25 mg / ml powder for injection , suspension 
azacitidine

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

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

What Azazitidine STADA is and what it is used for

What Azacitidine Stada is

Azacitidine Stada is an anticancer medicine that belongs to a group of medicines called ‘antimetabolites’. Azacitidine Stada contains the active substance “azacitidine”.

What Azacitidine Stada is used for

Azacitidine Stada is used in adults who cannot be treated with stem cell transplantation to treat:

  • myelodysplastic syndrome (MDS) with 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 Azacitidine Stada works

Azacitidine Stada works by preventing cancer cells from growing. Azacitidine is incorporated into the cells’ genetic material / ribonucleic acid [RNA] and deoxyribonucleic acid [DNA]. It is thought to work by altering how cells activate and deactivate genes, and also by disrupting 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 Azacitidine Stada works or why this medicine has been prescribed for you.

Azacitidine contained in Azacitidine Stada may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

What you need to know before you use Azacitidine STADA

Do not use Azacitidine STADA

  • 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 cautions

Talk to your doctor, pharmacist, or nurse before using Azacitidine Stada if you:

  • has decreased the number of platelets, red or white blood cells.
  • have kidney disease.
  • have liver disease.
  • have ever had heart disease or heart attack or have had a lung disease.

Blood sample

You will be given blood tests before starting treatment with Azacitidine Stada and at the beginning 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 functioning properly.

Children and young people

Azacitidine Stada is not recommended for use in children and adolescents below 18 years.

Other medicines and Azacitidine STADA

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. The reason for this is that Azacitidine Stada may affect the way other medicines work. Some other medicines may also affect the way Azacitidine Stada works.

Pregnancy, breastfeeding, and fertility

Pregnancy

You should not use this medicine during pregnancy as it may harm your baby.

Use an effective method of contraception during and up to 3 months after treatment. Tell your doctor immediately 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 must not use this medicine if you are breast-feeding. It is not known if this medicine passes into breast milk.

Fertility

Men should not have children while they are being treated with Azacitidine Stada. Use an effective method of contraception during and up to 3 months after treatment with this medicine.

Talk to your doctor if you want to save semen before undergoing this treatment.

Driving and using machines

Do not drive or use any tools or machines if you experience side effects such as fatigue.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

How to use Azacitidine STADA

Before your doctor gives you this medicine, he/she will give you another medicine so that you do not feel sick and vomit at the beginning of each treatment cycle.

Dosage

The recommended dose is 75 mg per m 2 of body surface area. Your doctor will decide on the dose of one of these medicines depending on your general condition and your height and weight. Your doctor will examine how your condition develops and may change the dose if necessary.

How Azacitidine Stada is given

  • Azacitidine Stada is given daily 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 can be given under the skin of the thigh, abdomen, or upper arm.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. 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, shaking, 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 heart rate, 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 too low levels of white blood cells, which can be life-threatening.
  • Chest pain or shortness of breath that may be accompanied by fever.
  • This can be due to pneumonia and can be life-threatening.
  • Bleeding.
  • As blood in the stool due to bleeding in the stomach or intestines, or bleeding inside the head. This may be a symptom that there are 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 effect is (can occur in more than 1 in 10)

  • decreased number of red blood cells ( anemia ). You may feel tired and pale
  • decreased white blood cell count. This may be accompanied by fever. You are also at greater risk of infection s
  • low platelet count ( thrombocytopenia ). You are more likely to have bleeding and bruising
  • constipation, diarrhea, nausea, vomiting
  • pneumonia
  • chest pain, shortness of breath
  • fatigue
  • an injection site reaction in the form of redness, pain, or a skin reaction
  • loss of appetite
  • joint pain
  • bruises
  • rash
  • red or bluish-red spots under the skin
  • stomach pain (abdominal pain)
  • itching
  • fever
  • nose and throat pain
  • dizziness
  • headache
  • difficulty sleeping (insomnia)
  • nosebleeds ( epistaxis )
  • muscle aches
  • weakness ( asthenia )
  • weight loss
  • low levels of potassium in the blood.

Common side effects are (may affect up to 1 in 10)

  • bleeding inside the head
  • a blood infection caused by bacteria ( sepsis ). This may be due to decreased 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 the decreased number of red and white blood cells and platelets
  • urinary tract 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 (hemorrhoid 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
  • reddening of the skin
  • skin infection ( cellulite )
  • 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 )
  • 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, inside the cheeks and sometimes in the palate, on the gums and tonsils ( oral fungal infection)
  • fainting
  • drop in blood pressure when you get up ( orthostatic hypotension ) which leads to dizziness when you get up or sit up
  • drowsiness, drowsiness ( somnolence )
  • bleeding due to a catheter.
  • a disease that affects the intestines and can lead to fever, vomiting, and abdominal pain ( diverticulitis )
  • fluid around the lungs (pleural effusion)
  • trembling (chills)
  • muscle spasms
  • Elevated itchy rash on the skin ( urticaria )
  • accumulation of fluid around the heart (pericardial effusion).

Less common side effects are (may affect up to 1 in 100)

  • allergic (hypersensitivity) reaction
  • shaking
  • 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 are (may affect up to 1 in 1000 users)

  • dry cough
  • painless swelling in 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 rate, seizures and sometimes death.

Has been reported (occurs in an unknown number of users)

  • infection in the deeper layers of the skin that spreads rapidly and damages the skin and tissue, which can be life-threatening ( necrotizing fasciitis).

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Azacitidine STADA

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 label and carton after EXP. The expiration date is the last day of the specified month.

Your doctor, pharmacist, or nurse is responsible for storing Azacitidine Stada. They are also responsible for the preparation and for ensuring that the remaining Azacitidine Stada is disposed of properly.

For unopened vials of this medicine – no special storage conditions.

For immediate use

After reconstitution, the suspension should be administered within 45 minutes.

For later use

If Azacitidine Stada suspension is reconstituted with water for non-cooled injections, suspension one must be placed in the refrigerator (2–8 ° C) immediately after reconstitution and stored in a refrigerator for up to a maximum of 8 hours.

If Azacitidine Stada suspension is reconstituted with water for cooled injections (2–8 ° C), suspension one must be placed in the refrigerator (2–8 ° C) immediately after reconstitution and refrigerated for up to a maximum of 22 hours.

The 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 suspension one, it should be discarded.

6. Contents of the packaging and other information

Content declaration

  • The active substance is azacitidine. One vial contains 100 mg of 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 the medicine looks like and the contents of the pack

Azacitidine STADA is a white to off-white powder for injection, suspension and provided in a vial of glass containing 100 mg azacitidine. Each pack contains a vial of Azacitidine Stada.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Other manufacturers

STADApharm

Feodor-Lynen-Strasse 35

30625 Hanover

Germany

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

Austria

Local representative

STADA Nordic ApS

Marielundvej 46A

2730 Herlev

Denmark

Muhammad Nadeem

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