encorafenib: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
encorafenib: clinical details
Prescribing considerations
- Confirm an appropriate tumour BRAF mutation using a suitable validated test before initiation.
- Initiate and supervise treatment through an oncology clinician experienced in systemic anti-cancer therapy.
- Review cardiac disease, QT-prolongation risks, bleeding history, ocular disease, hepatic or severe renal impairment and prior or concurrent RAS-associated malignancy.
- Assess the warnings, monitoring and toxicity-management requirements of every medicine in the selected combination.
- Consider tumour lysis syndrome risk in patients with high tumour burden, renal impairment, oliguria, dehydration or hypotension.
Contraindications and cautions
- Hypersensitivity to encorafenib or any capsule excipient.
Monitoring
- Clinical review for new or worsening visual symptoms, with prompt ophthalmological assessment when indicated.
- ECG and potassium and magnesium assessment before and during treatment according to product guidance and clinical risk.
- Liver tests before treatment and regularly thereafter.
- Renal function, hydration status and toxicity associated with vomiting or dehydration.
- Skin examination before treatment, during therapy and after discontinuation; investigate suspicious lesions.
- Left ventricular function when encorafenib is combined with binimetinib.
- Blood counts and examinations or imaging for new malignancy where clinically appropriate.
Clinical pharmacology
Encorafenib is an ATP-competitive RAF kinase inhibitor that suppresses mutant BRAF-driven RAF–MEK–ERK signalling. It is absorbed orally and metabolised mainly through CYP3A4; it also induces CYP3A4 and inhibits UGT1A1 and several transporters.
Formulation and product differences
- The selected product is a hard gelatin capsule.
- Capsules can be swallowed whole or opened for immediate dispersion in apple sauce when swallowing is difficult.
- The capsule contains gelatin and should be stored in its original packaging to protect it from moisture.
encorafenib preparations and strengths
Capsule
Route: Oral
Strengths: 50 mg, 75 mg
encorafenib interactions
The oncology team should review prescribed, over-the-counter and herbal products before and during treatment. Important examples include:
Strong CYP3A4 inhibitors, including ritonavir, itraconazole, posaconazole and clarithromycin
These can substantially increase encorafenib exposure and toxicity and should generally be avoided.
Moderate CYP3A4 inhibitors, including diltiazem, fluconazole, erythromycin and amiodarone
These may increase encorafenib exposure, requiring caution and closer safety monitoring.
CYP3A4 inducers, including rifampicin, carbamazepine, phenytoin and St John’s wort
These may lower encorafenib exposure and compromise its effect, so alternatives should be considered.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.