ICLUSIG is a medicine used to treat adults with the following types of leukemia who are no longer benefitting from treatment with other medicines:
- chronic myeloid leukemia (CML)
- Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL)
The approval with conditions is based on response rate. There are no studies showing increased survival. The majority patients showed improvements within 1 month in the clinical study. Talk to your doctor if your condition has not improved after taking ICLUSIG for 3 months (90 days). Your doctor may advise you to stop taking ICLUSIG.
ICLUSIG for this indication has been approved with conditions. Results of studies to prove its clinical benefit are pending. Please contact your health care providers for more information.
Please review the ICLUSIG Medication Guide with your doctor before beginning treatment with ICLUSIG.
Discuss any questions you have and tell your doctor about all medications that you are taking. You and your doctor will sign the Patient Informed Consent Form after reviewing the Medication Guide and having all your questions answered.