Uses

This medication is used to treat ovarian cancer. It works by slowing the growth of cancer cells.

How To Use

Read the Medication Guide provided by your pharmacist before you start taking olaparib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication also comes in a tablet form. Do not take the tablet form in place of the capsules unless your doctor tells you to do so. They do not work the same way. Ask your doctor for details.

Take this medication by mouth with or without food as directed by your doctor, usually twice daily. Swallow the capsules whole. Do not chew, dissolve, or open the capsules. Do not take capsules that look damaged or look like they have leaked.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Also avoid eating Seville oranges (often found in marmalade). Grapefruit and Seville oranges can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

The dosage is based on your medical condition and response to treatment.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

Side Effects

Nausea, vomiting, loss of appetite, diarrhea, constipation, bad taste in your mouth, dizziness, or joint/back/muscle pain may occur. Rarely, nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals or limiting activity may help lessen nausea and vomiting. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• signs of kidney problems (such as change in the amount of urine)
• swelling hands/ankles/feet

This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Rarely, these problems can also be symptoms of very serious (possibly fatal) cancer of the bone marrow or blood cells, especially if you have received past radiation or chemotherapy treatment for ovarian cancer. Your doctor will monitor your blood cell counts. Tell your doctor right away if you develop any of the following symptoms:

• signs of anemia (such as unusual tiredness, pale skin, rapid breathing, fast heartbeat)
• signs of infection (such as fever, chills, persistent sore throat)
• easy bruising/bleeding (such as pink/bloody urine, black/bloody stools)
• weakness
• weight loss

Get medical help right away if you have any very serious side effects, including:

• new/worsening shortness of breath
• cough
• wheezing

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking olaparib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• kidney disease

Olaparib can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using olaparib before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using olaparib. Olaparib may harm an unborn baby. Men with female partners of childbearing age should use reliable forms of birth control while using this medication and for at least 3 months after stopping treatment. Also, men should not donate sperm while using this medication and for 3 months after stopping treatment. Women of childbearing age should ask about reliable forms of birth control while using this medication and for at least 6 months after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for at least one month after stopping treatment is not recommended. Consult your doctor before breast-feeding.

Drug Interactions

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of olaparib from your body, which may affect how olaparib works. Examples include carbamazepine, phenytoin, rifamycins (such as rifampin), St. John's wort, among others.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 9-1-1. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as complete blood counts) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store in the refrigerator. Do not freeze. If needed, this medication may be stored at room temperature away from light and moisture for up to 3 months. Do not store in the bathroom. Do not use this medication if it has been exposed to temperatures above 104 degrees F (40 degrees C) or if it has been frozen. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Medical Alert

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).