Analysis of the Chinese instructions for use and precautions of Talazoparib (Tazena)

Talazoparib is an oral PARP inhibitor primarily used to treat breast cancer harboring BRCA1/2 mutations and other approved indications. As one of the drugs that have attracted much attention in the field of precision tumor treatment in recent years, it inhibits PARP enzyme activity, making tumor cells unable to repair DNA damage, thereby inducing cell death. It is especially suitable for cancers related to "homologous recombination repair deficiency (HRD)". The following content is analyzed in Chinese based on the structure of its official instructions, and is systematically organized from usage, dosage, monitoring indicators to important precautions to help patients and their families understand the medication specifications more clearly.

1. Usage and dosage: standard dosage and adjustment basis

Talazoparib is an oral medication that should be taken once daily. The recommended dose for adults is 1 mg once daily and continued until disease progression or intolerable toxicity. The tablets can be swallowed whole and should not be broken, dissolved or chewed. It is best to take the medicine at the same time every day to maintain stable blood concentration. If the patient has moderate renal impairment (such as CrCl 30–59 mL/min), it is recommended to reduce the dose to 0.75mg once a day; if the patient has severe renal impairment (CrCl 15–29 mL/min), and the dose was further adjusted to 0.5 mg once a day. In addition, if the patient is accompanied by serious adverse reactions during treatment, such as hematological toxicity of grade 3 or above, treatment should be suspended, and the dose should be gradually reduced according to the instructions after returning to the ideal level, such as 1mg → 0.75mg → 0.5mg → 0.25mg.

2. Medication steps and eating requirements

The taking of talazoparib has no direct impact on whether you eat or not, and can be taken with or without food. However, in order to avoid food affecting gastrointestinal reactions, some patients prefer to take it with meals to reduce minor side effects such as nausea and stomach discomfort. If vomiting occurs after taking the medicine, it is not recommended to take the next dose immediately. You should follow the original plan the next time you take the medicine. Medications should be stored in their original packaging, away from moisture and high temperatures, and away from children. If patients take other drugs at the same time, including herbal medicines, vitamins, health products, etc., they need to inform their doctors in advance, because some drugs may affect the metabolism of talazoparib. For example, strong P-gp inhibitors (such as azithromycin, amitriptyline) may increase drug concentrations, and doctors need to give dosage adjustment recommendations.

3. Monitoring items and potential adverse reaction tips

Because talazoparib has a strong DNA repair inhibitory effect, its most common adverse reactions are hematological toxicity, including anemia, neutropenia, thrombocytopenia, etc., which usually occur in the first two months of treatment. Therefore, blood routine must be monitored regularly during medication, usually before treatment and every 2 weeks to 1 months during treatment. If there is a significant drop, it should be dealt with immediately. Secondly, some patients will experience fatigue, nausea, oral mucositis, headache, diarrhea, etc. Although most cases are mild to moderate and can be improved through symptomatic treatment, if severe fatigue, progressive dyspnea, or abnormally pale skin occurs, one should be highly vigilant about the possibility of severe anemia or bone marrow suppression. Rare but possible serious risks include secondary myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). If persistent and irreversible hemogram abnormalities occur during treatment, treatment must be stopped immediately and bone marrow evaluation must be performed.

4. Medication precautions and taboos for special groups

For Talazoparib is strictly prohibited for pregnant and lactating women because the drug may cause serious harm to the embryo and affect the health of the baby. Women of childbearing age must take reliable contraceptive measures during treatment and continue for at least 7 months after stopping the drug; male patients also need to take contraceptive measures for at least 4 months after stopping the drug. In older adults, doctors will monitor adverse reactions more closely because decreased kidney function may affect drug metabolism. Patients with heart disease, hypertension, and previous hematopoietic system diseases also need to inform their doctor before use, because these basic diseases may increase the risk of side effects. If the patient plans to undergo major surgery, he or she also needs to inform the doctor in advance. It is generally recommended to suspend medications before surgery to avoid affecting wound healing.

Overall, talazoparib is an important PARP inhibitor in precision therapy and is of great value for patients carrying BRCA mutations or HRD positivity. However, in order to ensure efficacy and safety, patients must strictly follow the instructions and doctor's instructions, and conduct regular blood and renal function monitoring. If any abnormal discomfort occurs during treatment, especially persistent fatigue, bleeding, signs of infection, etc., you should seek medical treatment in time so that the doctor can determine whether the dosage needs to be adjusted or the medication needs to be suspended.

Reference materials:https://go.drugbank.com/drugs/DB11760