Zassida
How to use Zassida
Leaflet accompanying the packaging: patient information
Zassida, 25 mg/ml, powder for suspension for injection
Azacytidine
Read the leaflet carefully before using the medicine, as it contains
important information for the patient.
- Keep this leaflet, you may need to read it again.
- In case of any doubts, consult a doctor, pharmacist, or nurse.
- This medicine has been prescribed specifically for this person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
- If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
Table of contents of the leaflet
- 1. What is Zassida and what is it used for
- 2. Important information before using Zassida
- 3. How to use Zassida
- 4. Possible side effects
- 5. How to store Zassida
- 6. Contents of the packaging and other information
1. What is Zassida and what is it used for
What is Zassida
Zassida is an anti-cancer medicine that belongs to a group of medicines called "antimetabolites". Zassida contains the active substance azacitidine.
What is Zassida used for
Zassida is used in adult patients who cannot receive a stem cell transplant, for the treatment of:
- high-risk myelodysplastic syndromes (MDS);
- chronic myelomonocytic leukemia (CMML);
- acute myeloid leukemia (AML).
These are diseases that affect the bone marrow and can cause problems with the production of blood cells.
How Zassida works
Zassida works by preventing the growth of cancer cells. Azacitidine is incorporated into the genetic material of cells (RNA and DNA). It is thought to work by changing the way genes are activated and deactivated, and by disrupting the production of RNA and DNA. It is believed that these actions correct the abnormalities in the maturation and growth of young blood cells in the bone marrow, causing myelodysplastic syndromes, and that they kill cancer cells in leukemia.
2. Important information before using Zassida
When not to use Zassida
- if the patient is allergic to azacitidine or any of the other ingredients of this medicine (listed in section 6);
- if the patient has advanced liver cancer;
- if the patient is breastfeeding.
Warnings and precautions
Before starting treatment with Zassida, the patient should discuss it with their doctor or pharmacist if they:
- have a low platelet count, red or white blood cell count;
- have kidney disease;
- have liver disease;
- have a history of heart disease or heart attack, or any lung disease.
Zassida may cause a severe immune reaction called "differentiation syndrome" (see section 4).
Children and adolescents
Zassida is not recommended for use in children and adolescents under 18 years of age.
Zassida and other medicines
The patient should tell their doctor or pharmacist about all medicines they are taking, or have recently taken, and about any medicines they plan to take. Zassida may affect the way some other medicines work, and some other medicines may affect the way Zassida works.
Pregnancy, breastfeeding, and fertility
Pregnancy
Zassida should not be used during pregnancy, as it may harm the baby. Women who can become pregnant should use effective contraception during treatment with Zassida and for 6 months after stopping treatment with Zassida. If the patient becomes pregnant during treatment, they should consult their doctor immediately.
Breastfeeding
Zassida should not be used during breastfeeding. It is not known whether this medicine passes into breast milk.
Fertility
Men should not father a child during treatment with Zassida. Effective contraception should be used during treatment and for 3 months after treatment with Zassida. The patient should consult their doctor before starting treatment if they wish to preserve their sperm.
Driving and using machines
If the patient experiences side effects such as fatigue, they should not drive or operate machinery.
3. How to use Zassida
Before administering Zassida to the patient, the doctor will give another medicine to prevent nausea and vomiting at the start of each treatment cycle.
- The recommended dose is 75 mg per square meter of body surface area. The doctor will decide on the dose based on the patient's overall condition, height, and weight. The doctor will monitor the patient's progress and may adjust the dose if necessary.
- Zassida is given daily for one week, followed by a three-week break. This treatment cycle is repeated every four weeks. The patient will usually receive at least six treatment cycles.
This medicine is given by a doctor or nurse as a subcutaneous injection. It can be given under the skin of the thigh, abdomen, or arm.
4. Possible side effects
Like all medicines, Zassida can cause side effects, although not everybody gets them.
