Rucaparib Instructions and Precautions for Use

1. Common name: Rucaparib (Rucaparib)

Product name:Rubraca

2. Indications

Rucaparib(Rucaparib) is mainly suitable for the following clinical situations:

1. Maintenance treatment of mutated recurrent ovarian cancer: Rucaparib is an option for maintenance treatment in patients who have a complete or partial response to platinum-based chemotherapy, especially recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer associated withBRCA mutations (including germline and somatic mutations).

2. BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC): Applicable to adult patients who have received androgen receptor-directed therapy and taxane-based chemotherapy, especially those who carry harmful BRCA mutations.

3. Usage and dosage

1. Preparation before use: Before using rucapanib, doctors need to confirm whether the patient is eligible for treatment. Genetic testing is usually required to detect the presence of BRCA mutations. Even if the plasma sample results are negative, further genomic testing using tumor samples should still be considered.

2. Recommended dose: The recommended dose for ovarian cancer and prostate cancer is 600mg (two 300mg tablets) per day, divided into two doses, which can be taken with meals or on an empty stomach. The total dose is 1200mg per day, and the duration of continued treatment should be determined based on the patient's condition changes and tolerance.

3. Dosage adjustment recommendations: In order to control adverse reactions, it may be necessary to interrupt or reduce the dose of rucaparib. The starting dose is 600mg per day, which can be adjusted to different doses such as 500mg, 400mg, 300mg if necessary.

4. Adverse reactions

Rucapanib may cause a variety of adverse reactions. The following are common adverse reactions in clinical studies:

Adverse reactions in patients with ovarian cancer≥10% of adverse reactions: nausea, weakness/fatigue, anemia, increased AST/ALT, vomiting, diarrhea, decreased appetite, thrombocytopenia, etc.

Among prostate cancer patientsAdverse reactions ≥20%: mainly include fatigue, nausea, constipation, vomiting, diarrhea, anemia, thrombocytopenia, decreased appetite, rash, etc.

5. Storage

Rucaparib should be stored20°C to 25°C (68°F to 77°F), with an allowed temperature deviation of 15°C to 30°C (59°F to 86°F). Proper management of storage conditions is critical to maintaining drug stability.

6. Special groups

1. Female patients: Breastfeeding women should avoid breastfeeding while using this drug and within two weeks after the last dose to prevent potential serious adverse reactions. Females of reproductive potential should use effective contraception during treatment and for six months after the last dose.

2. Male patients: Male patients of reproductive potential need to use effective contraceptive methods during treatment and within three months after the last dose. It is also recommended that these patients not donate sperm during treatment and after taking the drug to reduce the impact.

7. Mechanism of action

The main mechanism of action of rucapanib is to exert anti-tumor effects by inhibiting poly (ADP-ribose) polymerase (PARP). PARP plays an important role in DNA repair, and the effects of rukaparib include:

Induction of cytotoxicity: By inhibiting PARP enzyme activity, it increases the formation of complexes between PARP and DNA, leading to DNA damage and cell apoptosis.

Increase anti-tumor activity: In tumor cells lackingBRCA1/2 and other DNA repair genes, the anti-tumor activity of rucapanib is significantly enhanced.

8. Precautions

When using rucapanib, special attention should be paid to the following points:

1. Risk reminder for myelodysplastic syndrome and acute myeloid leukemia: When using rucapanib, it is necessary to monitor the patient’s blood picture changes and adjust the treatment plan in a timely manner.

2. Embryo-Fetotoxicity: Any patient considering pregnancy must undergo adequate counseling and contraceptive measures while taking rucapanib.

Reference materials:https://www.drugs.com/mtm/rucaparib.html