TALZENNA Dosing and Dose Modifications
Dose Recommendation
Starting patients on TALZENNA1
- The recommended dose of TALZENNA is a 1 mg capsule taken orally once daily
- The capsules should be swallowed whole, and must not be opened or dissolved
- If a patient vomits or misses a dose, an additional dose should not be taken. Take the next prescribed dose at the usual time
- Patients should be treated until disease progression or unacceptable toxicity occurs
Available in 2 capsule strengths:
The 0.25 mg capsule is available for patients who require dose modifications.
Dose Adjustments for AEs
- First dose reduction: 0.75 mg (three 0.25 mg capsules) once daily
- Second dose reduction: 0.5 mg (two 0.25 mg capsules) once daily
- Third dose reduction: 0.25 mg (one 0.25 mg capsule) once daily
Please refer to SmPC for complete information on dose modification for TALZENNA.
Dose Modifications and Management
Monitoring and managing patients on TALZENNA
Complete blood count should be obtained prior to starting TALZENNA therapy and monitored monthly and as clinically indicated below1
Myelosuppression consisting of anemia, leukopenia/neutropenia, and/or thrombocytopenia have been reported in patients treated with TALZENNA. TALZENNA should not be started until patients have recovered from hematological toxicity caused by previous therapy (≤ Grade 1).
Myelodysplastic syndrome/Acute Myeloid Leukaemia (MDS/AML) have been reported in patients who received poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitors, including talazoparib. Overall, MDS/AML has been reported in < 1% of solid tumour patients treated with talazoparib in clinical studies. Potential contributing factors for the development of MDS/AML include previous platinum-containing chemotherapy, other DNA damaging agents or radiotherapy. Complete blood counts should be obtained at baseline and monitored monthly for signs of haematologic toxicity during treatment. If MDS/AML is confirmed, talazoparib should be discontinued.
AE=adverse event; AST=aspartate aminotransferase; BRCA=breast cancer susceptibility gene; BCRP=breast cancer resistance protein; CI=confidence interval; CrCl=creatinine clearance; HER2-=human epidermal growth factor receptor 2 negative; HR=hazard ratio; PARP=poly (ADP-ribose) polymerase; P-gp=P-glycoprotein; ULN=upper limit of normal.
- TALZENNA Summary of Product Characteristics.
- 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.
- Ettl J, Quek RGW, Lee KH, et al. Quality of life with talazoparib versus physician’s choice of chemotherapy in patients with advanced breast cancer and germline BRCA1/2 mutation: patient-reported outcomes from the EMBRACA phase III trial. Ann Oncol. 2018;29:1939-1947.
- Hurvitz SA, Gonçalvez A, Rugo HS, et al. Talazoparib, an oral poly(ADP-ribose) polymerase inhibitor for patients with locally advanced/metastatic breast cancer and a germline BRCA mutation: detailed safety analyses from the randomized, multinational, phase 3 EMBRACA trial. Poster presented at: 36th Annual Miami Breast Cancer Conference; March 7-10, 2019; Miami, FL. Poster 761.
▼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.
