Niraparib

Niraparib is used 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 stomach) cancer in people who have completely responded or partially responded to other chemotherapy medication(s). It is also used to treat certain types of ovarian, fallopian tube, or peritoneal cancer when the cancer has gotten worse after 3 or more chemotherapy treatments. Niraparib is in a class of medications called poly (ADP-ribose) polymerase (PARP) inhibitors. It works by killing cancer cells.

Niraparib comes as a capsule to take by mouth once daily. Take niraparib at around the same time every day with or without food. If you experience nausea after taking niraparib, take it once daily at bedtime. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take niraparib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not open, chew, or dissolve them.

If you vomit after taking niraparib, do not take another dose. Continue your regular dosing schedule.

Your doctor may decrease your dose of niraparib, or permanently or temporarily stop your treatment, if you experience certain side effects. Be sure to tell your doctor how you are feeling during your treatment with niraparib.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking niraparib,

• tell your doctor and pharmacist if you are allergic to niraparib, any other medications, or any of the ingredients in niraparib capsules. Ask your pharmacist 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.
• tell your doctor if you have or have ever had arrhythmias (abnormal heart rhythms), high blood pressure, or heart disease.
• tell your doctor if you are pregnant or plan to become pregnant. You will need to have a negative pregnancy test before you start treatment and should use birth control to prevent pregnancy during your treatment and for 6 months after your final dose of niraparib. Talk to your doctor about birth control methods that will work for you. If you become pregnant while taking niraparib, call your doctor immediately. Niraparib may harm the fetus.
• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while taking niraparib and for 1 month after your final dose.

Unless your doctor tells you otherwise, continue your normal diet.

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed dose.

Niraparib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• constipation
• heartburn
• dry mouth
• sores in the mouth
• loss of appetite
• back pain
• headache
• dizziness
• changes in taste
• difficulty falling asleep or staying asleep
• anxiety
• rash

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

• pale skin
• shortness of breath
• weakness
• tiredness
• weight loss
• bruising or bleeding easily
• blood in urine or stool
• burning feeling when you urinate
• frequent or urgent need to urinate
• fever, cough, runny nose, or other signs of infection

Niraparib may increase the risk that you will develop other cancers. Talk to your doctor about this risk.

Niraparib may decrease fertility in men. Talk to your doctor about the risks of taking niraparib.

Niraparib 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 will check your blood pressure regularly and order certain lab tests before and during your treatment to check your body's response to niraparib.

In some cases, niraparib may only be used in people with a certain genetic make-up. Your doctor may order a blood test to help decide if this medication is right for you.

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.

• Zejula^®