(talazoparib)
2 DOSAGE AND ADMINISTRATION
2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
Information on the FDA-approved tests for the detection of genetic mutations is available at http://www.fda.gov/companiondiagnostics.
gBRCAm HER2-negative Locally Advanced or Metastatic Breast Cancer
Select patients for the treatment of advanced breast cancer with TALZENNA based on the presence of germline BRCA mutations [see Indications and Usage (1.1), Clinical Studies (14.1)].
HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer
Select patients for the treatment of HRR gene-mutated mCRPC with TALZENNA based on the presence of alterations in genes directly or indirectly involved in HRR (ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, or RAD51C) [see Indications and Usage (1.2), Clinical Studies (14.2)].
An FDA-approved test for the detection of HRR gene mutations for use with TALZENNA is not currently available.
2.2 Recommended Dosage for gBRCAm HER2-negative Locally Advanced or Metastatic Breast Cancer
The recommended dosage of TALZENNA is 1 mg taken orally once daily, until disease progression or unacceptable toxicity.
2.3 Recommended Dosage for HRR Gene-mutated mCRPC
The recommended dosage of TALZENNA is 0.5 mg taken orally once daily with enzalutamide until disease progression or unacceptable toxicity.
Refer to the enzalutamide prescribing information for recommended enzalutamide dosing information.
Patients receiving TALZENNA and enzalutamide should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.
2.4 Administration
Take TALZENNA with or without food.
Swallow TALZENNA capsules whole. Do not open or dissolve.
If a patient vomits or misses a dose of TALZENNA, instruct them to take the next prescribed dose at the usual time.
2.5 Dosage Modifications for Adverse Reactions
To manage adverse reactions, consider interruption of treatment with or without dose reduction based on severity and clinical presentation. Recommended dose reductions are indicated in Table 1 and Table 2. Treatment with TALZENNA should be discontinued if more than 3 dose reductions are required.
gBRCAm HER2-negative Locally Advanced or Metastatic Breast Cancer
Dose Reductions | Dose Level |
Recommended starting dose | 1 mg once daily |
First dose reduction | 0.75 mg once daily |
Second dose reduction | 0.5 mg once daily |
Third dose reduction | 0.25 mg once daily |
HRR Gene-mutated mCRPC
Dose Reductions | Dose Level |
Recommended starting dose | 0.5 mg once daily |
First dose reduction | 0.35 mg once daily |
Second dose reduction | 0.25 mg once daily |
Third dose reduction | 0.1 mg once daily |
Refer to the enzalutamide prescribing information for dose modifications for adverse reactions associated with enzalutamide.
gBRCAm HER2-negative Locally Advanced or Metastatic Breast Cancer and HRR Gene-mutated mCRPC
Monitor complete blood counts monthly and as clinically indicated [see Warnings and Precautions (5.2)].
Adverse Reactions | Withhold TALZENNA Until Levels Resolve to | Resume TALZENNA |
Hemoglobin <8 g/dL | ≥9 g/dL | Resume TALZENNA at a reduced dose |
Platelet count <50,000/μL | ≥75,000/μL | |
Neutrophil count <1,000/μL | ≥1500/µL | |
Non-hematologic Grade 3 or Grade 4 | ≤Grade 1 | Consider resuming TALZENNA at a reduced dose or discontinue |
2.6 Recommended Dosage in Patients with Renal Impairment
gBRCAm HER2-negative Locally Advanced or Metastatic Breast Cancer
The recommended dosage of TALZENNA for patients with moderate renal impairment (CLcr 30 - 59 mL/min) is 0.75 mg taken orally once daily [see Use in Specific Populations (8.7)].
The recommended dosage of TALZENNA for patients with severe renal impairment (CLcr 15 - 29 mL/min) is 0.5 mg taken orally once daily [see Use in Specific Populations (8.7)].
HRR Gene-mutated mCRPC
The recommended dosage of TALZENNA for patients with moderate renal impairment (CLcr 30 - 59 mL/min) is 0.35 mg taken orally once daily with enzalutamide [see Use in Specific Populations (8.7)].
The recommended dosage of TALZENNA for patients with severe renal impairment (CLcr 15 - 29 mL/min) is 0.25 mg taken orally once daily with enzalutamide [see Use in Specific Populations (8.7)].
2.7 Dosage Modifications for P-glycoprotein Inhibitors
gBRCAm HER2-negative Locally Advanced or Metastatic Breast Cancer
Avoid coadministration of TALZENNA with the following P-glycoprotein (P-gp) inhibitors: itraconazole, amiodarone, carvedilol, clarithromycin, itraconazole, and verapamil. If coadministration of TALZENNA with these P-gp inhibitors cannot be avoided, reduce the dose of TALZENNA to 0.75 mg taken orally once daily. When the P-gp inhibitor is discontinued, increase the dose of TALZENNA (after 3 – 5 half-lives of the P-gp inhibitor) to the dose of TALZENNA that was used before starting the P-gp inhibitor [see Drug Interactions (7.1)].
Monitor for increased adverse reactions and modify the dosage as recommended for adverse reactions when TALZENNA is coadministered with other P-gp inhibitors [see Dosage and Administration (2.5)].
MEDICATION GUIDE
| This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 6/2025 | |
PATIENT INFORMATION | |
What is the most important information I should know about TALZENNA?
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○ weakness ○ weight loss ○ fever ○ frequent infections | ○ blood in urine or stool ○ shortness of breath ○ feeling very tired ○ bruising or bleeding more easily |
○ 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?
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:
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. | |
How should I take TALZENNA?
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What are the possible side effects of TALZENNA? TALZENNA may cause serious side effects, including: The most common side effects of TALZENNA when taken alone include: | |
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The most common side effects of TALZENNA when taken in combination with enzalutamide include: | |
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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. | |
How should I store TALZENNA?
Keep TALZENNA and all medicines out of the reach of children. | |
General information about the safe and effective use of TALZENNA. | |
What are the ingredients in TALZENNA? 
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