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RUBRACA tablets are a prescription medicine used in adults for:
It is not known if RUBRACA is safe and effective in children.
RUBRACA tablets may cause serious side effects including: Bone marrow problems called Myelodysplastic Syndrome (MDS) or a type of cancer of the blood called Acute Myeloid Leukemia (AML). Some people who have cancer and who have received previous treatment with chemotherapy or certain other medicines for their cancer have developed MDS or AML during or after treatment with RUBRACA. MDS or AML may lead to death. If you develop MDS or AML, your healthcare provider will stop treatment with RUBRACA. Symptoms of low blood cell counts are common during treatment with RUBRACA, but can be a sign of serious problems, including MDS or AML.
If you are a male with a female partner who is pregnant or able to become pregnant, effective birth control should be used during treatment and for 3 months after the last dose of RUBRACA. Do not donate sperm during use and for 3 months after the last dose of RUBRACA.
Your healthcare provider will do blood tests before and every month during treatment with RUBRACA to monitor your blood cell counts. Weekly blood tests will be performed if you have low blood cell counts for a long time. Your healthcare provider may stop treatment with RUBRACA until your blood cell counts improve.
Avoid spending time in sunlight while on RUBRACA since your skin may become more sensitive to the sun and may sunburn more easily. You should wear a hat and clothes that cover your skin and use sunscreen to help protect against sunburn if you have to be in the sunlight.
The most common side effects of RUBRACA in people with ovarian cancer include:
nausea, tiredness or weakness, decrease in hemoglobin (anemia), changes in liver and kidney function tests, vomiting, diarrhea, decreased appetite, low blood cell counts, changes in how food tastes, shortness of breath, dizziness, indigestion, reaction to sunlight
The most common side effects of RUBRACA in people with prostate cancer include:
tiredness or weakness, nausea, decrease in hemoglobin (anemia), changes in liver function tests, decreased appetite, rash, constipation, low blood cell counts, vomiting, diarrhea
RUBRACA can increase the amounts of other medications you may be taking, which can increase the risk of side effects. Tell your healthcare provider about all your medical conditions and all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to pharma& at 1-800-506-8501.
IMPORTANT: The information on this website is based on the US prescribing information (US PI).
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