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Azacitidine powder for suspension for injection

Updated 2 Feb 2023 | Antimetabolites


Powder for suspension for injection containing azacitidine.

Drugs List

  • azacitidine 100mg powder for suspension for injection
  • VIDAZA 100mg powder for suspension for injection
  • Therapeutic Indications


    Acute myeloid leukaemia (AML) - not eligible for stem cell transplant
    Chronic myelomonocytic syndrome (CMML)-ineligible for stem cell transplant
    High-risk myelodysplastic syndrome(MDS)-ineligible for stem cell transplant

    Treatment of adult patients who are not eligible for haematopoietic stem cell transplantation with:

    Intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS)

    Chronic myelomonocytic leukaemia (CMML) with 10 to 29% marrow blasts without myeloproliferative disorder

    Acute myeloid leukaemia (AML) with 20 to 30% blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification

    Acute myeloid leukaemia (AML) with greater than 30% marrow blasts, according to the WHO classification.


    Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.


    The recommended starting dose for the first treatment cycle is 75mg/square metre body surface area, daily for 7 days, followed by a rest period of 21 days (28-day treatment cycle).

    A minimum of 6 cycles is recommended and treatment should be continued as long as the patient continued to benefit or until disease progression or unacceptable toxicity.

    Patients with Renal Impairment

    No dose adjustments required in patients with renal impairment.

    If unexplained reduction in serum bicarbonate to less than 20 mmol/L, reduce dose by 50% in next cycle.
    If elevations in serum creatinine or blood urea nitrogen greater than or equal to 2 fold above baseline and upper limit of normal (ULN), suspend treatment until levels return to normal or baseline and reduce dose by 50% in next cycle.

    Additional Dosage Information

    Dose adjustment due to haematological toxicity:

    Patients without reduced baseline blood counts prior to first treatment
    Platelet count less than or equal to 50 x 10 to the power 9/L and/or absolute neutrophil count (ANC) less than or equal to 1 x 10 to the power 9/L: Suspend treatment until levels recover to higher than these.

    Recovery within 14 days: Resume treatment at normal dose.
    Recovery longer than 14 days:
    Platelet count less than or equal to 50 x 10 to the power 9/L and/or ANC less than or equal to 1 x 10 to the power 9/L: Reduce dose by 50%.
    Platelet count greater than 50 x 10 to the power 9/L and/or ANC greater than 1 x 10 to the power 9/L: Dose as normal (100% of the dose).

    Patients with reduced baseline blood counts prior to first treatment
    Platelet count, ANC or white blood cell count (WBC), less than a 50% decrease compared to baseline or greater than a 50% decrease but an improvement in cell line differentiation: Dose as normal.
    Platelet count, ANC or WBC, greater than a 50% decrease compared to baseline with no improvement in cell line differentiation: Suspend treatment until levels have recovered and dose as follows:

    Recovery within 14 days: Resume treatment at normal dose.
    Recovery longer than 14 days: Determine bone marrow cellularity.

    Bone marrow cellularity greater than 50%: Resume treatment at normal dose.
    Bone marrow cellularity less than or equal to 50%, suspend treatment and reduce dose as follows:
    Bone marrow cellularity between 15% and 50%, recovery within 21 days: Resume treatment at normal dose.
    Bone marrow cellularity less than 15%, recovery within 21 days: Resume treatment at normal dose.
    Bone marrow cellularity between 15% and 50%, recovery longer than 21 days: Reduce dose by 50%.
    Bone marrow cellularity less than 15%, recovery longer than 21 days: Reduce dose to 33%.

    Haematological toxicity is defined as the lowest count reached in a given cycle (nadir) if platelets less than or equal to 50 x 10 to the power 9/L and/or ANC less than or equal to 1 x 10 to the power 9/L.

    Recovery is defined as an increase of cell line(s) where haematological toxicity was observed of at least half of the difference of nadir and baseline count plus nadir count (i.e. blood count at recovery greater than or equal to nadir count plus (0.5x (baseline count-nadir count)).


    For subcutaneous injection.

    To be administered as a subcutaneous injection into the upper arm, thigh or abdomen. Injection sites should be rotated. New injections should be given at least 2.5cm away from previous sites and areas which are tender, bruised, red or hardened should be avoided.
    Doses of more than 100mg (4ml) should be equally divided into 2 syringes and injected into 2 separate sites.


