Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - vidaza

Document Subject

Generated Narrative: MedicinalProductDefinition mp5f8b8c4b9e5f26ff9f9320c47bf6fa58

identifier: http://ema.europa.eu/identifier/EU/1/08/488/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Vidaza 25 mg/mL powder for suspension for injection

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-5f8b8c4b9e5f26ff9f9320c47bf6fa58

identifier: http://ema.europa.eu/identifier/EU/1/08/488/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - vidaza

Attesters

What is in this leaflet:

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

What Vidaza is Vidaza is an anti-cancer agent which belongs to a group of medicines called anti-metabolites . Vidaza contains the active substance azacitidine .

What Vidaza is used for Vidaza is used in adults who are not able to have a stem cell transplantation to treat:

• higher-risk myelodysplastic syndromes (MDS).
• chronic myelomonocytic leukaemia (CMML).
• acute myeloid leukaemia (AML).

These are diseases which affect the bone marrow and can cause problems with normal blood cell production.

How Vidaza works Vidaza works by preventing cancer cells from growing. Azacitidine becomes incorporated into the genetic material of cells (ribonucleic acid (RNA) and deoxyribonucleic acid (DNA)). It is thought to work by altering the way the cell turns genes on and off and also by interfering with the production of new RNA and DNA. These actions are thought to correct problems with the maturation and growth of young blood cells in the bone marrow that cause myelodysplastic disorders, and to kill cancerous cells in leukaemia. Talk to your doctor or nurse if you have any questions about how Vidaza works or why this medicine has been prescribed for you.

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 breast-feeding.

Warnings and precautions Talk to your doctor, pharmacist or nurse before using Vidaza:

• if you have decreased counts of platelets, red or white blood cells.
• if you have kidney disease.
• if you have liver disease.
• if you have ever had a heart condition or heart attack or any history of lung disease.

Vidaza can cause a serious immune reaction called differentiation syndrome (see section 4).

Blood test 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.

Children and adolescents Vidaza is not recommended for use in children and adolescents below the age of 18. Other medicines and Vidaza Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. This is because Vidaza may affect the way some other medicines work. Also, some other medicines may affect the way Vidaza works.

Pregnancy, breast-feeding and fertility

Pregnancy You should not use Vidaza during pregnancy as it may be harmful to the baby. If you are a woman who can become pregnant you should use an effective method of contraception while taking Vidaza and for 6 months after stopping treatment with Vidaza. Tell your doctor straight away if you become pregnant during treatment.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Breast-feeding You should not breast-feed when using Vidaza. It is not known if this medicine passes into human milk.

Fertility Men should not father a child while receiving treatment 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 wish to conserve your sperm before starting this treatment.

Driving and using machines Do not drive or use any tools or machines if you experience side effects, such as tiredness.

Before giving you Vidaza, your doctor will give you another medicine to prevent nausea and vomiting at the start of each treatment cycle.

• The recommended dose is 75 mg per mP2 P body surface area. Your doctor will decide your dose of this medicine, 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. This medicine 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 medicine, ask your doctor, pharmacist or nurse.

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

Tell your doctor straight away if you notice any of the following side effects:

• Drowsiness, shaking, jaundice, abdominal bloating and easy bruising. These may be symptoms of liver failure and can be life-threatening.
• Swelling of the legs and feet, back pain, reduced passing of water, increased thirst, rapid pulse, dizziness and nausea, vomiting or reduced appetite and feelings of confusion, restlessness or fatigue. These may be symptoms of kidney failure and can be life-threatening.
• A fever. This could be due to an infection as a result of having low levels of white blood cells, which can be life-threatening.
• 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 , and can be life-threatening.
• Bleeding. Such as blood in the stools due to bleeding in the stomach or gut, or such as bleeding inside your head. These may be symptoms of having low levels of platelets in your 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)

