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Adverse event reporting can be found at the bottom of the page
Efficacy & safetyButtonLoading
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EMBRACA Study
EMBRACA StudyEfficacy OutcomesSafetyPROs
Safety and Tolerability
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Support & ResourcesSupportVideosMaterialsTALZENNA efficacyPrimary endpoint & subgroup analysisSecondary endpoints: ORRSecondary endpoint: OSExploratory endpoints: DoR & TTRTALZENNA safetySafety and tolerabillityAdverse eventsHematologic/Nonhematologic AEsPatient-reported outcomes with TALZENNAPatient-reported outcomesGHS/QoLBreast symptoms
Talzenna MoA

The content of this website has been produced in line with the Talzenna®▼ Summary of Product Characteristics for Great Britain and Northern Ireland. Talzenna® (talazoparib) Prescribing Information for Great Britain and Northern Ireland click here.  Adverse event reporting information can be found at the bottom of the page.

DosingStarting Patients on Convenient, Once Daily TALZENNA®1
  • TALZENNA® is available in 1 mg and 0.25 mg capsules
  • The recommended starting dose of TALZENNA® for adult patients with gBRCA1/2-mutated, HER2-negative locally advanced or metastatic breast cancer, is a 1 mg capsule taken orally once daily
  • 0.25 mg capsules are available for patients who require dose modification
    • To manage adverse reactions, consider interruption of treatment or dose reduction based on severity and clinical presentation

 

Special PopulationsHepatic Impairment1
  • No dose modification is recommended for patients with mild, moderate, or severe hepatic impairment.
Renal Impairment1
Level of renal impairment                                                                              Dose adjustment                                                                                       
Mild renal impairment (CrCl ≥60 to <90 mL/min) No adjustment is required
Moderate renal impairment (CrCl ≥30 to <60 mL/min) The recommended starting dose of TALZENNA® is 0.75 mg once daily
Severe renal impairment (CrCl ≥15 to <30 mL/min) The recommended starting dose of TALZENNA® is 0.5 mg once daily
CrCL <15 mL/min or patients requiring haemodialysis TALZENNA® has not been studied in these patients
Elderly1
  • No dose adjustment is necessary in elderly patients (>65 years of age)
Paediatric patients1
  • The safety and efficacy of TALZENNA in children and adolescents <18 years of age have not been established; no data are available
Monitoring and Managing Patients on TALZENNA®

Full blood count should be obtained prior to starting TALZENNA® and monitored monthly and as clinically indicated. 

To manage adverse reactions, consider interruption of treatment or dose reduction based on severity and clinical presentation.1 

Dose adjustments for adverse reactions

Adapted from TALZENNA® Summary of Product Characteristics.1

Administration Considerations

Administration considerations:1
Capsules can be taken with or without food
The hard capsules should be swallowed whole, and must not be opened or disolved
Patients should be treated until disease progression or unacceptable toxicity occurs
If patient vomits or misses a dose, an additional dose should not be taken; the next prescribed dose should be taken at the usual time

Drug-Drug Interactions

P-glycoprotein (P-gp) inhibitors1
  • Strong inhibitors of P-gp may lead to increased TALZENNA® exposure.* Concomitant use of stong P-gp inhibitors should be avoided. Coadministration should only be considered after careful evaluation of the potential benefits and risks. If coadministration with a strong P-gp
    inhibitor cannot be avoided, 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 initiation of the strong P-gp inhibitor
Breast cancer resistance protein (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 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®
In clinical studies, co-administration with strong P-gp inhibitors resulted in an approximate 45% increase in TALZENNA exposure relative to TALZENNA given alone.

Please refer to the Talzenna SmPC for complete information on dosing, dose modifications and guidance on the management of adverse events

Explore more

Safety & Tolerability

View the TALZENNA® Safety & Tolerability page

 Learn moreLoading

Support & Resources

View the TALZENNA® Support & Resources page

 Learn moreLoadingBRCP=breast cancer resistance protein; CrCL= creatinine clearance; NCI=National Cancer Institute; P-gp=P-glycoprotein; SmPC=Summary of Product CharacteristicsReferences:TALZENNA® Summary of Product Characteristics for Great Britain click here. TALZENNA® Summary of Product Characteristics for Northern Ireland click here.
PP-TAL-GBR-0205. July 2024

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for MHRA Yellow Card in Google Play or Apple App Store

 

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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