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At a glance
- Treatment
- Azacitidine injection; Vidaza and generic brands
- Used in selected settings
- Myelodysplastic syndromes (MDS), selected chronic myelomonocytic leukaemia (CMML) and acute myeloid leukaemia (AML)
- How it is given
- Usually injections just under the skin, into the abdomen, thigh or upper arm. More than one injection may be needed for a dose. Some products and protocols allow an infusion into a vein; the pharmacy must use the correct preparation for that route.
- Before you start
- Save your 24-hour oncology number. Have a thermometer and written treatment calendar available.
This sheet covers injectable azacitidine. Oral azacitidine (Onureg) has different uses, doses and schedules. The tablets and injections must not be substituted for one another.
What this treatment is and how it works
Azacitidine is an anticancer medicine often called a hypomethylating agent. It changes chemical signals that control how cells use their genes and also interferes with the materials cells need to grow. This can help abnormal bone-marrow cells behave more normally and reduce the number of abnormal cells. It can also affect healthy blood-forming cells.
When it may be used
It is used for selected people with myelodysplastic syndromes (MDS), chronic myelomonocytic leukaemia (CMML) or acute myeloid leukaemia (AML). These conditions affect the bone marrow, where blood cells are made. The exact blood disorder, its risk category and suitability for a stem-cell transplant affect the choice.
For some people with AML who cannot have intensive chemotherapy, injectable azacitidine is combined with another medicine, commonly venetoclax. That combination has additional infection, interaction and monitoring requirements. Read its separate treatment instructions as well.
Treatment often aims to control the disease, improve blood counts or reduce transfusion needs. It does not work immediately for everyone. This adult information sheet does not cover specialist treatment of children.
Licences and access differ by country and product. This sheet does not establish Indian regulatory approval or availability. Your oncologist will explain the locally appropriate treatment.
Before treatment
Before starting, tell the team about previous cancer treatment, allergies, infection symptoms, heart, lung, kidney or liver disease, hearing or nerve problems, diabetes and all medicines you take. Discuss pregnancy, contraception and fertility. Ask for a written treatment calendar, supportive-medicine instructions and a 24-hour oncology contact number. Baseline blood tests usually include a full blood count and kidney and liver function; additional tests depend on the medicine and your health. Before chemotherapy that reaches the whole body, the team should check for current or past hepatitis B infection. If a test is positive, extra monitoring or antiviral treatment may be needed to prevent the virus becoming active again. The team will coordinate testing and treatment; do not delay urgent cancer treatment yourself.
How treatment is given and the schedule
Usually injections just under the skin, into the abdomen, thigh or upper arm. More than one injection may be needed for a dose. Some products and protocols allow an infusion into a vein; the pharmacy must use the correct preparation for that route.
A usual course gives treatment on 7 days, followed by a rest period, with the next cycle starting about 4 weeks after the previous one. Some hospitals spread the 7 doses across a weekend break. Follow your own calendar: do not assume that 5 doses and 7 doses are the same treatment.
With azacitidine alone for MDS, several cycles may be needed before benefit is clear; the product information recommends at least 6 cycles when appropriate and tolerable. Treatment may continue while it is helping. This does not mean continuing despite serious toxicity or applying the same response timetable to every AML combination.
The dose is calculated for your treatment and health. Do not change the dose or treatment dates yourself. The team will provide a revised calendar if treatment needs to be delayed, reduced or stopped.
Tests and monitoring during treatment
- Full blood count before each cycle and more often when needed, especially early in treatment. Low counts may reflect both the illness and treatment; they can worsen during the first cycles. The team may arrange transfusions, infection-prevention medicines or growth-factor injections.
- Kidney and liver blood tests before treatment and each cycle. Kidney monitoring includes blood salts and bicarbonate, which helps show whether the body’s acid balance is normal. Tell the team promptly if you pass much less urine.
- Blood-count trends and sometimes bone-marrow tests assess response. If you have heart or lung disease, additional assessment may be needed. Combination treatment, especially with venetoclax, may require more frequent blood tests and precautions against tumour lysis.
