Rucaparib

Rucaparib is used to help maintain the response to other treatments for certain types of ovarian cancer (cancer that begins in the female reproductive organs where eggs are formed), fallopian tube (tube that transports eggs released by the ovaries to the uterus), and primary peritoneal (layer of tissue that lines the abdomen) cancer that has returned in adults who have completely responded or partially responded to other chemotherapy treatment(s). It is also used to treat certain types of ovarian cancer, fallopian tube cancer, and primary peritoneal cancer in people with a specific gene who have received treatment with at least two other chemotherapy treatments. Rucaparib is also used to treat certain types of prostate cancer that has spread to other areas in the body in people with a specific gene who have received other treatments. Rucaparib is in a class of medications called poly (ADP-ribose) polymerase (PARP) inhibitors. It works by killing cancer cells.

Rucaparib comes as a tablet to take by mouth. It is usually taken with or without food twice daily, about 12 hours apart. Take rucaparib at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take rucaparib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may need to delay your treatment or adjust your dose of rucaparib depending on your response to treatment and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment. Do not stop taking rucaparib without talking to your doctor.

If you vomit after taking rucaparib, do not take another dose. Continue your regular dosing schedule.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking rucaparib,

• tell your doctor and pharmacist if you are allergic to rucaparib, any other medications, or any of the ingredients in rucaparib tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, you are taking or plan to take. Be sure to mention any of the following: warfarin (Coumadin, Jantoven). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with rucaparib, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor if you are pregnant, plan to become pregnant, or plan to father a child. You should not become pregnant while you are taking rucaparib. You will need to take a pregnancy test before you start treatment. Use effective birth control during your treatment with rucaparib and for 6 months after your final dose. If you are a male, you and your female partner should use birth control during your treatment and for 3 months after your final dose. Talk to your doctor about birth control methods that will work for you. If you become pregnant while taking rucaparib, call your doctor.

• tell your doctor if you plan to breastfeed. You should not breastfeed during your treatment with rucaparib and for 2 weeks after your final dose.

• plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, a hat, sunglasses, and sunscreen. Rucaparib may make your skin sensitive to sunlight.

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

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

• Rucaparib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • nausea

  • vomiting

  • constipation

  • diarrhea

  • stomach pain

  • loss of appetite

  • bad taste in the mouth

  • itching

  • mouth sores

  • nasal congestion, runny nose, sneezing, sore or scratchy throat, or cough

• Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

  • weakness, tiredness, fever, weight loss, easy bruising or bleeding, or blood in urine or stool

  • pale skin

  • shortness of breath

  • rash

• Rucaparib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

• If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

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.