Niraparib (nye-RAP-a-rib)

Treats cancer of the ovary, fallopian tube, and peritoneum.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. Take this medicine at the same time each day. You may take this medicine at bedtime if you have nausea.
• Swallow the capsule whole. Do not crush, break, chew, or open it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses. If you vomit after taking a dose, do not take an extra dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 6 months after the last dose of this medicine.
• Do not breastfeed during treatment and for 1 month after your last dose.
• Tell your doctor if you have kidney disease, liver disease, heart disease, heart rhythm problems, or high blood pressure.
• This medicine may cause the following problems:
  • Bone marrow problems, including myelodysplastic syndrome or acute myeloid leukemia
  • High blood pressure
  • Nervous system problem, including posterior reversible encephalopathy syndrome (PRES)
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine contains a yellow dye called tartrazine, which may cause serious allergic reactions (including asthma). Tell your doctor if you have any allergies (including an aspirin allergy).
• If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blood in the urine or stool, trouble breathing, weight loss
• Change in how much or how often you urinate
• Fast, slow, pounding, or uneven heartbeat
• Fever, chills, cough, sore throat, body aches
• Headache, dizziness
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea, nausea, vomiting, stomach pain, loss of appetite
• Muscle or back pain
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088