TALZENNA 4 Dosage And Administration

talazoparib

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4.1 Dosing Considerations

  • Treatment with TALZENNA should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
  • Detection of a deleterious or suspected deleterious mutation(s) in hereditary breast cancer-related BRCA1 and BRCA2 genes should be determined by an experienced laboratory using a validated test method prior to treatment initiation.

4.2 Recommended Dose and Dosage Adjustment

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.

Table 1. Dose Modification Recommendations for Toxicities
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

Table 2. Dose Modification and Management

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.

4.4 Administration

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.

4.5 Missed 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.

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4 Dosage And Administration

4.1 Dosing Considerations

  • Treatment with TALZENNA should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
  • Detection of a deleterious or suspected deleterious mutation(s) in hereditary breast cancer-related BRCA1 and BRCA2 genes should be determined by an experienced laboratory using a validated test method prior to treatment initiation.

4.2 Recommended Dose and Dosage Adjustment

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.

Table 1. Dose Modification Recommendations for Toxicities
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

Table 2. Dose Modification and Management

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.

4.4 Administration

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.

4.5 Missed 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.

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