Decitabine

Registered South African indications:

• Acute myeloid leukaemia

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Breastfeeding

Cautions

• Pregnancy
• Renal impairment
• Hepatic impairment
• Acute onset or unexplained worsening of pulmonary symptoms 
• History of severe congestive heart failure or clinically unstable cardiac disease 
• Sodium controlled diet

Forms avail. in SA and covered in this monograph: inj

Used for the treatment of

Newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organisation  (WHO) classification in patients ≥ 65 years

Consult specialist for dosages and regimens

Not established for use in children

Pregnancy

• FDA Pregnancy Category Not Rated (NR)

Breastfeeding

• Contraindicated

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly            

• No dose adjustment recommended

Central Nervous System Disorders

• Headache

Respiratory Disorders

• Epistaxis
• Interstitial lung disease
• Pneumonia
• Sinusitis

Gastrointestinal Disorders

• Diarrhoea
• Nausea and vomiting
• Stomatitis
• Enterocolitis

Genitourinary Disorders

• Urinary tract infection

Skin and Subcutaneous Tissue Disorders

• Acute febrile neutrophilic dermatosis 

Immune, Blood and Lymphatic System Disorders

• Septic shock
• Sepsis
• Pyrexia
• Hypersensitivity
• Anaphylactic reaction
• Febrile neutropaenia
• Neutropaenia
• Thrombocytopaenia
• Anaemia
• Leukopaenia
• Pancytopaenia

No information available

• Full blood count with differential
• Hepatic function
• Renal function

Decitabine is a cytosine nucleoside analogue that selectively inhibits DNA methyltransferases at low doses, resulting in gene promoter hypomethylation that can result in reactivation of tumour suppressor genes, induction of cellular differentiation or cellular senescence followed by programmed cell death.

Injection (per 20ml) 50mg

• Dacogen (Janssen) originator