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Generic Name: talazoparib
Dosage Form: Capsules
Date of Approval: October 16, 2018
Company: Pfizer Inc.

Treatment for: Breast Cancer

Medically reviewed on Oct 17, 2018

FDA Approves Talzenna

See also: Kisqali

The U.S. Food and Drug Administration (FDA) has approved Talzenna (talazoparib), a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2 negative locally advanced or metastatic breast cancer. Patients must be selected for therapy based on an FDA-approved companion diagnostic.

Patient Information

Read this Patient Information before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

Important 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 your treatment.
  • 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:

    • before you start treatment
    • every month during treatment
    • weekly if you have low blood cell counts that last a long time. Your healthcare provider may stop treatment until your blood cell counts improve.

    See Talzenna side effects below for other side effects.

What is Talzenna?

Talzenna is a prescription medicine used to treat adults with:

  • a certain type of breast cancer (human epidermal growth factor receptor 2 [HER2]-negative), and
  • an 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 this medicine is safe and effective in children.

Before taking Talzenna

Before you start treatment, 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. Tell your healthcare provider right away if you are pregnant or become pregnant during treatment.
    • If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment.
    • Females who are able to become pregnant should use effective birth control (contraception) during treatment, and for at least seven months after receiving the last dose. Talk to your healthcare provider about forms of birth control that may be right for you.
    • Males with female partners who are pregnant or are able to become pregnant should use effective birth control during treatment, and for at least four months after receiving the last dose.
  • are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk. Do not breastfeed during treatment, and for one month after receiving the last dose. 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 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 should I take Talzenna?

  • Take Talzenna exactly as your healthcare provider tells you.
  • Do not change your dose or stop treatment without first talking with your healthcare provider.
  • Take Talzenna one time a day.
  • Take the Talzenna capsules with or without food.
  • Swallow the capsules whole. Do not dissolve or open the capsules.
  • Your healthcare provider may change your dose, or tell you to stop treatment depending on your response.
  • If you miss a dose 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 or overdose, call your healthcare provider or go to the nearest hospital emergency room right away.

Talzenna side effects

Talzenna may cause serious side effects, including:

  • See Important information

The most common side effects include:

  • tiredness or weakness
  • ow number of red or white blood cells
  • nausea
  • low number of platelets
  • headache
  • loss of appetite
  • diarrhea
  • vomiting
  • hair loss

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 may report side effects to FDA at 1-800-FDA-1088.

How should I store Talzenna?

Store Talzenna at 68°F to 77°F (20°C to 25°C ).

Keep all medicines out of the reach of children and pets.

General information about the safe and effective use of Talzenna.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it is not prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information that is written for health professionals.

What are the ingredients in Talzenna?

Active ingredient: talazoparib tosylate

Inactive ingredients: silicified microcrystalline cellulose (sMCC). The white and ivory and white and light red opaque capsule shells contain hypromellose (HPMC), yellow iron oxide, red iron oxide and titanium dioxide. The printing ink contains shellac, black iron oxide, potassium hydroxide, ammonium hydroxide, and propylene glycol.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

More about Talzenna (talazoparib)

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