China's Niraparib(甲苯磺酸尼拉帕利胶囊):Pictures,Uses,Dosage,Side Effects,Warnings-SEAGULL HEALTH

Introduction of Niraparib

Niraparib Tosylate Capsules exerts a synthetic lethality effect by inhibiting the activity of PARP enzyme and blocking DNA repair in tumor cells, and can achieve antitumor efficacy in both BRCA-mutated and wild-type tumor cells.

Indications

1.Niraparib Tosylate Capsules are indicated for the maintenance treatment of adult patients with advanced epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma who have achieved complete response or partial response to first-line platinum-containing chemotherapy.

2.Niraparib Tosylate Capsules are indicated for the maintenance treatment of adult patients with platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma who have achieved complete response or partial response to platinum-containing chemotherapy.

Overview

Generic Name

Niraparib Tosilate Capsules,甲苯磺酸尼拉帕利胶囊

Brand Name

则乐

Drug Type

Rx Drug,targeted drug

Approval No.

国药准字H20190035

Active Ingredient

Niraparib

Dosage Form

100mg*30capsules

Specification

Capsules

Description

The contents of Niraparib Tosylate Capsules are white to off-white powder.

Expiry Date

18 months

Manufacturer

Zai Lab (Suzhou) Co., Ltd.

Storage

Sealed, store below 25℃.

Dosage and Administration

This product should be used under the guidance of physicians experienced in the use of antineoplastic agents.

Dosage

First-line maintenance treatment of ovarian cancer:

For patients with a body weight of less than 77 kg or a baseline platelet count of less than 150,000/μL, the recommended dose of this product is 200 mg, orally administered once daily.

For patients with a body weight of 77 kg or more and a baseline platelet count of 150,000/μL or more, the recommended dose of this product is 300 mg, orally administered once daily.

Treatment should continue until disease progression or unacceptable adverse reactions occur. Patients should initiate treatment with this product within 12 weeks after the completion of first-line platinum-containing chemotherapy.

Maintenance treatment of recurrent ovarian cancer:

The recommended dose of this product is 300 mg, orally administered once daily, until disease progression or unacceptable adverse reactions occur. Patients should initiate treatment with this product within 8 weeks after the completion of platinum-containing chemotherapy.

Administration Instructions

It is recommended that patients take the medication at approximately the same time each day, and swallow the capsules whole. This product may be taken with or without food. Administration at bedtime may help manage nausea.

If a patient vomits or misses a dose, they should not take an extra dose, but take the next scheduled dose at the regular time on the following day.

Contraindications

Hypersensitivity reactions to niraparib or any of the excipients contained in the capsules.

Adverse Reactions

The most common adverse reactions are nausea, thrombocytopenia, anemia, fatigue, constipation, musculoskeletal pain, abdominal pain, vomiting, neutropenia, anorexia, leukopenia, insomnia, headache, dyspnea, rash, diarrhea, hypertension, cough, dizziness, acute kidney injury, urinary tract infection and hypomagnesemia.

Use in Special Populations

Use in Pregnant and Lactating Women

Pregnancy

There are no or limited data on the use of this product in pregnant women. Animal reproductive and developmental toxicity studies have not been conducted.

However, based on its mechanism of action, this product may cause embryo or fetal harm if administered to pregnant women, including embryolethal and teratogenic effects. Avoid use during pregnancy.

Lactation

There are no available data regarding the presence of niraparib or its metabolites in human milk, their passage across the blood-milk barrier, or their effects on breastfed infants or milk production.

Due to the potential of this product to cause serious adverse reactions in breastfed infants, it is recommended that lactating women avoid breastfeeding during treatment with this product and for 1 month after the last dose.

Contraception

Females of reproductive potential should not become pregnant during treatment and should be non-pregnant at the start of treatment. A pregnancy test is recommended for females of reproductive potential prior to initiating treatment.

Females of reproductive potential must use effective contraceptive measures during treatment with this product and for 6 months after the last dose.

Fertility

Based on animal studies, this product may impair fertility in males of reproductive potential.

Pediatric Use

The safety and effectiveness of this product have not been established in pediatric patients.

Geriatric Use

In the PRIMA trial, 39% of patients were aged ≥ 65 years, and 10% were aged ≥ 75 years. In the NOVA trial, 35% of patients were aged ≥ 65 years, and 8% were aged ≥ 75 years.

Overall, no differences in safety and effectiveness were observed between these patients and younger patients, but the possibility that some elderly individuals may be more sensitive cannot be excluded.

For more detailed drug information, please consult the official package leaflet.