Encorafenib's precise treatment strategy for BRAFV600E/V600K mutations has further promoted the development of cancer treatment towards individualization and precision.

1、 Drug name

1. Product Name: BRAFTOVI ™

2. Common name: encorafenib

2、 Indications

1. BRAFTOVI is used in combination with binimetinib to treat melanoma patients with BRAFV600E or V600K mutations that cannot be resected or metastasized. The mutations must be confirmed through FDA approved testing methods.

2. BRAFTOVI is not suitable for treating patients with wild-type BRAF melanoma.

3、 Specifications

Specification: 75mg hard capsule

4、 Main components

1. Active ingredient: encorafenib

2. Accessories: including copovidone, poloxamer188, microcrystalline cellulose, succinic acid crospovidone、 Colloidal silica, plant-based magnesium stearate, etc.

5、 Usage and dosage

1. Recommended dosage: once daily, 450mg each time, in combination with binimetinib.

2. Administration method: Oral, can be taken with or without food.

6、 Dose adjustment

1. According to the severity of adverse reactions, the dose of BRAFTOVI can be reduced to 300mg once daily, and further reduced to 200mg once daily. If unable to tolerate 200mg once daily, the medication will be permanently discontinued.

2. If the medication is suspended due to biimetinib, BRAFTOVI should be reduced to a maximum of 300mg once daily until biimetinib is resumed.

7、 Medication precautions

1. Before and after meals: can be taken with or without food.

2. Missing medication: If missed, take it as soon as possible within 12 hours; If it exceeds 12 hours, skip the missed dose and take the next dose at the regular time.

3. Vomiting: If vomiting occurs after taking medication, there is no need to take additional doses, and the next dose should be taken at the regular time.

8、 Medication for special populations

1. Pregnant women: May cause harm to the fetus, effective non hormonal contraceptive measures should be taken during medication and within 2 weeks after discontinuation.

2. Breastfeeding women: It is recommended to avoid breastfeeding during medication and for 2 weeks after discontinuation.

3. Fertility: Male medication may affect fertility.

4. Children: Safety and efficacy have not yet been established.

5. Elderly: Patients aged 65 and above do not need to adjust their dosage, but close monitoring is required.

6. Liver and kidney dysfunction: Patients with mild liver injury do not need to adjust the dosage; The dosage for patients with moderate to severe liver injury and renal insufficiency has not been established yet.

9、 Adverse reactions

1. Common adverse reactions (>25%): fatigue, nausea, vomiting, abdominal pain, and joint pain.

2. Serious adverse reactions: including new primary malignant tumors (skin and non skin), bleeding, uveitis, QT interval prolongation, embryo fetal toxicity, etc.

10、 Contraindications

There are no specific contraindications.

11、 Drug interactions

1. Strong or moderate CYP3A4 inhibitors: may increase the plasma concentration of encorofenib and require dose adjustment.

2. Strong or moderate CYP3A4 inducers: may reduce plasma concentrations of encorofenib and should be avoided in combination.

3. Sensitive CYP3A4 substrates: may increase the toxicity or reduce the efficacy of these drugs, and should be avoided in combination, especially with hormonal contraceptives.

4. Medications that prolong QT interval: Combination use should be avoided.

12、 Storage method

1. Store in an environment of 20 ° C to 25 ° C (68 ° F to 77 ° F), allowing temperature fluctuations between 15 ° C to 30 ° C (59 ° F to 86 ° F).

2. Keep the container tightly closed to prevent moisture.

3. Store in the original bottle with desiccant inside, do not remove the desiccant.

Encorafenibinformation