Medical Information

The use of Encorafenib requires strict monitoring of adverse reactions and drug interactions, involving various precautions such as cardiac toxicity, liver and kidney function, and bleeding risk. The dosage should be adjusted or discontinued according to clinical conditions, and the safety of medication for special populations should be taken seriously.

1. Precautions for combination therapy

When used in combination with bimetinib or cetuximab, the contraindications and precautions of the combination therapy should also be considered. If the combination therapy is suspended or terminated, the dosage of Enkafenib should be adjusted or discontinued accordingly.

2. Adverse reaction monitoring and management

(1) Newly diagnosed malignant tumor

Regular screening is required for skin and non skin malignant tumors. If RAS mutation positive non skin tumors appear, permanent discontinuation of medication is required.

(2) Cardiomyopathy

Assess cardiovascular risk before treatment and regularly monitor LVEF. When symptomatic heart failure or significant decrease in LVEF occurs, treatment should be reduced or suspended.

(3) Hepatotoxicity

Before treatment and monthly monitoring of liver function, if AST/ALT elevation occurs, medication should be temporarily suspended, reduced, or permanently discontinued according to the grading.

(4) Risk of bleeding

Avoid using anticoagulant/antiplatelet drugs in combination. If severe bleeding occurs, discontinue treatment and evaluate subsequent medication plans.

(5) Uveitis

When eye pain or visual changes occur, medication should be temporarily suspended, and if there is a grade 4 reaction, medication should be permanently discontinued.

(6) QT interval prolongation

Regular monitoring of electrocardiogram, if QTcF>500ms or an increase of>60ms from baseline, permanent discontinuation of medication is required.

3. Medication for special populations

(1) Liver and kidney dysfunction

Mild to moderate damage does not require dose adjustment, while severe liver and kidney function damage lacks safety data and should be used with caution.

(2) Pregnancy and lactation

There is a risk of fetal malformation, and pregnancy status should be confirmed before medication. Contraceptive measures should be taken during treatment and after discontinuation of medication.

4. Drug interactions

Strong inhibitors of CYP3A4 need to be reduced to 150mg/day, while intermediate inhibitors need to be reduced to 225mg/day, and adverse reactions should be closely monitored.

5. Emergency medical indications

Seek medical attention immediately if vomiting blood, black stool, severe headache, chest pain, difficulty breathing, jaundice, or persistent high fever occurs.