What is the Zydelig REMS?
A REMS (Risk Evaluation and Mitigation Strategy) is a program required by the Food and Drug
Administration (FDA) to manage known or potential serious risks associated with a drug product.
The purpose of the Zydelig REMS is to inform healthcare providers about the following risks
Fatal and/or Serious Hepatotoxicity
- Fatal and/or serious hepatotoxicity occurred in 14% of patients treated with Zydelig. Elevations in
ALT and AST greater than 5 times the upper limit of normal have occurred. These findings were
generally observed within the first 12 weeks of treatment and were reversible with dose
interruption. After resumption of treatment at a lower dose, 26% of patients had recurrence of ALT
and AST elevations. Discontinue Zydelig for recurrent hepatotoxicity.
- Avoid concurrent use of Zydelig with other drugs that may cause liver toxicity.
- Monitor ALT and AST in all patients every 2 weeks for the first 3 months of treatment, every 4
weeks for the next 3 months, then every 1 to 3 months thereafter. Monitor weekly for liver toxicity if
the ALT or AST rises above 3 times the upper limit of normal until resolved. Withhold Zydelig if the
ALT or AST is greater than 5 times the upper limit of normal, and continue to monitor AST, ALT and
total bilirubin weekly until the abnormality is resolved.
Fatal and/or Serious and Severe Diarrhea or Colitis
- Fatal and/or serious and severe diarrhea or colitis (Grade 3 or higher) occurred in 14% of Zydelig-treated
patients across clinical trials. Diarrhea can occur at any time.
- Avoid concurrent use of Zydelig and other drugs that cause diarrhea. Diarrhea due to Zydelig responds
poorly to anti-motility agents. Median time to resolution ranged between one week and one month across
trials following interruption of Zydelig therapy - and in some instances, use of corticosteroids.
Materials for Patients
Fatal and Serious Pneumonitis
- Fatal and serious pneumonitis occurred in patients treated with Zydelig.
- Patients taking Zydelig who present with pulmonary symptoms such as cough, dyspnea, hypoxia, interstitial infiltrates on a radiologic exam, or a decline by more than 5% in oxygen saturation should be evaluated for pneumonitis.
- If pneumonitis is suspected, interrupt Zydelig until the etiology of the pulmonary symptoms has been determined.
- Patients with pneumonitis thought to be caused by Zydelig have been treated with discontinuation of Zydelig and administration of corticosteroids.
Fatal and Serious Intestinal Perforation
- Fatal and serious intestinal perforation occurred in Zydelig-treated patients. At the time of perforation, some patients had moderate to severe diarrhea.
- Advise patients to promptly report any new or worsening abdominal pain, chills, fever, nausea, or vomiting.
- Discontinue Zydelig permanently in patients who experience intestinal perforation.
Zydelig Fact Sheet: A non-promotional fact sheet, reviewed by the FDA, with more detailed safety information on these risks is available. (See link in the box labeled “Materials for Healthcare Providers”)
Zydelig Patient Safety Information Card: This card should be given to all patients by Zydelig prescribers and should be carried by patients on Zydelig at all times. Patients should show this card to any healthcare professional that sees them in a health-related encounter. (See link in the box labeled “Materials for Patients”)
Zydelig is a kinase inhibitor indicated for the treatment of patients with
- Relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities.
- Relapsed follicular B-cell non-Hodgkin lymphoma (FL) in patients who have received at least two prior systemic therapies.
- Relapsed small lymphocytic lymphoma (SLL) in patients who have received at least two prior systemic therapies.
You are encouraged to report negative side effects of Zydelig to Gilead at 1-800-445-3235 and/or the FDA at www.fda.gov/medwatch or call
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