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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 eventsHaematologic/Nonhaematologic AEsPatient-reported outcomes with TALZENNAPatient-reported outcomesGHS/QoLBreast symptomsDosingDosingDose recommendation and special populationsDose modifications/managementPatient ProfilesSupport & ResourcesSupport & ResourcesMaterials
Starting patients on convenient, once-daily TALZENNA1 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
Drug interactionsUse with P-gp inhibitors1
  • 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
BCRP inhibitors1
  • 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, patient should be monitored for potential increased adverse reactions
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. 
​​​​​​​ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of full SmPC for how to report adverse reactions.

Legal Category: S1A 
Further information is available upon request

PP-TAL-IRL-0062 April 2023
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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