Niraparib is used as a "maintenance" treatment in adults to keep certain types of cancer from coming back. This includes cancers of the ovary, fallopian tube, or peritoneum (the membrane that lines the inside of your abdomen and covers some of your internal organs).

Niraparib is given after you have received chemotherapy (with cisplatin, oxaliplatin, carboplatin, or other similar products) and your cancer has responded to that medicine.

Niraparib is sometimes used only if your cancer has a specific genetic marker (an abnormal "BRCA" gene) or other gene mutations. Your doctor will make sure you have the correct tumor type to be treated with niraparib.

Niraparib may also be used for purposes not listed in this medication guide.

Stop taking this medicine and call your doctor at once if you have fever, frequent infections, weakness, tiredness, shortness of breath, weight loss, blood in your urine or stools, easy bruising or bleeding. These may be symptoms of bone marrow disorder and may lead to death.

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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take niraparib with or without food, but take it at the same time each day.

Take this medicine at bedtime if it upsets your stomach.

Swallow the tablet or capsule whole and do not crush, chew, break, or open it.

If you vomit shortly after taking niraparib, do not take another dose. Take your next dose as scheduled.

You may need frequent medical tests and your cancer treatments may be delayed based on the results.

Your blood pressure and heart rate will need to be checked often.

Store this medicine in the original container at room temperature away from moisture and heat.

Tell your doctor if you have or have ever had:

• an allergy or sensitivity to aspirin or tartrazine (food dye);

• heart disease;

• high blood pressure; or

• liver disease.

You may need to have a negative pregnancy test before starting this treatment.

May harm an unborn baby. Do not use if you are pregnant. Use effective birth control while using niraparib and for at least 6 months after your last dose. Tell your doctor if you become pregnant.

It may be harder for you to get a woman pregnant while you are using niraparib.

Do not breastfeed while using this medicine, and for at least 1 month after your last dose.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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. http://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 (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop taking niraparib and call your doctor at once if you have signs of a bone marrow disorder: fever, frequent infections, weakness, tiredness, feeling short of breath, weight loss, blood in your urine or stools, easy bruising or bleeding.

Niraparib may cause serious side effects. Call your doctor at once if you have:

• pounding heartbeats or fluttering in your chest;

• sores or white patches in or around your mouth, trouble swallowing or talking, dry mouth, bad breath, altered sense of taste;

• pain or burning when you urinate; or

• headache, vision changes, confusion, seizure with our without pounding in your neck or ears.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of niraparib may include:

• stomach pain, loss of appetite, nausea, vomiting;

• constipation, diarrhea;

• abnormal blood tests;

• little or no urination, changes in the color of your urine, painful urination;

• back or muscle pain;

• headache, dizziness;

• sleep problems (insomnia);

• tiredness;

• cough, shortness of breath; or

• rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect niraparib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

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.