The patient should tell their doctor immediately if they experience any of the following side effects:
- Drowsiness, tremors, jaundice, abdominal swelling, and easy bruising. These may be symptoms of liver failure and can be life-threatening.
- Swelling of the feet and ankles, back pain, decreased urine output, increased thirst, rapid heartbeat, dizziness, and nausea or vomiting, as well as disorientation, anxiety, or fatigue. These may be symptoms of kidney failure and can be life-threatening.
- Fever. This may be due to an infection caused by a low white blood cell count, which can be life-threatening.
- Chest pain or difficulty breathing, which may be accompanied by fever. This may be due to a lung infection called "pneumonia" and can be life-threatening.
- Bleeding. Such as blood in the stool due to bleeding in the stomach or intestine, or bleeding in the head. These may be symptoms of a low platelet count.
- Difficulty breathing, swelling of the lips, itching, or rash. This may be due to an allergic reaction (hypersensitivity).
Other side effects include:
Very common side effects(may affect more than 1 in 10 people)
- Decreased red blood cell count (anemia). The patient may feel tired and pale.
- Decreased white blood cell count. This may be accompanied by fever. The patient is also more susceptible to infections.
- Low platelet count (thrombocytopenia). The patient is more susceptible to bleeding and bruising.
- Constipation, diarrhea, nausea, vomiting.
- Pneumonia.
- Chest pain, difficulty breathing.
- Fatigue.
- Reaction at the injection site, including redness, pain, or skin reaction.
- Loss of appetite.
- Joint pain.
- Bruising.
- Rash.
- Purple spots under the skin.
- Abdominal pain.
- Itching.
- Fever.
- Nose and throat pain.
- Dizziness.
- Headache.
- Sleep problems (insomnia).
- Nosebleeds.
- Muscle pain.
- Weakness.
- Weight loss.
- Low potassium levels in the blood.
Common side effects(may affect up to 1 in 10 people)
- Bleeding in the brain.
- Blood infection caused by bacteria (sepsis). This may be due to a low white blood cell count in the blood.
- Bone marrow failure. This may lead to a low red and white blood cell and platelet count.
- A type of anemia where the red, white, and platelet counts are low.
- Urinary tract infection.
- Viral infection causing cold sores.
- Bleeding in the stomach or intestine, or bleeding from the anus due to hemorrhoids (hemorrhoidal bleeding), eye bleeding, or bleeding under the skin or in the skin (hematoma).
- Blood in the urine.
- Mouth or tongue ulcers.
- Skin changes at the injection site, including swelling, hard lumps, bruising, bleeding in the skin (hematoma), rash, itching, and skin color changes.
- Redness of the skin.
- Skin infection (cellulitis).
- Nose and throat infection or sore throat.
- Nose or sinus pain (sinusitis).
- High or low blood pressure (hypertension or hypotension).
- Shortness of breath when moving.
- Throat and larynx pain.
- Nausea.
- Numbsness.
- General feeling of being unwell.
- Anxiety. Disorientation.
- Excessive hair loss.
- Kidney failure.
- Dehydration.
- White patches on the tongue, inside the cheeks, and sometimes on the palate, gums, and tonsils (oral thrush).
- Fainting.
- Drop in blood pressure when standing up (orthostatic hypotension), leading to dizziness when changing position to standing or sitting.
- Drowsiness, numbness.
- Bleeding at the injection site.
- A disease of the intestines that can cause fever, vomiting, and abdominal pain (diverticulitis).
- Fluid around the lungs (pleural effusion).
- Chills.
- Muscle spasms.
- A raised, itchy rash on the skin (hives).
- Fluid around the heart (pericardial effusion).
Uncommon side effects(may affect up to 1 in 100 people)
- Allergic reaction (hypersensitivity).
- Tremors.
- Liver failure.
- Large, raised, painful spots on the skin, with fever.
