What are the precautions for taking Talazoparib?

In the study of the use of Talazoparib (Talazoparib) in the treatment of BRCA-mutated HER2-negative locally advanced or metastatic breast cancer and HRR gene-mutated metastatic castration-resistant prostate cancer, warnings and precautions such as myelodysplastic syndrome/acute myeloid leukemia, bone marrow suppression, and embryo-fetal toxicity have emerged.

1. Myelodysplastic syndrome/Acute myeloid leukemia (MDS/AML): including cases with fatal outcomes. Do not initiate talazopanib until the patient has fully recovered from hematological toxicity caused by prior chemotherapy. During treatment, monitor blood cell counts monthly. For long-term hematologic toxicity, interrupt talazopanib and monitor blood counts weekly until recovery. If the count does not return within 4 weeks, refer the patient to a hematologist . IfMDS/AMLis confirmed, discontinue usetalazopanib.

2. Myelosuppression: Myelosuppression, including anemia, neutropenia, and/or thrombocytopenia, has been reported in patients receiving talazopanib treatment. In the study, 39% of the patients required red blood cell transfusions, and 22%of the patients may require multiple transfusions. Do not use talazoparib until the patient has fully recovered from hematologic toxicity from prior therapy. During treatment, monitor blood cell counts monthly. If hematologic toxicity does not resolve within 28 days, discontinue talazopanib and refer the patient to a hematologist, including bone marrow analysis and cytogenetic blood samples.

3. Embryonic-Fetal Toxicity:In an animal reproduction study, administration of talazoparib to pregnant rats during organogenesis resulted in fetal malformations and structural skeletal abnormalities, and embryo-fetal death in patients receiving the recommended human dose of 1 mg daily, at an exposure of 0.24 times the area under the concentration-time curve (AUC). Inform pregnant women and women of reproductive potential of the potential risks to the fetus. Advise females of reproductive potential to use an effective method of contraception during treatment and for 7 months after the last dose. Based on the results of genotoxicity and animal reproduction studies, it is recommended that male patients with a female partner of reproductive potential or who are pregnant use effective contraception during treatment and for 4 months after the last dose of talazopanib.

The original drug of talazopanib has not yet been marketed in China, so it has not been included in medical insurance. The original drug specification of talazopanib listed overseas is 0.25mg*30 capsules, and the price per box may be around RMB 10,000 (the price may fluctuate due to exchange rate effects), which is relatively expensive. There are also cheaper generics of talazopanib overseas. For example, the price of a box of 1mg*30 pills produced by a Laos pharmaceutical factory may be more than 3,000 yuan (the price may fluctuate due to the exchange rate).