cedazuridine + decitabine: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
cedazuridine + decitabine: clinical details
Prescribing considerations
- Initiation and supervision require experience with anticancer therapy.
- Consider antiemetic prophylaxis where nausea or vomiting is anticipated.
- Review infection risk, baseline organ function, cardiac history, reproductive plans and concomitant medicines.
- Use caution with hepatic impairment, severe renal impairment, unstable cardiac disease or previous severe heart failure.
- Use cytotoxic handling and disposal procedures; tablets must remain intact.
- The tablet contains lactose and is unsuitable for certain rare hereditary disorders of carbohydrate metabolism.
Contraindications and cautions
- Hypersensitivity to either active ingredient or an excipient.
- Breastfeeding.
Monitoring
- Full blood count before treatment and regularly thereafter, with prompt assessment of fever, bleeding or other signs of myelosuppression.
- Liver and renal function before and during treatment.
- Clinical response and toxicity.
- Signs of infection, interstitial lung disease, differentiation syndrome and heart failure.
Clinical pharmacology
Decitabine is a pyrimidine analogue that inhibits DNA methyltransferase after intracellular activation and incorporation into DNA. Cedazuridine inhibits cytidine deaminase-mediated first-pass degradation, producing decitabine exposure comparable to intravenous decitabine in crossover pharmacokinetic studies.
Formulation and product differences
- Fixed-combination oral film-coated tablet containing both active ingredients.
- Cedazuridine enables oral decitabine exposure by limiting breakdown in the gut and liver.
- Food reduces decitabine exposure, so fasting administration is required.
- The intact coating limits handling exposure; tablets must not be crushed, divided or chewed.
cedazuridine + decitabine preparations and strengths
Tablet
Route: Oral
Strengths: 35 mg + 100 mg
cedazuridine + decitabine interactions
The cancer team should review all prescribed, non-prescribed and complementary products before treatment.
Cytarabine, gemcitabine or azacitidine
Cedazuridine may increase exposure to these medicines and increase toxicity, so combined use should be avoided.
Other cytidine deaminase inhibitors
These may reduce decitabine breakdown and increase its exposure, so combined use should be avoided.
CYP enzyme inhibitors or inducers
A clinically significant pharmacokinetic interaction is not expected because neither active ingredient is a CYP substrate or inhibitor.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.