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TALZENNA Medication Guide (talazoparib)

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

  • MDS/AML: Advise patients to contact their healthcare provider if they experience weakness, feeling tired, fever, weight loss, frequent infections, bruising, bleeding easily, breathlessness, blood in urine or stool, and/or laboratory findings of low blood cell counts, or a need for blood transfusions. This may be a sign of hematological toxicity or a more serious uncommon bone marrow problem called MDS or AML, which have been reported in patients who received PARP inhibitors [see Warnings and Precautions (5.1)].
  • Myelosuppression: Advise patients that TALZENNA may affect hematopoiesis and can cause anemia, leukopenia/neutropenia, and/or thrombocytopenia [see Warnings and Precautions (5.2)].
  • Administration Instructions: Advise patients that TALZENNA can be taken once daily with or without food. Instruct patients that if they miss a dose of TALZENNA, they should take their next normal dose at the usual time. Also advise patients to swallow each capsule whole, and that capsules must not be opened or dissolved [see Dosage and Administration (2.2)].
  • Embryo-Fetal Toxicity: Advise females to inform their healthcare provider if they are pregnant or become pregnant. Inform female patients of the risk to a fetus and potential loss of the pregnancy [see Use in Specific Populations (8.1)]. Advise females of reproductive potential to use effective contraception during treatment with TALZENNA and for at least 7 months after the last dose. Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for at least 4 months after receiving the last dose of TALZENNA [see Warnings and Precautions (5.3), Use in Specific Populations (8.1, 8.3)].
  • Lactation: Advise patients not to breastfeed while taking TALZENNA and for at least 1 month after receiving the last dose [see Use in Specific Populations (8.2)].

This Patient Information has been approved by the U.S. Food and Drug Administration.Issued 9/2021
PATIENT INFORMATION
TALZENNA® (Tal-ZEN-ah)
(talazoparib)
capsules
What is the most important information I should know about TALZENNA?
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:
  • before treatment with TALZENNA
  • 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.
See "What are the possible side effects of TALZENNA?" below for other side effects of TALZENNA.
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 TALZENNA is safe and effective in children.
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.
    • If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with TALZENNA.
    • Females who are able to become pregnant should use effective birth control (contraception) during treatment with TALZENNA and for at least 7 months after receiving the last dose of TALZENNA. 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 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. Do not breastfeed during treatment with TALZENNA and for at least 1 month after receiving 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 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 taking TALZENNA without first talking with your healthcare provider.
  • Take TALZENNA 1 time a day.
  • Take TALZENNA with or without food.
  • Swallow TALZENNA capsules whole. Do not dissolve or open TALZENNA capsules.
  • Your healthcare provider may change your dose of TALZENNA or tell you to stop taking TALZENNA depending on how you respond to treatment.
  • 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.
What are the possible side effects of TALZENNA?
TALZENNA may cause serious side effects, including:
  See "What is the most important information I should know about TALZENNA?"
The most common side effects of TALZENNA include:
  • tiredness or weakness
  • low 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 TALZENNA and all medicines out of the reach of children.
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 TALZENNA for a condition for which it is not prescribed. Do not give TALZENNA 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 about TALZENNA that is written for health professionals.
What are the ingredients in TALZENNA?
Active ingredient: talazoparib tosylate
Inactive ingredients: silicified microcrystalline cellulose (sMCC). The 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.

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For more information, go to www.TALZENNA.com or call 1-800-438-1985.
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