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 rucaparib, but further studies are needed.

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

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.

Rucaparib can lead to leukemia or serious bone marrow issues. You might be at risk for infections or have an increased tendency to bleed. Contact your doctor if you notice unusual bruising or bleeding, blood in your urine or stools, shortness of breath, or symptoms of infection (fever, feeling weak or tired, weight loss).

Using rucaparib may increase your risk of serious bone marrow problems or other cancers, including leukemia. Ask your doctor about your specific risk.

Rucaparib can harm an unborn baby if either 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 can become pregnant. Keep using birth control for at least 3 months after your last dose.
• Tell your doctor immediately if you become pregnant.

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

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 right away 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 stopped permanently 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.

Usual Adult Dose for Ovarian Cancer:

600 mg orally twice a dayDuration of therapy: Until disease progression or unacceptable toxicityUses: 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 dayDuration of therapy: Until disease progression or unacceptable toxicityUses: 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 dayDuration of therapy: Until disease progression or unacceptable toxicityUses: 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 dayDuration of therapy: Until disease progression or unacceptable toxicityComments:-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

Skip the missed dose and take your next dose at the usual time. Do not take two doses at once.

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

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.

Sometimes it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may lead to more side effects or make the medicines not work as well.

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

• What type of cancer is Rubraca used to treat?