- Inflammation of the sac surrounding the heart (pericarditis).
Rare side effects(may affect up to 1 in 1000 people)
- Dry cough
- Painless swelling of the fingertips (clubbing).
- Tumor lysis syndrome - a complication of metabolism that can occur during cancer treatment, as well as sometimes without treatment. These complications are caused by the breakdown of dying cancer cells and can include changes in blood chemistry; high levels of potassium, phosphorus, uric acid, and low levels of calcium, leading to kidney problems, irregular heartbeat, seizures, and sometimes death.
Frequency not known(cannot be estimated from the available data)
- Infection of the deep layers of the skin, which can spread quickly, causing skin and tissue damage, and can be life-threatening (necrotizing fasciitis).
- A severe immune reaction (differentiation syndrome), which can cause fever, cough, difficulty breathing, rash, decreased urine output, low blood pressure (hypotension), swelling of the hands or feet, and sudden weight gain.
- Inflammation of the blood vessels in the skin, which can cause a rash (vasculitis).
Reporting side effects
If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative.
Reporting side effects will help to gather more information on the safety of this medicine.
5. How to store Zassida
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or label on the syringe after EXP. The expiry date refers to the last day of the month stated.
The doctor, pharmacist, or nurse is responsible for storing Zassida. They are also responsible for preparing Zassida and disposing of any unused remains properly.
Unopened vials of this medicine - no special storage precautions.
For immediate use
After preparation, the suspension should be administered within 45 minutes.
For later use
If the Zassida suspension was prepared using uncooled water for injections, the prepared suspension should be placed in the refrigerator (2°C - 8°C) immediately after preparation and stored in the refrigerator for no more than 8 hours.
If the Zassida suspension was prepared using cooled (2°C - 8°C) water for injections, the prepared suspension should be placed in the refrigerator (2°C - 8°C) immediately after preparation and stored in the refrigerator for no more than 32 hours.
Before administration, the suspension should be allowed to reach room temperature (20°C - 25°C) for a maximum of 30 minutes.
6. Contents of the packaging and other information
What Zassida contains
The active substance is azacitidine.
One vial contains 100 mg or 150 mg of azacitidine. After preparation with 4 ml or 6 ml of water for injections, the suspension contains 25 mg/ml of azacitidine.
The other ingredient is mannitol.
What Zassida looks like and contents of the pack
Zassida is a white powder for suspension for injection.
The powder is in a vial made of colorless glass type I with a stopper made of bromobutyl rubber coated with ETFE and an aluminum seal, containing 100 mg or 150 mg of azacitidine.
One pack contains one vial.
Marketing authorization holder
Zentiva k.s.
U kabelovny 130
Dolni Měcholupy
102 37 Prague 10
Czech Republic
Manufacturer/Importer
AqVida GmbH
Kaiser-Wilhelm-Strasse 89
20355 Hamburg, Germany
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel: +48 22 375 92 00
Date of last revision of the leaflet:December 2023
Information intended for healthcare professionals only:
Recommendations for safe handling
Zassida is a cytotoxic medicinal product, and as with other potentially toxic compounds, caution should be exercised when handling the azacitidine suspension. The procedures for the proper handling and disposal of anti-cancer medicinal products should be followed.
In case of skin contact with prepared azacitidine, the area should be washed immediately with soap and water. In case of contact with mucous membranes, they should be flushed with water.
Incompatibilities
This medicinal product should not be mixed with other medicinal products, except for those mentioned below (see "Preparation procedure").
Preparation procedure
Zassida should be prepared using water for injections. The shelf-life of the prepared medicinal product can be extended by preparing the product with cooled (2°C - 8°C) water for injections. Details on the storage of the prepared product are given above.
- 1. One pack contains one vial of azacitidine.
- 2. Vial 100 mg - 4 ml of water for injections should be drawn into a syringe, ensuring that the syringe does not contain air bubbles. Vial 150 mg - 6 ml of water for injections should be drawn into a syringe, ensuring that the syringe does not contain air bubbles.
