Pronunciation:

nye-RAP-a-rib

Brand Names:

• Zejula

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

Niraparib is used as first-line maintenance treatment in patients with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. It is also used as maintenance treatment in patients with recurrent (cancer that comes back) ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) abnormal BRCA gene. Your doctor will test for the presence of this gene (deleterious or suspected deleterious germline BRCA gene). This medicine is used in patients who have had received platinum-based cancer medicines.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of niraparib in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of niraparib in the elderly. However, elderly patients are more likely to be sensitive to the effects of this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to aspirin—Use with caution. This medicine contains a yellow dye called tartrazine, which may cause allergic reactions (including asthma) in patients with this condition.

• Anemia or
• Bone marrow problems (eg, acute myeloid leukemia, myelodysplastic syndrome) or
• Heart disease or
• Heart rhythm problems (eg, arrhythmia) or
• Hypertension (high blood pressure) or
• Neutropenia (low number of white blood cells) or
• Pancytopenia (low number of red blood cells, white blood cells, and platelets) or
• Thrombocytopenia (low number of platelets)—Use with caution. May make these conditions worse.

• Liver disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before using 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.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine usually comes with patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Swallow the capsules whole. Do not crush, break, chew, or open it. You may take this medicine with or without food.

Take this medicine at the same time each day. You may take this medicine at bedtime if you have nausea.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For first-line maintenance treatment of advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer:
    • Adults—Dose is base on body weight or platelet count and must be determined by your doctor:
      • Weighs 77 kilograms (kg) or more, or platelet count 150,000 microliters (µL) or more—300 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated.
      • Weighs less than 77 kilograms (kg) or platelet count less than 150,000 microliters (µL)—200 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.
  • For maintenance treatment of recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer:
    • Adults—300 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.

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.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. 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. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause bone marrow problems, including myelodysplastic syndrome or acute myeloid leukemia. Check with your doctor right away if you have a fever, blood in the urine or stool, chills, unusual bleeding, bruising, tiredness, or weakness, or weight loss.

Niraparib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

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).

Your doctor will check your blood pressure on a regular basis while you are using this medicine. You might need to monitor your blood pressure at home. Tell your doctor right away if you have a severe headache, lightheadedness, or changes in your vision.

Check with your doctor right away if you have agitation, back pain, blurred vision, change in consciousness, confusion, dizziness, drowsiness, fever, hallucinations, headache, irritability, loss of consciousness, mood or mental changes, seizures, stiff neck, unusual tiredness or weakness, or vomiting. These may be symptoms of a serious nervous system problem called posterior reversible encephalopathy syndrome (PRES).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Black, tarry stools

bleeding gums

blood in the urine or stools

blurred vision

chills

cough

dizziness

fast, irregular, pounding, or racing heartbeat or pulse

fever

headache

lower back or side pain

nervousness

painful or difficult urination

pale skin

pinpoint red spots on the skin

pounding in the ears

slow or fast heartbeat

sore throat

trouble breathing

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

Less common

Chest pain

swollen glands

Incidence not known

Agitation

back pain

change in consciousness

drowsiness

enlarged pupils

general feeling of discomfort or illness

increased sensitivity of the eyes to light

increased sensitivity of the skin to sunlight

increased sweating, possibly with fever or cold, clammy skin

irritability

mood or mental changes

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness or other discoloration of the skin

seeing, hearing, or feeling things that are not there

seizures

severe sunburn

skin rash

sores, ulcers, or white spots on the lips or in the mouth

stiff neck

thickening of bronchial secretions

tightness in the chest

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach

belching

bladder pain

bloody or cloudy urine

change in taste

cracked lips

decreased appetite

diarrhea

difficulty having a bowel movement (stool)

difficulty with swallowing

dry mouth

fear or nervousness

frequent urge to urinate

heartburn

indigestion

lack or loss of strength

loss of taste

lower back or side pain

nausea

stomach discomfort, upset, or pain

trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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