Summit SD is excited to announce that we are now the exclusive distributor of RUBRACA®, a breakthrough cancer treatment. RUBRACA® has been proven effective in treating certain ovarian and prostate cancers, and we are thrilled to offer this therapy to our customers. You can now place orders for RUBRACA® through Summit SD, and our knowledgeable team is available to answer any questions you may have. We are committed to providing the highest quality products and service to our customers, and we believe that RUBRACA® will make a significant impact for appropriate patients in the fight against cancer.
Myelodysplastic Syndrome Acute Myeloid Leukemia (MDS/AML), including cases with a fatal outcome, have occurred in patients exposed to RUBRACA. In 1594 treated patients, MDS/AML occurred in 32 out of 1594 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 to approximately 72 months. 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. 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®.
Embryo-Fetal Toxicity and Lactation: Based on its mechanism of action and findings from animal studies, RUBRACA® can cause fetal harm Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 6 months after receiving their final dose of RUBRACA®. Advise males 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®. 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.
Most common adverse reactions in ARIEL3 (≥ 20%; Grade 1-4) were nausea (79%), fatigue/asthenia (74%), abdominal pain/distention (48%), rash (45%), anemia (41%), constipation (39%), vomiting (37%), thrombocytopenia (35%), diarrhea (34%), dysgeusia (33%), AST/ALT elevation (33%), nasopharyngitis/upper respiratory tract infection (29%), stomatitis (28%), decreased appetite (23%), headache (22%), 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%).
Co-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. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring.
Please see full Prescribing Information for additional Important Safety Information.