Important side effect information
Rubraca 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. Tell your doctor if you have any of the following symptoms during treatment with Rubraca:
- weakness
- weight loss
- fever
- frequent infections
- blood in urine or stool
- shortness of breath
- feeling very tired
- bruising or bleeding more easily
Your doctor will do blood tests to check your blood cell counts:
- before treatment with Rubraca
- every month during treatment with Rubraca
- weekly if you have low blood cell counts for a long time
The most common side effects of Rubraca include:
- weakness/fatigue
- nausea
- decreased red blood cell count
- changes in liver function tests
- decreased appetite
- constipation
- rash
- decreased platelet count
- vomiting
- diarrhea
Talk to your healthcare team if you experience any side effects while you’re taking Rubraca, no matter how minor, to learn how to properly manage them.
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).