Tell the team about symptoms since the previous dose, including problems that have already settled. A normal earlier test does not make new symptoms safe to ignore.
Side effects: what to expect
The common-effects table groups effects described as common or very common in injectable Vidaza information. The likelihood varies with the blood disorder, baseline counts and accompanying treatment. Injection-site problems apply to injections under the skin.
You are unlikely to have every effect listed, and this is not an exhaustive list. Report new symptoms even if they are not mentioned here.
Common or more frequent side effects
| Possible effect | What you can do | When to contact the team |
|---|---|---|
| Low blood counts | White cells fight infection, red cells carry oxygen and platelets help clotting. Treatment can lower one or more of these. Wash hands, avoid close contact with people who are unwell and keep blood-test appointments. | Call immediately for fever, shaking chills or feeling suddenly unwell. Report unusual bruising, bleeding, marked tiredness or increasing breathlessness. Do not wait for a blood-test result before seeking help. |
| Feeling or being sick | Take preventive anti-sickness medicines at the prescribed times. Try small meals and frequent small drinks; avoid strong food smells if they worsen nausea. | Contact the team the same day if medicines are not controlling symptoms. Seek urgent advice if you cannot keep fluids down, feel faint or pass much less urine. |
| Constipation | Keep a bowel record. Gentle movement, usual fluids and a prescribed laxative can help. Ask before using suppositories or enemas when blood counts may be low. | Contact the team for worsening constipation. A swollen or painful abdomen, vomiting or inability to pass wind needs urgent assessment; do not simply add laxatives. |
| Loose or more frequent stools (diarrhoea) | Record how often you pass stools and follow the team’s fluid and anti-diarrhoea plan. Use small, regular drinks unless you have a fluid restriction. | Report new or worsening diarrhoea promptly. Fever, blood, severe abdominal pain, dizziness or difficulty drinking needs urgent assessment. |
| Tiredness and reduced stamina | Balance rest with short periods of gentle activity. Prioritise tasks and accept help with shopping, meals or transport. Tell the team about poor sleep or pain. | Report fatigue that prevents basic activities or is worsening. Sudden breathlessness, chest pain, fainting or confusion needs urgent assessment. |
| Reduced appetite or changes in eating | Try smaller, frequent meals with protein and energy-rich foods you tolerate. Ask for a dietitian if your weight or intake is falling. | Report ongoing weight loss or difficulty eating. Inability to drink or signs of dehydration needs same-day urgent advice. |
| Injection-site redness, darker colour, tenderness or swelling | Let the nurse rotate injection sites. Avoid tight clothing or rubbing sore skin. Ask which simple skin care or pain relief is suitable for you. | Report increasing pain, warmth or spreading redness the same day. Severe pain, rapid swelling, blistering, darkening skin or fever needs urgent assessment. |
| Skin itching or rash; muscle or joint aches | Use a plain moisturiser and gentle skin care. Keep moving gently if comfortable. Check painkillers with your team, particularly if platelets are low. | Report troublesome symptoms. Do not assume a painful spreading rash is a normal injection reaction. |
| Headache or dizziness | Rest if needed, rise slowly and avoid driving while dizzy. Use only agreed pain relief. | Report new or persistent symptoms. A sudden severe headache, fainting, confusion or weakness needs urgent assessment. |
Other reported side effects (frequency varies)
Mouth soreness, indigestion, sleep disturbance, anxiety, hair thinning and swelling can also occur. Some are classified as common in the product information; they are not all “less common”. A severe allergic reaction is uncommon. Other infrequent or unquantified serious problems are described below. Fever must always be assessed for infection, even if treatment can also cause fever.
Important serious side effects, including rare effects
Serious effects can be common, uncommon, rare or have an uncertain frequency. The following advice explains when to seek help; it does not label all serious effects as rare.
Infection, sepsis and serious bleeding
A fall in blood cells can cause life-threatening infection or bleeding. Call immediately for fever, shaking chills, new breathlessness, unusual bleeding or sudden deterioration. Black stools, vomiting blood, a severe headache or bleeding that does not stop require emergency assessment. These risks are not necessarily rare in people with blood cancers.
