What is the important information in the Chinese instructions for Nirapali, Abiraterone Tablets?

1. Basic information

Niraparib Abiraterone Tablets (trade name: Akeega, Zebeike) is a drug that combines two active ingredients, niraparib (niraparib) and abiraterone acetate (abiraterone).

2. Indications

Niraparib, abiraterone tablets (Akeega) is primarily indicated for the treatment of adult patients with or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC). Use of this drug is based on patients selected for the FDA-approved AKEEGA trial.

3. Usage and dosage

The recommended dosage is 200 mgniraparib and 1000 mg abiraterone taken orally once daily, in combination with 10 mg prednisone, until disease progression or unacceptable toxicity occurs. Patients need to take it on an empty stomach, that is, they should not eat two hours before and one hour after taking the medicine.

At the same time, patients should be treated with gonadotropin-releasing hormone (GnRH) analogues or undergo bilateral orchiectomy. This drug should be discontinued if myelodysplastic syndrome or acute myeloid leukemia (MDS/AML) is confirmed.

4. Adverse reactions

The incidence rate of common adverse reactions of niraparibabiraterone tablets is higher than10%, including musculoskeletal pain, fatigue, constipation, hypertension, nausea, edema, dyspnea, decreased appetite, vomiting, dizziness, etc. In addition, more than 10% of common abnormalities in laboratory tests are found, such as decreased hemoglobin, thrombocytopenia, and neutropenia.

5. Storage conditions

Niraparib Abiraterone Tablets should be stored at 20°C to 25°C, with a permitted temperature deviation of 15°C to 30°C. Because this drug may harm a developing fetus, women who are pregnant or may become pregnant should use protective measures, such as wearing gloves, when handling this drug.

6. Precautions for special groups of people

1. Women: According to research, niraparib and abiraterone tablets may cause fetal harm and risk of miscarriage, so they should be used with caution.

2. Males: It is recommended that men of childbearing potential take effective contraceptive measures during treatment and within 4 months after the last dose.

3. Patients with liver function impairment: Patients with moderate or severe liver function impairment should avoid using this drug, and patients with mild liver function impairment do not need to adjust the dosage.

7. Mechanism of action

Niraparib, as an inhibitor ofPARP enzyme, plays an important role in DNA repair. Studies have shown that niraparib induces cytotoxicity by inhibiting PARP enzyme activity, thereby triggering DNA damage and cell death. Abiraterone interferes with the synthesis of androgens by inhibiting 17α-hydroxylase/C17,20-lyase, further enhancing the anti-tumor effect.

8. Treatment of overdose

In the event of overdose, use of Niraparib and Abiraterone Tablets should be discontinued immediately and general supportive measures should be taken. This includes monitoring for arrhythmias and heart failure, and assessing liver function. There is currently no specific treatment for overdose with niraparib and abiraterone tablets.

In summary, niraparib and abiraterone tablets are an important drug for the treatment of metastatic castration-resistant prostate cancer. Its use, dosage, adverse reactions and precautions for special groups must be carried out under professional guidance to ensure patient safety and efficacy.

Reference materials:https://www.drugs.com/akeega.html