Olaparib is used to treat cancers of the breast, ovary, fallopian tube, pancreas, prostate, or peritoneum (the membrane that lines the inside of your abdomen and covers some of your internal organs).

Olaparib is sometimes used when the cancer has spread to other parts of the body, or when cancer has come back after treatment with other medications.

Olaparib is sometimes used only if your cancer has a specific genetic marker (an abnormal "BRCA" or "HRR" gene). Your doctor will test you for this gene.

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

Olaparib affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, weakness, tiredness, trouble breathing, easy bruising or bleeding, blood in your urine or stools, or weight loss.

You will need weekly or monthly blood tests, and your cancer treatments may be delayed based on the results.

Some people who take olaparib with a gonadotropin-releasing hormone (GnRH) medicine may develop a blood clot in the leg or in the lung. Call your doctor if you have pain or swelling in your arm or leg, shortness of breath, chest pain, rapid breathing, or fast heartbeats.

Olaparib may also cause serious lung problems. Call your doctor if you have chest pain, wheezing, trouble breathing, or a new or worsening cough.

Olaparib comes as a tablet 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 tablets whole; do not crush chew, divide, or dissolve them.

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.

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.

Olaparib is usually taken twice per day. Take your doses at regular intervals, about 12 hours apart. You may take olaparib with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

Olaparib affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

You may also need chest x-rays to be sure this medicine is not causing harmful effects on your lungs. Your cancer treatments may be delayed based on the results.

Store at room temperature away from moisture and heat.

Tell your doctor if you have ever had:

• lung disease, breathing problems; or

• kidney disease.

Olaparib can harm an unborn baby or cause a miscarriage if the mother or the father is using olaparib.

• If you are a woman, do not use this medicine if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are 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. Also do not donate sperm during the 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using olaparib.

Do not breastfeed while using this medicine, and for at least 1 month 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.

Do not take more than 4 olaparib tablets in one day.

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.

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

Grapefruit and Seville oranges may interact with olaparib and cause side effects. Avoid consuming grapefruit products and orange marmalades.

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

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

• fever, chills, weakness, feeling light-headed or very tired;

• mouth sores, skin sores;

• easy bruising, unusual bleeding;

• pain or burning when you urinate, blood in your urine or stools;

• pale skin, cold hands and feet;

• weight loss; or

• cough, wheezing, shortness of breath.

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

Some people who take olaparib with a gonadotropin-releasing hormone (GnRH) medicine may develop a blood clot in the leg or in the lung. Call your doctor if you have pain or swelling in your arm or leg, shortness of breath, chest pain, rapid breathing, or fast heartbeats.

Common side effects of olaparib may include:

• low blood cell counts;

• nausea, vomiting, diarrhea;

• heartburn, indigestion, loss of appetite;

• dizziness, feeling weak or tired;

• headache;

• cough, shortness of breath; or

• altered sense of taste.

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 medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may affect olaparib, 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 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.