Fuzuloparib(氟唑帕利胶囊)

Introduction of Fuzuloparib

Fluzoparib Capsules were granted conditional approval for marketing by the National Medical Products Administration (NMPA) in December 2020, and exert their anti-tumor effect by specifically killing tumor cells with BRCA mutations or homologous recombination repair deficiency (HRD) through the "synthetic lethality" mechanism.

Indications

1.It is indicated for the treatment of adult patients with platinum-sensitive recurrent ovarian, fallopian tube, or primary peritoneal cancer with germline BRCA mutation (gBRCAm) who have received two or more lines of prior chemotherapy.

2.It is indicated for the maintenance treatment of adult patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have achieved a complete response or partial response to platinum-based chemotherapy.

3.It is indicated for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have achieved a complete response or partial response to first-line platinum-based chemotherapy.

4.It is indicated as monotherapy or in combination with apatinib mesylate for the treatment of adult patients with human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer with germline BRCA mutation (gBRCAm) who have received chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. For hormone receptor (HR)-positive breast cancer patients, prior endocrine therapy should have been received or endocrine therapy is considered inappropriate.

Overview

Dosage and Administration

This product must be administered under the supervision of a physician experienced in anti-tumor therapy.

For Platinum-sensitive Recurrent Ovarian Cancer with Germline BRCA Mutation (gBRCAm) or HER2-negative Breast Cancer with Germline BRCA Mutation (gBRCAm)

Prior to treatment with this product, patients shall be confirmed to have deleterious or suspected deleterious gBRCA1/2 mutations using a detection method approved by the National Medical Products Administration (NMPA).

For Maintenance Treatment of Platinum-sensitive Recurrent Ovarian Cancer

Patients should initiate treatment with this product within 4–8 weeks after the completion of platinum-based chemotherapy.

For First-line Maintenance Treatment of Advanced Ovarian Cancer

Patients should initiate treatment with this product within 4–12 weeks after the completion of platinum-based chemotherapy.

Recommended Dose

Ovarian Cancer Treatment

The recommended dose is 150 mg (3 capsules) per administration, twice daily (once in the morning and once in the evening).

HER2-negative Breast Cancer with Germline BRCA Mutation (gBRCAm)

(1) Monotherapy: The recommended dose is 150 mg (3capsules) per administration, twice daily (once in the morning and once in the evening).

(2) Combination Therapy: The recommended dose is 100 mg (2capsules) per administration, twice daily (once in the morning and once in the evening), in combination with apatinib mesylate 500 mg once daily, taken orally.

Contraindications

1.Hypersensitivity to the active ingredient or any excipient of Fluzoparib Capsules.

2.Breastfeeding is prohibited during treatment and within 1 month after the last dose.

Adverse Reactions

The most common adverse reactions associated with monotherapy of Fluzoparib Capsules include leukopenia, anemia, neutropenia, thrombocytopenia, nausea, fatigue, hyperlipidemia, lymphopenia, increased serum creatinine, increased ALT/AST, other laboratory abnormalities, vomiting, decreased appetite, hyperglycemia, musculoskeletal pain, and urinary tract infection.

The most common adverse reactions of grade ≥3 include anemia, neutropenia, thrombocytopenia, leukopenia, lymphopenia, and hyperlipidemia.

Use in Special Populations

Use in Pregnant and Lactating Women

Contraception

Females of childbearing potential must not become pregnant at the start of and during treatment with this product. A pregnancy test is required for all such females prior to the initiation of treatment. Effective contraceptive measures must be adopted by females of childbearing potential during treatment and for 6 months after the last dose of this product.

Pregnancy

Animal studies have demonstrated that this product has reproductive toxicity in female rats. There are no available data on the use of fluzoparib in pregnant women. However, based on the mechanism of action of fluzoparib, this product must not be used in pregnant women or females of childbearing potential who do not use reliable contraceptive measures during treatment and for 6 months after the last dose.

Lactation

Animal studies to evaluate the excretion of fluzoparib in breast milk have not been conducted. It is unknown whether fluzoparib or its metabolites are excreted in human milk. Based on the pharmacological properties of this product, breastfeeding is recommended to be discontinued during treatment and for 1 month after the last dose.

Fertility

No clinical data on fertility are available. Animal studies have shown that fluzoparib can impair the reproductive function of female rats, reducing the weights of the uterus, gravid uterus, placental uterus and fetuses.

Use in Pediatric Patients

The safety and efficacy of fluzoparib in children and adolescents under 18 years of age have not been established.

Use in Geriatric Patients

Among the 630 patients who received fluzoparib monotherapy, 42 patients (6.7%) were aged over 65 years. The incidence of adverse reactions of all grades was 97.4% in patients aged ≤ 65 years and 97.6% in patients aged > 65 years, while the incidence of adverse reactions of grade ≥ 3 was 48.8% and 57.1%, respectively.

Among the 223 patients who received fluzoparib in combination with apatinib mesylate, 54 patients (24.2%) were aged over 65 years. The incidence of fluzoparib-related adverse reactions of all grades was 96.4% in patients aged ≤ 65 years and 98.1% in patients aged > 65 years, while the incidence of fluzoparib-related adverse reactions of grade ≥ 3 was 42.6% and 53.7%, respectively.

No special dose adjustment was performed for geriatric patients in clinical studies. Due to the limited number of geriatric patients enrolled in current clinical trials, it is recommended that geriatric patients be administered this product under the guidance of a physician.

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

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