Vidaza (Azacitidine)
Vidaza 25 mg/ml powder for suspension for injection
Azacitidine
1. WHAT VIDAZA IS AND WHAT IT IS USED FOR
Vidaza contains the active substance azacitidine. It works by preventing the growth of cancer cells.
Vidaza is used in adults who are not eligible for stem cell transplantation to treat:
• higher-risk myelodysplastic syndromes (MDS) a group of illnesses of the bone marrow resulting in the production of too few blood cells.
• chronic myelomonocytic leukaemia (CMML).
• acute myeloid leukaemia (AML).
Talk to your doctor if you have any questions about how Vidaza works or why this medicine has been prescribed for you.
2. BEFORE YOU USE VIDAZA
Do not use Vidaza
• if you are allergic (hypersensitive) to azacitidine or to any of the other ingredients of Vidaza.
• if you have advanced liver cancer.
• if you are breast-feeding.
Take special care with Vidaza
Check with your doctor or nurse before using this medicine if you have:
• decreased counts of platelets, red or white blood cells.
• kidney disease.
• liver disease.
If you are not sure if any of the above applies to you, talk to your doctor or nurse before having Vidaza.
Vidaza is not recommended for use in children and adolescents below the age of 18.
You will have blood tests before you begin treatment with Vidaza and at the start of each period of treatment (called a ‘cycle’). This is to check that you have enough blood cells and that your liver and kidneys are working properly.
For men having Vidaza, please see the section “Pregnancy and breast feeding” below.
Taking other medicines
Please tell your doctor or nurse if you are using or have recently used any other medicines including medicines obtained without a prescription and herbal preparations. This is because Vidaza may affect the way some other medicines work. Also, some other medicines may affect the way Vidaza works.
Pregnancy and breast-feeding
You should not use Vidaza during pregnancy as it may be harmful to the baby.
Use an effective method of contraception during and up to 3 months after treatment with Vidaza.
Tell your doctor straight away if you become pregnant during treatment with Vidaza.
You must not use Vidaza if you are breast-feeding. It is not known if Vidaza passes into the mother’s milk and therefore you must not breast-feed your baby during treatment.
Men should not father a child while receiving treatment with Vidaza. Use an effective method of contraception during and up to 3 months after treatment with Vidaza.
Talk to your doctor if you wish to conserve your sperm before starting this treatment.
Driving and using machines
No studies of the effects on the ability to drive and use machines have been performed. Some people may feel tired after being given Vidaza. If this happens to you, do not drive or use any tools or machines.
3. HOW TO USE VIDAZA
Your doctor will give you another medicine to prevent nausea and vomiting at the start of each treatment cycle, before giving you Vidaza.
• The usual dose is 75 mg per m2 body surface area. Your doctor will chose your dose of Vidaza, depending on your general condition, height and weight. Your doctor will check your progress and may change your dose if necessary.
• Vidaza is given every day for one week, followed by a rest period of 3 weeks. This “treatment cycle” will be repeated every 4 weeks. You will usually receive at least 6 treatment cycles.
Vidaza will be given to you as an injection under the skin (subcutaneously) by a doctor or nurse. It may be given under the skin on your thigh, tummy or upper arm.
If you have any further questions on the use of this product, ask your doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Vidaza can cause side effects, although not everybody gets them.
Tell your doctor straight away if you notice any of the following side effects:
• A fever. This may be due to an infection as a result of having low levels of white blood cells.
• Chest pain or shortness of breath which may be accompanied with a fever. This may be due to an infection of the lung called “pneumonia”.
• Bleeding. Such as blood in the stools due to bleeding in the stomach or gut.
• Difficulty breathing, swelling of the lips, itching or rash. This may be due to an allergic (hypersensitivity) reaction.
Side effects may occur with certain frequencies, which are defined as follows:
| very common: | affects more than 1 user in 10 |
| common: | affects 1 to 10 users in 100 |
| uncommon: | affects 1 to 10 users in 1,000 |
| rare: | affects 1 to 10 users in 10,000 |
| very rare: | affects less than 1 user in 10,000 |
| not known: | frequency cannot be estimated from the available data |
Very common side effects
• Reduced red blood count (anaemia). You may feel tired and pale.
• Reduced white blood cell count. This may be accompanied by a fever. You are also more likely to get infections.
• A low blood platelet count (thrombocytopenia). You are more prone to bleeding and bruising.
• Constipation, diarrhoea, nausea, vomiting.
• Pneumonia.
• Chest pain, being short of breath.
• Tiredness (fatigue).
• Injection site reaction including redness, pain or a skin reaction.
• Loss of appetite.
• Joint aches.
• Bruising.
• Rash.
• Red or purple spots under your skin.
• Pain in your belly (abdominal pain).
• Itching.
• Fever.
• Sore nose and throat.
• Dizziness.
• Headache.
Common side effects
• Bleeding inside your head.
• An infection of the blood caused by bacteria (sepsis). This may be due to low levels of white cells in your blood.
• Bone marrow failure. This can cause low levels of red and white blood cells and platelets.
• A type of anaemia where your red and white blood cells and platelets are reduced.
• An infection in your urine.
• A viral infection causing cold sores (herpes).
• Bleeding gums, bleeding in the stomach or gut, bleeding from around your back passage due to piles (haemorrhoidal haemorrhage), bleeding in your eye, bleeding under your skin, or into your skin (haematoma).
• Blood in your urine.
• Ulcers of your mouth or tongue.
• Changes to your skin at the injection site. These include swelling, a hard lump, bruising, bleeding into your skin (haematoma), rash, itching and changes in the skin colour.
• Redness of your skin.
• An infection of the nose and throat, or sore throat.
• Sore or runny nose or sinuses (sinusitis).
• Low levels of potassium in your blood.
• High or low blood pressure (hypertension or hypotension).
• Being short of breath when you move.
• Pain in your throat and voicebox.
• Indigestion.
• Weight loss.
• Lethargy.
• Feeling generally unwell.
• Muscle aches.
• Anxiety or having trouble sleeping (insomnia).
• Being confused.
• Hair loss.
Uncommon side effects
• Allergic (hypersensitivity) reaction.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
5. HOW TO STORE VIDAZA
Keep out of the reach and sight of children.
Do not use Vidaza after the expiry date which is stated on the vial label and the carton. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
The reconstituted suspension may be stored at 25 °C for 45 minutes or at 2°C to 8°C for 8 hours.
Your doctor or pharmacist are responsible for storing Vidaza. They are also responsible for disposing of any unused Vidaza correctly.
6. FURTHER INFORMATION
What Vidaza contains
• The active substance is azacitidine. 1 vial contains 100 mg azacitidine. After reconstitution with 4 ml of water for injections, the reconstituted suspension contains 25 mg/ml azacitidine.
• The other ingredient is mannitol (E421).
What Vidaza looks like and contents of the pack
Vidaza is a white powder for suspension for injection and is supplied in a glass vial containing 100 mg of azacitidine.
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