Talazoparib Tosylate/Tazena Full Insert Guide

Talazoparib is a poly(ADP-ribose) polymerase (PARP) inhibitor that is primarily used to treat certain types of cancer, particularly breast cancer and metastatic castration-resistant prostate cancer associated with BRCA gene mutations. Its mechanism of action is mainly by inhibiting the DNA repair process, thereby producing a cytotoxic effect on cancer cells.

1. Indications

The main indications for talazoparib include:

1. BRCA-mutated breast cancer : For the treatment of HER2-negative locally advanced or metastatic breast cancer patients, especially those adult patients with harmful or suspected harmful BRCA mutations.

2. Metastatic castration-resistant prostate cancer (mCRPC): used in combination with enzalutamide for adult patients with homologous recombination repair (HRR) gene mutations.

2. Usage and dosage

Before treatment with talazoparib, doctors will decide whether to use this drug based on whether the patient has a BRCA mutation or an HRR gene mutation. Recommended dosages are as follows:

1. Breast cancer: The recommended dose is 1 mg taken orally daily until disease progression or unacceptable toxicity occurs.

2. Prostate cancer: The recommended dose is 0.5mg orally administered daily, in combination with enzalutamide until disease progression or unacceptable toxicity occurs. In addition, patients need to receiveGnRH analog therapy or undergo bilateral orchiectomy.

3. Dose adjustment: If adverse reactions occur, the dose needs to be adjusted according to the severity. The dose of breast cancer patients can be gradually reduced, while the initial dose of prostate cancer patients is reduced to 0.35mg, and can be adjusted to 0.25mg and 0.1mg subsequently.

Renal impairment adaptation

1. For patients with impaired renal function, the drug dosage needs to be adjusted accordingly:

2.Moderate renal impairment: Breast cancer patients 0.75 mg daily, prostate cancer patients 0.35 mg daily.

3. Severe renal impairment: 0.5 mg per day for breast cancer patients and 0.25 mg per day for prostate cancer patients.

3. Adverse reactions

In clinical studies, common adverse reactions include:

1. Breast cancer: decreased hemoglobin, neutropenia, lymphopenia, fatigue, nausea, etc.

2. Prostate cancer: decreased hemoglobin, fatigue, decreased calcium, decreased appetite, etc.

4. Storage conditions

Talazoparib should be stored at 20°C to 25°C, allowing temperature fluctuations between 15°C and 30°C.

5. Guidance for special groups

1. Women: Breastfeeding women should avoid breastfeeding during treatment with talazoparib and within 1 month after the last dose. Females of reproductive potential should use effective contraception during treatment and for 7 months after the last dose.

2. Males: Because it may affect fertility, it is recommended that male patients with reproductive potential and their partners use effective contraceptive measures during treatment and within 4 months after the last dose.

6. Mechanism of action

Talazoparib , as a PARP inhibitor , mainly prevents the DNA repair of cancer cells by inhibiting the activities of PARP1 and PARP2. Studies have shown that in cancer cells carrying BRCA mutations, inhibition of PARP enzyme activity leads to accumulation of DNA damage, thereby promoting cell death. In BRCA-mutated breast cancer models, talazoparib showed significant anti-tumor activity.

Reference materials:https://www.talzenna.com/