Your Health, We Care
Encorafenib, whether used alone, in combination with binimetinib, in combination with cetuximab plus mFOLFOX, or in combination with cetuximab, may cause skin cancers known as cutaneous squamous cell carcinoma or basal cell carcinoma. Discuss your risk of developing these cancers with your healthcare provider.
Examine your skin regularly and inform your healthcare provider immediately of any skin changes, including:
New warts.
Small, painful or reddened skin lumps that bleed or fail to heal.
Changes in the size or color of moles.
Your healthcare provider should examine your skin for any new skin cancers before treatment initiation, every 2 months during treatment, and for up to 6 months after treatment discontinuation.
Your healthcare provider should also screen for cancers that may develop outside the skin. Inform your healthcare provider of any new symptoms that occur during treatment.
Your healthcare provider will assess your cardiac function before treatment and during treatment. Inform your healthcare provider immediately if you experience any signs or symptoms of cardiac disorders, including:
A feeling of a strong or rapid heartbeat.
Shortness of breath.
Swelling of the hands, ankles, legs or feet.
Dizziness or lightheadedness.
Your healthcare provider will perform blood tests to monitor your liver function before treatment and during treatment. Inform your healthcare provider if you experience any signs or symptoms of hepatic disorders, including:
Yellowing of the skin or eyes.
Dark or brown (tea-colored) urine.
Nausea or vomiting.
Loss of appetite.
Fatigue.
Easy bruising.
Bleeding.
Binimetinib, when used in combination with encorafenib, may cause severe musculoskeletal disorders. Binimetinib may increase the blood level of an enzyme called creatine phosphokinase (CPK), which may be a sign of muscle damage. Your healthcare provider should perform blood tests to monitor your CPK levels before treatment and during treatment. Inform your healthcare provider immediately if you experience any of the following symptoms:
Weakness.
Muscle aches or pain.
Dark or reddish urine.
Encorafenib, when used in combination with binimetinib, in combination with cetuximab plus mFOLFOX6, or in combination with cetuximab, may cause severe bleeding disorders, including potentially fatal bleeding in the stomach or brain. Inform your healthcare provider immediately and seek medical attention if you experience any signs of bleeding, including:
Headache, dizziness or feelings of weakness.
Coughing up blood or blood clots.
Vomiting blood or material that looks like coffee grounds.
Red or black, tarry stools.
Nosebleeds.
Binimetinib, when used in combination with encorafenib, may cause blood clots in the arms or legs, which can travel to the lungs and result in death.
Seek immediate medical attention if you experience the following symptoms:
Chest pain.
Sudden shortness of breath or difficulty breathing.
Pain in the legs (with or without swelling).
Swelling of the arms and legs.
Cold, pale skin on the arms or legs.
Your healthcare provider should perform regular eye examinations during treatment. Inform your healthcare provider immediately if you experience any new or worsening signs or symptoms of ocular disorders, including:
Blurred vision, vision loss or other changes in vision.
Seeing colored spots.
Seeing halos (blurred outlines around objects).
Pain, swelling or redness of the eyes.
QT prolongation may lead to life-threatening cardiac arrhythmias. Your healthcare provider should perform tests to monitor your blood salt (electrolyte) levels before you start treatment with encorafenib in combination with binimetinib, encorafenib in combination with cetuximab plus mFOLFOX6, or encorafenib in combination with cetuximab, and during treatment. Inform your healthcare provider immediately if you experience fainting, dizziness, lightheadedness, or a feeling of an irregular or rapid heartbeat during treatment with encorafenib in combination with binimetinib, encorafenib in combination with cetuximab plus mFOLFOX6, or encorafenib in combination with cetuximab. These symptoms may be related to QT prolongation.
Binimetinib, when used in combination with encorafenib, may cause pulmonary or respiratory disorders. Inform your healthcare provider if you experience any new or worsening signs or symptoms of pulmonary or respiratory disorders, including:
Shortness of breath.
Cough.
If you experience certain adverse reactions, your healthcare provider may adjust your dosage, temporarily interrupt, or permanently discontinue treatment with encorafenib and binimetinib.
FDA，2025.03
