Talzenna Dosage/Direction for Use

Treatment with Talzenna should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Patients should be selected for the treatment of breast cancer with Talzenna based on the presence of deleterious or suspected deleterious germline BRCA mutations determined by an experienced laboratory using a validated test method.
Genetic counselling for patients with BRCA mutations should be performed according to local regulations, as applicable.
Posology: The recommended dose is 1 mg talazoparib once daily. Patients should be treated until disease progression or unacceptable toxicity occurs.
Missing dose: If the patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the usual time.
Dose adjustments: To manage adverse drug reactions, interruption of treatment or dose reduction based on severity and clinical presentation should be considered (Table 4). Recommended dose reductions are indicated in Table 3. (See Table 3.)

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Complete blood count should be obtained prior to starting Talzenna therapy and monitored monthly and as clinically indicated (see Table 4 and Precautions).

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Concomitant treatment with inhibitors of P-glycoprotein (P-gp): Strong inhibitors of P-gp may lead to increased talazoparib exposure. Concomitant use of strong P-gp inhibitors during treatment with talazoparib should be avoided. Co-administration should only be considered after careful evaluation of the potential benefits and risks. If co-administration with a strong P-gp inhibitor is unavoidable, the Talzenna dose should be reduced to the next lower dose. When the strong P-gp inhibitor is discontinued, the Talzenna dose should be increased (after 3-5 half-lives of the P-gp inhibitor) to the dose used prior to the initiation of the strong P-gp inhibitor (see Interactions).
Special populations: Hepatic impairment: No dose adjustment is required for patients with mild hepatic impairment (total bilirubin ≤1 x upper limit of normal [ULN] and aspartate aminotransferase (AST) >ULN, or total bilirubin >1.0 to 1.5 x ULN and any AST), moderate hepatic impairment (total bilirubin >1.5 to 3.0 x ULN and any AST) or severe hepatic impairment (total bilirubin >3.0 x ULN and any AST) (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment is required for patients with mild renal impairment (60 mL/min ≤creatinine clearance [CrCL] <90 mL/min). For patients with moderate renal impairment (30 mL/min ≤CrCL <60 mL/min), the recommended starting dose of Talzenna is 0.75 mg once daily. For patients with severe renal impairment (15 mL/min ≤ CrCL < 30 mL/min), the recommended starting dose of Talzenna is 0.5 mg once daily. Talzenna has not been studied in patients with CrCL < 15 mL/min or patients requiring haemodialysis (see Pharmacology: Pharmacokinetics under Actions).
Elderly: No dose adjustment is necessary in elderly (≥65 years of age) patients (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of Talzenna in children and adolescents <18 years of age have not been established. No data are available.
Method of administration: Talzenna is for oral use. To avoid contact with the capsule content, the capsules should be swallowed whole, and must not be opened or dissolved. They can be taken with or without food (see Pharmacology: Pharmacokinetics under Actions).