Severe skin or soft-tissue infection
A rapidly spreading deep infection has been reported, including around an injection site; its frequency is not established. Severe or increasing pain, rapidly spreading swelling or skin colour change, blisters and feeling very ill need emergency assessment. Do not wait for the next injection visit.
Kidney, liver, heart or lung problems
Urgently report a marked drop in urine, yellow eyes or skin, new chest discomfort, swelling or new cough or breathlessness. These symptoms need assessment rather than an assumption that they are part of the blood disorder. Severe breathing difficulty or chest pain is an emergency.
Tumour lysis syndrome
When many abnormal cells break down quickly, blood salts can change and damage the kidneys or heart. Risk varies and can be greater with combinations. Take prescribed prevention medicines and follow the fluid plan. Severe weakness, cramps, palpitations, reduced urine, confusion or a seizure need urgent assessment.
Differentiation syndrome
A serious inflammatory reaction has been reported with injectable azacitidine; its frequency is not established. Fever with new breathlessness, swelling, rapid weight gain or dizziness needs immediate assessment. The hospital may need to give steroids and temporarily pause treatment.
Severe allergic reaction
Tell the nurse immediately about itching, flushing, wheeze, dizziness or swelling during treatment. Breathing difficulty, collapse or swelling of the face or throat requires emergency help.
Practical advice for this treatment
Keep a record of injection sites and symptoms between visits. Check with the unit before taking fever-reducing medicine for a new fever. Take anti-sickness medicines on schedule; they can contribute to constipation, so ask for a bowel plan. If you cannot attend an injection appointment, telephone the unit rather than skipping or rearranging doses yourself.
Medicines, interactions and vaccinations
Give the oncology pharmacist a complete list of prescription medicines, over-the-counter products, vitamins, herbal and Ayurvedic remedies and supplements. Ask before starting anything new. Do not stop prescribed medicines, including anticoagulants or infection-prevention medicines, without a coordinated plan. Live vaccines are generally unsuitable while immunity is suppressed; discuss vaccine type and timing with the team. Non-live vaccines may be offered, although protection can be reduced. Follow any specific stop-and-call instructions for the cancer medicine on this page or in your written treatment plan.
No formal clinical interaction studies establish that azacitidine is free of interactions. Review all medicines, including those affecting blood counts or kidneys. If venetoclax is part of your plan, some antibiotics and antifungal medicines can require major venetoclax dose changes even though injectable azacitidine itself has fewer enzyme-related interactions. Only the treating team should make those changes.
Pregnancy, fertility and breastfeeding
Chemotherapy can harm a developing baby and may affect fertility temporarily or permanently. Discuss sperm, egg or embryo storage before treatment when feasible. Tell the team immediately about a suspected pregnancy. Periods stopping does not guarantee infertility.
The referenced Vidaza SmPC advises effective contraception during treatment and for at least 6 months after treatment for women who could become pregnant, and at least 3 months for men with partners who could become pregnant. A combination or the product actually supplied may require a longer interval. Ask for a written end date. Do not breastfeed during treatment; agree any restart with the team.
Everyday life
Gentle activity, regular meals and rest can help you cope. Prepare food hygienically and drink according to your individual fluid plan. Avoid smoking; ask whether alcohol is safe with your exact treatment and other medicines. Plan work, travel and driving around symptoms and monitoring visits. Do not drive if dizzy, sleepy, weak, visually affected or impaired by neuropathy. You can usually be close to family and friends: chemotherapy does not make you radioactive. Follow the unit’s instructions for handling urine, vomit, laundry and sexual precautions for the period it specifies.
When to contact the oncology team
Contact the oncology team the same day for persistent vomiting or diarrhoea, difficulty drinking, reduced urine, mouth pain affecting eating, new cough, jaundice, a painful or spreading rash, unusual bruising, worsening constipation or new nerve symptoms. Use the more urgent instructions for the particular symptom when given above. If the team cannot be reached and you are unwell, seek urgent medical care.
Write down your hospital’s daytime and out-of-hours numbers before treatment. CTI’s general contact details do not replace the emergency number provided by your treating hospital.