- 3. Insert the syringe needle containing 4 ml or 6 ml of water for injections through the rubber stopper of the azacitidine vial, and then inject the water for injections into the vial.
- 4. After removing the syringe and needle, shake the vial vigorously until a uniform, cloudy suspension is obtained. After preparation, each ml of suspension contains 25 mg of azacitidine (100 mg/4 ml or 150 mg/6 ml). The prepared product is a uniform suspension without agglomerates, large particles, or foreign bodies. The product should be discarded if it contains large particles or agglomerates. The suspension should not be filtered after preparation, as this may remove the active substance. It should be noted that some adapters, needles, and closed systems contain filters. Therefore, such components should not be used to administer the medicinal product after preparation.
- 5. Clean the rubber stopper and insert a new syringe with a needle into the vial. Then, turn the vial upside down, ensuring that the needle tip is below the level of the liquid. Then, pull back the plunger to draw up the required amount of medicinal product for the correct dose. Ensure that the air has been removed from the syringe. Then, withdraw the needle from the vial and discard the needle.
- 6. Attach a new subcutaneous injection needle (25G recommended) firmly to the syringe. Do not flush the needle before injection to reduce the frequency of local reactions at the injection site.
- 7. For 150 mg = dose 6 ml - use a vial containing 150 mg. Due to the retention in the vial and needle, it may not be possible to withdraw the entire suspension from the vial.
- 8. The contents of the syringe with the dose must be resuspended immediately before administration. Before administration, the syringe filled with the prepared suspension should be allowed to reach a temperature of approximately 20°C - 25°C. To resuspend, vigorously rotate the syringe between the hands until a uniform, cloudy suspension is obtained.
The suspension should be discarded if it contains large particles or agglomerates.
Storage of the prepared product
For immediate use
Zassida can be prepared immediately before administration and administered within 45 minutes. If more than 45 minutes have passed, the prepared suspension should be properly discarded and a new dose prepared.
For later use
If the product was prepared using uncooled water for injections, the prepared suspension should be placed in the refrigerator (2°C - 8°C) immediately after preparation and stored in the refrigerator for no more than 8 hours. If more than 8 hours have passed, the suspension should be properly discarded and a new dose prepared.
If the product was prepared using cooled (2°C - 8°C) water for injections, the prepared suspension should be placed in the refrigerator (2°C - 8°C) immediately after preparation and stored in the refrigerator for no more than 32 hours. If more than 32 hours have passed, the suspension should be properly discarded and a new dose prepared.
Before administration, the syringe filled with the prepared suspension should be allowed to reach a temperature of approximately 20°C - 25°C for a maximum of 30 minutes. If more than 30 minutes have passed, the suspension should be properly discarded and a new dose prepared.
Calculation of the individual dose
The total dose can be calculated based on the body surface area (BSA) as follows:
Total dose (mg) = dose (mg/m2) x BSA (m2)
The following table is an example of how to calculate the individual dose of azacitidine based on a body surface area of 1.8 m2.
Dose mg/m2 BSA
(% of the recommended initial dose)
Required total volume of prepared suspension
75 mg/m2 (100%)
135 mg
1 vial of 150 mg
5.4 ml
37.5 mg/m2 (50%)
67.5 mg
1 vial of 100 mg
2.7 ml
25 mg/m2 (33%)
45 mg
1 vial of 100 mg
1.8 ml
Administration method
The prepared Zassida should be administered subcutaneously (the needle should be inserted at an angle of 45-90°) using a 25G needle in the arm, thigh, or abdomen.
Doses greater than 4 ml should be administered at two different sites.
The injection sites should be changed. New injections should be administered at a distance of at least 2.5 cm from the previous injection site and never in sensitive, bruised, red, or hard areas.
Disposal
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- ImporterAqVida GmbH
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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