Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. Most common adverse reactions in Study 10 and ARIEL2 (≥ 20% Grade 1-4) were nausea (77%), asthenia/fatigue (77%), vomiting (46%), anemia (44%), constipation (40%), dysgeusia (39%), decreased appetite (39%), diarrhea (34%), abdominal pain (32%), dyspnea (21%), and thrombocytopenia (21%).Ĭo-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Most common adverse reactions in ARIE元 (≥ 20% Grade 1-4) were nausea (76%), fatigue/asthenia (73%), abdominal pain/distention (46%), rash (43%), dysgeusia (40%), anemia (39%), AST/ALT elevation (38%), constipation (37%), vomiting (37%), diarrhea (32%), thrombocytopenia (29%), nasopharyngitis/upper respiratory tract infection (29%), stomatitis (28%), decreased appetite (23%), and neutropenia (20%). Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca. Apprise pregnant women of the potential risk to a fetus. If MDS/AML is confirmed, discontinue Rubraca.īased on its mechanism of action and findings from animal studies, Rubraca can cause fetal harm when administered to a pregnant woman. 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. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose and monitor blood counts weekly until recovery. Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. The cases were typical of secondary MDS/cancer therapy-related AML in all cases, patients had received previous platinum-containing regimens and/or other DNA damaging agents.ĭo not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 53 months. Of these, 8 occurred during treatment or during the 28 day safety follow-up (0.7%). In 1146 treated patients, MDS/AML occurred in 20 patients (1.7%), including those in long term follow-up. Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) have occurred in patients treated with Rubraca, and are potentially fatal adverse reactions.