What is the most important information I should know about TALZENNA?

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Bone marrow problems called Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML). Some people who have cancer and who have received previous treatment with chemotherapy or certain other medicines for their cancer have developed MDS or AML during or after treatment with TALZENNA. MDS or AML may lead to death. If you develop MDS or AML, your healthcare provider will stop treatment with TALZENNA.
Symptoms of low blood cell counts are common during treatment with TALZENNA, but can be a sign of serious problems, including MDS or AML. Tell your healthcare provider if you have any of the following symptoms during treatment with TALZENNA:

  ○ weakness

  ○ weight loss

  ○ fever

  ○ frequent infections

 ○ blood in urine or stool

 ○ shortness of breath

 ○ feeling very tired

 ○ bruising or bleeding more easily

 

Your healthcare provider will do blood tests to check your blood cell counts:

  ○ every month during treatment with TALZENNA.

  ○ weekly if you have low blood cell counts that last a long time.

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with TALZENNA if you get certain side effects.

See “What are the possible side effects of TALZENNA?” below for other side effects of TALZENNA.