Possible increased risk of death, serious side effects with duvelisib (Copiktra)
The FDA released a Drug Safety Communication on June 30, 2022 warning of possible increased risk of death with with cancer drug duvelisib (Copiktra).
Duvelisib is a Phosphoinositide 3-kinase inhibitor approved by the FDA in 2018 for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies and for the treatment of refractory follicular lymphoma (FL) after at least two prior systemic therapies.
The FDA evaluated the final 5-year survival results from the DUO trial, which compared duvelisib to the monoclonal antibody ofatumumab in the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who received a previous therapy that did not work or stopped working. The results showed a possible increased risk of death with duvelisib compared to the monoclonal antibody ofatumumab. Serious adverse drug events such as infections, diarrhea, inflammation of the intestines and lungs, skin reactions, and high liver enzyme levels in the blood that resulted in treatment modifications were higher among patients receiving duvelisib.
Recommendations for Patients
- Talk to your health care professionals about the risks and benefits of duvelisib (Copiktra) or about possible alternative treatments.
- Read the patient Medication Guide every time you receive a prescription for Copiktra as the information may be updated. The
Medication Guide explains the important things you need to know about the medicine. These include the side effects, what the
medicine is used for, how to take and store it properly, and other things to watch out for when you are taking the medicine.
Recommendations for Health Care Providers
- Review patients’ progress on duvelisib and discuss the risks and benefits of continuing duvelisib in the context of other available treatments.
- Encourage patients to read the Medication Guide they receive with each prescription, which explains the safety risks and provides other important information, as the information may be updated.
To help the FDA track safety issues with duvelisib (Copiktra) and other medications, please report adverse events to the MedWatch program as
recommended in the Indian Health Manual. Instructions for reporting can be found online at the NPTC Pharmacovigilance website