200 mg and 300 mg film-coated tablets
azacitidine
What Onureg is and what it is used for
What Onureg is
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 leukemia (AML). It is a form of cancer that affects the bone marrow and can lead to problems with the production of normal blood cells.
Onureg is used to keep the disease under control ( remission – when the disease is milder or inactive).
How Onureg works
Onureg works by preventing the growth of cancer cells. Azacitidine, the active substance in Onureg, works by changing the way cells activate and deactivate genes. It also reduces the production of new genetic material ( RNA and DNA ). These mechanisms are thought to block the growth of cancer cells in leukemia.
Talk to your doctor or nurse if you have any questions about how Onureg works and why you have been given this medicine.
What you need to know before using 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 cautions
Blood tests
You may have blood samples taken before you start taking Onureg and also while you are being treated with Onureg to make sure you have enough blood cells and that your liver and kidneys are working properly. Your doctor will decide how often you need to take blood samples.
If you get any of these symptoms during treatment with Onureg, tell your doctor, pharmacist, or nurse immediately:
- bruising or bleeding – can be caused by you having a low number of a type of blood cell called platelets;
- fever – can be caused by an infection due to low white blood cell count , which can be life threatening;
- diarrhea, vomiting or nausea.
Your doctor may need to change your dose, take a break or stop taking Onureg altogether. Your doctor may prescribe other medicines to relieve these symptoms.
Children and young people
Onureg is not recommended for children and adolescents under 18 years of age.
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 some other medicines work. Other medicines may also affect the way Onureg works.
Pregnancy, contraception and breastfeeding
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 using this medicine. Men should not have children during treatment with Onureg.
Pregnancy
You should not take Onureg if you are pregnant as it may harm your baby. Tell your doctor immediately if you become pregnant during treatment.
Contraceptive
If you are a fertile woman, you should use an effective method of contraception while taking Onureg and up to 6 months after stopping treatment with Onureg. Men should use an effective method of contraception while taking Onureg and up to 3 months after stopping treatment with Onureg.
Your doctor will talk to you about which contraceptive method is most appropriate.
Breast-feeding
Do not breast-feed while you are being treated with Onureg as it may be harmful to your baby.
Fertility
Onureg may affect your ability to have children. Talk to your doctor before using it.
Driving and using machines
You may feel tired, weak, or have difficulty concentrating. If you notice this or if you get any other side effects, do not drive or use any tools or implements.
Onureg contains lactose and sodium
Onureg contains lactose
Onureg 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.
Onureg contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to take Onureg
Always take this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
How much to take
- The recommended dose is 300 mg orally once daily.
- Your doctor may reduce your dose to 200 mg once a day.
Onureg is given in treatment cycles of 28 days.
- You take Onureg daily for the first 14 days of each 28-day cycle.
- Then follows a treatment-free period of 14 days for the rest of the cycle.
Your doctor will tell you which dose to take. The doctor may decide to:
- extend the treatment time beyond the 14 days in each treatment cycle
- reduce the dose one or make a temporary pause in the treatment
- shorten the treatment time to 7 days.
Always take Onureg exactly as your doctor has told you.
Your doctor will give you medicine to reduce nausea and vomiting. You take it 30 minutes before each Onureg tablet, during the first and second treatment cycles. If necessary, your doctor will instruct you to take it for a long time.
How to take this medicine
- Take Onureg once daily, at the same time each day.
- Swallow the tablets whole with a full glass of water.
- To ensure the correct dose , do not divide, crush, dissolve or chew the tablets.
- You can take the tablets with food or between meals.
If you vomit after taking a tablet, do not take a new dose that day. Instead, wait until the next day and take your scheduled dose as usual. Do not take two doses on the same day.
If you get powder from a broken tablet on your skin, wash your skin immediately with soap and water. If you get powder in your eyes, nose, or mouth, rinse the area thoroughly with water.
If you take more Onureg than you should
If you have taken too many tablets, consult a doctor or go to the 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 usual dose as soon as you remember on the same day, and then 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 product, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
If you get any of these symptoms during treatment with Onureg, tell your doctor, pharmacist, or nurse immediately:
- bruising or bleeding – can be caused by you having a low number of a type of blood cell called platelets;
- fever – can be caused by an infection due to low white blood cell count , which can be life threatening;
- diarrhea, vomiting or nausea.
Other side effects are:
Very common side effects ( may affect more than 1 in 10 people):
- constipation
- abdominal pain
- infection of the nose, sinuses and throat
- lung infection ( pneumonia )
- fatigue or weakness
- decreased appetite
- pain in different parts of the body – can be anything from cutting pain to excruciating pain
- stiff joints
- back pain.
Common side effects ( may affect up to 1 in 10 people):
- influenza
- urinary tract infection
- hay fever
- concern
- weight loss.
How to store 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. The expiration date is the last day of the specified month.
No special storage instructions.
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 to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is azacitidine. Each film-coated tablet contains either 200 mg or 300 mg of azacitidine.
- The other ingredients are croscarmellose sodium (E468), magnesium stearate (E572), mannitol (E421) and silica-treated microcrystalline cellulose (E460, E551).
- The 200 mg tablet coating – Pink Opadry II contains: hypromellose (E464), titanium dioxide (E171), lactose monohydrate , polyethylene glycol / macrogol (E1521), triacetin (E1518) and red iron oxide (E172). See section 2 “Onureg contains sodium”.
- The 300 mg tablet coating – Brown Opadry II 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 sodium”.
What the medicine looks like and contents of the pack
Onureg 200 mg film-coated tablets are pink and oval with “200” debossed on one side and “ONU” on the other side.
Onureg 300 mg film-coated tablets are brown and oval with “300” debossed on one side and “ONU” on the other side.
The film-coated tablets are packaged in aluminum blisters.
Each pack contains 7 or 14 film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Bristol ‑ Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland
Manufacturer
Celgene Distribution BV
Orteliuslaan 1000
3528 BD Utrecht
Netherlands