Niraparib capsules

What is this medicine?

NIRAPARIB (nye RAP a rib) is a chemotherapy drug. It targets specific enzymes within cancer cells and stops the cancer cell from growing. This medicine is used to treat ovarian cancer, fallopian tube cancer, and peritoneal cancer.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• fast, irregular heartbeat

• palpitations

• signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine

• signs of decreased red blood cells - unusually weak or tired, feeling faint or lightheaded, falls

• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• constipation

• diarrhea

• dizziness

• headache

• loss of appetite

• mouth sores

• nausea, vomiting

• stomach pain

• trouble sleeping

What may interact with this medicine?

Interactions have not been studied.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children.

Store between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• heart disease

• high blood pressure

• history of irregular heartbeat

• infection (especially a virus infection such as chickenpox, cold sores, or herpes)

• low blood counts, like low white cell, platelet, or red cell counts

• an unusual or allergic reaction to niraparib, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this medicine.

Do not become pregnant while taking this medicine or for 6 months after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Men should inform their doctors if they wish to father a child. This medicine may lower sperm counts. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for 1 month after stopping it.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

Be careful brushing and flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.