25 mg/ml powder for injection, suspension
azacitidine
What Vidaza is and what it is used for
What Vidaza is
Vidaza is an anti-cancer agent that belongs to a group of medicines called ‘antimetabolites’. Vidaza contains the active substance “azacytidine”.
What Vidaza is used for
Vidaza is used in adults who cannot be treated with a stem cell transplant to treat:
- myelodysplastic syndrome (MDS) at higher risk.
- chronic myelomonocytic leukemia (CMML).
- acute myeloid leukemia (AML).
These are diseases that affect the bone marrow and can cause problems with normal blood cell production.
How Vidaza works
Vidaza works by stopping cancer cells from growing. Azacitidine is incorporated into the cell’s genetic material ( ribonucleic acid ( RNA ) and deoxyribonucleic acid ( DNA )). It is thought to work by changing the way cells activate and deactivate genes, and also by interfering with the production of new RNA and DNA. These measures are considered to correct problems with the maturation and growth of new blood cells in the bone marrow that cause myelodysplastic syndromes, as well as dead cancer cells in leukemia.
Talk to your doctor or nurse if you have any questions about how Vidaza works or why this medicine has been prescribed for you.
What you need to know before you use Vidaza
Do not use Vidaza
- if you are allergic to azacitidine or any of the other ingredients of this medicine (listed in section 6).
- if you have advanced liver cancer.
- if you are breastfeeding.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Vidaza:
- If you have a reduced number of platelets, red or white blood cells.
- If you have kidney disease.
- If you have liver disease.
- If you have ever had heart disease or heart attack or have had lung disease
Vidaza can cause a serious immune reaction called ‘differentiation syndrome’ (see section 4).
Blood sample
You will be given blood tests before you start treatment with Vidaza and at the start of each treatment period (called a ‘cycle’). The intention is to check that you have enough blood cells and that the liver and kidneys are working as they should.
Children and young people
Vidaza is not recommended for children and adolescents under 18 years of age.
Other medicines and Vidaza
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Vidaza can affect the way other medicines work. Some other medicines can also affect the way Vidaza works.
Pregnancy, breastfeeding, and fertility
Pregnancy
You should not use Vidaza during pregnancy as it may harm the baby. If you are a woman of childbearing potential, you must use effective contraception while taking Vidaza and for 6 months after stopping treatment with Vidaza. Tell your doctor immediately if you become pregnant during treatment.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Breast-feeding
You must not use Vidaza if you are breastfeeding. It is not known whether Vidaza passes into breast milk.
Fertility
Men should not father children while being treated with Vidaza. Men should use an effective method of contraception while taking Vidaza and for 3 months after stopping treatment with Vidaza.
Talk to your doctor if you want to save sperm before undergoing this treatment.
Driving ability and use of machinery
Do not drive a car and do not use tools or machines if you experience side effects such as fatigue.
How to use Vidaza
Before your doctor gives you Vidaza, he/she will give you another medicine to prevent you from feeling sick and vomiting at the start of each treatment cycle.
- The recommended dose is 75 mg per m 2 body surface. Your doctor determines the amount of this medicine depending on your general condition and your height and weight. Your doctor will examine how your condition develops and may change the amount if necessary.
- Vidaza is given every day for a week, followed by a rest period of 3 weeks. This “treatment cycle” will be repeated every 4 weeks. You normally receive at least 6 treatment cycles.
This medicine will be given to you as an injection under the skin ( subcutaneously ) by a doctor or nurse. It can be given under the skin of the thigh, abdomen, or upper arm.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you notice any of the following side effects:
- Drowsiness, tremors, jaundice, swollen abdomen, and frequent bruising. These can be symptoms of liver failure and can be life-threatening.
- Swelling of the legs and feet, back pain, decreased urination, increased thirst, rapid pulse, dizziness and nausea, vomiting or decreased appetite, and feeling confused, restlessness or fatigue. These can be symptoms of kidney failure and can be life-threatening.
- Fever. Fever can be due to an infection due to low levels of white blood cells, which can be life-threatening.
- Chest pain or shortness of breath may be accompanied by fever. This can be due to pneumonia and can be life-threatening.
- Bleeding. Like blood in the stool due to bleeding in the stomach or intestines, or bleeding inside the head. These may be symptoms of low levels of platelets in the blood.
- Difficulty breathing, swelling of the lips, itching, or rash. This may be due to an allergic (hypersensitivity) reaction.
Other side effects include:
Very common side effects ( may affect more than 1 in 10 people)
- Decreased number of red blood cells ( anemia ). You may feel tired and pale.
- Decreased number of white blood cells. This may be accompanied by fever. You are also at greater risk of getting an infection.
- Low platelet count ( thrombocytopenia ). You are more likely to bleed and bruise.
- Constipation, diarrhea, nausea, vomiting.
- Pneumonia.
- Chest pain, shortness of breath.
- Fatigue.
- A reaction at the injection site in the form of redness, pain, or a skin reaction.
