Niraparib (By mouth)

Zejula

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

Capsule

• 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 tell you how much medicine to use. Do not use more than directed. Take this medicine at the same time each day.
• 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.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

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

Niraparib (nye-RAP-a-rib)

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

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
• Fast, slow, pounding, or uneven heartbeat
• Fever, chills, cough, sore throat, body aches
• Unusual bleeding, bruising, or weakness

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

• Constipation, nausea, vomiting

• 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. 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, or heart rhythm problems.
• This medicine may cause the following problems:
  • Bone marrow problems, such as myelodysplastic syndrome or acute myeloid leukemia
  • High blood pressure
• 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 could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• 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.