    Children under 18 years
    Advanced liver cancer

    Precautions and Warnings

    Females of childbearing potential
    Hepatic impairment
    Pulmonary disease
    Renal impairment
    Severe congestive cardiac failure
    Unstable cardiac disorder

    Consider anti-infective prophylaxis in immunocompromised patients
    Advise ability to drive/operate machinery may be affected by side effects
    Anti-diarrhoeals may be required during treatment
    Give pre-treatment counselling and consideration of sperm cryopreservation
    Maintain adequate hydration of patient prior / during treatment
    Prophylactic G-CSF should be considered
    Treatment to be initiated and supervised by a specialist
    Consult local policy on the safe use of anti-cancer drugs
    Staff: Not to be handled by pregnant staff
    Monitor liver function tests at baseline and before each dose
    Monitor renal function at baseline and prior to each dose
    Monitor serum creatinine prior to and during treatment
    Perform full blood count before each treatment cycle
    Consider dose reduction if BUN and serum creatinine rise during treatment
    Monitor closely patient with pre-existing renal impairment
    Monitor for bleeding during treatment
    Monitor for constipation; give laxatives as required
    Monitor patients for signs of tumour lysis syndrome
    Monitor serum sodium bicarbonate
    Advise patient to report oliguria and anuria
    Advise patient to report unexplained fever, sore throat, bruising, bleeding
    Consider the use of anti-emetics before and during therapy
    Consider treatment interruption & dose reduction in haematological toxicity
    Discontinue if necrotising fasciitis occurs
    Discontinue permanently if severe hypersensitivity reactions occur
    Male & female: Contraception required during & for 3 months after treatment

    Patients with extensive tumour burden due to metastatic disease have been reported to experience progressive hepatic coma and death during azacitidine treatment, especially in patients with baseline serum albumin less than 30g/L.

    Patients with a known history of cardiovascular or pulmonary disease are at an increased risk of cardiac events, caution is advised in these patients. Cardiopulmonary assessment before and during treatment should be considered.

    Pregnancy and Lactation


    Azacitidine is contraindicated during pregnancy.
    The manufacturer recommends azacitidine should not be used during pregnancy, especially during the first trimester. There is no data on the use of azacitidine in human pregnancy. Studies in mice have shown reproductive toxicity.


    Azacitidine is contraindicated during breastfeeding.
    The manufacturer recommends that breastfeeding is contraindicated during azacitidine therapy. It is unknown whether azacitidine and its metabolites are excreted in human breast milk, however, due to the molecular weight it is expected that it will, a risk to neonates cannot be excluded.

    Side Effects

    Abdominal pain
    Acute febrile dermatosis (Sweet's syndrome)
    Bruising at injection site
    Chest pain
    Conjunctival haemorrhage
    Decreased appetite
    Discolouration (injection site)
    Erythema at injection site
    Febrile neutropenia
    Gastro-intestinal haemorrhage
    Gingival bleeding
    Haematoma (injection site)
    Haemorrhage (injection site)
    Haemorrhoidal bleeding
    Hepatic coma
    Hepatic failure
    Herpes simplex
    Hypersensitivity reactions
    Induration (injection site)
    Inflammation (injection site)
    Injection site reactions
    Interstitial lung disease
    Intracranial bleeding
    Itching (injection site)
    Local pain (injection site)
    Maculopapular rash
    Musculoskeletal pain
    Necrosis (injection site)
    Necrotising fasciitis
    Neutropenic sepsis
    Nodules (injection site)
    Ocular haemorrhage
    Pharyngolaryngeal pain
    Pleural effusion
    Pyoderma gangrenosum
    Rash at injection site
    Renal failure
    Renal tubular acidosis
    Serum creatinine increased
    Skin infection
    Tumour lysis syndrome
    Upper respiratory tract infection
    Urinary tract infections
    Weight loss


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: July 2021

    Reference Sources

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Summary of Product Characteristics: Azacitidine betapharm 25mg/ml powder for suspension for injection. Dr Reddy's Laboratories (UK) Ltd. Revised March 2020.
    Summary of Product Characteristics: Vidaza 25mg/ml powder for suspension for injection. Celgene Ltd. Revised November 2020.

    NICE Evidence Services Available at: Last accessed: 21 June 2021

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