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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.
Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) have occurred in patients treated with RUBRACA, and are potentially fatal adverse reactions. In 1594 treated patients with ovarian cancer, MDS/AML occurred in 32 patients (2%), including those in long term follow-up. Of these, 14 occurred during treatment or during the 28-day safety follow-up (0.9%). The duration of RUBRACA treatment prior to the diagnosis of MDS/AML ranged from < 2 months to approximately 72 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing chemotherapy regimens and/or other DNA damaging agents. In ARIEL3, of patients with a germline and/or somatic BRCA mutation treated with RUBRACA, MDS/AML occurred in 9 out of 129 (7%) patients treated with RUBRACA and 4 out of 66 (6%) patients treated with placebo. The duration of therapy with RUBRACA in patients who developed secondary MDS/cancer therapy-related AML varied from 1.2 to 4.7 years.
In TRITON2, MDS/AML was not observed in patients with mCRPC (n=209) regardless of homologous recombination deficiency (HRD) mutation.
Do not start RUBRACA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt RUBRACA or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue RUBRACA.
RUBRACA can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings from animal studies. Apprise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of RUBRACA.
For males on RUBRACA treatment who have female partners of reproductive potential or who are pregnant, effective contraception should be used during treatment and for 3 months following the last dose of RUBRACA. Advise male patients on RUBRACA treatment, who have female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 3 months following the last dose of RUBRACA.
Most common adverse reactions in ARIEL3 (≥ 20%; Grade 1-4) were nausea (79%), fatigue/asthenia (74%), abdominal pain/distention (48%), rash (45%), dysgeusia (33%), anemia (41%), AST/ALT elevation (33%), constipation (39%), vomiting (37%), diarrhea (34%), thrombocytopenia (35%), nasopharyngitis/upper respiratory tract infection (29%), stomatitis (28%), decreased appetite (23%), and neutropenia (22%).
Most common adverse reactions in TRITON2 (≥ 20%; Grade 1-4) were fatigue/asthenia (62%), nausea (52%), anemia (43%), AST/ALT elevation (33%), decreased appetite (28%), rash (27%), constipation (27%), thrombocytopenia (25%), vomiting (22%), and diarrhea (20%).
Concomitant administration of RUBRACA with CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates can increase the systemic exposure of these substrates, which may increase the frequency or severity of adverse reactions of these substrates. If concomitant administration is unavoidable between RUBRACA and substrates of these enzymes where minimal concentration changes may lead to serious adverse reactions decrease the substrate dosage in accordance with the approved prescribing information. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring.
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 after the last dose.
Please see full Prescribing Information for RUBRACA.
IMPORTANT: The information on this website is based on the US prescribing information (US PI).
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