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Braftovi

Last reviewed on RxList: 4/20/2020
Braftovi Side Effects Center

What Is Braftovi?

Braftovi (encorafenib) is a kinase inhibitor indicated, in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by anFDA-approved test.

What Are Side Effects of Braftovi?

Common side effects of Braftovi, in combination with binimetinib, include:

  • fatigue,
  • nausea,
  • vomiting,
  • abdominal pain,
  • joint pain,
  • fever,
  • constipation,
  • muscle weakness,
  • pain in extremities,
  • thickening skin,
  • rash,
  • dry skin,
  • hair loss,
  • itching,
  • headache,
  • dizziness,
  • nerve pain in extremities, and
  • bleeding

Dosage for Braftovi

The recommended dose of Braftovi is 450 mg orally once daily in combination with binimetinib. Take Braftovi with or without food.

What Drugs, Substances, or Supplements Interact with Braftovi?

Braftovi may interact with strong or moderate CYP3A4 inhibitors or inducers including grapefruit juice, hormonal contraceptives, and drugs that prolong the QT interval. Tell your doctor all medications and supplements you use.

Braftovi During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Braftovi; it may harm a fetus. It is unknown if Braftovi passes into breast milk. Because of the potential for serious adverse reactions from Braftovi in breastfed infants, breastfeeding is not recommended while using Braftovi.

Additional Information

Our Braftovi (encorafenib) Capsules Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Braftovi Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects are more likely to occur if you take encorafenib and binimetinib together. Call your doctor at once if you have:

  • eye pain or swelling, vision changes, seeing halos around lights, seeing color "dots" in your vision;
  • severe skin rash, skin pain or swelling, redness and peeling skin on your hands or feet;
  • fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out); or
  • signs of bleeding--weakness, dizziness, headache, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • nausea, vomiting, stomach pain;
  • tiredness; or
  • joint pain or swelling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Braftovi (Encorafenib Capsules)

QUESTION

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Braftovi Professional Information

SIDE EFFECTS

The following adverse reactions are described elsewhere in the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of BRAFTOVI in combination with binimetinib is described in 192 patients with BRAF V600 mutation-positive unresectable or metastatic melanoma who received BRAFTOVI (450 mg once daily) in combination with binimetinib (45 mg twice daily) in a randomized open-label, active-controlled trial (COLUMBUS).

The COLUMBUS trial [see Clinical Studies] excluded patients with a history of Gilbert's syndrome, abnormal left ventricular ejection fraction, prolonged QTc (>480 msec), uncontrolled hypertension, and history or current evidence of retinal vein occlusion. The median duration of exposure was 11.8 months for patients treated with BRAFTOVI in combination with binimetinib and 6.2 months for patients treated with vemurafenib.

The most common (> 25%) adverse reactions in patients receiving BRAFTOVI in combination with binimetinib were fatigue, nausea, vomiting, abdominal pain, and arthralgia.

Adverse reactions leading to dose interruptions of BRAFTOVI occurred in 30% of patients receiving BRAFTOVI in combination with binimetinib; the most common were nausea (7%), vomiting (7%) and pyrexia (4%). Adverse reactions leading to dose reductions of BRAFTOVI occurred in 14% of patients receiving BRAFTOVI in combination with binimetinib; the most common were arthralgia (2%), fatigue (2%) and nausea (2%). Five percent (5%) of patients receiving BRAFTOVI in combination with binimetinib experienced an adverse reaction that resulted in permanent discontinuation of BRAFTOVI; the most common were hemorrhage in 2% and headache in 1% of patients.

Table 4 and Table 5 present adverse drug reactions and laboratory abnormalities, respectively, identified in COLUMBUS. The COLUMBUS trial was not designed to demonstrate a statistically significant difference in adverse reaction rates for BRAFTOVI in combination with binimetinib, as compared to vemurafenib, for any specific adverse reaction listed in Table 4.

