dacomitinib monohydrate: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
dacomitinib monohydrate: clinical details
Prescribing considerations
- Confirm an activating EGFR mutation using a validated assay before initiation.
- Treatment should be initiated and supervised by a clinician experienced in anticancer therapy.
- Establish a proactive plan for early diarrhoea and skin-toxicity management.
- Review acid-suppressing treatment and CYP2D6 substrates before initiation.
- Data are limited in severe renal impairment and unavailable for haemodialysis; severe hepatic impairment requires specialist consideration.
- Safety and efficacy have not been established in people under 18.
Contraindications and cautions
- Hypersensitivity to dacomitinib or any listed excipient.
- The tablets contain lactose and should not be used in rare hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
- Previous interstitial lung disease was not studied; assess pulmonary history and risk carefully.
Monitoring
- Validated tumour EGFR mutation status before treatment.
- New or worsening respiratory symptoms; withhold during investigation for interstitial lung disease or pneumonitis.
- Bowel frequency, hydration, renal function and electrolytes when diarrhoea occurs.
- Skin, nails and mucosal toxicity, particularly early in treatment.
- Liver function tests; interrupt treatment for severe transaminase elevations.
- Clinical status, weight, full blood count, renal profile and liver profile as locally appropriate.
Clinical pharmacology
Dacomitinib is an orally absorbed, irreversible pan-HER inhibitor targeting EGFR/HER1, HER2 and HER4. It is extensively distributed, highly protein-bound and metabolised mainly through oxidation and glutathione conjugation; CYP2D6 contributes to formation of the active O-desmethyl metabolite. Elimination is predominantly faecal and the plasma half-life is prolonged.
Formulation and product differences
- Film-coated oral tablets are available in multiple strengths for prescribed treatment modification.
- Tablets contain lactose monohydrate and are essentially sodium-free.
- Tablet markings distinguish the available strengths; the preparation catalogue should be checked for exact presentations.
dacomitinib monohydrate preparations and strengths
Tablet
Route: Oral
Strengths: 15 mg, 30 mg, 45 mg
dacomitinib monohydrate interactions
The oncology team should review prescription, non-prescription and herbal products before and during treatment.
Proton pump inhibitors, such as omeprazole or rabeprazole
They raise stomach pH and can substantially reduce dacomitinib absorption, so concomitant use should be avoided.
Histamine-2 receptor antagonists
These require carefully separated administration from dacomitinib; obtain exact timing instructions from the oncology team.
Local antacids
These may be suitable alternatives to longer-acting acid suppression, but should still be checked with the oncology team.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.