Braftovi Side Effects

Generic name: encorafenib

Medically reviewed by Drugs.com. Last updated on Aug 3, 2024.

Note: This document provides detailed information about Braftovi.

Applies to encorafenib: oral capsule 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.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests will be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (eg, condoms, spermicide). Use an effective form of birth control during treatment and for at least 2 weeks after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

Some men who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

This medicine may increase your risk of having cutaneous squamous cell carcinoma (cuSCC) or other skin cancers. Check with your doctor right away if you develop any skin changes, including a new wart, change in size or color of a mole, or a skin sore or reddish bump that does not heal. Your doctor may want your skin be checked for new skin lesions before treatment, during treatment, and for up to 6 months after the last dose.

This medicine may cause hemorrhage (severe bleeding) in the stomach and bowel areas or in the brain. Call your doctor right away if you have any unusual or unexplained bleeding.

This medicine may cause heart problems (eg, cardiomyopathy). Check with your doctor right away if you have chest discomfort or pain, dizziness, faintness, fast, irregular, or pounding heartbeat, swelling of the feet or lower legs, trouble breathing, or unusual tiredness or weakness.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor right away if eye pain or a change in vision occurs during treatment. This could be a sign of a serious eye problem. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you had a heart rhythm problem, including QT prolongation.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

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:

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

See also:

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.

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