Zydelig fda prescribing information, side effects and uses. Highlights of prescribing information palmarplantar. Fda required updated rems safety information zydelig. Each tablet contains either 100 mg or 150 mg of idelalisib with the following inactive ingredients. See full prescribing information for complete boxed warning. Zydelig idelalisib tablets are for oral administration. A placebocontrolled study of idelalisib in patients with relapsed chronic lymphocytic leukemia who were receiving rituximab was stopped early because of significant improvement in.
Monitor hepatic function prior to and during treatment. See 17 for patient counseling information and fdaapproved patient labeling. See full prescribing information, including boxed warning. Zydelig should not be used as the first medicine to treat people who have been diagnosed with cll. Upon rechallenge at a lower dose, altast elevations recurred in 26% of patients. Zydelig can cause serious side effects that can lead to death, including. Idelalisib and rituximab in relapsed chronic lymphocytic. 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. Idelalisib is a selective inhibitor of adenosine5triphosphate atp binding to the catalytic domain of pi3k. If altast is 3x upper limit of normal uln, monitor for liver toxicity weekly. Abnormal liver blood test results are common during treatment with zydelig. Please see full prescribing information, including boxed warning regarding fatal and serious toxicities of hepatotoxicity, severe.
Find information on zydelig idelalisib and how you may be able to help your patients with. Zydelig is a kinase inhibitor indicated for the treatment of patients with. Idelalisib inhibits atp binding, which results in apoptosis and thereby decreases. See full prescribing information, including medication guide, with important warnings. Your doctor will do blood tests before and during your treatment with zydelig to check for liver problems. Fatal andor serious pneumonitis occurred in 4% of zydeligtreated patients. Monitor for the development of severe diarrhea or colitis. Idelalisib, sold under the brand name zydelig, is a medication used to treat certain blood.
Fatal andor serious and severe diarrhea or colitis occurred in 14% to 20% of zydeligtreated patients. Relapsed chronic lymphocytic leukemia cll, in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other comorbidities. 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 is a secondline drug for patients whose chronic lymphocytic leukemia cll has relapsed. Find patient medical information for idelalisib oral on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Zydelig, innidelalisib european medicines agency europa eu.