not available. The number of patients in the Sunitinib treatment is not available, and there is a decreasing graph with time in months on the X-axis and the overall survival percentage on the Y-axis. There are no other details available from the provided text.*
Figure 4 (Inlyta 05)
This is a comparison of the median progression-free survival for two drugs, INLYTA and Sorafenib, tested on two separate groups (N = 361 and N = 362). INLYTA had a median progression-free survival of 6.7 months and Sorafenib had a median progression-free survival of 4.7 months. The Hazard Ratio for INLYTA compared to Sorafenib was 0.67 (95% CI [0.54,0.81], P value < 0.0001). The graph shows the proportion of patients who were progression-free over time (months).*
Logo (Inlyta 06)
Logo (Inlyta 07)
Principal Display Panel (1 mg Tablet Bottle Label)
This text provides instructions for storing and dispensing Inlyta axitinib tablets, which contain 1 mg of the drug. It should be stored in a tightly sealed, child-resistant container at temperatures between 20-25°C (68-77°F), with some permitted temperature fluctuations between 15-30°C (59-86°F). The text also includes information about distribution, lot number, and product code. Prescribing information is not available.*
Principal Display Panel (5 mg Tablet Bottle Label)
This is a medication containing axitinib tablets that should be stored in a temperature range of 20°C to 25°C (68°F to 77°F). Excursions of 15°C to 30°C (59°F to 86°F) are permitted. Each tablet contains 5mg of axitinib and should be dispensed in tight (USP), child-resistant containers. The medication can only be obtained with a prescription. Further information can be found in the prescribing information accompanying the medication. The product is distributed by Pfizer Labs Exp. Division of Pfizer Inc.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.