Onureg

Patient Information Leaflet: Information for the User

Onureg 200 mg film-coated tablets, 300 mg film-coated tablets

azacitidine
Please 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What Onureg is and what it is used for

What Onureg is
Onureg is an antitumour medicine belonging 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 normal production of 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 cancer cells from growing. Azacitidine, the active substance in Onureg, works by altering the way cells switch genes on and off. It also reduces the production of new genetic material (RNA and DNA). These effects are believed to block the growth of cancer cells in leukaemia.
If you have any questions about how Onureg works or why it has been prescribed for you, speak to your doctor or nurse.

2. What you need to know before taking Onureg

Do not take Onureg

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

Warnings and precautions
Blood tests
Before and during treatment with Onureg, you will undergo blood tests to check whether you have an adequate number of blood cells and to assess whether your liver and kidneys are functioning normally. Your doctor will determine how often these blood tests should be performed.
Immediately inform your doctor, pharmacist, or nurse if you experience any of the following symptoms during treatment with Onureg:

• bruising or bleeding – which could be due to a low number of blood cells called platelets;
• fever – which could be due to an infection caused by a reduced number of white blood cells, which can be life-threatening;
• diarrhoea, vomiting, or nausea (feeling unwell).

Azacitidine may cause a serious immune reaction called “differentiation syndrome” (see section 4 “Possible side effects”).
Your doctor may need to adjust the dose, temporarily suspend, or permanently discontinue treatment with Onureg. Your doctor may prescribe other medicines to manage these symptoms (see section 3 “How to take Onureg”).
Children and adolescents
Onureg is not recommended for children and adolescents under 18 years of age.
Other medicines and Onureg
Inform your doctor if you are taking, have recently taken, or might take any other medicines. This is because Onureg may affect how other medicines work. Other medicines may also affect how Onureg works.
Pregnancy, contraception, and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. Men should not father a child while receiving treatment with Onureg.
Pregnancy
Do not use Onureg during pregnancy, as it may harm the unborn baby. Inform your doctor immediately if you become pregnant during treatment with Onureg.
Contraception
Women of childbearing potential must use an effective method of contraception during treatment with Onureg and for 6 months after stopping treatment with Onureg. Men must use an effective method of contraception while taking Onureg and for 3 months after stopping treatment with Onureg.
Your doctor will discuss with you the most appropriate contraceptive method to use.
Breastfeeding
Do not breastfeed while taking Onureg, as it may harm the baby (see section 2 “Do not take Onureg”).
Fertility
Onureg may affect your ability to have children. Consult your doctor before using this medicine.
Driving and using machines or tools
You may feel tired, weak, or have difficulty concentrating. If this occurs or if you experience other side effects, do not drive and do not operate tools or machinery.
Onureg contains lactose
Onureg contains lactose monohydrate. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
Onureg contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

3. How to take Onureg

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor.

How much Onureg to take

• The recommended dose is 300 mg, taken orally once daily.
• Your doctor may reduce the dose to 200 mg once daily if you experience adverse reactions.

Onureg is administered in 28-day treatment cycles.

• You must take Onureg every day for the first 14 days of each 28-day cycle.
• You will then have a 14-day treatment break for the remainder of the cycle.

Your doctor will determine the dose of Onureg you should take. Your doctor may decide to:

• extend the treatment period beyond 14 days in each treatment cycle
• reduce the dose or temporarily interrupt treatment
• reduce the duration of treatment to 7 days.

Always take Onureg exactly as prescribed by your doctor.
Your doctor will prescribe a medicine to help reduce nausea (feeling of sickness) and vomiting.
Take this medicine 30 minutes before each Onureg tablet during the first and second treatment cycles. Your doctor will inform you if you need to take it for a longer period, if necessary.

How to take this medicine

• Take Onureg once daily, at the same time each day.
• Swallow the tablets whole with a glass of water.
• To ensure you take the correct dose, do not break, crush, dissolve, or chew the tablets.
• You may take the medicine with food or between meals.

If you vomit after taking a tablet, do not take another one on the same day. Instead, wait until the next day and take the next scheduled dose. Do not take two doses on the same day.
If powder from a broken tablet comes into contact with your skin, wash the skin immediately and thoroughly with soap and water. If the powder gets into your eyes, nose, or mouth, rinse the affected area thoroughly with water.

If you take more Onureg than you should
If you take more tablets than prescribed, contact your doctor or go to a hospital immediately. If possible, bring the medicine package and this patient information leaflet with you.

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

If you stop taking Onureg
Do not stop taking Onureg unless your doctor tells you to do so.
If you have any questions about how to use this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects
Immediately contact your doctor, pharmacist or nurse if you experience any of the
following symptoms during treatment with Onureg:
Very common: may affect more than 1 in 10 people

• bruising or bleeding – which could be due to a low number of blood cells called platelets;
• fever – which could be due to an infection caused by a reduced number of white blood cells, which can be life-threatening;
• diarrhoea, vomiting or nausea (feeling sick).

Other side effects include:
Very common: may affect more than 1 in 10 people

• constipation
• abdominal pain
• infection of nose, sinuses and throat
• lung infection
• feeling tired or weak
• loss of appetite
• pain affecting various parts of the body, which may range from sharp to dull
• joint stiffness
• back pain.