Table 4: Adverse Reactions Occurring in ≥ 10% of Patients Receiving BRAFTOVI in Combination with Binimetinib in COLUMBUSa

Adverse Reaction BRAFTOVI with binimetinib
N=192
Vemurafenib
N=186
All Grades (%) Grades 3 and 4b (%) All Grades (%) Grades 3 and 4 (%)
General Disorders and Administration Site Conditions
Fatiguec 43 3 46 6
Pyrexiac 18 4 30 0
Gastrointestinal Disorders
Nausea 41 2 34 2
Vomitingc 30 2 16 1
Abdominal painc 28 4 16 1
Constipation 22 0 6 1
Musculoskeletal and Connective Tissue Disorders
Arthralgiac 26 1 46 6
Myopathyc 23 0 22 1
Pain in extremity 11 1 13 1
Skin and Subcutaneous Tissue Disorders
Hyperkeratosisc 23 1 49 1
Rashc 22 1 53 13
Dry skinc 16 0 26 0
Alopeciac 14 0 38 0
Pruritusc 13 1 21 1
Nervous System Disorders
Headachec 22 2 20 1
Dizzinessc 15 3 4 0
Peripheral neuropathyc 12 1 13 2
Vascular Disorders
Hemorrhagec 19 3 9 2
a Grades per National Cancer Institute CTCAE v4.03.
b Grade 4 adverse reactions limited to fatigue (n=1), pruritus (n=1) and rash (n=1) in the BRAFTOVI with binimetinib arm.
c Represents a composite of multiple, related preferred terms.

BRAFTOVI when used as a single agent increases the risk of certain adverse reactions compared to BRAFTOVI in combination with binimetinib. In patients receiving BRAFTOVI 300 mg orally once daily as a single agent, the following adverse reactions were observed at a higher rate (≥ 5%) compared to patients receiving BRAFTOVI in combination with binimetinib: palmar-plantar erythrodysesthesia syndrome (51% vs. 7%), hyperkeratosis (57% vs. 23%), dry skin (38% vs. 16%), erythema (16% vs. 7%), rash (41% vs. 22%), alopecia (56% vs. 14%), pruritus (31% vs. 13%), arthralgia (44% vs. 26%), myopathy (33% vs. 23%), back pain (15% vs. 9%), dysgeusia (13% vs. 6%), and acneiform dermatitis (8% vs. 3%).

Other clinically important adverse reactions occurring in < 10% of patients who received BRAFTOVI in combination with binimetinib were:

Nervous system disorders: Facial paresis

Gastrointestinal disorders: Pancreatitis

Skin and subcutaneous tissue disorders: Panniculitis

Immune system disorders: Drug hypersensitivity

Table 5: Laboratory Abnormalities Occurring in ≥ 10% (All Grades) of Patients Receiving BRAFTOVI in Combination with Binimetinib in COLUMBUSa

Laboratory Abnormality BRAFTOVI with binimetinib
N=192
Vemurafenib
N=186
All Grades (%) Grades 3 and 4 (%) All Grades (%) Grades 3 and 4 (%)
Hematology
Anemia 36 3.6 34 2.2
Leukopenia 13 0 10 0.5
Lymphopenia 13 2.1 30 7
Neutropenia 13 3.1 4.8 0.5
Chemistry
Increased Creatinine 93 3.6 92 1.1
Increased Gamma Glutamyl Transferase 45 11 34 4.8
Increased ALT 29 6 27 2.2
Increased AST 27 2.6 24 1.6
Hyperglycemia 28 5 20 2.7
Increased Alkaline Phosphatase 21 0.5 35 2.2
Hyponatremia 18 3.6 15 0.5
Hypermagnesemia 10 1.0 26 0.5
a Grades per National Cancer Institute CTCAE v4.03.

Read the entire FDA prescribing information for Braftovi (Encorafenib Capsules)

Related Resources for Braftovi

Related Health

© Braftovi Patient Information is supplied by Cerner Multum, Inc. and Braftovi Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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