Important Safety Information & Use

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 stop treatment with TALZENNA until your blood cell counts improve.

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. Tell your healthcare provider right away if you are pregnant or become pregnant during treatment with TALZENNA.
  • Males with female partners who are pregnant or are able to become pregnant should use effective birth control during treatment with TALZENNA and for at least 4 months after receiving the last dose of TALZENNA.
• are breastfeeding or plan to breastfeed. It is not known if TALZENNA passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. Taking TALZENNA and 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.
• Do not change your dose or stop taking TALZENNA without first talking with your healthcare provider.
• You should start or continue a gonadotropin-releasing hormone (GnRH) analog therapy during your treatment with TALZENNA and enzalutamide unless you have had a surgery to lower the amount of testosterone in your body (surgical castration).
• If you miss a dose of TALZENNA or vomit, take your next dose at your regular time. Do not take an extra dose to make up for a missed dose.
• If you take too much TALZENNA, call your healthcare provider or go to the nearest hospital emergency room right away.

The most common side effects of TALZENNA when taken in combination with enzalutamide include:

• low red blood cell counts
• low white blood cell counts
• tiredness or weakness
• low platelet counts
• low calcium in the blood
• nausea
• decreased appetite
• low sodium in the blood
• low phosphate in the blood
• bone injuries
• low magnesium in the blood
• dizziness
• increased bilirubin in the blood
• low potassium in the blood
• changes in your sense of taste

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.

What is TALZENNA?

TALZENNA is a prescription medicine used in combination with a medicine called enzalutamide, to treat adults with prostate cancer

• with certain abnormal inherited or acquired genes called homologous recombination repair (HRR genes) and
• which no longer responds to a hormone therapy or surgical treatment to lower testosterone and has spread to other parts of the body (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.