Olaparib

Olaparib is used alone or in combination with bevacizumab (Avastin) 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 is 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. It is also used to treat certain types of early breast cancer in people who have already been treated with surgery and other chemotherapy treatments. Olaparib is 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). It is also used in combination with abiraterone and prednisone to treat a certain type of prostate cancer that has spread to other parts of the body and no longer responds to medical or surgical treatments to lower testosterone levels. Olaparib is 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 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 (https://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. 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. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• The following herbal products may interact with olaparib: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking olaparib. Do not start this medication while taking olaparib without discussing it with your healthcare provider.
• tell your doctor if you have or have ever had have lung or breathing problems, blood clots in your legs or lungs, 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.
• you should know that olaparib may cause nausea and vomiting. Tell your doctor if you have nausea or vomiting. Your doctor may give you another medication to help treat nausea and vomiting.

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:

• diarrhea
• constipation
• heartburn
• headache
• decreased appetite
• muscle, joint, or back pain
• fatigue
• dizziness
• stomach pain or discomfort
• taste changes
• mouth pain or sores
• rash

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

• shortness of breath, new or worsening cough, difficulty breathing, wheezing, or fever
• weakness
• extreme tiredness
• weight loss
• unusual bruising or bleeding
• pale skin
• blood in urine or stool
• fever, chills, cough, sore throat, difficulty urinating, pain when urinating, or other signs of infection
• pain, tenderness, redness, or swelling in one leg
• chest pain or tightness, shortness of breath, coughing up blood, fast or pounding heartbeat, rapid breathing

Olaparib may increase the risk that you will develop other cancers. Talk to your doctor about this risks of taking this medication.

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 (https://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. https://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 (https://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.

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