When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to olaparib, or if you are pregnant.

How to Use This Medicine:
Capsule

• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Swallow the capsules whole. Do not crush, break, chew, open, or dissolve them. Do not take capsules if they look damaged or are leaking.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how olaparib works. Tell your doctor if you are using any of the following:
  
  • Aprepitant, boceprevir, bosentan, modafinil, nefazodone, rifampicin, St John's wort, telaprevir
  • Blood pressure medicine (such as diltiazem, verapamil)
  • Other cancer medicine (such as crizotinib, imatinib)
  • Medicine to treat an infection, including HIV infection
  • Medicine to treat seizures (such as carbamazepine, phenytoin)
• Do not eat grapefruit or Seville oranges, or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 1 month after the last dose of this medicine.
• Tell your doctor if you are breastfeeding, or if you have kidney disease or liver disease.
• This medicine may cause the following problems:
  
  • Bone marrow problems, such as myelodysplastic syndrome or acute myeloid leukemia
  • Pneumonitis (lung disease)
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blood in the urine or stool
• Chest pain or trouble breathing
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches
• Unusual bleeding, bruising, or weakness
• Weight loss

If you notice these less serious side effects, talk with your doctor:

• Back, joint, or muscle pain
• Decreased appetite
• Diarrhea, nausea, vomiting, stomach pain or upset

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088