(talazoparib)

Prescribing Information
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HIGHLIGHTS OF PRESCRIBING INFORMATION

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use TALZENNA safely and effectively. See full prescribing information for TALZENNA.

TALZENNA® (talazoparib) capsules, for oral use
Initial U.S. Approval: 2018

INDICATIONS AND USAGE

TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for:

Breast Cancer

•
As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA. (1.1)

HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). (1.2)

DOSAGE AND ADMINISTRATION

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Take TALZENNA with or without food. (2.4)

Breast Cancer

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The recommended dosage of TALZENNA is 1 mg taken orally once daily until disease progression or unacceptable toxicity. (2.2)
•
For adverse reactions, consider dosing interruption or dose reduction. (2.5)

HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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The recommended dosage of TALZENNA is 0.5 mg taken orally once daily with enzalutamide until disease progression or unacceptable toxicity. (2.3)
•
Patients should also receive a gonadotropic-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. (2.3)

DOSAGE FORMS AND STRENGTHS

Capsules: 0.1 mg, 0.25 mg, 0.35 mg, 0.5 mg, 0.75 mg, and 1 mg (3)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

•
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): MDS/AML occurred in patients exposed to TALZENNA, and some cases were fatal. Monitor patients for hematological toxicity and discontinue if MDS/AML is confirmed. (5.1)
•
Myelosuppression: TALZENNA may affect hematopoiesis and can cause anemia, neutropenia, and/or thrombocytopenia. (5.2)
•
Embryo-Fetal Toxicity: TALZENNA can cause fetal harm. Advise of the potential risk to the fetus and to use effective contraception. (5.3, 8.1, 8.3)

ADVERSE REACTIONS

Most common adverse reactions (≥20%) as a single agent, including laboratory abnormalities, are:

•
Hemoglobin decreased, neutrophils decreased, lymphocytes decreased, platelets decreased, fatigue, glucose increased, aspartate aminotransferase increased, alkaline phosphatase increased, alanine aminotransferase increased, calcium decreased, nausea, headache, vomiting, alopecia, diarrhea, and decreased appetite. (6.1)

Most common adverse reactions (≥10%) in combination with enzalutamide, including laboratory abnormalities, are:

•
Hemoglobin decreased, neutrophils decreased, lymphocytes decreased, fatigue, platelets decreased, calcium decreased, nausea, decreased appetite, sodium decreased, phosphate decreased, fractures, magnesium decreased, dizziness, bilirubin increased, potassium decreased, and dysgeusia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

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P-gp Inhibitors: Reduce the dose when coadministered with certain P-gp inhibitors. Monitor for increased adverse reactions. (2.7, 7.1)
•
BCRP Inhibitors: Monitor for potential increased adverse reactions. (7.1)

USE IN SPECIFIC POPULATIONS

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Lactation: Advise women not to breastfeed. (8.2)
•
Renal Impairment: Reduce the dose and monitor for increased adverse reactions for patients with moderate or severe renal impairment. (2.6, 8.7)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 6/2025

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