rucaparib

What is the most important information I should know about rucaparib?

What is rucaparib?

Rucaparib is used to treat ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (cancer of the membrane lining the organs inside your abdomen). Rucaparib is sometimes used for these conditions only if your cancer has a specific genetic marker (an abnormal "BRCA" gene). Your doctor will test you for this gene.

Rucaparib is also used to treat prostate cancer with an abnormal BRCA gene. Rucaparib is given for this condition when the cancer has spread to other parts of the body and surgery or other cancer treatments did not work or have stopped working.

Rucaparib was approved for prostate cancer by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to this medicine, but further studies are needed.

Rucaparib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking rucaparib?

Using rucaparib may increase your risk of developing serious bone marrow problems or other types of cancer, such as leukemia. Ask your doctor about your specific risk.

• If you are a woman, you may need to have a negative pregnancy test before starting this treatment. Do not use rucaparib if you are pregnant. Use effective birth control to prevent pregnancy while using this medicine and for at least 6 months after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
• Tell your doctor right away if a pregnancy occurs.

How should I take rucaparib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Rucaparib is usually taken once every 12 hours, with or without food.

If you take rucaparib for prostate cancer, you may also be treated with another medicine called a gonadotropin-releasing hormone, or GnRH. GnRH helps prevent the testicles from producing testosterone.

If you vomit shortly after taking rucaparib, do not take another dose. Wait until your next scheduled dose to take the medicine again, but do not take 2 doses at the same time.

You may need frequent medical tests and your cancer treatments may be delayed based on the results.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

What should I avoid while taking rucaparib?

Men should not donate sperm while taking rucaparib and for at least 3 months after the last dose.

What are the possible side effects of rucaparib?

• blood in your urine; or
• low blood cell counts --fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• low blood cell counts;
• shortness of breath;
• upset stomach, loss of appetite;
• nausea, vomiting, diarrhea, constipation;
• changes in your sense of taste;
• dizziness, feeling weak or tired;
• increased sensitivity to light;
• rash; or
• abnormal liver and kidney function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect rucaparib?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medicines less effective.

Other drugs may affect rucaparib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Where can I get more information?

Your doctor or pharmacist can provide more information about rucaparib.