Talzenna
TALZENNA- talazoparib tosylate capsule
U.S. Pharmaceuticals
1 INDICATIONS AND USAGE
1.1 BRCA -mutated (gBRCA m) HER2-negative Locally Advanced or Metastatic Breast Cancer
TALZENNA is indicated as a single agent for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated (gBRCA m) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA [see Dosage and Administration (2.1)].
1.2 HRR Gene-mutated mCRPC
TALZENNA is indicated in combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) [see Dosage and Administration (2.3)].
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.
gBRCA m 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 gBRCA m 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 in combination 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 three dose reductions are required.
gBRCA m 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.
gBRCA m 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 TALZENNAUntil 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 orGrade 4 | ≤Grade 1 | Consider resuming TALZENNA at a reduced dose or discontinue |
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