Encorafenib is an oral small-molecule BRAF kinase inhibitor developed and manufactured by Pierre Fabre in France. In 2018, encorafenib received marketing approval from the U.S. Food and Drug Administration (FDA).
Side Effects Requiring Immediate Medical Attention
If the following side effects occur while taking encorafenib, please seek immediate medical attention:
1. Common Side Effects
(1) Black, tarry stools, bleeding gums, abdominal distension, blood in urine or stool, chest pain or tightness, chills, constipation, hemoptysis, dark urine, difficulty breathing or swallowing, dizziness, rapid heartbeat, fever, headache, hives, itching, rash, hoarseness, increased menstrual flow or vaginal bleeding, indigestion, local irritation, joint pain, stiffness or swelling, loss of appetite, lower back or lateral pain Pain, nausea, nosebleeds, painful or difficult urination, abdominal and lower back pain (possibly radiating to the back);
(2) Pale skin, partial or mild facial numbness, pinpoint red spots on the skin, persistent bleeding from wounds, red or black tarry stools, red or dark brown urine, red, swollen or painful skin, peeling skin on the hands and feet, sore throat, swelling of the eyelids, face, lips, hands or feet, swollen glands, thickened skin, numbness and tingling in the hands and feet, ulcers, sores or white spots in the mouth, skin ulcers, abnormal bleeding or bruising, abnormal fatigue and weakness, vomiting, yellowing of the eyes or skin, etc.
2. Rare side effects
Vomiting bloody or coffee-ground-like vomit.
Mild Side Effects
If any of the following side effects persist, cause discomfort, or you have any questions while taking Encorafenib, please consult a healthcare professional:
Back pain, burning, numbness, tingling, or aching sensations; altered taste; difficulty moving; dry skin; hair loss; thinning hair; loss of taste; muscle pain, tenderness, atrophy, or weakness; pain in the arms or legs; stomach pain; unsteadiness or clumsiness; weakness in the arms, hands, legs, or feet.
Side Effects for Healthcare Professionals Only
Common Adverse Reactions
The most common adverse reactions when patients use Encorafenib alone, or in combination with bimetinib or cetuximab, include nausea, diarrhea/colitis, anemia, elevated creatinine, hyperglycemia, elevated gamma-glutamyl transferase, elevated creatine kinase, musculoskeletal pain, arthralgia, skin adverse reactions, and fatigue. In clinical trials, the incidence of adverse reactions was highest when encorafenib was used alone; however, encorafenib is currently only approved for use in combination with other drugs.
Cardiovascular System
Very common (10% and above): Left ventricular dysfunction/cardiomyopathy (up to 11%), hypertension (up to 10.9%).
Common (1%-10%): QT interval prolongation, supraventricular tachycardia, venous thromboembolism, myocardial infarction.
Left ventricular dysfunction includes decreased ejection fraction and/or abnormalities, heart failure. Venous thromboembolism includes pulmonary embolism, deep vein thrombosis, embolism, thrombophlebitis, and superficial thrombophlebitis and thrombosis. Supraventricular tachycardia includes premature contractions, sinus tachycardia, supraventricular premature contractions, tachyarrhythmias, and tachycardia.
Skin System
Very Common (10% and above): Hyperkeratosis (up to 57%), Alopecia (up to 56%), Palmoplantar erythematous eczema (up to 51%), Rash (up to 41%), Dry Skin (up to 38%), Acne-like Dermatitis (up to 33%), Pruritus (up to 31%), Erythema (up to 16%), Melanocytic Nevus (up to 15.7%), Skin Papilloma (up to 11%), Sunburn (up to 10.2%), Hyperpigmentation.
Common (1%-10%): Skin Exfoliation, Palmoplantar Keratosis, Panniculitis, Trichokeratosis, Maculopapular Rash, Photosensitivity.
Gastrointestinal System
Very common (10% and above): Nausea (up to 58%), diarrhea/colitis (up to 52%), elevated lipase (up to 40%), vomiting (up to 37%), abdominal pain/abdominal discomfort (up to 32%), constipation (up to 27%), upper abdominal pain (12%).
Uncommon (0.1%-1%): Pancreatitis.
Hematologic System
Very common (10% and above): Anemia (up to 47%), lymphopenia (up to 24%), thrombocytopenia (up to 20%), bleeding (including intracranial hemorrhage, up to 21.3%), prolonged activated partial thromboplastin time (up to 19%), leukopenia (up to 13%), neutropenia (up to 13%).
Bleeding can occur in multiple sites, including the brain, anus, gastrointestinal tract, intracranial region, small intestine, upper gastrointestinal tract, and vagina, and may manifest as hemothorax, hematochezia, hematuria, hemoptysis, hyphema, etc. Liver System
Very common (10% and above): Elevated gamma-glutamyl transferase (GGT) (up to 45%), elevated alanine aminotransferase (ALT) (up to 34%), elevated aspartate aminotransferase (AST) (up to 31%), elevated alkaline phosphatase (up to 21%), elevated transaminases (8.8%).
Allergic Reactions
Common (1%-10%): Drug allergy.
Metabolic System
Very common (10% and above): Hyperglycemia (up to 48%), hypoalbuminemia (up to 32%), hyperkalemia (up to 31%), decreased appetite (up to 27%), elevated serum amylase (up to 22%), hypermagnesemia (up to 19%), hyponatremia (up to 26%), hypokalemia (up to 12%), hypocalcemia (up to 12%).
Frequency not clearly reported: Tumor lysis syndrome.
Musculoskeletal System
Very common (10% and above): Musculoskeletal pain (up to 48%), arthralgia (up to 44%), myopathy (up to 33%), back pain (up to 15%), myalgia (14%), limb pain (up to 11%), muscle spasms (10.4%).
Uncommon (0.1%-1%): Rhabdomyolysis.
Common (1%-10%): Arthritis.
Musculoskeletal pain includes back pain, arthralgia, limb pain, myalgia, musculoskeletal chest pain, non-cardiac chest pain, and neck pain.
Nervous System
Very common (10% and above): Headache (up to 29.5%), peripheral neuropathy (up to 22.6%), dizziness (up to 17%), taste disturbances (up to 13%).
Common (1%-10%): Facial nerve palsy.
Eye-related
Very common (10% and above): Retinal pigment epithelium detachment (up to 29.6%), visual impairment (up to 29%)
Common (1%-10%): Uveitis (including iritis and iridocyclitis), retinal detachment. Visual impairment includes blurred vision, floaters, photophobia, decreased vision, and flashes of light.
Tumor-related
Common (1%-10%): Basal cell carcinoma, new-onset primary melanoma, squamous cell carcinoma of the skin (including keratoacanthoma), central nervous system metastases, basal cell carcinoma.
Other
Very common (10% and above): Fatigue (up to 61%), elevated creatine kinase (up to 41%), edema (up to 23%), fever (up to 22%), weakness (20%), weight gain (up to 11%), peripheral edema (10.9%).
Common (1%-10%): Deterioration of overall health, device-related infections, weight loss.
Nervous System
Very common (10% and above): Insomnia (up to 22.1%).
Renal System
Very common (10% and above): Elevated creatinine (up to 93%).
Common (1%-10%): Acute kidney injury, kidney failure.
Respiratory System
Very common (10% and above): Cough (26%), dyspnea (up to 17%), nasopharyngitis (10.4%).
Common (1%-10%): Pleural effusion, pneumonia.
