100 mg film-coated tablets
niraparib
What Zejula is and what it is used for
What Zejula is and how it works
Zejula contains the active substance niraparib. Niraparib is a type of cancer drug called a PARP inhibitor. PARP inhibitors block an enzyme called PARP (poly[adenosine diphosphate‑ribose] polymerase). PARP helps cells repair damaged DNA. When niraparib blocks PARP, the DNA in the cancer cells cannot be repaired, leading to tumor cell death.
What Zejula is used for
Zejula is used in adult women to treat cancer of the ovaries, fallopian tubes (part of the female reproductive system that runs from the ovaries to the uterus), or the peritoneum (the membrane that surrounds the abdominal cavity).
It is used after cancer has:
- responded to the first treatment with platinum-based cytostatics ( chemotherapy er), or
- has come back (recurred) after cancer has responded to previous standard treatment with platinum-based cytostatics.
What you need to know before you take Zejula
Do not take Zejula
- if you are allergic to niraparib or any of the other ingredients of this medicine (listed in section 6).
- if you are breastfeeding.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before or while taking this medicine if any of the following apply to you:
Low blood counts
Zejula lowers your blood values, such as the number of red blood cells (anemia; anemia ), the number of white blood cells ( neutropenia ), or the number of platelets ( thrombocytopenia ). You should look out for signs and symptoms such as fever or infection and abnormal bruising or bleeding (see section 4 for more information). Your doctor will take blood samples regularly during treatment.
Myelodysplastic syndrome/acute myelogenous leukemia
In rare cases, low blood counts can be a sign of a more serious bone marrow problem, such as myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). Your doctor may want to check your bone marrow to see if you have developed such problems.
High blood pressure
Zejula can cause high blood pressure, which in some cases can be serious. Your doctor will measure your blood pressure regularly throughout your treatment. The doctor can also give you medicine for high blood pressure and, if necessary, adjust your dose of Zejula. Your doctor can advise you to measure your blood pressure at home and inform you when to contact him or her if your blood pressure rises.
Posterior reversible encephalopathy syndrome (PRES)
A rare neurological side effect called PRES has been associated with treatment with Zejula. If you get a headache, vision changes, seizures, or become confused, with or without high blood pressure, you should contact a doctor.
Children and young people
Children under 18 should not take Zejula. The drug has not been studied in that age group.
Other medicines and Zejula
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy
You should not take Zejula if you are pregnant, as it may harm your baby. If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
If you are a woman and could become pregnant, you must use effective contraception while taking Zejula, and you must continue to use effective contraception for 1 month after you have taken the last dose. Your doctor will ask you to take a pregnancy test to confirm that you are not pregnant before starting treatment. Contact your doctor immediately if you become pregnant while taking Zejula.
Breast-feeding
You should not take Zejula if you are breastfeeding, as it is not known whether the medicine passes into breast milk. If you are breastfeeding, you must stop breastfeeding before you start taking Zejula, and you must not start breastfeeding again until 1 month after you have taken the last dose. Consult a doctor before taking this medicine.
Driving ability and use of machinery
Zejula can make you feel weak, unfocused, tired, or dizzy so that your ability to drive and use machines is affected. Be careful when driving or using machinery.
Zejula contains lactose
If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
How to take Zejula
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
For ovarian cancer that has responded to the first treatment with platinum-based chemotherapy
The recommended starting dose is 200 mg (two 100 mg tablets) taken at the same time once a day, with or without food. If you weigh 77 kg or more and have a platelet count of 150,000/µl or more before starting treatment, the recommended starting dose is 300 mg (three 100 mg tablets) taken at the same time once a day, with or without food.
For ovarian cancer that has come back (recurred)
The recommended starting dose is 300 mg (three 100 mg tablets) taken at the same time once a day, with or without food.
Take Zejula at about the same time each day. Taking Zejula at bedtime can reduce the risk of possible nausea.
Your doctor may adjust your starting dose if you have liver problems.
If you experience side effects (eg nausea, tiredness, abnormal bleeding/bruising, anemia ( lack of blood )) your doctor may recommend a lower dose.
The doctor will carry out regular checks, and you will usually continue to take Zejula as long as you benefit from the treatment and do not experience unacceptable side effects.
If you have taken too much Zejula
If you have taken more than your normal dose, contact your doctor immediately.
