ZEJULA is a prescription medicine used to treat adults for:

• maintenance treatment of advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of abnormal BRCA gene or a positive laboratory tumor test for genomic instability called homologous recombination deficiency (HRD). ZEJULA is used after the cancer has responded (complete or partial response) to treatment with first-line platinum-based chemotherapy.
• maintenance treatment of ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) abnormal BRCA gene that comes back. ZEJULA is used after the cancer has responded (complete or partial response) to treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that ZEJULA is right for you.

It is not known if ZEJULA is safe and effective in children

Important Safety Information
ZEJULA may cause serious side effects, including:

Bone marrow problems called Myelodysplastic Syndrome (MDS) or a type of blood cancer called Acute Myeloid Leukemia (AML). Some people who have ovarian cancer and who have received previous treatment with chemotherapy or certain other medicines for their cancer have developed MDS or AML during treatment with ZEJULA. MDS or AML may lead to death.

Symptoms of low blood cell counts (low red blood cells, low white blood cells, and low platelets) are common during treatment with ZEJULA. They can be a sign of serious bone marrow problems, including MDS or AML. These symptoms may include the following:

• Weakness
• Feeling tired
• Weight loss
• Frequent infections
• Fever
• Shortness of breath
• Blood in urine or stool
• Bruising or bleeding more easily

Your doctor will do blood tests to check your blood cell counts before treatment with ZEJULA. You will be tested weekly for the first month of treatment with ZEJULA, monthly for the next 11 months of treatment, and as needed afterward.

High blood pressure is common during treatment with ZEJULA, and it can become serious. Your doctor will check your blood pressure and heart rate at least weekly for the first two months, then monthly for the first year, and as needed thereafter during your treatment with ZEJULA.

Posterior reversible encephalopathy syndrome (PRES) is a condition that affects the brain and may happen during treatment with ZEJULA. If you have headache, vision changes, confusion, or seizure, with or without high blood pressure, please contact your doctor.

Before starting to take ZEJULA, tell your doctor about all of your medical conditions, including if you:

• Have heart problems
• Have liver problems
• Have high blood pressure
• Are pregnant or plan to become pregnant. ZEJULA can harm an unborn baby and may cause loss of pregnancy (miscarriage)
  • If you are able to become pregnant, your doctor should perform a pregnancy test before you start treatment with ZEJULA
  • If you are able to become pregnant, you should use effective birth control (contraception) during treatment with ZEJULA and for 6 months after taking the last dose of ZEJULA
  • You should tell your doctor right away if you become pregnant
• Are breastfeeding or plan to breastfeed
  • ZEJULA may harm your baby. You should not breastfeed your baby during treatment with ZEJULA and for 1 month after taking the last dose of ZEJULA

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of ZEJULA include the following:

• Nausea
• Tiredness
• Constipation
• Pain in your muscles and back
• Pain in the stomach area
• Vomiting
• Loss of appetite
• Trouble sleeping
• Headache
• Shortness of breath
• Rash
• Diarrhea
• Cough
• Dizziness
• Changes in the amount or color of your urine
• Urinary tract infection
• Low levels of magnesium in the blood

If you have certain side effects, then your doctor may change your dose of ZEJULA, temporarily stop, or permanently stop treatment with ZEJULA.

These are not all the possible side effects of ZEJULA. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

Please see the full Prescribing Information, including Patient Information for ZEJULA.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report negative side effects to GSK at gsk.public.reportum.com or 1-888-825-5249.

--Brand Name--
US Brand Name: Zejula

--Description--
Niraparib is used as first-line maintenance treatment of advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in patients with a certain type of inherited (germline) abnormal BRCA gene or a positive tumor test for genomic instability called homologous recombination deficiency (HRD). It is also used as maintenance treatment of recurrent (cancer that comes back) ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in patients 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) and genomic instability. This medicine is used in patients who have had received platinum-based cancer medicines.

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

This product is available in the following dosage forms: Tablet

--Before Using--
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.

Pediatric
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.

Geriatric
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.

Breastfeeding
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.

Drug Interactions
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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bacillus of Calmette and Guerin Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Cholera Vaccine
• Ebola Zaire Vaccine, Live
• Influenza Virus Vaccine, Live
• Rotavirus Vaccine, Live

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--
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--
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--
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.