This site is intended for UK healthcare professionals
Medscape UK Univadis Logo
Medscape UK Univadis Logo

Decitabine parenteral

Updated 2 Feb 2023 | Antimetabolites


Infusions containing decitabine.

Drugs List

  • DACOGEN 50mg powder for concentrate for soln for infusion vial
  • decitabine 50mg powder for concentrate for soln for infusion vial
  • Therapeutic Indications


    Leukaemia - acute myeloid

    Treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), who are not candidates for standard induction chemotherapy.


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


    20 mg/metre squared body surface area intravenously daily for 5 consecutive days (one treatment cycle). The total daily dose must not exceed 20 mg/metre squared and the total dose per treatment cycle must not exceed 100 mg/metre squared.

    The cycle should be repeated every 4 weeks depending on the patient's clinical response.

    Patients should be treated for a minimum of 4 cycles and continued for as long as the patient continues to benefit. If after 4 cycles, the patient's haematological values (e.g. platelet counts or absolute neutrophil count), have not returned to pre-treatment levels or if disease progression occurs (peripheral blast counts are increasing or bone marrow blast counts are worsening), the patient may be considered to be a non responder and alternative therapies should be considered.

    Additional Dosage Information

    Dose reductions are not recommended, adverse reactions should be managed by interrupting treatment.

    Treatment should be suspended in the following cases:
    Febrile neutropenia (temperature greater than or equal to 38.5 degrees celsius and neutrophil count less than 1 x 10 to the power 9/L).
    Acute viral, bacterial or fungal infection (requiring intravenous anti-infectives or extensive supportive care).
    Haemorrhage (gastrointestinal, genito-urinary or pulmonary with platelet count less than 25 x 10 to the power 9/L or any central nervous system haemorrhage)

    Once symptoms have improved or have been stabilised by supportive measures, treatment with decitabine may be resumed.

    Pre-medication for the prevention of nausea and vomiting is not routinely recommended but may be administered if required.


    For intravenous infusion over 1 hour.


    Children under 18 years

    Precautions and Warnings

    Females of childbearing potential
    Hepatic impairment
    Renal impairment - creatinine clearance below 30 ml/minute
    Severe congestive cardiac failure
    Unstable cardiac disorder

    Administration of live vaccines is not recommended
    Sodium content of formulation may be significant
    Advise ability to drive/operate machinery may be affected by side effects
    Consider use of anti-infective prophylaxis during neutropenic phase
    Give pre-treatment counselling and consideration of oocyte cryopreservation
    Give pre-treatment counselling and consideration of sperm cryopreservation
    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
    Exclude pregnancy prior to initiation of treatment
    Monitor liver function tests at baseline and before each dose
    Monitor renal function at baseline and prior to each dose
    Perform full blood count before each treatment cycle
    Monitor for signs and symptoms of interstitial lung disease
    Monitor full blood count regularly
    Monitor patients for signs and symptoms of cardiac failure
    Monitor platelet count prior to each dose
    Advise patient to report any new or worsening respiratory symptoms
    Advise patient to report symptoms of infection immediately
    Consider high dose IV steroids if differentiation syndrome is suspected
    Risk of developing opportunistic infections
    Consider interrupting treatment if differentiation syndrome occurs
    Consider interrupting treatment if haemorrhage occurs
    Interrupt treatment if febrile neutropenia occurs
    Interrupt treatment if severe infection develops
    Female: Contraception required during and for 6 months after treatment
    Male: Contraception required during and for 3 months after treatment

    In patients receiving decitabine, there have been reports of interstitial lung disease (including pulmonary fibrosis, pulmonary infiltrates and organising pneumonia) without signs of infectious aetiology. Consequently, in the event of a patient developing acute onset or unexplained worsening of pulmonary symptoms, a careful assessment of the patient should be performed to exclude interstitial lung disease. If interstitial lung disease is diagnosed, appropriate treatment should be initiated.

    Differentiation syndrome (also known as retinoic acid syndrome)
    Differentiation syndrome has been reported in some patients treated with this agent. Differentiation syndrome may be fatal. If patients present with signs and symptoms suggestive of differentiation syndrome, treatment with high dose intravenous corticosteroids and haemodynamic monitoring should be considered. Interruption of the suspected causative agent should be considered until the symptoms resolve. Once symptoms have resolved, if treatment with the suspected causative agent is resumed, caution is advised.

    Pregnancy and Lactation


    Decitabine is contraindicated during pregnancy.

    The manufacturer recommends that decitabine should not be used during pregnancy. At the time of writing there is no data on the use of decitabine in human pregnancy. Studies in animals have shown teratogenic effects.


    Decitabine is contraindicated during breastfeeding.

    The manufacturer recommends that decitabine is contraindicated during breastfeeding. It is unknown if decitabine will be excreted in breast milk. However, due to the molecular weight and the lack of plasma protein binding it is likely but, the very short terminal half-life will limit the amount excreted. A risk to neonates cannot be excluded.

    Side Effects

    Abnormal liver function
    Acute febrile dermatosis (Sweet's syndrome)
    Anaphylactic reaction
    Anaphylactic shock
    Anaphylactoid reaction
    CNS haemorrhage
    Differentiation syndrome
    Febrile neutropenia
    Gastro-intestinal haemorrhage
    Hypersensitivity reactions
    Interstitial lung disease
    Neutropenic colitis
    Septic shock
    Urinary tract infections


    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: October 2019

    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.

    Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press. Accessed on 11 October 2019.

    Martindale: The Complete Drug Reference (online) London: Brayfield A (ed). Pharmaceutical Press. Accessed on 25 August 2015.

    Summary of Product Characteristics: Dacogen 50mg powder for concentrate for solution for infusion. Janssen-Cilag Ltd. Revised February 2022.

    Access the full UK drug database with a FREE Medscape UK Account
    It takes just a few minutes, and you’ll get unlimited access to information on over 11,000 UK drugs.
    Register for Free

    Already a member? Log in

    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

    FDB Logo

    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.