talazoparib

Generic name: Talazoparib

Trade name: Talzenna

All names: talazoparib, talazoparib, tazledosin, talazoparib, Talzenna

Indications:

This product is used for the treatment of breast cancer patients with hereditary BRCA1 or BRCA2 gene mutations.

Usage and dosage:

The recommended dosage is 1 mg once a day, orally, before or after meals.

Adverse reactions:

>10%:

Hemoglobin decrease

Leukopenia

Lymphopenia

Neutrophil decrease

Fatigue

increased glucose

anemia

nausea

increased AST (aspartate aminotransferase)

increased alkaline phosphatase

neutropenia

increased ALT (alanine aminotransferase)

Decreased calcium

Vomiting

Hair loss

Diarrhea

Loss of appetite

Abdominal pain

Dizziness

1-10%:

Taste disorder

Indigestion

Stomatitis

lymphopenia

thrombocytopenia

neutropenia

fatigue

increased glucose

increased alkaline phosphate

vomiting

headache

AST / Increased ALT (aspartate aminotransferase/alanine aminotransferase)

Decreased calcium

<1%:

Decreased appetite

Nausea

Lymphopenia

Leukopenia

Contraindications:

Unclear.

Precautions:

Before taking TALZENNA, tell your healthcare provider about all of your medical conditions, including whether you:

have kidney problems.

are pregnant or plan to become pregnant. TALZENNA can harm your unborn baby and may cause miscarriage. Tell your healthcare provider right away if you become pregnant or become pregnant during treatment with TALZENNA.

If you are able to get pregnant, your healthcare provider may give you a pregnancy test before you start treatment with TALZENNA.

Females of the ability to become pregnant should use effective contraception during treatment with TALZENNA and for at least 7 months after receiving the last dose of TALZENNA. Talk to your healthcare provider about birth control methods that may be right for you.

Men with a female partner who are or are able to become pregnant should use effective birth control during treatment with TALZENNA and for at least 4 months after receiving the last dose of TALZENNA.

Breastfeeding or planning to breastfeed. It is not known whether TALZENNA passes into your breast milk. Do not breastfeed during treatment with TALZENNA and for 1 month after receiving the last dose of TALZENNA. Talk to your health care provider about the best way to feed your baby during this time. Tell your healthcare provider about all the medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.

Taking TALZENNA with certain other medicines can affect how TALZENNA works and may cause side effects.

Storage:

Store at 20-25°C (68-77°F); Short trips allowed between 15-30°C (59-86°F)

Mechanism of action:

Talazoparib is a highly potent dual inhibitor of PARP that inhibits the PARP enzyme and effectively blocks the effect of PARP on single-strand DNA breaks, preventing DNA damage repair and causing death of BRCA1/2 mutant cells.

Safety and Efficacy:

This approval is based on the results of an open-label, Phase 3 clinical trial called EMBRACA. In the study, 431 patients received talazoparib or physician's choice of chemotherapy in a 2:1 ratio. All patients need to carry a germline BRCA mutation.

The trial results showed that patients who received talazoparib had a significantly longer progression-free survival (PFS) than those who received chemotherapy. The median PFS in the talazoparib group was 8.6 months, and the median PFS in the chemotherapy group was 5.6 months (HR 0.54, 95% CI: 0.41, 0.71; p<0.0001). This means that talazoparib reduced the risk of disease progression by 46%. Moreover, the objective response rate in the talazoparib group was 62.6%, which was more than twice that of the chemotherapy group (27.2%) (p<0.0001).