ONUREG 300 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Onureg 200 mg film-coated tablets

Onureg 300 mg film-coated tablets

azacitidine

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.

Contents of the pack

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

1. What is Onureg and what is it used for

What is Onureg

Onureg is a cancer medicine that belongs to a group of medicines called antimetabolites. Onureg contains the active substance azacitidine.

What Onureg is used for

Onureg is used to treat adults with acute myeloid leukaemia (AML). This is a type of cancer that affects the bone marrow and can cause problems with the production of normal blood cells.

Onureg is used to keep the disease under control (remission, when the disease is less severe or not active).

How Onureg works

Onureg works by preventing the growth of cancer cells. Azacitidine, the active substance in Onureg, works by altering the way cells activate or deactivate genes. It also reduces the production of new genetic material (RNA and DNA). It is thought that these effects block the growth of cancer cells in leukaemia.

Ask your doctor or nurse if you have any questions about how Onureg works or why you have been prescribed this medicine.

2. What you need to know before you take Onureg

Do not take Onureg

• if you are allergic to azacitidine or any of the other ingredients of this medicine (listed in section 6);
• if you are breast-feeding.

Warnings and precautions

Blood tests

You will have blood tests before and during treatment with Onureg to check that you have enough blood cells and that your liver and kidneys are working properly. Your doctor will decide how often you need to have blood tests.

Tell your doctor, pharmacist, or nurse immediately if you get any of the following symptoms during treatment with Onureg:

• bruising or bleeding: this could be due to a low count of blood cells called platelets;
• fever: this could be due to an infection as a result of having low white blood cell counts, which can be life-threatening;
• diarrhoea, vomiting, or nausea (feeling sick).

Your doctor may need to change your dose or stop your treatment with Onureg temporarily or permanently. The doctor may prescribe you other medicines to help treat these symptoms.

Children and adolescents

Onureg is not recommended for use in children and adolescents under 18 years.

Other medicines and Onureg

Tell your doctor if you are taking, have recently taken, or might take any other medicines. This is because Onureg may affect the way other medicines work. Similarly, other medicines may affect the way Onureg works.

Pregnancy, contraception, and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Men should not father a child while receiving treatment with Onureg.

Pregnancy

Onureg must not be used during pregnancy because it may harm the baby. Tell your doctor immediately if you become pregnant during treatment.

Contraception

If you are a woman who can become pregnant, you must use effective contraception while taking Onureg and for 6 months after stopping treatment with Onureg. Men must use effective contraception while taking Onureg and for 3 months after stopping treatment with Onureg.

Your doctor will discuss with you the most suitable method of contraception for you.

Breast-feeding

Do not breast-feed while taking Onureg as it may harm your child.

Fertility

Onureg may affect your ability to have children. Ask your doctor for advice before taking this medicine.

Driving and using machines or tools

You may feel tired or weak or have problems with concentration. If this happens or if you have other side effects, do not drive or use machines or tools.

Onureg contains lactose

Onureg contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Onureg contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take Onureg

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor.

How much to take

• The recommended dose is 300 mg by mouth once a day.
• Your doctor may reduce your dose to 200 mg once a day.

Onureg is given in 28-day treatment cycles.

• Onureg is taken every day for the first 14 days of each 28-day cycle.
• This is followed by a 14-day period without treatment for the rest of the cycle.

Your doctor will tell you which dose of Onureg to take. The doctor may decide to:

• extend treatment beyond 14 days of each treatment cycle;
• reduce your dose or stop your treatment temporarily;
• reduce treatment to 7 days.

Always take Onureg as your doctor has told you.

Your doctor will give you a medicine to help reduce nausea (feeling sick) and vomiting. You will take this medicine 30 minutes before each Onureg tablet, during the first and second treatment cycles. If necessary, your doctor will tell you to take it for a longer period.

Taking this medicine

• Take Onureg once a day - at the same time each day.
• Swallow the tablets whole with a full glass of water.
• In order to ensure that you receive the correct dose, do not break, crush, dissolve, or chew the tablets.
• You can take the medicine with food or between meals.

If you vomit after taking a tablet, do not take another dose on the same day. Instead, wait until the next day to take your next scheduled dose. Do not take two doses on the same day.

If the powder from a broken tablet comes into contact with your skin, wash the skin immediately and thoroughly with water and soap. If the powder comes into contact with your eyes, nose, or mouth, rinse the area thoroughly with water.

If you take more Onureg than you should

If you take more tablets than you should, contact your doctor or go to a hospital immediately. If possible, take the medicine pack and this leaflet with you.

If you forget to take Onureg

If you forget to take Onureg at the usual time, take your dose as soon as you remember on the same day and take the next dose at the usual time the next day. Do not take a double dose to make up for a forgotten or vomited tablet.

If you stop taking Onureg

Do not stop taking Onureg unless your doctor tells you to.

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

4. Possible side effects

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

Serious side effects

Tell your doctor, pharmacist, or nurse immediatelyif you get any of the following symptoms during treatment with Onureg:

• bruising or bleeding: this could be due to a low count of blood cells called platelets;
• fever: this could be due to an infection as a result of having low white blood cell counts, which can be life-threatening;
• diarrhoea, vomiting, or nausea (feeling sick).

Other side effects include:

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

• constipation;
• abdominal pain;
• infections of the nose, sinuses, and throat;
• lung infection;
• fatigue or weakness;
• loss of appetite;
• pain that affects different parts of the body, which can range from a stabbing pain to a constant pain;
• stiffness of the joints;
• back pain.

Common side effects(may affect up to 1 in 10 people):

• flu;
• urinary tract infection;
• hay fever;
• anxiety;
• weight loss.

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 the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Onureg

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 blister and carton after EXP or CAD. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Onureg contains

• The active substance is azacitidine. Each film-coated tablet contains 200 mg or 300 mg of azacitidine.

• The other ingredients are croscarmellose sodium (E468), magnesium stearate (E572), mannitol (E421), and silicified microcrystalline cellulose (E460, E551).

• The 200 mg tablet coating, Opadry II pink, contains: hypromellose (E464), titanium dioxide (E171), lactose monohydrate, polyethylene glycol/macrogols (E1521), triacetin (E1518), and iron oxide red (E172). See section 2 “Onureg contains sodium”.

• The 300 mg tablet coating, Opadry II brown, contains: hypromellose (E464), titanium dioxide (E171), lactose monohydrate, polyethylene glycol/macrogols (E1521), triacetin (E1518), iron oxide red (E172), iron oxide yellow (E172), and iron oxide black (E172). See section 2 “Onureg contains sodium”.

Appearance and packaging

Onureg 200 mg film-coated tablets are pink and oblong with “200” printed on one side and “ONU” on the other side.

Onureg 300 mg film-coated tablets are brown and oblong with “300” printed on one side and “ONU” on the other side.

The film-coated tablets are packaged in aluminium blisters.

Each pack contains 7 or 14 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorisation holder

Bristol-Myers Squibb Pharma EEIG

Plaza 254

Blanchardstown Corporate Park 2

Dublin 15, D15 T867

Ireland

Manufacturer

Celgene Distribution B.V.

Orteliuslaan 1000

3528 BD Utrecht

Netherlands

Date of last revision of this leaflet

Other sources of information

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