TALZENNA Dosing and Dose Modifications

Dose Recommendation

Starting patients on TALZENNA1

talzenna-dosing-and-dose-modifications
 
  • 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:

talzenna-dosing-and-dose-modifications

          

The 0.25 mg capsule is available for patients who require dose modifications.

 

 

Dose Adjustments for AEs 

Dose reduction schedule and dosing in special populations
To manage adverse reactions, consider interruption of treatment or dose reduction based on severity and clinical presentation1
Recommended starting dose
1 mg (one 1 mg capsule) once daily
  • 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
Dose Reduction Levels for Adverse Events
talzenna-dosing-and-dose-modifications

 

Please refer to SmPC for complete information on dose modification for TALZENNA.

 
special-populations

 

 

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 below

dm_mgmt_table

MYELOSUPPRESSION1
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).
Precautions should be taken to routinely monitor hematology parameters and signs and symptoms associated with anemia, 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 chart above). 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 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.

 
REFERENCES
  1. TALZENNA Summary of Product Characteristics.
  2. 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.
  3. 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.
  4. 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.