Idelalisib package insert pdf

Upon rechallenge at a lower dose, altast elevations recurred in 26% of patients. Although cll is not curable, your doctor can use different therapies or combinations of therapies. Idelalisib inhibits atp binding, which results in apoptosis and thereby decreases. Accelerated approval was granted for fl and sll based on. In relapsed cll, zydelig is used in combination with rituxan rituximab when cll comes back after prior cancer treatment and when rituxan treatment alone may be used due to other health problems.

Idelalisib, sold under the brand name zydelig, is a medication used to treat certain blood. Fatal andor serious pneumonitis occurred in 4% of zydeligtreated patients. Please see full prescribing information, including boxed warning regarding fatal and serious toxicities of hepatotoxicity, severe. Learn about zydelig idelalisib treatment, including managing side effects, and discover helpful resources related to your treatment. See full prescribing information, including medication guide, with important warnings. In all patients, monitor altast every 2 weeks for the first 3 months, every 4 weeks for the next 3 months, and every 1 to 3 months thereafter. Fatal andor serious and severe diarrhea or colitis occurred in 14% to 20% of zydeligtreated patients. Zydelig fda prescribing information, side effects and uses. Monitor hepatic function prior to and during treatment. Find patient medical information for idelalisib oral on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. See full prescribing information, including boxed warning. Find information on zydelig idelalisib and how you may be able to help your patients with.

See full prescribing information for complete boxed warning. Zydelig idelalisib tablets are for oral administration. Each tablet contains either 100 mg or 150 mg of idelalisib with the following inactive ingredients. Zydelig should not be used as the first medicine to treat people who have been diagnosed with cll. Fatal andor serious and severe diarrhea or colitis occurred in 14% to 19% of zydeligtreated patients.

Idelalisib is a selective inhibitor of adenosine5triphosphate atp binding to the catalytic domain of pi3k. Monitor for the development of severe diarrhea or colitis. Fda required updated rems safety information zydelig. Abnormal liver blood test results are common during treatment with zydelig. Idelalisib is a secondline drug for patients whose chronic lymphocytic leukemia cll has relapsed. Idelalisib and rituximab in relapsed chronic lymphocytic. If altast is 3x upper limit of normal uln, monitor for liver toxicity weekly. See 17 for patient counseling information and fdaapproved patient labeling.