- Loss of appetite.
- Joint pain.
- Bruises.
- Rash.
- Red or blue-red spots under the skin.
- Stomachache (abdominal pain).
- Itching.
- Fever.
- Sore nose and throat.
- Dizziness.
- Headache.
- Difficulty sleeping (insomnia).
- Epistaxis ( epistaxis ).
- Muscle pain.
- Weakness ( asthenia ).
- Weight loss.
- Low levels of potassium in the blood.
Common side effects ( may affect up to 1 in 10 people)
- Bleeding inside the head.
- A blood infection caused by bacteria ( sepsis ). This may be due to reduced levels of white blood cells in the blood.
- Bone marrow failure. This can cause low levels of red and white blood cells and platelets.
- A type of anemia with reduced numbers of red and white blood cells and platelets.
- Urine infection.
- A viral infection that causes cold sores ( herpes ).
- Bleeding gums, bleeding in the stomach or intestines, bleeding from the anal opening due to hemorrhoids (hemorrhoidal bleeding), bleeding in the eyes, bleeding under the skin or in the skin (hematoma).
- Blood in the urine.
- Sores in the mouth or on the tongue.
- Changes in the skin at the injection site in the form of swelling, a hard lump, bruising, bleeding in the skin (hematoma), rash, itching, and discoloration of the skin.
- Skin redness.
- Skin infection ( cellulitis ).
- An infection in the nose and throat or a sore throat.
- Sore or runny nose or sinuses ( sinusitis ).
- High or low blood pressure ( hypertension or hypotension ).
- Shortness of breath on exertion.
- Pain in the throat and vocal cords.
- Indigestion.
- Lethargy.
- General malaise.
- Anxiety.
- State of confusion.
- Hair loss.
- Kidney failure.
- Dehydration.
- White coating on the tongue, the inside of the cheeks, and sometimes in the palate, on the gums and tonsils ( oral fungal infection).
- Fainting.
- Drop in blood pressure when standing up ( orthostatic hypotension ) leading to dizziness when standing up or sitting up.
- Sleepiness, drowsiness ( somnolence ).
- Bleeding due to a catheter.
- A disease that affects the intestine and can lead to fever, vomiting, and stomach pain ( diverticulitis ).
- Fluid around the lungs (pleural effusion).
- Tremors (chills).
- Muscle spasms.
- Raised itchy rashes on the skin ( urticaria )
- Accumulation of fluid around the heart (pericardial effusion).
Uncommon side effects ( may affect up to 1 in 100 people)
- Allergic (hypersensitivity) reaction.
- Tremors.
- Liver failure.
- Large dark purple raised painful spots on the skin and fever.
- Painful skin ulcer (pyoderma gangrenosum).
- Inflammation of the pericardium (pericarditis).
Rare side effects ( may affect up to 1 in 1,000 people)
- Dry cough.
- Painless swelling of the fingertips.
- Tumor lysis syndrome – metabolic complications that can occur during cancer treatment and sometimes even without treatment. These complications are caused by the products of dying cancer cells and can include the following: changes in blood chemistry, such as high levels of potassium, phosphorus, and uric acid, and low levels of calcium, which can lead to changes in kidney function and heart rhythm, seizures and sometimes death.
Frequency not known (cannot be estimated from available data)
- Infection in the deeper skin layers spreads quickly and damages the skin and tissue, which can be life-threatening ( necrotizing fasciitis).
- Severe immune reaction (differentiation syndrome) which may cause fever, cough, difficulty breathing, itching, decreased urine, low blood pressure ( hypotension ), swollen arms or legs, and rapid weight gain.
How to store Vidaza
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the vial label and carton. The expiration date is the last day of the specified month.
Your doctor, pharmacist, or nurse is responsible for storing Vidaza. They are also responsible for the preparation and proper disposal of leftover Vidaza.
For unopened vials of this medicine – no special storage conditions.
For immediate use
After preparation, the suspension should be administered within 45 minutes.
For later use
If Vidaza suspension is prepared with water for injection that is not chilled, the suspension must be placed in the refrigerator (2-8 °C) immediately after preparation and refrigerated for up to 8 hours.
If Vidaza suspension is prepared with water for injection that is cooled (2-8°C), the suspension must be placed in the refrigerator (2-8°C) immediately after preparation and refrigerated for up to a maximum of 22 hours.
Suspension should be allowed to stand for up to 30 minutes before administration to reach room temperature (20–25 °C).
If there are large particles in the suspension, they should be discarded.
Contents of the packaging and other information
Contents declaration
- The active substance is azacitidine. One vial contains 100 mg of azacitidine. After reconstitution with 4 ml water for injection, the prepared suspension contains 25 mg/ml azacitidine.
- The other ingredient is mannitol (E421).
Appearance and package sizes of the medicine
Vidaza is a white powder for suspension for injection and is supplied in a glass vial containing 100 mg of azacitidine. Each pack contains one vial of Vidaza.
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