Common: may affect up to 1 in 10 people

• a blood infection caused by bacteria (sepsis) – which could be due to a reduced number of white blood cells in the blood
• influenza
• urinary tract infection
• hay fever
• anxiety
• weight loss.

Not known (frequency cannot be estimated from the available data)

• Severe immune reaction (differentiation syndrome) which may cause fever, cough, difficulty in breathing, rash, decreased urine output, low blood pressure (hypotension), swelling of the arms or legs and rapid weight gain.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Onureg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after
Exp/EXP. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer used. This will help protect the environment.

6. Package contents 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 components are croscarmellose sodium (E468), magnesium stearate (E572), mannitol (E421), and silicified microcrystalline cellulose (E460, E551).
• The coating of the 200 mg tablets - Opadry II pink - contains: hypromellose (E464), titanium dioxide (E171), lactose monohydrate, polyethylene glycol/macrogol (E1521), triacetin (E1518), and red iron oxide (E172). See section 2 “Onureg contains lactose and sodium”.
• The coating of the 300 mg tablets - Opadry II brown - contains: hypromellose (E464), titanium dioxide (E171), lactose monohydrate, polyethylene glycol/macrogol (E1521), triacetin (E1518), red iron oxide (E172), yellow iron oxide (E172), and black iron oxide (E172). See section 2 “Onureg contains lactose and sodium”.

Description of the appearance of Onureg and contents of the pack
Onureg 200 mg film-coated tablets (tablets) are oval-shaped, pink in colour, with "200" printed on one side and "ONU" on the other side.
Onureg 300 mg film-coated tablets (tablets) are oval-shaped, brown in colour, with "300" printed on one side and "ONU" on the other side.
The tablets are packed 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
The Netherlands

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

Belgique/België/Belgien Lietuva
N.V. Bristol-Myers Squibb Belgium S.A. Swixx Biopharma UAB
Tél/Tel: + 32 2 352 76 11 Tel: + 370 52 369140
[email protected] [email protected]

България Luxembourg/Luxemburg
Swixx Biopharma EOOD N.V. Bristol-Myers Squibb Belgium S.A.
Teл.: + 359 2 4942 480 Tél/Tel: + 32 2 352 76 11
[email protected] [email protected]

Česká republika Magyarország
Bristol-Myers Squibb spol. s r.o. Bristol-Myers Squibb Kft.
Tel: + 420 221 016 111 Tel.: + 36 1 301 9797
[email protected] [email protected]

Danmark Malta
Bristol-Myers Squibb Denmark A.M. Mangion Ltd
Tlf: + 45 45 93 05 06 Tel: + 356 23976333
[email protected] [email protected]

Deutschland Nederland
Bristol-Myers Squibb GmbH & Co. KGaA Bristol-Myers Squibb B.V.
Tel: 0800 0752002 (+ 49 89 121 42 350) Tel: + 31 (0)30 300 2222
[email protected] [email protected]

Eesti Norge
Swixx Biopharma OÜ Bristol-Myers Squibb Norway AS
Tel: + 372 640 1030 Tlf: + 47 67 55 53 50
[email protected] [email protected]

Ελλάδα Österreich
Bristol-Myers Squibb A.E. Bristol-Myers Squibb GesmbH
Τηλ: + 30 210 6074300 Tel: + 43 1 60 14 30
[email protected] [email protected]

España Polska
Bristol-Myers Squibb, S.A. Bristol-Myers Squibb Polska Sp. z o.o.
Tel: + 34 91 456 53 00 Tel.: + 48 22 2606400
[email protected] [email protected]

France Portugal
Bristol-Myers Squibb SAS Bristol-Myers Squibb Farmacêutica Portuguesa, S.A.
Tél: + 33 (0)1 58 83 84 96 Tel: + 351 21 440 70 00
[email protected] [email protected]

Hrvatska România
Swixx Biopharma d.o.o. Bristol-Myers Squibb Marketing Services S.R.L.
Tel: + 385 1 2078 500 Tel: + 40 (0)21 272 16 19
[email protected] [email protected]

Ireland Slovenija
Bristol-Myers Squibb Pharmaceuticals uc Swixx Biopharma d.o.o.
Tel: 1 800 749 749 (+ 353 (0)1 483 3625) Tel: + 386 1 2355 100
[email protected] [email protected]

Ísland Slovenská republika
Vistor ehf. Swixx Biopharma s.r.o.
Sími: + 354 535 7000 Tel: + 421 2 20833 600
[email protected] [email protected]

Italia Suomi/Finland
Bristol-Myers Squibb S.r.l. Oy Bristol-Myers Squibb (Finland) Ab
Tel: + 39 06 50 39 61 Puh/Tel: + 358 9 251 21 230
[email protected] [email protected]

Κύπρος Sverige
Bristol-Myers Squibb A.E. Bristol-Myers Squibb Aktiebolag
Τηλ: 800 92666 (+ 30 210 6074300) Tel: + 46 8 704 71 00
[email protected] [email protected]

Latvija
Swixx Biopharma SIA
Tel: + 371 66164750
[email protected]

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu.