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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
Manageable safety and tolerability with TALZENNA vs chemotherapy1,2Adverse events* (in ≥20% in patients receiving TALZENNA) in EMBRACA3,4
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Adverse reactions TALZENNA n=286 (%) Chemotherapy† n=126 (%)
Grades
1-4		 Grade 3 Grade 4 Grades
1-4		 Grade 3 Grade 4
Blood and lymphatic system disorders
Anaemia​​​​​​​‡ 53 39 1 18 4 1
Neutropenia§ 35 18 3 43 20 15
Thrombocytopenia|| 27 11 4 7 2 0
Metabolism and nutrition disorders
Decreased appetite 21 <1 0 22 1 0
Nervous system disorders
Headache 33 2 0 22 1 0
Gastrointestinal disorders
Nausea 49 <1 0 47 2 0
Vomiting 25 2 0 23 2 0
Diarrhea 22 1 0 26 6 0
Skin and subcutaneous tissue disorders
Alopecia 25 N/A N/A 28 N/A N/A
General disorders and administration site conditions
Fatigue 50 2 0 43 3 0
Adapted from Litton et al. N Engl J Med (suppl appendix). 2018.1Special Warnings and Precautions for TALZENNA5Myelosuppression5

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 Leukemia5

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. The duration of TALZENNA treatment in these three patients prior to developing MDS/AML was 4 months, 24 months, and 60 months respectively. 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 count should be obtained prior to starting Talzenna therapy and monitored monthly and as clinically indicated.

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:Litton JK, Rugo HS, Ettl J, et al. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med. 2018;379(8):753-763.Hurvitz SA, Gonҫalves A, Rugo HS, et al. Talazoparib in patients with a germline BRCA-mutated advanced breast cancer: detailed safety analyses from the phase III EMBRACA trial. Oncologist. 2019;24:1-12.Litton JK, Rugo HS, Ettl J, et al. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation (supplementary appendix). N Engl J Med. 2018;379(8):753-763.National Institutes of Health, US Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE). Bethesda, MD: National Institutes of Health. Revised June 2010, version 4.03. NIH publication 09-5410.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-0061 April 2023
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. 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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