The recommended dose of TALZENNA is 1 mg capsule taken orally once daily.
The 0.25 mg capsule is available for dose reduction.
Patients should be treated until disease progression or unacceptable toxicity occurs.
Dose modifications
To manage adverse reactions, consider interruption of treatment or dose reduction based on severity and clinical presentation. Recommended dose reductions are indicated in Table 1.
| Dose Level | Dose |
| Recommended starting dose | 1 mg (one 1 mg capsule) once daily |
| First dose reduction | 0.75 mg (three 0.25 mg capsules) once daily |
| Second dose reduction | 0.5 mg (two 0.25 mg capsules) once daily |
| Third dose reduction | 0.25 mg (one 0.25 mg capsule) once daily |
Monitor complete blood counts monthly for the first 12 months of treatment and periodically thereafter and as clinically indicated (see 7 WARNINGS AND PRECAUTIONS).
| 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 |
≥50,000/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 |
During treatment with the 1 mg dose, switching from the 1 mg capsules to the 4 x 0.25 mg capsules is not recommended.
Concomitant treatment with inhibitors or inducers 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.
If coadministration 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 to 5 half-lives of the P-gp inhibitor) to the dose used prior to the initiation of the strong P-gp inhibitor (see Section 9.4 Drug-Drug Interactions).
Coadministration of rifampin, a strong P-gp inducer, had no significant impact on talazoparib exposure. No talazoparib dose adjustments are required when coadministered with rifampin. However, the effect of other P-gp inducers on talazoparib exposure has not been studied.
Concomitant treatment with inhibitors of Breast Cancer Resistance Protein (BCRP)
The effect of coadministration of BCRP inhibitors with TALZENNA has not been studied. Therefore, concomitant use of strong BCRP inhibitors during treatment with talazoparib should be avoided (see Section 9.4 Drug-Drug Interactions).
Special populations
Hepatic impairment
No dose adjustment is required for patients with mild hepatic impairment (total bilirubin ≤1 × upper limit of normal [ULN] and aspartate aminotransferase (AST) > ULN, or total bilirubin >1.0 to 1.5 × ULN and any AST), moderate hepatic impairment (total bilirubin >1.5 to 3.0 × ULN and any AST), or severe hepatic impairment (total bilirubin >3.0 × ULN and any AST) (see Section 10.3 Pharmacokinetics, Special Populations and Conditions, Hepatic Impairment).
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 dose of TALZENNA is 0.75 mg once daily. For patients with severe renal impairment (15 mL/min ≤ CrCL < 30 mL/min), the recommended dose of TALZENNA is 0.5 mg once daily. TALZENNA has not been studied in patients requiring hemodialysis (see Section 10.3 Pharmacokinetics, Special Populations and Conditions, Renal Impairment).
Geriatric (≥65 years of age)
No dose adjustment is necessary in elderly (≥65 years of age) patients (see Section 10.3 Pharmacokinetics, Special Populations and Conditions, Geriatrics).
Pediatric (<18 years)
The safety and efficacy of TALZENNA in children and adolescents <18 years of age have not been established. Health Canada has not authorized an indication for pediatric use.
The capsule(s) should be swallowed whole, and must not be opened, crushed, chewed or dissolved.
The capsules should be taken at approximately the same time every day and can be taken with or without food.
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.
)The recommended dose of TALZENNA is 1 mg capsule taken orally once daily.
The 0.25 mg capsule is available for dose reduction.
Patients should be treated until disease progression or unacceptable toxicity occurs.
Dose modifications
To manage adverse reactions, consider interruption of treatment or dose reduction based on severity and clinical presentation. Recommended dose reductions are indicated in Table 1.
| Dose Level | Dose |
| Recommended starting dose | 1 mg (one 1 mg capsule) once daily |
| First dose reduction | 0.75 mg (three 0.25 mg capsules) once daily |
| Second dose reduction | 0.5 mg (two 0.25 mg capsules) once daily |
| Third dose reduction | 0.25 mg (one 0.25 mg capsule) once daily |
Monitor complete blood counts monthly for the first 12 months of treatment and periodically thereafter and as clinically indicated (see 7 WARNINGS AND PRECAUTIONS).
| 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 |
≥50,000/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 |
During treatment with the 1 mg dose, switching from the 1 mg capsules to the 4 x 0.25 mg capsules is not recommended.
Concomitant treatment with inhibitors or inducers 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.
If coadministration 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 to 5 half-lives of the P-gp inhibitor) to the dose used prior to the initiation of the strong P-gp inhibitor (see Section 9.4 Drug-Drug Interactions).
Coadministration of rifampin, a strong P-gp inducer, had no significant impact on talazoparib exposure. No talazoparib dose adjustments are required when coadministered with rifampin. However, the effect of other P-gp inducers on talazoparib exposure has not been studied.
Concomitant treatment with inhibitors of Breast Cancer Resistance Protein (BCRP)
The effect of coadministration of BCRP inhibitors with TALZENNA has not been studied. Therefore, concomitant use of strong BCRP inhibitors during treatment with talazoparib should be avoided (see Section 9.4 Drug-Drug Interactions).
Special populations
Hepatic impairment
No dose adjustment is required for patients with mild hepatic impairment (total bilirubin ≤1 × upper limit of normal [ULN] and aspartate aminotransferase (AST) > ULN, or total bilirubin >1.0 to 1.5 × ULN and any AST), moderate hepatic impairment (total bilirubin >1.5 to 3.0 × ULN and any AST), or severe hepatic impairment (total bilirubin >3.0 × ULN and any AST) (see Section 10.3 Pharmacokinetics, Special Populations and Conditions, Hepatic Impairment).
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 dose of TALZENNA is 0.75 mg once daily. For patients with severe renal impairment (15 mL/min ≤ CrCL < 30 mL/min), the recommended dose of TALZENNA is 0.5 mg once daily. TALZENNA has not been studied in patients requiring hemodialysis (see Section 10.3 Pharmacokinetics, Special Populations and Conditions, Renal Impairment).
Geriatric (≥65 years of age)
No dose adjustment is necessary in elderly (≥65 years of age) patients (see Section 10.3 Pharmacokinetics, Special Populations and Conditions, Geriatrics).
Pediatric (<18 years)
The safety and efficacy of TALZENNA in children and adolescents <18 years of age have not been established. Health Canada has not authorized an indication for pediatric use.
The capsule(s) should be swallowed whole, and must not be opened, crushed, chewed or dissolved.
The capsules should be taken at approximately the same time every day and can be taken with or without food.
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.
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