Jakafi Xr Tablet, Extended Release
Product Images NDC 50881-044

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Jakafi Xr (NDC 50881-044). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Incyte Corporation, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Ruxolitinib Phosphate Structure (Jakafi 1)

Chemical structure diagram of ruxolitinib, the active ingredient in JAKAFI. The diagram shows the molecular arrangement including a pyrrolidine group, cyano group, and multiple nitrogen-containing heterocycles.*

FDA Label Image

Jakafi (ruxolitinib) 20mg Tablets (60 Tablet Bottle Label)

Label for Jakafi (ruxolitinib) Tablets 20 mg by Incyte Corporation. The label indicates 60 tablets per container, with storage instructions to keep at room temperature between 20°-25°C, protect from light, and dispense in a tight container. Contact information for Incyte Corporation is provided along with the NDC 50881-020-60 barcode.*

FDA Label Image

Jakafi (ruxolitinib) 25mg Tablets (60 Tablet Bottle Label)

Label for Jakafi (ruxolitinib) Tablets 25 mg by Incyte Corporation. The label includes storage instructions (20°-25°C, protect from light), dispensing guidelines, and states each tablet contains 33 mg ruxolitinib phosphate equivalent to 25 mg ruxolitinib free base. Package contains 60 tablets.*

FDA Label Image

Percent Change From Baseline In Spleen Volume At Week 24 Or Last Observation For Each Patient (study 1) (Jakafi 2)

A bar chart showing percent change from baseline in spleen volume at week 24 or last observation for patients in Study 1, comparing Jakafi (ruxolitinib) treated group (N=155) with placebo group (N=153). The chart depicts individual patient data with Jakafi group showing mostly negative percent changes (reduction) and placebo group mostly positive changes. A 35% reduction threshold is indicated.*

FDA Label Image

Percent Change From Baseline In Total Symptom Score At Week 24 Or Last Observation For Each Patient (study 1) (Jakafi 3)

A vertical bar chart comparing percent change from baseline in total symptom score at week 24 or last observation for patients in Study 1. It shows data for two groups: Jakafi (ruxolitinib) with 145 patients and placebo with 145 patients. The y-axis represents percent change from baseline ranging from -100% to 150% with a marker for 50% reduction, while the x-axis lists individual patients. The chart illustrates symptom changes, including reductions and worsening, truncated at 150% worsening.*

FDA Label Image

Proportion Of Patients With Myelofibrosis Achieving 50% Or Greater Reduction In Individual Symptom Scores At Week 24 (Jakafi 4)

A bar chart showing the proportion of patients with myelofibrosis achieving a 50% or greater reduction in individual symptom scores at week 24. Symptoms evaluated include abdominal discomfort, pain under left ribs, early satiety, night sweats, itching, and bone or muscle pain. The chart compares JAKAFI (ruxolitinib) versus placebo, with higher proportions in the JAKAFI group across all symptoms.*

FDA Label Image

Overall Survival (Kaplan-Meier Curves by Treatment Group in Study 1)

Kaplan-Meier survival curve displaying overall survival probabilities over 42 months for two treatment groups: Jakafi and Placebo. The graph shows survival probability on the y-axis and time in months on the x-axis. Jakafi group consistently shows higher survival probabilities than Placebo. A table within the graph presents 1-, 2-, and 3-year survival percentages for both groups. Patient numbers at risk decrease over time for both treatments.*

FDA Label Image

Overall Survival (Kaplan Meier Curves by Treatment Group in Study 2)

A Kaplan-Meier survival curve chart comparing overall survival probabilities over time in months for Jakafi versus Best Available Therapy in Study 2. The chart shows survival rates at 1, 2, and 3 years with Jakafi having higher survival percentages. The number of patients at risk at various time points is listed for both treatment groups below the graph.*

FDA Label Image

Jakafi (ruxolitinib) 5mg Tablets (60 Tablet Bottle Label)

Label for Jakafi (ruxolitinib) tablets, 5 mg strength, oral dosage form, manufactured for Incyte Corporation. The label indicates a quantity of 60 tablets and includes storage instructions to keep at room temperature with specific temperature ranges, protect from light, and dispense in a tight container. The label also shows the NDC number 50881-005-60 and the prescription-only symbol.*

FDA Label Image

Jakafi (ruxolitinib) 10mg Tablets (60 Tablet Bottle Label)

Label for Jakafi (ruxolitinib) Tablets, 10 mg strength, oral tablets. The label states a quantity of 60 tablets and is manufactured for Incyte Corporation. Storage instructions include room temperature with specific temperature ranges, and it advises protecting from light. The label includes the NDC 50881-010-60 and a barcode.*

FDA Label Image

Jakafi (ruxolitinib) 15mg Tablets (60 Tablet Bottle Label)

Jakafi 15 mg (ruxolitinib) tablets label showing a 60-count bottle manufactured by Incyte Corporation. The label includes storage instructions for controlled room temperature (20°-25°C) and protection from light. Contact information for Incyte Corporation is also provided, along with a barcode and the NDC 50881-015-60.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.