olaparib

What is the most important information I should know about olaparib?

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

What is olaparib?

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.

What should I discuss with my healthcare provider before taking olaparib?

Tell your doctor if you have ever had:

• lung disease, breathing problems; or
• kidney disease.

• 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.

How should I take olaparib?

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.

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.

What happens if I miss a 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.

What happens if I overdose?

What should I avoid while taking olaparib?

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

What are the possible side effects of olaparib?

• 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.

Common side effects 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.

What other drugs will affect olaparib?

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.

Where can I get more information?

Your doctor or pharmacist can provide more information about olaparib.