What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Black triangle. This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: EU/1/17/1235/001 .

Zejula 100 mg hard capsules

Package leaflet: Information for the patient

Zejula® 100 mg hard capsules

niraparib

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Zejula is and what it is used for
2. What you need to know before you take Zejula
3. How to take Zejula
4. Possible side effects
5. How to store Zejula
6. Contents of the pack and other information

1. 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 anti-cancer medicine called a PARP inhibitor. PARP inhibitors block an enzyme called poly [adenosine diphosphate-ribose] polymerase (PARP). PARP helps cells repair damaged DNA so blocking it means that the DNA of cancer cells cannot be repaired. This results in tumour cell death, helping to control the cancer.

What Zejula is used for

Zejula is used in adult women for the treatment of cancer of the ovary, the fallopian tubes (part of the female reproductive system that connects the ovaries to the uterus), or the peritoneum (the membrane lining the abdomen). It is used after the cancer has responded to previous treatment with standard platinum-based chemotherapy.

2. 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 breast-feeding.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before or while taking this medicine if any of the following could apply to you:

Low blood-cell counts

Zejula lowers your blood-cell counts, such as your red blood-cell count (anaemia), white blood-cell count (neutropenia), or blood-platelet count (thrombocytopenia). Signs and symptoms you need to look out for include fever or infection, and abnormal bruising or bleeding (see section 4 for more information). Your doctor will test your blood regularly throughout your treatment.

Myelodysplastic syndrome/acute myeloid leukaemia

Rarely, low blood-cell counts may be a sign of more serious problems with the bone marrow such as 'myelodysplastic syndrome' (MDS) or 'acute myeloid leukaemia' (AML). Your doctor may want to test your bone marrow to check for these problems.

High blood pressure

Zejula can cause high blood pressure, which in some cases, could be severe. Your doctor will measure your blood pressure regularly throughout your treatment. He or she may also give you medicine to treat high blood pressure and adjust your Zejula dose, if necessary.

Children and adolescents

Children under 18 years of age should not be given Zejula. This medicine has not been studied in this 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

Zejula should not be taken during pregnancy as it could harm your baby. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

If you are a woman who could become pregnant you must use reliable contraception while you are taking Zejula, and you must continue to use reliable contraception for 1 month after taking your last dose. Your doctor will ask you to confirm that you are not pregnant with a pregnancy test before starting your treatment. Contact your doctor straightaway if you become pregnant while you are taking Zejula.

Breast-feeding

Zejula should not be taken if you are breast-feeding as it is not known if it passes into breast milk. If you are breast-feeding, you must stop before you start taking Zejula and you must not begin breast-feeding again until 1 month after taking your last dose. Ask your doctor for advice before taking this medicine.

Driving and using machines

When you are taking Zejula it may make you feel weak, tired or dizzy and therefore influence your ability to drive and use machines. Observe caution when driving or using machines.

Zejula contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Zejula contains tartrazine (E 102)

It may cause allergic reactions.

3. How to take Zejula

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended starting dose is 3 capsules taken together once a day (total daily dose of 300 mg), with or without food. Take Zejula at approximately the same time each day. Taking Zejula at bedtime may help you to manage nausea.

Swallow the capsules whole, with some water. Do not chew or crush the capsules.

Your doctor may recommend a lower dose if you experience side effects (such as nausea, tiredness, abnormal bleeding/ bruising, anaemia).

Your doctor will check you on a regular basis, and you will normally continue to take Zejula as long as you experience benefit, and do not suffer unacceptable side effects.

If you take more Zejula than you should

If you take more than your normal dose, contact your doctor immediately.

If you forget to take Zejula

Do not take an additional dose if you miss a dose or vomit after taking Zejula. Take your next dose at its scheduled time. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor straight away if you notice any of the following SERIOUS side effects - you may need urgent medical treatment:

Very common (may affect more than 1 in 10 people)

  • Bruising or bleeding for longer than usual if you hurt yourself - these may be signs of a low blood platelet count (thrombocytopenia).
  • Being short of breath, feeling very tired, having pale skin, or fast heartbeat - these may be signs of a low red blood cell count (anaemia).
  • Fever or infection - these may be signs of a low white blood cell count (neutropenia).

Common (may affect up to 1 in 10 people)

  • Reduction in the number of white cells in the blood (leukopenia)

Talk to your doctor if you get any other side effects. These can include:

Very common (may affect more than 1 in 10 people)

  • Feeling sick
  • Feeling tired
  • Feeling of weakness
  • Constipation
  • Vomiting
  • Stomach pain
  • Inability to sleep
  • Headache
  • Decreased appetite
  • Runny or stuffy nose
  • Diarrhoea
  • Shortness of breath
  • High blood pressure
  • Indigestion
  • Dizziness
  • Cough
  • Urinary tract infection
  • Palpitations (feeling like your heart is skipping beats or beating harder than usual)
  • Abnormal taste in mouth

Common (may affect up to 1 in 10 people)

  • Sunburn-like reactions following exposure to light
  • Swelling in the feet, ankles, legs, and/or hands
  • Low potassium levels in the blood
  • Inflammation or swelling of the air passages between the mouth and nose and the lungs, bronchitis
  • Feeling of worry, nervousness, or unease
  • Feelings of sadness, depressed
  • Nose bleed
  • Decrease in weight
  • Muscle pain
  • Back pain
  • Joint pain
  • Pink eye
  • Fast heart beat may cause dizziness, chest pain or breathlessness
  • Dry mouth
  • Inflammation of the mouth
  • Rash
  • Elevated blood tests
  • Abnormal blood tests

Uncommon (may affect up to 1 in 100 people)

  • Reduction in the number of red blood cells, white blood cells and platelets

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via

United Kingdom

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Zejula

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30 °C.

Do not use this medicine if you notice any damage or signs of tampering to the pack.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Zejula contains

  • The active substance is niraparib. Each hard capsule contains niraparib tosylate monohydrate equivalent to 100 mg niraparib.
  • The other ingredients (excipients) are:
    capsule content: magnesium stearate, lactose monohydrate
    capsule shell: titanium dioxide (E 171), gelatin, brilliant blue FCF (E 133), erythrosine (E 127), tartrazine (E 102)
    printing ink: shellac (E 904), propylene glycol (E 1520), potassium hydroxide (E 525), black iron oxide (E 172), sodium hydroxide (E 524), and povidone (E 1201).

This medicine contains lactose and tartrazine - see section 2 for more information.

What Zejula looks like and contents of the pack

Zejula hard capsules have a white opaque body and a purple opaque cap. The white opaque capsule body is printed with '100 mg' in black ink, and the purple capsule cap is printed with 'Niraparib' in white ink. The capsules contain a white to off-white powder.

The hard capsules are packed in blister packs of

  • 84 x 1 hard capsules
  • 56 x 1 hard capsules
  • 28 x 1 hard capsules

Marketing Authorisation Holder

TESARO Bio Netherlands B.V.
Joop Geesinkweg 901
1114 AB Amsterdam-Duivendrecht
Netherlands

Manufacturer

TESARO Bio Netherlands B.V.
Joop Geesinkweg 901
1114 AB Amsterdam-Duivendrecht
Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom
TESARO Bio Netherlands B.V.
Tel: +44 330 3328100

This leaflet was last revised in 01/2019.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.