RUBRACA- rucaparib tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

RUCAPARIB CAMSYLATE (UNII: 41AX9SJ8KO) (RUCAPARIB - UNII:8237F3U7EH)

Boleh didapati daripada:

pharmaand GmbH

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Rubraca is indicated for the maintenance treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)- associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca [see Dosage and Administration ( 2.1)]. This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies ( 14.2)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. None. Risk Summary Based on findings from animal studies and its mechanism of action, Rubraca can cause fetal harm when administered to pregnant women. There are no available data in pregnant women to inform the drug-associated risk. In an animal reproduction study, administration of rucaparib to pregnant rats during organogenesis resulted in embryo-fetal death at maternal exposures that were 0.04 times the AUC 0-24h in patients receiving the recommended dose of 600 mg twice daily [see Data] . Apprise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In a dose range-finding embryo-fetal development study, pregnant rats received oral doses of 50, 150, 500, or 1000 mg/kg/day of rucaparib during the period of organogenesis. Post-implantation loss (100% early resorptions) was observed in all animals at doses greater than or equal to 50 mg/kg/day (with maternal systemic exposures approximately 0.04 times the human exposure at the recommended dose based on AUC 0-24h ). Risk Summary There is no information regarding the presence of rucaparib in human milk, or on its effects on milk production or the breast-fed child. Because of the potential for serious adverse reactions in breast-fed children from Rubraca, advise lactating women not to breastfeed during treatment with Rubraca and for 2 weeks following the last dose. Rubraca can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1)] . Pregnancy Testing Pregnancy testing is recommended for females of reproductive potential prior to initiating Rubraca. Contraception Females Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca [see Use in Specific Populations ( 8.1)] . Males Based on findings in genetic toxicity and animal reproduction studies, advise male patients with female partners of reproductive potential or who are pregnant to use effective methods of contraception during treatment and for 3 months following last dose of Rubraca. Advise male patients not to donate sperm during therapy and for 3 months following the last dose of Rubraca [see Use in Specific Populations ( 8.1) and Nonclinical Toxicology ( 13.1)]. The safety and effectiveness of Rubraca in pediatric patients have not been established. Of the 937 patients with ovarian cancer who received Rubraca in clinical trials including ARIEL3, 41% were age 65 or older and 10% were 75 years or older. No major differences in safety were observed between younger and older patients with ovarian cancer. Of the 209 patients with mCRPC who received Rubraca in TRITON2, 77% were age 65 or older and 33% were 75 years or older. No major differences in safety were observed between younger and older patients with mCRPC. No dosage modification is recommended for patients with mild to moderate renal impairment (creatinine clearance [CLcr] between 30 and 89 mL/min, as estimated by the Cockcroft-Gault method) [see Clinical Pharmacology ( 12.3)]. Rubraca has not been studied in patients with CLcr < 30 mL/min or patients on dialysis. No dosage modification is recommended for patients with mild to moderate hepatic impairment (total bilirubin ≤ 3 x upper limit of normal [ULN] or AST > ULN) [see Clinical Pharmacology ( 12.3)] . Rubraca has not been studied in patients with severe hepatic impairment (total bilirubin > 3 x ULN and any AST).

Ringkasan produk:

How Supplied Rubraca is available as 200 mg, 250 mg, and 300 mg tablets. 200 mg Tablets: 250 mg Tablets: 300 mg Tablets: Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [ see USP Controlled Room Temperature ].

Status kebenaran:

New Drug Application

Ciri produk

RUBRACA- RUCAPARIB TABLET, FILM COATED
ZR PHARMA & GMBH
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RUBRACA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RUBRACA.
RUBRACA
(RUCAPARIB) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2016
RECENT MAJOR CHANGES
Indications and Usage ( 1.1)
12/2022
Indications and Usage, Treatment of _BRCA_-mutated Ovarian Cancer
after 2
or More Chemotherapies ( 1.1) Removed
06/2022
Dosage and Administration ( 2.1)
12/2022
Dosage and Administration, Treatment of _BRCA_-mutated Ovarian Cancer
after 2 or More Chemotherapies ( 2.1) Removed
06/2022
Warnings and Precautions ( 5.1)
12/2022
INDICATIONS AND USAGE
RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:
Ovarian cancer
for the maintenance treatment of adult patients with a deleterious
_BRCA_mutation (germline and/or
somatic)- associated recurrent epithelial ovarian, fallopian tube, or
primary peritoneal cancer who are in
a complete or partial response to platinum-based chemotherapy. ( 1.1)
Prostate cancer
for the treatment of adult patients with a deleterious _BRCA_mutation
(germline and/or somatic)-
associated metastatic castration-resistant prostate cancer (mCRPC) who
have been treated with
androgen receptor-directed therapy and a taxane-based chemotherapy.
Select patients for therapy
based on an FDA-approved companion diagnostic for RUBRACA. ( 1.2, 2.1)
This indication is approved under accelerated approval based on
objective response rate and duration of
response. Continued approval for this indication may be contingent
upon verification and description of
clinical benefit in confirmatory trials. ( 1.2)
DOSAGE AND ADMINISTRATION
Recommended dose is 600 mg orally twice daily with or without food. (
2.2)
Continue treatment until disease progression or unacceptable toxicity.
( 2.2)
For adverse reactions, consider interruption of treatment or dose
reduction. ( 2.3)
Patients receiving RUBRACA for mCRPC should also receive a
gonadotropi