Olaparib tablets are used to help maintain the response of certain types of ovarian (female reproductive organs where eggs are formed), fallopian tube (tube that transports eggs released by the ovaries to the uterus), and peritoneal (layer of tissue that lines the abdomen) cancer in people who have completely responded or partially responded to their first or later chemotherapy treatments. Olaparib tablets are also used to treat certain types of breast cancer that has spread to other parts of the body and has not improved or has worsened after treatment with other therapies. Olaparib tablets are also used to treat a certain type of prostate cancer that has spread to other parts of the body, no longer responds to medical or surgical treatments to lower testosterone levels, and has progressed after treatment with enzalutamide (Xtandi) or abiraterone (Yonsa, Zytiga). Olaparib tablets and capsules are also used to treat ovarian cancer that has not improved or has worsened after treatment with at least three other therapies. Olaparib tablets are also used to help maintain the response of a certain type of pancreatic cancer that has not spread or progressed after the first chemotherapy treatment. Olaparib is a polyadenosine 5′-diphosphoribose polymerase (PARP) enzyme inhibitor. It works by killing cancer cells.

Olaparib comes as a tablet or a capsule to take by mouth twice daily with or without food. Try to space your doses about 12 hours apart. Take olaparib 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 olaparib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablet or capsule whole; do not crush chew, divide, or dissolve them.

Olaparib is available as a tablet and as a capsule. The tablets and capsules contain different amounts of olaparib and should not be substituted for one another. Talk to your doctor or pharmacist if you have any questions about the tablet and capsule preparations.

Your doctor may decrease your dose of olaparib or tell you to stop taking olaparib for a period of time during your treatment. This will depend on how well the medication works for you and any side effects you may experience. Be sure to tell your doctor how you are feeling during your treatment with olaparib.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with olaparib. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.

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

Before taking olaparib,

• Tell your doctor and pharmacist if you are allergic to olaparib, any other medications, or any of the ingredients in olaparib tablets or capsules. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antibiotics such as ciprofloxacin (Cipro), clarithromycin (Biaxin, in Prevpac), erythromycin (E.E.S., Erythrocin, others), nafcillin, and telithromycin (no longer available in U.S., Ketek); antifungals such as fluconazole (Diflucan), itraconazole (Onmel, Sporanox), ketoconazole (Extina, Nizoral, Xolegel), posaconazole (Noxafil), and voriconazole (Vfend); aprepitant (Emend); certain medications to treat seizures such as carbamazepine (Carbatrol, Epitol, Tegretol, Teril), and phenytoin (Dilantin, Phenytek); bosentan (Tracleer); crizotinib (Xalkori); diltiazem (Cardizem, Cartia, Tiazac, others); certain medications to treat hepatitis C such as boceprevir (no longer available in U.S., Victrelis) and telaprevir (no longer available in U.S., Incivek); certain medications to treat human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) such as amprenavir (no longer available in U.S., Agenerase), atazanavir (Reyataz, in Evotaz), darunavir (Prezista), efavirenz (Sustiva, in Atripla), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); imatinib (Gleevec); modafinil (Provigil); nefazodone; other chemotherapy medications for cancer, rifampin (Rifadin, Rimactane, in Rifamate, in Rifater), and verapamil (Calan, Verelan, in Tarka). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• Tell your doctor what herbal products you are taking, especially St. John’s wort. You should not take St. John’s wort while you are taking olaparib.
• Tell your doctor if you have or have ever had have lung or breathing problems, or kidney or liver disease.
• Tell your doctor if you are pregnant, plan to become pregnant, or plan to father a child. You may need to have a pregnancy test before starting treatment, You should not become pregnant while you are taking olaparib. You should use effective birth control to prevent pregnancy during your treatment with olaparib and for at least 6 months after your final dose. If you are a male and your partner can become pregnant, you should use effective birth control during your treatment with olaparib tablets 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 olaparib, call your doctor immediately. Olaparib may harm the fetus.
• Tell your doctor if you are breastfeeding. Do not breastfeed while you are taking olaparib and for 1 month after your final dose.
• You should know that you should not donate sperm while you are taking olaparib tablets and for 3 months after your final dose.

Do not eat grapefruit or Seville oranges (sometimes used in marmalades), or drink grapefruit juice or Seville orange juice while taking this medication.

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

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

• Nausea
• Vomiting
• Diarrhea
• Constipation
• Heartburn
• Headache
• Decreased appetite
• Muscle, joint, or back pain
• Fatigue
• Stomach pain or discomfort
• Taste changes
• Mouth pain or sores
• Anxiety
• Depression
• Dry skin
• Itching
• Rash
• Difficulty falling asleep or staying asleep
• Pain urinating

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

• Fever, shortness of breath, cough, or wheezing
• Shortness of breath
• Weakness
• Extreme tiredness
• Weight loss
• Unusual bruising or bleeding
• Pale skin
• Blood in urine or stool
• Fever, chills, cough, sore throat, or other signs of infection
• Pain, tenderness, redness, or swelling in one leg
• Chest pain or tightness; shortness of breath; coughing up blood; or rapid breathing

Olaparib 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 may order a lab test before you begin your treatment to see whether your condition can be treated with olaparib. Your doctor will order certain lab tests during your treatment to check your body’s response to olaparib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

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.