TALZENNA® (talazoparib)| Dosing | Dose Recommendations and special populations

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TALZENNA MoA

Talzenna MoA

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Personalising Breast Cancer Treatment

Understanding and Optimising PARP Inhibitors for mBC

PARP Inhibitors in mBC: the role of Real World Evidence

Starting patients on convenient, once-daily TALZENNA^®1

1 mg capsule¹

The recommended starting dose is a 1 mg capsule taken orally once daily

0.25 mg capsule¹

Available for patients who require dose modifications

Capsules not actual size (~5 mm x ~14 mm).

Administration considerations¹

Dose reduction schedule

To manage adverse reactions, consider interruption of treatment or dose reduction based on severity and clinical presentation¹

Capsules not actual size (~5 mm x ~14 mm).

Please refer to SmPC for complete information on dose modifications for TALZENNA^®.

Special populations

Hepatic impairment¹

No dose modification is recommended for patients with mild, moderate, or severe hepatic impairment (based on NCI criteria)

Renal impairment¹

No dose adjustment is required for patients with mild renal impairment (60 mL/min ≤ 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 hemodialysis

Elderly¹

No dose adjustment is necessary in elderly (≥65 years of age) patients

Paediatric Population¹

The safety and efficacy of Talzenna^® in children and adolescents <18 years of age have not been established. No data are available.

Breastfeeding¹

It is unknown whether TALZENNA^® is excreted in human breast milk. A risk to breast-fed children cannot be excluded and therefore breastfeeding is not recommended during treatment with TALZENNA^® and for at least 1 month after the final dose.

Drug interactions

Use with P-gp inhibitors¹

Strong inhibitors of P-gp may lead to increased TALZENNA^® exposure*
Concomitant use of strong P-gp inhibitors during treatment with TALZENNA^® 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 lowest dose.
When the strong P-gp ihibitor 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
No TALZENNA^® dose adjustments are required when co-administered with rifampin
However, the effect of other P-gp inducers on TALZENNA^® exposure has not been studied
Other P-gp inducers (including but not limited to carbamazepine, phenytoin, and St. John’s wort) may decrease TALZENNA^® exposure.

BCRP inhibitors¹

The effect of BCRP inhibitors on TALZENNA^® pharmacokinetics has not been studied in vivo.
Co-administration of TALZENNA^® with BCRP inhibitors may increase TALZENNA^® exposure.
Concomitant use of strong BCRP inhibitors (including but not limited to curcumin and cyclosporine) should be avoided.
If co-administration of strong BCRP inhibitors cannot be avoided, the patients should be monitored for potential increased adverse reactions.

Effects of systemic hormonal contraception¹

Drug-drug interaction between TALZENNA^® and oral contraceptives have not been conducted.

Effect of acid-reducing agents¹

Co-administration of acid-reducing agents including proton pump inhibitors, histamine receptor 2 antagonists (H²RA), or other acid-reducing agents had no significant impact on the absorption of TALZENNA^®

AE=adverse event; AST=aspartate aminotransferase; BCRP=breast cancer resistance protein; CrCL=creatinine clearance; PFS=progression-free survival; P-gp=P-glycoprotein; ULN=upper limit of normal.

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Dose modifications

Reference:

TALZENNA^® Summary of Product Characteristics.

Legal Category: S1A
Further information is available upon request

PP-TAL-IRL-0105 May 2024

Dosing

Significantly longer PFS

Superior to chemotherapy in delaying disease progression¹

See the data

Manageable safety profile

AEs were manageable with a low discontinuation rate¹

Review safety

TALZENNA Summary of Product Characteristics

Product Characteristics

Adverse events should be reported.

If you wish to make a medical information inquiry or report an adverse event please contact Pfizer on 1800 633 363
or email Pfizer at [email protected] or visit www.PfizerMedicalInformation.ie

Report an adverse event to your national reporting system (HPRA Pharmacovigilance)

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PP-UNP-IRL-0891. February 2025

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PP-UNP-IRL-0891. February 2025