TALZENNA (talazoparib) is an inhibitor of mammalian polyadenosine 5’-diphosphoribose polymerase (PARP) enzyme. Inactive ingredients: silicified microcrystalline cellulose (sMCC). The capsule shells contain hypromellose (HPMC), yellow iron oxide, red iron oxide and titanium dioxide; and the printing ink contains shellac, black iron oxide, potassium hydroxide, ammonium hydroxide, and propylene glycol.
TALZENNA (talazoparib) Capsules: 0.1 mg, 0.25 mg, 0.35 mg, 0.5 mg, 0.75 mg, and 1 mg .
Breast Cancer • The recommended dosage of TALZENNA is 1 mg taken orally once daily until disease progression or unacceptable toxicity. • For adverse reactions, consider dosing interruption or dose reduction. 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. • Patients should also receive a gonadotropic-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.
1.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.
2. HRR Gene-mutated mCRPC• In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC).