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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 ProfilesPrescribing InformationSupport & ResourcesSupport & ResourcesMaterialsElevatePersonalising Breast Cancer TreatmentUnderstanding and Optimising PARP Inhibitors for mBCPARP Inhibitors in mBC: the role of Real World Evidence
Safety profile and tolerabilityAdverse events, per the Talzenna® Summary of Product Characteristics1

The overall safety profile of Talzenna® is based on pooled data from 1088 patients who received TALZENNA at the recommended dose in clinical studies for solid tumours and metastatic castration-resistant prostate cancer (mCRPC). This included:1

  • 690 patients from clinical studies for solid tumours.
  • 398 patients with mCRPC from the TALAPRO-2 study
In solid tumours dose modifications due to any adverse reaction occurred in 58.7% of patients receiving TALZENNA® 1 mg daily for solid tumours. The most common adverse reactions leading to dose modifications were anaemia (33.5%), neutropenia (11.7%) and thrombocytopenia (9.9%)1.

Permanent discontinuation due to an adverse reaction occurred in 2.9% of patients receiving TALZENNA®; the most common was anaemia (0.6%). The median duration of treatment exposure was 5.6 months (range: 0.0 to 70.2).1

In mCRPC dose interruptions due to adverse reactions occurred in 62.1% of patients with mCRPC receiving TALZENNA®; the most common was anaemia, dose reductions due to adverse reactions occurred in 52.8% of patients; the most common was anaemia (43.2%).1

Permanent discontinuation of TALZENNA® due to an adverse event occurred in 18.8% of patients; the most common was anaemia (8.3%)  exposure was (range 0.29-186.14). The median duration of treatment exposure was 86 weeks (range: 0.29-186.14).1
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Adapted from Litton et al. N Engl J Med (suppl appendix). 2018.1Special Warnings and Precautions for TALZENNA®1Myelosuppression1

Myelosuppression consisting of anaemia, leukopenia/neutropenia, and/or thrombocytopenia have been reported in patients treated with TALZENNA®. TALZENNA® should not be started until patients have recovered from haematological toxicity caused by previous therapy (≤Grade 1).
 
Precautions should be taken to routinely monitor haematology parameters and signs and symptoms associated with anaemia, leukopenia/neutropenia, and/or thrombocytopenia in patients receiving TALZENNA®. If such events occur, dose modifications (reduction or interruption) are recommended (refer to full SmPC or Dosing section). Supportive care with or without blood and/or platelet transfusions and/or administration of colony stimulating factors may be used as appropriate.

Myelodysplastic syndrome/Acute Myeloid Leukemia1

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) have been reported in patients who received TALZENNA®. Overall, MDS/AML has been reported in <1% (3 out of 787, 0.4%) of solid tumor patients treated with TALZENNA® in clinical studies. These patients had received previous chemotherapy with platinum agents and/or other DNA damaging agents including radiotherapy. 

TALZENNA® should not be started until patients have adequately recovered from haematological toxicity caused by previous chemotherapy. 

Complete blood counts should be obtained at baseline and monitored monthly for signs of haematologic toxicity during treatment. If MDS/AML is confirmed, discontinue TALZENNA®1

Contraception in Women of Childbearing Potential1

TALZENNA® may cause foetal harm when administered to a pregnant woman. Pregnant women should be advised of the potential risk to the foetus. Women of childbearing potential should not become pregnant while receiving TALZENNA® and should not be pregnant at the beginning of treatment. A pregnancy test should be performed on all women of childbearing potential prior to treatment.1

A highly effective method of contraception is required for female patients during treatment with TALZENNA®, and for at least 7 months after completing therapy. Since the use of hormonal contraception is not recommended in patients with breast cancer, two non-hormonal and complementary contraception methods should be used.1

Male patients with female partners of reproductive potential or pregnant partners should be advised to use effective contraception (even after vasectomy), during treatment with TALZENNA® and for at least 4 months after the final dose.1

Interactions1

TALZENNA® is a substrate for drug transporters P-glycoprotein (P-gp) and Breast Cancer Resistance Protein (BCRP), and is mainly eliminated by renal clearance as unchanged compound.1

Agents that may affect TALZENNA® plasma concentrations include P-gp inhibitors, P-gp inducers, BCRP inhibitors, acid-reducing agents, and systemic hormonal contraception.1

To find out more about TALZENNA® interactions, please visit the Summary of Characteristics

AE=adverse event; CTCAE=Common Terminology Criteria for Adverse Events; N/A=not applicable; NCl=National Cancer Institute; PARP=poly (ADP-ribose) polymerase; PFS=progression-free survival.Graded according to NCI CTCAE 4.03.Capecitabine, eribulin, gemcitabine, or vinorelbine.​​​​​​​Includes anaemia and decreased hemoglobin level.Includes neutropenia, decreased neutrophil count, and neutropenic sepsis. 
lncludes thrombocytopenia and decreased platelet count.Alopecia Grade 1: 23% with TALZENNA vs 20% with chemotherapy; Grade 2: 2% with TALZENNA® vs 8% with chemotherapy. Grade 1 defined as hair loss of <50% of normal for that individual that is not obvious from a distance but only on close inspection. A different hairstyle may be required to cover the hair loss, but it does not require a wig or hairpiece to camouflage. Grade 2 defined as hair loss of ≥50% of normal for that individual that is readily apparent to others. A wig or hairpiece is necessary if the patient desires to completely camouflage the hair loss; associated with psychosocial impact. Explore more Adverse events
References:
1. Talzenna Summary of Product Characteristics

Legal Category: S1A 
Further information is available upon request

PP-TAL-IRL-0107 May 2024
TALZENNA safety Significantly longer PFS

Superior to chemotherapy in delaying disease progression5

 See the data  Convenient, once-daily oral dosing

One dose once a day with or without food5

 Learn more
TALZENNA Summary of Product Characteristics Product CharacteristicsLoading

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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