Important Safety Information and Indication

Important Safety Information

TALZENNA may cause serious side effects, including:

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.

Before taking TALZENNA, tell your healthcare provider about all of your medical conditions, including if you:

• have kidney problems.

• are pregnant or plan to become pregnant. TALZENNA can harm your unborn baby, and may cause loss of pregnancy (miscarriage). You should not become pregnant during treatment with TALZENNA.

  Females who are able to become pregnant:

  • Your healthcare provider may do a pregnancy test before you start treatment with TALZENNA.
  • You should use effective birth control (contraception) during treatment with TALZENNA and for 7 months after the last dose of TALZENNA. Talk to your healthcare provider about forms of birth control that may be right for you.
  • Tell your healthcare provider right away if you are pregnant or think you are pregnant during treatment with TALZENNA.

   

  Males with female partners who are pregnant or are able to become pregnant:

  • You should use effective birth control during treatment with TALZENNA and for 4 months after the last dose of TALZENNA.
• are breastfeeding or plan to breastfeed. It is not known if TALZENNA passes into your breast milk. Do not breastfeed during treatment with TALZENNA and for 1 month after the last dose of TALZENNA. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking TALZENNA with certain other medicines can affect how TALZENNA works and may cause side effects.

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

How to take TALZENNA

• Take TALZENNA exactly as your healthcare provider tells you.
• Swallow TALZENNA capsules whole. Do not dissolve or open TALZENNA capsules.
• If you vomit or miss a dose of TALZENNA, take your next dose at your regular time. Do not take an extra dose to make up for a missed dose.

The most common side effects of TALZENNA when taken alone include:

• decreased red blood cell counts
• decreased white blood cell counts
• tiredness or weakness
• decreased platelet counts
• increased blood sugar levels
• increased liver function tests
• nausea
• headache
• decreased blood calcium levels
• vomiting
• hair loss
• diarrhea
• decreased appetite

TALZENNA may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if this is a concern for you.

These are not all of the possible side effects of TALZENNA. Call your doctor for medical advice about side effects.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Indication

TALZENNA is a prescription medicine used:

• alone to treat adults with human epidermal growth factor receptor 2 (HER2)-negative breast cancer:
  • who have a certain type of abnormal inherited BRCA gene, and 
  • whose cancer has spread to other parts of the body (locally advanced or metastatic).

Your healthcare provider will perform a test to make sure that TALZENNA is right for you. It is not known if TALZENNA is safe and effective in children.