Braftovi Side Effects

Generic name: encorafenib

Medically reviewed by Drugs.com. Last updated on Nov 27, 2024.

Note: This document provides detailed information about Braftovi Side Effects associated with encorafenib. Some dosage forms listed on this page may not apply specifically to the brand name Braftovi.

Applies to encorafenib: oral capsule.

Serious side effects of Braftovi

Along with its needed effects, encorafenib (the active ingredient contained in Braftovi) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking encorafenib:

More common side effects

• black, tarry stools
• bleeding gums
• bloating
• blood in the urine or stools
• chest pain or tightness
• chills
• constipation
• coughing up blood
• dark urine
• difficulty in breathing or swallowing
• dizziness
• fast heartbeat
• fever
• headache
• hives, itching, skin rash
• hoarseness
• increased menstrual flow or vaginal bleeding
• indigestion
• irritation
• joint pain, stiffness, or swelling
• loss of appetite
• lower back or side pain
• nausea
• nosebleed
• painful or difficult urination
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• partial or slight paralysis of the face
• pinpoint red spots on the skin
• prolonged bleeding from cuts
• red or black, tarry stools
• red or dark-brown urine
• redness, swelling, or pain of the skin
• scaling of the skin on the hands and feet
• sore throat
• swelling of the eyelids, face, lips, hands, or feet
• swollen glands
• thickening of the skin
• tingling of the hands and feet
• ulcers, sores, or white spots in the mouth
• ulceration of the skin
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• yellow eyes or skin

Rare side effects

• vomiting of blood or material that looks like coffee grounds

Other side effects of Braftovi

Some side effects of encorafenib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common side effects

• back pain
• burning, numbness, tingling, or painful sensations
• change in taste
• difficulty in moving
• dry skin
• hair loss, thinning of hair
• loss of taste
• muscular pain, tenderness, wasting, or weakness
• pain in the arms or legs
• stomach pain
• unsteadiness or awkwardness
• weakness in the arms, hands, legs, or feet

For healthcare professionals

Applies to encorafenib: oral capsule.

General adverse events

The most common adverse reactions occurring in patients receiving this drug as a single agent, or in combination with binimetinib or cetuximab, included nausea, diarrhea/colitis, anemia, increased creatinine, hyperglycemia, increased gamma glutamyl transferase, increased creatine kinase, musculoskeletal pain, arthralgia, dermatologic adverse events, and fatigue. The incidence of adverse reactions was greatest when this drug was used a single agent in clinical trials; however, this drug is only indicated for use as part of a combination regimen.^[Ref]

Cardiovascular

• Very common (10% or more): Left ventricular dysfunction/cardiomyopathy (up to 11%), hypertension (up to 10.9%)
• Common (1% to 10%): QTc interval prolongation, supraventricular tachycardia, venous thromboembolism, myocardial infarction

Left ventricular dysfunction included decreased and/or abnormal ejection fraction, and cardiac failure.

Venous thromboembolism included pulmonary embolism, deep vein thrombosis, embolism, thrombophlebitis, and superficial thrombophlebitis and thrombosis.

Supraventricular tachycardia included extrasystoles, sinus tachycardia, supraventricular extrasystoles, tachyarrhythmia, tachycardia.

Dermatologic

• Very common (10% or more): Hyperkeratosis (up to 57%), alopecia (up to 56%), palmar-plantar erythrodysesthesia syndrome (up to 51%), rash (up to 41%), dry skin (up to 38%), acneiform 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%), skin hyperpigmentation,
• Common (1% to 10%): Skin exfoliation, palmoplantar keratoderma, panniculitis, keratosis pilaris, maculo-papular rash, photosensitivity

Gastrointestinal

• Very common (10% or more): Nausea (up to 58%), diarrhea/colitis (up to 52%), increased lipase (up to 40%), vomiting (up to 37%), abdominal pain/discomfort (up to 32%), constipation (up to 27%), upper abdominal pain (12%)
• Uncommon (0.1% to 1%): Pancreatitis

Hematologic

• Very common (10% or more): Anemia (up to 47%), lymphopenia (up to 24%), thrombocytopenia (up to 20%), hemorrhage, including intracranial (up to 21.3%), increased activated partial thromboplastin time (up to 19%), leukopenia (up to 13%), neutropenia (up to 13%)

Hemorrhage included hemorrhage at various sites including cerebral, anal, gastrointestinal, intracranial, small intestinal, upper gastrointestinal, and vaginal hemorrhage, as well as bleeding events such as hemothorax, hematochezia, hematuria, hemoptysis, hyphema.

Hepatic

• Very common (10% or more): Increased gamma glutamyl transferase (up to 45%), increased ALT (up to 34%), increased AST (up to 31%), increased alkaline phosphatase (up to 21%), increased transaminases (8.8%)

Hypersensitivity

• Common (1% to 10%): Drug hypersensitivity

Metabolic

• Very common (10% or more): Hyperglycemia (up to 48%), hypoalbuminemia (up to 32%), hyperkalemia (up to 31%), decreased appetite (up to 27%), increased serum amylase (up to 22%), hypermagnesemia (up to 19%), hyponatremia (up to 26%), hypokalemia (up to 12%), hypocalcemia (up to 12%)
• Frequency not reported: Tumor lysis syndrome

Musculoskeletal

• Very common (10% or more): Musculoskeletal pain (up to 48%), arthralgia (up to 44%), myopathy (up to 33%), back pain (up to 15%), myalgia (14%), pain in extremity (up to 11%), muscle spasms (10.4%)
• Uncommon (0.1% to 1%): Rhabdomyolysis
• Common (1% to 10%): Arthritis

Musculoskeletal pain included back pain, arthralgia, pain in extremity, myalgia, musculoskeletal chest pain, non-cardiac chest pain, and neck pain.

Nervous system

• Very common (10% or more): Headache (up to 29.5%), peripheral neuropathy (up to 22.6%), dizziness (up to 17%), dysgeusia (up to 13%)
• Common (1% to 10%): Facial paresis/paralysis

Ocular

• Very common (10% or more): Retinal pigment epithelial detachment (up to 29.6%), visual impairment (up to 29%)
• Common (1% to 10%): Uveitis, including iritis and iridocyclitis, retinal detachment

Visual impairment included blurred vision, vitreous floaters, photophobia, reduced visual acuity, and photopsia.

Oncologic

• Common (1% to 10%): Basal cell carcinoma, new primary melanoma, cutaneous squamous cell carcinoma including keratoacanthoma, metastases to central nervous system, basal cell carcinoma

Other

• Very common (10% or more): Fatigue (up to 61%), increased creatine kinase (up to 41%), edema (up to 23%), pyrexia (up to 22%), asthenia (20%), increased weight (up to 11%), peripheral edema (10.9%)
• Common (1% to 10%): General physical health deterioration, device related infection, weight decreased

Psychiatric

• Very common (10% or more): Insomnia (up to 22.1%)

Renal

• Very common (10% or more): Increased creatinine (up to 93%)
• Common (1% to 10%): Acute kidney injury, renal failure

Respiratory

• Very common (10% or more): Cough (26%), dyspnea (up to 17%), nasopharyngitis (10.4%)
• Common (1% to 10%): Pleural effusion, pneumonia

Frequently asked questions

• What is Braftovi used to treat?
• What is Mektovi used to treat?

Further information

Braftovi side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer