Talzenna Dosage

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.

​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).

​An FDA-approved test for the detection of HRR gene mutations for use with TALZENNA is not currently available.

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.

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.

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.

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.

​gBRCAm HER2-negative Locally Advanced or Metastatic Breast Cancer

​HRR Gene-mutated mCRPC

​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.

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.

​The recommended dosage of TALZENNA for patients with severe renal impairment (CLcr 15 - 29 mL/min) is 0.5 mg taken orally once daily.

​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 in combination with enzalutamide.

​The recommended dosage of TALZENNA for patients with severe renal impairment (CLcr 15 - 29 mL/min) is 0.25 mg taken orally once daily in combination with enzalutamide.

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.

​Monitor for increased adverse reactions and modify the dosage as recommended for adverse reactions when TALZENNA is coadministered with other P-gp inhibitors.