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【Function and indication】RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of patients with advanced ovarian cancer with deleterious BRCA mutations (germline and/or somatic) who have been treated with two or more chemotherapy regimens based on an FDA-approved companion diagnostic for Rubraca as a treatment option for patients.
【Model and specification】Tablets: 200 mg and 300 mg
【Usage and dosage】The recommended dose is 600 mg orally twice a day with or without food.
【Precautions】
●Myelodysplastic syndrome/acute myeloid leukemia (MDS/AML):
MDS/AML occurred in patients exposed to RUBRACA, including a fatal event of AML. Monitor patients for hematological toxicity at baseline and monthly thereafter. Discontinue if MDS/AML is confirmed.
●Embryo-fetal toxicity: RUBRACA may cause fetal harm. Advise females of reproductive potential of potential risks to the fetus and use effective contraception.
[Adverse Reactions] The most common adverse reactions (≥ 20%) are nausea, fatigue (including asthenia), vomiting, anemia, abdominal pain, taste disturbance, constipation, loss of appetite, diarrhea, thrombocytopenia, and dyspnea.
[Pregnant women use] Rubraca may cause fetal harm when given to a pregnant woman
[Pediatric use] The safety and efficacy of Rubraca in pediatric patients have not been established.
[Manufacturer] Clovis Oncology, Inc.
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