Niraparib

Niraparib is used as a "maintenance" treatment in adults to prevent certain types of cancer from returning. 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 completed chemotherapy (with cisplatin, oxaliplatin, carboplatin, or other similar products) and your cancer has responded to that treatment.

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

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

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 makes your stomach upset.

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.

Stop taking this medicine and call your doctor right away 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 signs of a bone marrow disorder and could lead to death.

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 take a pregnancy test that shows you are not pregnant before starting this treatment.

May harm an unborn baby. Do not use if you are pregnant. Use effective birth control while taking 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 taking niraparib.

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

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 right away 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 right away 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 or without pounding in your neck or ears.

Your cancer treatments may be delayed or stopped permanently 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.

If you miss a dose, skip it and take your next dose at the usual time. Do not take two doses at the same time.

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

Follow your doctor's instructions regarding any restrictions on food, drinks, or activities.

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

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