Patient Medication Information: uses, side effects, how to take - Zejula (Glaxosmithkline, Capsule)
Serious warnings and precautions box
What ZEJULA is used for:
ZEJULA is used in adult women for:
- the maintenance treatment of ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (the membrane that lines the inside of the abdomen).
- the maintenance treatment of ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has come back (reoccurred).
In both cases ZEJULA is used after your cancer responds to platinum-based chemotherapy. ZEJULA helps to keep or maintain that response.
How ZEJULA works:
ZEJULA is a type of drug called a PARP inhibitor. PARP inhibitors block a protein called poly [adenosine diphosphate-ribose] polymerase (PARP). This protein helps cells to repair their damaged DNA. Blocking PARP activity prevents the repair of damaged DNA in cancer cells leading to cell death.
The ingredients in ZEJULA are:
Medicinal ingredients: niraparib, as niraparib tosylate
Non-medicinal ingredients (capsules): FD&C Blue #1, FD&C Red #3, FD&C Yellow #5 (tartrazine), gelatin, lactose monohydrate, magnesium stearate, pharmaceutical grade printing ink, and titanium dioxide
Non-medicinal ingredients (tablets): Crospovidone, ferrosoferric oxide, lactose monohydrate,
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magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide
ZEJULA comes in the following dosage forms:
Capsules, 100 mg
Tablets, 100 mg
Do not use ZEJULA if:
- you are allergic to niraparib tosylate or to any of the other ingredients of ZEJULA.
- you are breast-feeding or plan to breastfeed. It is not known if ZEJULA passes into breast milk. You and your doctor should decide if you will take ZEJULA or breastfeed. You should not do both. Do not breastfeed for 1 month after taking your last dose of ZEJULA. Talk to your doctor about the best way to feed your baby while you are being treated with ZEJULA.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ZEJULA. Talk about any health conditions or problems you may have, including if you:
- have or have had high blood pressure or heart problems.
- have or have had liver or kidney problems.
- are pregnant or plan to become pregnant.
- have an allergy to lactose. This is because ZEJULA contains lactose.
- have an allergy to a yellow dye called tartrazine (FD&C Yellow #5). This is because ZEJULA contains tartrazine.
- are over 65 years of age.
Other warnings you should know about:
Posterior Reversible Encephalopathy Syndrome (PRES):
- Cases of PRES have been reported with ZEJULA use. PRES is a rare neurological disorder. Contact your doctor immediately if you develop the following symptoms: headaches, confusion, speech and vision loss, vision changes, seizures, with or without high blood pressure.
Pregnancy and fertility:
- If you are pregnant or still able to get pregnant, there are specific risks you must discuss with your healthcare professional.
- Avoid becoming pregnant while taking ZEJULA. It may harm your unborn child or make you lose the pregnancy. Use highly effective methods of birth control while taking ZEJULA. Keep using birth control for 6 months after taking your last dose of ZEJULA. If you do become pregnant while taking ZEJULA, tell your doctor right away. Talk to your doctor about birth control methods that may be right for you.
- For women who can get pregnant: a pregnancy test should be done before you start to take ZEJULA; regularly while you are taking it; and one month after taking your last dose.
- ZEJULA may affect your fertility.
Children and adolescents:
- ZEJULA is not for use in patients under the age of 18 years.
Sensitivity to sunlight:
- While taking ZEJULA, your skin may be more sensitive to the sun. You may burn more easily during treatment with ZEJULA. Avoid sun exposure. When in the sunlight, wear a sunscreen with a high protection factor of at least SPF 15 and protective clothing.
Driving and using machines:
- Before you do tasks, which may require special attention, wait until you know how you respond to ZEJULA. If you feel dizzy, weak, unfocused or tired, do not drive or use tools or machines.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with ZEJULA:
- clozapine, used to treat mental health problems such as schizophrenia
- theophylline, used to treat lung and breathing problems such as COPD and asthma
- ropinirole, used to treat Parkinson’s disease
- metformin, used to lower blood sugar in people with type 2 diabetes. Your healthcare professional may have to adjust your dose of metformin, especially when you are starting or stopping treatment with ZEJULA.
How to take ZEJULA:
- Take ZEJULA exactly as your healthcare professional tells you. Check with your doctor, pharmacist or nurse if you are not sure.
- Do not change your dose or stop taking ZEJULA without first talking with your doctor.
- Your doctor will tell you when to start ZEJULA after you finish your chemotherapy treatment.
Take with or without food at about the same time each day.
- Take ZEJULA at bedtime if it upsets your stomach. This may help you to manage nausea.
- Swallow capsules or tablets whole.
- If you vomit after taking your dose, do NOT take another one. Take your next dose at your regular time.
Usual dose:
The recommended dose is different for different patients. Your doctor will determine the right dose for you. Be sure to take the dose prescribed to you by your doctor. Your doctor will decide how long you stay on ZEJULA treatment.
For the maintenance therapy of ovarian cancer, fallopian tube cancer or primary peritoneal cancer:
The recommended dose is:
200 mg (two 100 mg capsules or tablets) by mouth once a day
OR
300 mg (three 100 mg capsules or tablets) by mouth once a day.
The dose prescribed will depend on your body weight and platelet count.
For the maintenance therapy of ovarian cancer, fallopian tube cancer or primary peritoneal cancer that has come back (reoccurred):
The recommended dose is 300 mg (three 100 mg capsules or tablets) by mouth once a day.
