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IMPORTANT SAFETY INFORMATION

What is RUBRACA used for?

RUBRACA tablets are a prescription medicine used in adults for:

The treatment of castration-resistant prostate cancer (prostate cancer that no longer responds to medical or surgical treatment that lowers testosterone):
- That has spread to other parts of the body (metastatic), and
- Has a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene, and you have been treated with certain medicines for your cancer.
Your healthcare provider will perform a test to make sure RUBRACA is right for you.

It is not known if RUBRACA is safe and effective in children.

What Warnings should you 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 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 may include weakness, weight loss, fever, frequent infections, blood in urine or stool, shortness of breath, feeling very tired, bruising or bleeding more easily. Symptoms of low blood cell counts are common during treatment with RUBRACA, but can be a sign of serious problems, including MDS or AML.

Before you take RUBRACA, tell your healthcare provider about all of your medical conditions, including 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.

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 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, and diarrhea. These are not all the possible side effects of RUBRACA. Call your healthcare provider for medical advice about side effects.

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 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.

This information is not comprehensive.

How to get more information:

Talk to your health care provider or pharmacist.

Please see full Prescribing Information for RUBRACA.

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