(talazoparib)

Prescribing Information
Download Prescribing Information

13 NONCLINICAL TOXICOLOGY

13 NONCLINICAL TOXICOLOGY

     

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies have not been conducted with talazoparib.

Talazoparib was clastogenic in an in vitro chromosomal aberration assay in human peripheral blood lymphocytes and in an in vivo bone marrow micronucleus assay in rats. This clastogenicity is consistent with genomic instability resulting from the primary pharmacology of talazoparib, indicating the potential for genotoxicity in humans. Talazoparib was not mutagenic in a bacterial reverse mutation (Ames) test.

Fertility studies in animals have not been conducted with talazoparib. In repeat-dose toxicity studies up to 3-months duration, talazoparib-related findings in the testis and epididymis at doses ≥0.04 mg/kg/day in rats and ≥0.01 mg/kg/day in dogs included decreased organ weights, luminal cellular debris, reduced sperm, and degeneration/atrophy. These doses in rats and dogs resulted in approximately 1.0 times and 0.2 times, respectively, the exposure (AUC) in humans at the recommended dose of 1 mg daily. Follicular atresia of the ovary was observed in rats at doses ≥1 mg/kg/day talazoparib, approximately 9.5 times the AUC in patients at the recommended dose of 1 mg daily.

Medication Guide

MEDICATION GUIDE

This Patient Information has been approved by the U.S. Food and Drug Administration.  Revised: 6/2025

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:

  ○ 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.

What is TALZENNA?
TALZENNA is a prescription medicine used:

•
alone to treat adults with human epidermal growth factor receptor 2 (HER2)-negative breast cancer:
o
who have a certain type of an abnormal inherited BRCA gene, and
o
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.
•
in combination with a medicine called enzalutamide, to treat adults with prostate cancer
o
with certain abnormal inherited or acquired genes called homologous recombination repair (HRR genes) and
o
which no longer responds to 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.

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:
o
Your healthcare provider may do a pregnancy test before you start treatment with TALZENNA.
o
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.
o
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:
o
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 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.
•
If you are prescribed TALZENNA for breast cancer, take TALZENNA 1 time a day.
•
If you are prescribed TALZENNA for prostate cancer:
o
Take TALZENNA with enzalutamide 1 time a day.
o
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).
•
Take TALZENNA with or without food.
•
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.

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 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

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

•
decreased red blood cell counts
•
decreased white blood cell counts
•
tiredness or weakness
•
decreased platelet counts
•
decreased calcium in the blood
•
nausea
•
decreased appetite
•
decreased sodium in the blood
•
decreased phosphate in the blood
•
bone injuries
•
decreased magnesium in the blood
•
dizziness
•
increased bilirubin in the blood
•
decreased 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 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 that 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: gelatin, glycerol, iron oxide (red), iron oxide (yellow), polyethylene glycol 400, purified water, sorbitol, titanium dioxide, and tocopherol

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