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 rucaparib, but further studies are needed.

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

Rucaparib can cause leukemia or serious bone marrow problems. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, blood in your urine or stools, shortness of breath, or signs of infection (fever, feeling weak or tired, weight loss).

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.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Ovarian Cancer:

600 mg orally twice a day
Duration of therapy: Until disease progression or unacceptable toxicity

Uses: For the maintenance treatment of patients with a deleterious BRCA (breast cancer gene) mutation (germline and/or somatic)-associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy

Usual Adult Dose for Fallopian Tube Cancer:

600 mg orally twice a day
Duration of therapy: Until disease progression or unacceptable toxicity

Uses: For the maintenance treatment of patients with a deleterious BRCA (breast cancer gene) mutation (germline and/or somatic)-associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy

Usual Adult Dose for Peritoneal Cancer:

600 mg orally twice a day
Duration of therapy: Until disease progression or unacceptable toxicity

Uses: For the maintenance treatment of patients with a deleterious BRCA (breast cancer gene) mutation (germline and/or somatic)-associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy

Usual Adult Dose for Prostate Cancer:

600 mg orally twice a day
Duration of therapy: Until disease progression or unacceptable toxicity

Comments:
-This indication was approved under accelerated approval based on objective response rate and duration of response; continued approval may depend on verification and description of clinical benefit in confirmatory trials.
-Selection of patients for treatment should be based on a US FDA-approved companion diagnostic for this drug.
-Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.

Use: For the treatment of patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy

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.

Rucaparib can harm an unborn baby if the mother or the father is using rucaparib.

• 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.

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

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

Rucaparib could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Rucaparib may cause serious side effects. Call your doctor at once if you have:

• 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 of rucaparib 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.

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.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before you start and at various times throughout your treatment to check your body's response to rucaparib. For some conditions, your doctor will order a lab test before you begin your treatment to see whether your cancer can be treated with rucaparib.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.