25 mg / ml powder for suspension for injection
azacitidine
What Azacitidine Accord is and what it is used for
What Azacitidine Accord is
Azacitidine Accord is an anticancer medicine that belongs to a group of medicines called “antimetabolites”. Azacitidine Accord contains the active substance ‘azacitidine’.
What Azacitidine Accord is used for
Azacitidine Accord 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 Accord works
Azacitidine Accord 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 Accord works or why this medicine has been prescribed for you.
2. What you need to know before you use Azacitidine Accord
Do not use Azacitidine Accord
- 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 Accord:
- If you have a decrease in the 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 a lung disease
Blood sample
You will be given a blood test before starting treatment with Azacitidine Accord 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 Accord is not recommended for use in children and adolescents below 18 years.
Other medicines and Azacitidine Accord
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 Accord may affect the way other medicines work. Some other medicines may also affect the way Azacitidine Accord works.
Pregnancy, breastfeeding, and fertility
Pregnancy
You should not use Azacitidine Accord 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 Azacitidine Accord if you are breast-feeding. It is not known if Azacitidine Accord passes into breast milk.
Fertility
Men should not have children while they are being treated with Azacitidine Accord. 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.
3. How to use Azacitidine Accord
Before your doctor gives you Azacitidine Accord, he/she will give you another medicine to prevent you from feeling sick and vomiting at the beginning of each treatment cycle.
- 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.
- Azacitidine Accord 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 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 red blood cell count ( 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 getting an infection.
- Low platelet count ( thrombocytopenia ). You are more likely to have bleeding and bruising.
- 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 bluish-red spots under the skin.
- Stomach pain (abdominal pain).
- Itching.
- Fever.
- Nasal congestion.
- Dizziness.
- Headache.
- Difficulty sleeping (insomnia).
- Nasal blood ( 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 people)
- 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.
- Confusion state.
- 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).
- Tremors (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 light 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 spreads quickly 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 Accord
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 carton. The expiration date is the last day of the specified month.
Your doctor, pharmacist, or nurse is responsible for storing Azacitidine Accord. They are also responsible for the preparation and for ensuring that the remaining Azacitidine Accord 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 60 minutes.
For later use
If Azacitidine Accord‑ 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 refrigerated for up to a maximum of 8 hours.
If Azacitidine Accord‑ suspension is reconstituted with water for injections cooled (2–8 ° C), 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 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 Accord is a white powder for injection , suspension and provided in a vial of glass containing 100 mg azacitidine. Each pack contains a vial of Azacitidine Accord.
Marketing Authorization Holder and Manufacturer
Accord Healthcare SLU
World Trade Center,
Moll de Barcelona, s / n,
Edifici Est 6ª planta,
08039 Barcelona, Spain
Manufacturer:
Accord Healthcare Limited,
Sage House, 319 Pinner Road, North Harrow,
Middlesex, HA1 4HF,
UK
Or
Accord Healthcare Polska Sp.z oo
ul. Lutomierska 50,
95-200 Pabianice
Poland
Or
Laboratori Fundació Dau
C / C, 12-14 Pol. Ind.
Zona Franca, Barcelona, 08040,
Spain