If you forget to take Zejula
Do not take an extra dose if you miss a dose or vomit after taking Zejula. Take the next dose at the same time as planned. Do not take a double dose to make up for a missed dose.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you get any of the following serious side effects – you may need urgent medical attention:
Very common (may affect more than 1 in 10 users):
- Bruising or bleeding that lasts longer than usual when you injure yourself. It may be a sign of a low number of blood platelets ( thrombocytopenia ).
- Shortness of breath, pronounced tiredness, pale skin, or fast pulse. It may be a sign of a low number of red blood cells ( anemia ).
- Fever or infection – low white blood cell count ( neutropenia ) can increase the risk of infection. Signs may include fever, chills, feeling weak or confused, cough, pain, or a burning sensation when urinating. Some infections can be serious and lead to death.
- Decreased number of white blood cells in the blood ( leukopenia ).
Common (may affect up to 1 in 10 users):
- Allergic reaction (includes severe allergic reactions that can be life-threatening). Signs of this include raised and itchy skin rashes ( hives ) and swelling – sometimes swelling of the face or mouth ( angioedema ) which can cause breathing difficulties, collapse, or loss of consciousness.
Rare (may affect up to 1 in 1,000 users):
- A sudden increase in blood pressure. This can be an acute medical condition that can lead to organ damage or be life-threatening.
- A condition of the brain with symptoms such as seizures, headaches, confusion, and visual changes (posterior reversible encephalopathy syndrome or PRES). This is an acute medical condition that can lead to organ damage or be life-threatening.
Talk to your doctor if you get any other side effects. It can be about:
Very common (may affect more than 1 in 10 users):
- Nausea
- Heartburn ( dyspepsia )
- Decreased number of white blood cells in the blood
- Decreased number of platelets in the blood
- Decreased number of red blood cells in the blood ( anemia )
- Fatigue
- Impotence
- Constipation
- Vomiting
- Stomach pains
- Insomnia
- Headache
- Decreased appetite
- Runny or stuffy nose
- Diarrhea
- Shortness of breath
- Back pain
- Joint pain
- High blood pressure
- Indigestion
- Dizziness
- Cough
- Urinary tract infection
- Palpitations (feeling like your heart is skipping beats or beating faster than usual)
Common (may affect up to 1 in 10 users):
- Skin reactions after exposure to light that is similar to those you get after getting sunburned
- Swollen feet, ankles, legs, and/or hands
- Low levels of potassium in the blood
- Inflammation or swelling of the airways between the mouth, nose, and lungs ( bronchitis )
- Bloated stomach
- Anxiety, nervousness
- Low mood, depression
- Nosebleed
- Weight loss
- Muscle pain
- Impaired concentration, understanding, memory, and thinking ability ( cognitive impairment)
- Inflamed red eyes
- Fast heartbeat (may cause dizziness, chest pain, or shortness of breath)
- Dry mouth
- Inflammation of the mouth and/or gastrointestinal tract
- Rash
- Elevated blood test values
- Abnormal blood test values
- Abnormal taste in the mouth
Uncommon (may affect up to 1 in 100 users):
- Decreased number of red blood cells, white blood cells, and platelets
- State of confusion
- Inflammation of the lungs that can cause shortness of breath and breathing difficulties (non-infectious pneumonia)
How to store Zejula
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and blister after “EXP”. The expiration date is the last day of the specified month.
No special instructions on storage temperature.
Store in the original packaging. Moisture sensitive.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is niraparib. Each film-coated tablet contains niraparib tosylate monohydrate equivalent to 100 mg niraparib.
- Other ingredients (excipients) are:
Tablet core: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose (E 460), povidone (E 1201), colloidal hydrogenated silicon dioxide.
Film coating: polyvinyl alcohol (E 1203), titanium dioxide (E 171), macrogol (E 1521), talc (E 553b), black iron oxide (E 172).
This medicine contains lactose – see section 2 for more information.
Appearance and package sizes of the medicine
Zejula 100 mg film-coated tablets are grey, oval, film-coated tablets debossed with “100 mg” on one side and “Zejula” on the other side.
The film-coated tablets are packed in blister packs with
- 84 × 1 film-coated tablets
- 56 × 1 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
GlaxoSmithKline (Ireland) Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
Manufacturer
GlaxoSmithKline Trading Services Ltd.
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
Millmount Healthcare Ltd.
Block 7, City North Business Campus,
Stamullen, Co Meath
Ireland
Glaxo Wellcome, SA
Abda. Extremadura, 3
09400 Aranda de Duero
Burgos
Spain
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
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