• 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.
• Having trouble sleeping (insomnia).
• Nosebleeds (epistaxis).
• Muscle aches.
• Weakness (asthenia).
• Weight loss.
• Low levels of potassium in your blood. Common side effects (may affect up to 1 in 10 people)
• 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.
• Skin infection (cellulitis).
• An infection of the nose and throat, or sore throat.
• Sore or runny nose or sinuses (sinusitis).
• High or low blood pressure (hypertension or hypotension).
• Being short of breath when you move.
• Pain in your throat and voicebox.
• Indigestion.
• Lethargy.
• Feeling generally unwell.
• Anxiety.
• Being confused.
• Hair loss.
• Kidney failure.
• Dehydration.
• White coating covering tongue, inner cheeks, and sometimes on the roof of your mouth, gums and tonsils (oral fungal infection).
• Fainting.
• A fall in blood pressure when standing (orthostatic hypotension) leading to dizziness when moving to a standing or sitting position.
• Sleepiness, drowsiness (somnolence).
• Bleeding due to a catheter line.
• A disease affecting the gut which can result in fever, vomiting and stomach pain (diverticulitis).
• Fluid around the lungs (pleural effusion).
• Shivering (chills).
• Muscle spasms.
• Raised itchy rash on the skin (urticaria).
• Collection of fluid around the heart (pericardial effusion).

Uncommon side effects (may affect up to 1 in 100 people)

• Allergic (hypersensitivity) reaction.
• Shaking.
• Liver failure.
• Large plum-coloured, raised painful patches on the skin with fever.
• Painful skin ulceration (pyoderma gangrenosum).
• Inflammation of the lining around the heart (pericarditis).

Rare side effects (may affect up to 1 in 1,000 people)

• Dry cough.
• Painless swelling in the finger tips (clubbing).
• Tumour lysis syndrome - Metabolic complications that can occur during treatment of cancer and sometimes even without treatment. These complications are caused by the product of dying cancer cells and may include the following: changes to blood chemistry; high potassium, phosphorus, uric acid, and low calcium consequently leading to changes in kidney function, heartbeat, seizures, and sometimes death.

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

• Infection of the deeper layers of skin, which spreads quickly, damaging the skin and tissue, which can be life-threatening (necrotizing fasciitis).
• Serious immune reaction (differentiation syndrome) that may cause fever, cough, difficulty breathing, rash, decreased urine, low blood pressure (hypotension), swelling of the arms or legs and rapid weight gain.
• Inflammation of blood vessels in the skin which may result in rash (cutaneous vasculitis).

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 37TAppendix V37T. By reporting side effects you can help provide more information on the safety of this medicine.

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 vial label and the carton. The expiry date refers to the last day of that month.

Your doctor, pharmacist or nurse are responsible for storing Vidaza. They are also responsible for preparing and disposing of any unused Vidaza correctly.

For unopened vials of this medicine there are no special storage conditions.

When using immediately Once the suspension has been prepared it should be administered within 45 minutes.

When using later on If the Vidaza suspension is prepared using water for injections that has not been refrigerated, the suspension must be placed in the refrigerator (2 C 8 C) immediately after it is prepared and kept refrigerated for up to a maximum of 8 hours. If the Vidaza suspension is prepared using water for injections that has been stored in the refrigerator (2 C 8 C), the suspension must be placed in the refrigerator (2 C 8 C) immediately after it is prepared and kept refrigerated for up to a maximum of 22 hours.

The suspension should be allowed up to 30 minutes prior to administration to reach room temperature (20 C 25 C).

If large particles are present in the suspension it should be discarded.

What Vidaza contains

• The active substance is azacitidine. One 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. Each pack contains one vial of Vidaza.

Marketing Authorisation Holder Bristol-Myers Squibb Pharma EEIG Plaza Blanchardstown Corporate Park 2 Dublin 15, D15 TIreland

Manufacturer Celgene Distribution B.V. Orteliuslaan 13528 BD Utrecht Netherlands

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: