This site is intended only for healthcare professionals resident in the Republic of Ireland

Search

Menu

Close

Sign in or RegisterLog out
Our medicinesTherapy areasExplore contentExplore contentMaterialsVideosPodcastsLet’s connectLet's connectContact usSign up

Menu

Close

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

PfizerPro AccountPfizerPro Account

Please sign in or register to gain access to information relating to Pfizer medicines and vaccines, medical conditions, patient materials and services.

Sign in or RegisterRegisterAccountLog out

This site is intended only for healthcare professionals resident in the Republic of Ireland. If you are a member of the public wishing to access information on a specific medicine, please visit https://www.medicines.ie

 

This website is brought to you by Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Registered in the Republic of Ireland No. 127002.

 

Copyright © 2023 Pfizer Limited. All rights reserved.

PP-UNP-IRL-0176. January 2023
For Healthcare Professionals in the Republic of Ireland *

The information contained on this site is reserved exclusively for healthcare professionals resident in the Republic of Ireland.

I confirm that I am a healthcare professional resident in the Republic of Ireland.*

I accept and agree to the terms of use.*

If you select 'No', you will be redirected to Pfizer.ie, where you will be able to access information on Pfizer Healthcare Ireland.

PP-UNP-IRL-0176. January 2023

Yes No
You are now leaving PfizerPro
You are now leaving PfizerPro Ireland. Links to external websites are provided as a resource to the viewer. This website is neither owned nor controlled by Pfizer. Pfizer accepts no responsibility for the content or services of the linked site.