decitabine: clinical use

Prescribing considerations

• Initiate under clinicians experienced in cytotoxic therapy.
• Myelosuppression may worsen, increasing serious infection and bleeding risks; supportive management may be required.
• Use cautiously in hepatic impairment and severe renal impairment because these groups have not been adequately studied.
• Assess unexplained pulmonary symptoms for interstitial lung disease.
• Monitor patients with cardiac disease for heart-failure symptoms.
• Recognise differentiation syndrome promptly; it can be fatal and requires urgent management.

Contraindications and cautions

• Hypersensitivity to decitabine or an excipient.
• Breastfeeding.

Monitoring

• Full blood count, including platelet count, before treatment and regularly during therapy.
• Liver and renal function before treatment and during therapy.
• Clinical evidence of infection, bleeding, pulmonary toxicity and differentiation syndrome.
• Signs or symptoms of heart failure, particularly in patients with previous cardiac disease.

Clinical pharmacology

A cytidine deoxynucleoside analogue activated by intracellular phosphorylation and incorporated into DNA. It inhibits DNA methyltransferases and is mainly inactivated through deamination rather than CYP450 metabolism; protein binding is negligible and accumulation is not expected.

Formulation and product differences

• The selected product is a single-use powder requiring aseptic reconstitution and further dilution for intravenous infusion.
• It must not be infused through the same intravenous line as other medicines.
• Oral decitabine combined with cedazuridine is a separate product; its formulation and administration instructions are not interchangeable with intravenous decitabine alone.

Solution for infusion

Route: Intravenous

Strengths: 50 mg