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|Adverse reactions||TALZENNA n=286 (%)||Chemotherapy† n=126 (%)|
|Grade 3||Grade 4||Grades
|Grade 3||Grade 4|
|Blood and lymphatic system disorders|
|Metabolism and nutrition disorders|
|Nervous system disorders|
|Skin and subcutaneous tissue disorders|
|General disorders and administration site conditions|
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 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.
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Superior to chemotherapy in delaying disease progression5
One dose once a day with or without food5
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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PP-UNP-IRL-0176. January 2023