After treatment
Keep the planned blood tests and follow-up appointments after the last dose. Blood counts and immunity may take time to recover, and some effects can start or persist later. Contact the team about symptoms rather than waiting for a routine visit. Keep a treatment summary, including drug names, dates and any serious reactions, for future doctors. Response may be assessed with examination, scans or blood or marrow tests, depending on the cancer.
Words you may hear
- Bone marrow
- The soft tissue inside bones that makes blood cells.
- Hypomethylating agent
- A medicine that changes some chemical signals controlling gene activity.
- Cycle
- A planned period of treatment followed by recovery time.
Frequently asked questions
Are the injections interchangeable with azacitidine tablets?
No. Oral azacitidine (Onureg) is a distinct formulation with a different treatment schedule and clinical role. Never switch between them yourself.
Why are my blood counts lower at the beginning?
Both the disease and treatment can lower counts. This is particularly important during early cycles. Your team will interpret the results and arrange support or change the schedule if needed.
How soon will we know if it is helping?
Benefit from azacitidine alone for MDS may take several months. The team follows symptoms, transfusion needs, blood counts and sometimes bone-marrow tests. AML combinations may use a different assessment timetable.
Can I take a break because the injections are uncomfortable?
Call the team first. They can review injection technique, sites, symptom relief or the treatment plan. Do not miss treatment without discussing it.
Do I still need tests if I feel well?
Yes. Blood-count, kidney and liver changes may appear before symptoms. Keep appointments during treatment breaks too.
Will I definitely lose my hair?
Complete hair loss is not a typical expectation with azacitidine alone, although thinning can occur. Other medicines in the plan may change this.
What should I do about a red injection site?
Mild local irritation can occur. Report increasing warmth, pain, spreading colour change or swelling; severe pain, blistering or fever needs urgent assessment.
Can I take herbal or Ayurvedic products?
Check every product with the oncology pharmacist. Avoid starting supplements or remedies during treatment without that check.
Related treatment information
If this medicine is combined with other treatments, ask for each medicine’s information and the complete combination calendar. An individual-drug sheet does not describe every additional risk of a combination.
Sources and further reading
Summary of Product Characteristics
Professional reference resources. The SmPC describes product-specific warnings, interactions, adverse effects and monitoring. US prescribing information is identified separately. Original-brand or direct manufacturer documents are linked where retrieved. The team must also check the product actually supplied in India.
- Vidaza — company-supplied UK SmPC, Bristol Myers Squibb. Accessed 16 October 2026. Original brand. Text revised 5 December 2023; current emc entry accessed.
- Vidaza — EMA product information including SmPC. Accessed 16 October 2026. Original brand; current EMA-hosted product information.
- Vidaza — manufacturer-hosted US prescribing information. Accessed 16 October 2026. Bristol Myers Squibb; revised January 2024. US route and indication distinctions.
Other authoritative references
- Macmillan Cancer Support — Azacitidine. Accessed 16 October 2026. Patient care and adverse effects.
- BC Cancer — Azacitidine monograph. Accessed 16 October 2026. Revised 1 June 2026. Injectable and oral formulations distinguished; older contraception statements do not override current product-specific SmPC.
- BC Cancer — Azacitidine subcutaneous patient handout. Accessed 16 October 2026. Injection-specific patient advice.
- NCI — Acute Myeloid Leukemia Treatment (PDQ), health professional version. Accessed 16 October 2026. Low-intensity treatment and venetoclax combinations.
- NCI — infection and neutropenia. Accessed 16 October 2026.
- NCI — mouth and throat problems. Accessed 16 October 2026.
- NCI — diarrhoea. Accessed 16 October 2026.
- NCI — fatigue. Accessed 16 October 2026.
- ASCO hepatitis B screening and management opinion. Accessed 16 October 2026. Independent cross-check: Provisional Clinical Opinion: universal three-test screening before or at systemic anticancer therapy; chronic/past infection management.
Editorially approved by Dr (Prof) Vijay Agarwal
Professor and Lead Consultant – Medical Oncology