If you have a low body weight, your doctor may prescribe a dose of 200 mg (two 100 mg capsules or tablets) by mouth once a day.
Your doctor may change (reduce) or interrupt your dose or tell you to stop taking it. This may happen if you have:
- certain side effects while taking ZEJULA
- liver problems
Reduced daily adult doses:
- 200 mg (two 100 mg capsules or tablets) by mouth once a day
- 100 mg (one 100 mg capsule or tablet) by mouth once a day
Overdose:
| If you think you, or a person you are caring for, have taken too much ZEJULA, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
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Missed dose:
If you miss a dose of ZEJULA, take your next dose at your regular time. Do not take an extra dose to make up for a missed dose.
Possible side effects from using ZEJULA:
These are not all the possible side effects you may have when taking ZEJULA. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- pain in the stomach area
- indigestion or heartburn
- dry mouth
- feeling tired or weak
- loss of appetite
- loss of weight
- pain in your joints, muscles and back
- headache
- feeling dizzy
- changes in the way food tastes
- trouble sleeping
- anxiety and depression
- inflammation of the nose and throat
- shortness of breath
- cough
- rash
- constipation
- hot flashes
- nose bleeds
- pink eye
- swelling
- increased sensitivity to the sun, sunburn
Your healthcare professional will test your blood:
- before you start on ZEJULA
- every week for the first month, and
- once a month for the next eleven months and periodically thereafter.
ZEJULA can cause abnormal blood test results. This includes low blood cell counts and increased creatinine and liver enzyme levels in your blood. Your doctor may adjust your treatment to correct these side effects and run additional tests.
Your healthcare professional will check your blood pressure and heart rate regularly throughout your treatment. Your doctor may adjust your treatment and give you medicine to treat your high blood pressure.
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |||||
|---|---|---|---|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |||||
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |||||
| Only if severe | In all cases | ||||||
| Only if severe | In all cases | ||||||
| Only if severe | In all cases | ||||||
| Very common | |||||||
| Anemia (low red blood cells): Being short of breath, feeling very tired, having pale skin, fast heartbeat, loss of energy, or weakness. | X | ||||||
| Diarrhea: Severe, at least 3 loose or liquid bowel movements in a day. | X | ||||||
| Hypertension (high blood pressure): shortness of breath, fatigue, dizziness or fainting, chest pain or pressure, swelling in your ankles and legs, bluish colour to your lips and skin, racing pulse or heart palpitations. | X | ||||||
| Nausea and Vomiting: Feeling sick. Being sick or throwing up. | X | ||||||
| Neutropenia or Leukopenia (low white blood cells: neutrophils and leukocytes): Fever or infection, fatigue, aches and pains, and flu-like symptoms. | X | ||||||
| Stomatitis (mouth sores, inflammation of the mouth) or Mucosal Inflammation (inflammation of the moist body surfaces): Red, sore or swollen mouth, lips, gums, nose or eyes, and ulcers. | X | ||||||
| Thrombocytopenia (low blood platelets): Bruising or bleeding for longer than usual if you hurt yourself, fatigue and weakness. | X | ||||||
| Urinary Tract Infection (UTI) (infection in urinary system including kidneys, ureters, bladder and urethra): Pain or burning sensation while urinating, frequent urination, blood in urine, pain in the pelvis, strong smelling urine, cloudy urine. | X | ||||||
| Common | |||||||
| Allergic Reactions, including Anaphylaxis: Rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing. | X | ||||||
| Myelodysplastic Syndrome or Acute Myeloid Leukemia (a group of diseases in which the body produces large numbers of abnormal blood cells): Fever, infection, bruising or bleeding easily, breathlessness, blood in urine or stool. | X | ||||||
| Uncommon | |||||||
| Kidney Disorder/Problems: nausea, vomiting, fever, swelling of extremities, fatigue, thirst, dry skin, irritability, dark urine, increased or decreased urine output, blood in the urine, rash, weight gain (from retaining fluid), loss of appetite, abnormal blood | X | ||||||
| test results, mental status changes (drowsiness, confusion, coma). | |||||||
| Psychiatric Disorders: seeing or hearing things that are not really there, confusion or difficulty concentrating/thinking, bad memory. | X | ||||||
| Bronchitis/Pneumonitis (inflammation in the lungs): persistent cough with or without mucous, fatigue, trouble breathing, shortness of breath. | X | ||||||
| Palpitation/Tachycardia (fast- beating, fluttering or pounding heart): skipping beats, beating too fast, pounding, fluttering rapidly. | X | ||||||
| Posterior Reversible Encephalopathy Syndrome, PRES – also known as Reversible Posterior Leukoencephalopathy Syndrome, RPLS (a rare neurological disorder): headaches, seizures, confusion, speech and visual loss, visual changes, with or without high blood pressure. | X | ||||||
| Rare | |||||||
| Hypertensive Crisis: a sudden increase in blood pressure, which may be a medical emergency that could lead to organ damage or can be life-threatening. | X | ||||||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
- Store ZEJULA capsules up to 25°C.
- Store ZEJULA tablets between 15°C and 30°C, in the original container.
- Do not use after the expiry date stated on the carton and blister pack. The expiry day refers to the last day of that month.
- Do not throw away any medicines via wastewater or household waste. Ask your healthcare provider or pharmacist about the right way to throw away outdated or unused ZEJULA. These measures will help protect the environment.
- Keep out of reach and sight of children.
If you want more information about ZEJULA:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website www.gsk.ca, or by calling 1-800-387-7374.
Date of Authorization: 2025-05-26
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