olaparix

Olaparib is a prescription medicine used to treat adults who have:

• advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene. Olaparib is used alone as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that Olaparib is right for you.
• advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer with a certain type of abnormal BRCA gene or a positive laboratory tumor test for genomic instability called HRD. Olaparib is used in combination with another anti-cancer medicine, bevacizumab, as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that Olaparib is right for you.
• ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, as maintenance treatment, when the cancer has come back. Olaparib is used after the cancer has responded to treatment with platinum-based chemotherapy.
• human epidermal growth factor receptor 2 (HER2)-negative early breast cancer with a certain type of inherited (germline) abnormal BRCA gene. Olaparib is given after surgery (treatment after surgery is called adjuvant therapy). You should have received chemotherapy medicines before or after surgery to remove the tumor. Your healthcare provider will perform a test to make sure that Olaparib is right for you.
• a certain type of abnormal inherited BRCA gene, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic). You should have received chemotherapy medicines, either before or after your cancer has spread. If you have hormone receptor (HR)-positive disease, you should have been treated with hormonal therapy. Your healthcare provider will perform a test to make sure that Olaparib is right for you.
• metastatic pancreatic cancer with a certain type of abnormal inherited BRCA gene. Olaparib is used as maintenance treatment after your cancer has not progressed on at least 16 weeks of treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that Olaparib is right for you.
• prostate cancer with certain inherited or acquired abnormal genes called homologous recombination repair (HRR genes). Olaparib is used when the cancer has spread to other parts of the body (metastatic), and no longer responds to a medical or surgical treatment that lowers testosterone and has progressed after treatment with enzalutamide or abiraterone. Your healthcare provider will perform a test to make sure Olaparib is right for you. It is not known if Olaparib is safe and effective in children.

Before taking Olaparib, tell your healthcare provider about all of your medical conditions, including if you:

• have lung or breathing problems
• have kidney problems
• are pregnant, become pregnant, or plan to become pregnant. Olaparib can harm your unborn baby and may cause loss of pregnancy (miscarriage).

° If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with Olaparib.

° Females who are able to become pregnant should use effective birth control (contraception) during treatment with Olaparib and for 6 months after the last dose of Olaparib. Talk to your healthcare provider about birth control methods that may be right for you. Tell your healthcare provider right away if you become pregnant or think you might be pregnant following treatment with Olaparib.

° Males with female partners who are pregnant or able to become pregnant should use effective birth control (contraception) during treatment with Olaparib and for 3 months after the last dose of Olaparib.

° Do not donate sperm during treatment with Olaparib and for 3 months after your last dose.

• are breastfeeding or plan to breastfeed. It is not known if Olaparib passes into your breast milk. Do not breastfeed during treatment with Olaparib and for 1 month after receiving the last dose of Olaparib. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking Olaparib and certain other medicines may affect how Olaparib works and may cause side effects.

How should I take Olaparib?

• Take Olaparib tablets exactly as your healthcare provider tells you.
• Do not change your dose or stop taking Olaparib unless your healthcare provider tells you to. Your healthcare provider may temporarily stop treatment with Olaparib or change your dose of Olaparib if you experience side effects.
• Your healthcare provider will decide how long you stay on treatment.
• Do not take more than 4 Olaparib tablets in 1 day. If you have any questions about Olaparib, please talk to your healthcare provider or pharmacist.

• Take Olaparib by mouth 2 times a day.
• Each dose should be taken about 12 hours apart.
• Swallow Olaparib tablets whole. Do not chew, crush, dissolve, or divide the tablets.
• Take Olaparib with or without food.
• If you are taking Olaparib for early breast cancer and you have hormone receptor-positive disease, you should continue to take hormonal therapy during your treatment with Olaparib.
• If you are taking Olaparib for prostate cancer and you are receiving gonadotropin-releasing hormone (GnRH) analog therapy, you should continue with this treatment during your treatment with Olaparib unless you have had a surgery to lower the amount of testosterone in your body (surgical castration).
• If you miss a dose of Olaparib, take your next dose at your usual scheduled time. Do not take an extra dose to make up for a missed dose.
• If you take too much Olaparib, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking Olaparib?

Avoid grapefruit, grapefruit juice, Seville oranges and Seville orange juice during treatment with Olaparib since they may increase the level of Olaparib in your blood.

What are the possible side effects of Olaparib?

Olaparib may cause serious side effects.

The most common side effects of Olaparib are:

• nausea or vomiting. Tell your healthcare provider if you get nausea or vomiting. Your healthcare provider may prescribe medicines to treat these symptoms.
• tiredness or weakness • cough
• low red blood cell counts • low white blood cell counts
• diarrhea • shortness of breath
• loss of appetite • dizziness
• headache • indigestion or heartburn
• changes in the way food tastes • low platelet counts

These are not all of the possible side effects of Olaparib.

How should I store Olaparib?

• Store Olaparib at room temperature, between 68°F to 77°F (20°C to 25°C).
• Store Olaparib in the original bottle to protect it from moisture.

Keep Olaparib and all medicines out of reach of children.

General information about the safe and effective use of Olaparib.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Olaparib for a condition for which it was not prescribed. Do not give Olaparib to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist f