We at Clovis Oncology admire the strength and courage of women living with recurrent ovarian cancer, and extend our sincere gratitude to participants of the Rubraca clinical trials.
What is Rubraca used for?
Rubraca is a prescription medicine used for the maintenance treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer whose cancer has come back and who are in response (complete or partial response) to a platinum-based chemotherapy.
It is not known if Rubraca is safe and effective in children.
What Warnings should I know about Rubraca?
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 ovarian 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.
You should not use Rubraca if:
- you are pregnant or plan to become pregnant. Rubraca can harm your unborn baby and may cause loss of pregnancy (miscarriage). You should not become pregnant during treatment with Rubraca
- If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with Rubraca
- Females who are able to become pregnant should use effective birth control during treatment and for at least 6 months after receiving the last dose of Rubraca
- Talk to your healthcare provider about birth control methods that may be right for you
- Tell your healthcare provider right away if you become pregnant
- you are breastfeeding or plan to breastfeed. It is not known if Rubraca passes into breast milk. Do not breastfeed during treatment and for 2 weeks after the last dose of Rubraca. Talk to your healthcare provider about the best way to feed your baby during this time
What other important information should I know about 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.
What are the side effects of Rubraca?
The most common side effects for women in the Rubraca clinical studies were nausea, tiredness/weakness, stomach pain, rash, altered taste, decrease in hemoglobin, abnormal liver or kidney function blood tests, constipation, vomiting, diarrhea, decreased platelet count, upper respiratory tract infection, mouth sores, decreased appetite, shortness of breath, and decrease in white blood cell count.
What other medications might interact with Rubraca?
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 of 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 Clovis Oncology, Inc. at 1-415-409-7220 (US toll) or 1-844-CLVS-ONC (1-844-258-7662; US toll-free).
Please see full Prescribing Information for Important Safety Information.
