(talazoparib)

Prescribing Information
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8 USE IN SPECIFIC POPULATIONS

8 USE IN SPECIFIC POPULATIONS

     

8.1 Pregnancy

Risk Summary

Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1)], TALZENNA can cause embryo-fetal harm when administered to a pregnant woman. There are no available data on TALZENNA use in pregnant women to inform a drug-associated risk. In an animal reproduction study, the administration of talazoparib to pregnant rats during the period of organogenesis caused fetal malformations and structural skeletal variations and embryo-fetal death at maternal exposures that were 0.24 times the AUC in patients receiving the recommended dose of 1 mg daily (see Data). Apprise pregnant women and females of reproductive potential of the potential risk to a fetus.

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the general U.S. population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively.

Data

Animal Data

In an embryo-fetal development toxicity study, pregnant rats received oral doses of 0.015, 0.05, and 0.15 mg/kg/day talazoparib during the period of organogenesis. Talazoparib caused embryo-fetal death at doses ≥0.015 mg/kg/day (approximately 0.24 times the AUC in patients at the recommended dose of 1 mg daily). A dose of 0.015 mg/kg/day caused decreased fetal body weights and an increased incidence of fetal malformations (depressed eye bulge, small eye, split sternebra, and fused cervical vertebral arch) and structural variations including misshapen or incomplete ossification of the sternebra, skull, rib, and vertebra.

8.2 Lactation

Risk Summary

There are no data on the presence of talazoparib in human milk, the effects of the drug on milk production, or the effects of the drug on the breastfed child. Because of the potential for serious adverse reactions in a breastfed child from talazoparib, advise lactating women not to breastfeed during treatment with TALZENNA and for 1 month after the last dose.

8.3 Females and Males of Reproductive Potential

TALZENNA can cause fetal harm when administered to pregnant women [see Use in Specific Populations (8.1)].

Pregnancy Testing
Verify pregnancy status in females of reproductive potential prior to initiating TALZENNA treatment.

Contraception
Females
Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of TALZENNA.

Males
Based on genotoxicity and animal reproduction studies, advise male patients with female partners of reproductive potential and pregnant partners to use effective contraception during treatment with TALZENNA and for 4 months following the last dose [see Use in Specific Populations (8.1), Nonclinical Toxicology (13.1)].

Infertility
Males
Based on animal studies, TALZENNA may impair fertility in males of reproductive potential [see Nonclinical Toxicology (13.1)].

8.4 Pediatric Use

The safety and effectiveness of TALZENNA have not been established in pediatric patients.

8.5 Geriatric Use

In clinical trials of TALZENNA enrolling 494 patients with advanced solid tumors who received TALZENNA 1 mg daily as a single agent, 85 (17%) patients were ≥65 years of age, and this included 19 (4%) patients who were ≥75 years old. There were 5 patients ≥85 years old. In the TALAPRO-2 trial, of 197 patients who received TALZENNA, 77% were ≥65 years of age, while 30% were ≥75 years of age. No overall differences in safety or effectiveness of TALZENNA were observed between these patients and younger patients.

8.6 Hepatic Impairment

No dosage modification is recommended for patients with hepatic impairment [see Clinical Pharmacology (12.3)].

8.7 Renal Impairment

Reduce the recommended dosage of TALZENNA in patients with moderate (CLcr 30 – 59 mL/min) and severe (CLcr 15 – 29 mL/min) renal impairment [see Dosage and Administration (2.7)]. Monitor patients with severe renal impairment for increased adverse reactions and modify the dosage as recommended for adverse reactions [see Dosage and Administration (2.5)].

No dose adjustment is recommended for patients with mild renal impairment (CLcr 60 – 89 mL/min). TALZENNA has not been studied in patients requiring hemodialysis.

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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