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AboutTALZENNA MoATalzenna MoAgBRCA testingIdentifying patientsGuidelinesStudy designStudy designBaseline characteristicsEfficacy & SafetyTALZENNA efficacyPrimary endpoint & subgroup analysisSecondary endpoints: ORRSecondary endpoint: OSExploratory endpoints: DoR & TTRTALZENNA safetySafety and tolerabillityAdverse eventsPatient-reported outcomes with TALZENNAPatient-reported outcomesGHS/QoLBreast symptomsDosingDosingDose recommendation and special populationsDose modifications/managementPatient ProfilesSupport & ResourcesSupport & ResourcesMaterialsElevatePersonalising Breast Cancer TreatmentUnderstanding and Optimising PARP Inhibitors for mBCPARP 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 considerations1Dose 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 interactionsUse 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. Explore more 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 CharacteristicsLoading

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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PP-UNP-IRL-0784. June 2024