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Brand Name :
Braftovi
(United States) [Available]Synonyms :
encorafenib
Class :
Anti-cancer and BRAF Kinase inhibitor
Brand Name :
Braftovi
(United States) [Available]Synonyms :
encorafenib
Class :
Anti-cancer and BRAF Kinase inhibitor
Dosage forms & StrengthsÂ
ADULT DOSINGÂ
capsule:Â
75 mg Â
Melanoma:Â
Encorafenib treats metastatic melanoma. It is given in combination with binimetinib as 450 mg orally, four times daily.Â
Metastatic colorectal cancer:Â
Encorafenib, in combination with cetuximab, is used for the treatment of metastatic colorectal cancer. The oral dose given in the case is 300 mg four times daily.Â
encorafenib treats metastatic melanoma. It is given in combination with binimetinib as 450 mg orally, four times daily.
Dose Modifications:
If binimetinib is held back, reduce encorafenib maximum to a dose of 300 mg/day
1st dose reduction: 300 mg orally each day
2nd dose reduction: 225 mg orally each day
Subsequently, discontinue the dose permanently if unable to tolerate more than 225 mg/day
encorafenib, in combination with cetuximab, is used for the treatment of metastatic colorectal cancer. The oral dose given in the case is 300 mg four times daily.
Dose Modifications:
Discontinue encorafenib, if ceftuximab is discontinued.
1st dose reduction: 225 mg orally each day
2nd dose reduction: 150 mg orally each day
Subsequently, discontinue the dose permanently if unable to tolerate more than 150 mg/day
Safety and efficacy are not found in pediatrics  Â
Refer to the adult dosing
may enhance the concentration of serum when combined with encorafenib
may enhance the concentration of serum when combined with encorafenib
may enhance the concentration of serum when combined with encorafenib
may enhance the concentration of serum when combined with encorafenib
may enhance the concentration of serum when combined with encorafenib
encorafenib: they may increase the QTc-prolonging effect of QTc-prolonging agents
encorafenib: they may increase the QTc-prolonging effect of QTc-prolonging agents
encorafenib: they may increase the QTc-prolonging effect of QTc-prolonging agents
encorafenib: they may increase the QTc-prolonging effect of QTc-prolonging agents
encorafenib: they may increase the QTc-prolonging effect of QTc-prolonging agents
encorafenib: they may enhance the serum concentration of CYP3A Inhibitors
encorafenib: they may enhance the serum concentration of CYP3A Inhibitors
encorafenib: they may enhance the serum concentration of CYP3A Inhibitors
encorafenib: they may enhance the serum concentration of CYP3A Inhibitors
encorafenib: they may enhance the serum concentration of CYP3A Inhibitors
it decreases by affecting the hepatic enzyme CYP3A4 metabolism
when used together, encorafenib and alfuzosin both increase the QTc interval
when used together, encorafenib and apomorphine both increase the QTc interval
when used together, encorafenib and bedaquiline both increase the QTc interval
when used together, encorafenib and citalopram both increase the QTc interval
when used together, encorafenib and degarelix both increase the QTc interval
when used together, encorafenib and eliglustat both increase the QTc interval
erythromycin stearate increases the effect of encorafenib by altering the intestinal or hepatic CYP3A4 enzyme metabolism
etravirine decreases the effect of encorafenib by altering the intestinal or hepatic CYP3A4 enzyme metabolism
fluconazole increases the effect of encorafenib by altering the intestinal or hepatic CYP3A4 enzyme metabolism
fostamatinib increases the effect of encorafenib by altering the intestinal or hepatic CYP3A4 enzyme metabolism
when used together, encorafenib and gilteritinib both increase the QTc interval
when used together, encorafenib and haloperidol both increase the QTc interval
idelalisib increases the effect of encorafenib by altering the intestinal or hepatic CYP3A4 enzyme metabolism
when used together, encorafenib and isoflurane both increase the QTc interval
ketoconazole increases the effect of encorafenib by altering the intestinal or hepatic CYP3A4 enzyme metabolism
when used together, encorafenib and lefamulin both increase the QTc interval
when used together, encorafenib and levofloxacin both increase the QTc interval
when used together, encorafenib and lithium both increase the QTc interval
when used together, encorafenib and lumefantrine both increase the QTc interval
when used together, encorafenib and methadone both increase the QTc interval
when used together, encorafenib and midostaurin both increase the QTc interval
nefazodone increases the effect of encorafenib by altering the intestinal or hepatic CYP3A4 enzyme metabolism
when used together, encorafenib and nortriptyline both increase the QTc interval
when used together, encorafenib and osimertinib both increase the QTc interval
when used together, encorafenib and panobinostat both increase the QTc interval
when used together, encorafenib and quinine both increase the QTc interval
when used together, encorafenib and ranolazine both increase the QTc interval
when used together, encorafenib and risperidone both increase the QTc interval
when used together, encorafenib and romidepsin both increase the QTc interval
when used together, encorafenib and midostaurin both increase the QTc interval
when used together, encorafenib and sorafenib both increase the QTc interval
when used together, encorafenib and midostaurin both increase the QTc interval
when used together, encorafenib and trazodone both increase the QTc interval
when used together, encorafenib and vandetanib both increase the QTc interval
verapamil increases the effect of encorafenib by altering the intestinal or hepatic CYP3A4 enzyme metabolism
when used together, encorafenib and vorinostat both increase the QTc interval
when used together, encorafenib and ziprasidone both increase the QTc interval
encorafenib: they may diminish the serum concentration of hormonal contraceptives
encorafenib: they may diminish the serum concentration of hormonal contraceptives
encorafenib: they may diminish the serum concentration of hormonal contraceptives
encorafenib: they may diminish the serum concentration of hormonal contraceptives
encorafenib: they may diminish the serum concentration of CYP3A4 Inducers
encorafenib: they may diminish the serum concentration of CYP3A4 Inducers
It may diminish the effect when combined with lumateperone by affecting CYP3A4 metabolism
It may enhance QTc interval when combined with lithium
it may enhance the qtc interval when combined with lofexidine
Could potentially reduce the concentration serum of hormonal contraceptives
Could potentially reduce the concentration serum of hormonal contraceptives
Could potentially reduce the concentration serum of hormonal contraceptives
Could potentially reduce the concentration serum of hormonal contraceptives
Could potentially reduce the concentration serum of hormonal contraceptives
Could potentially reduce the concentration serum of hormonal contraceptives
Could potentially lead to a reduction in the concentration serum of Hormonal Contraceptives
Could potentially lead to a reduction in the concentration serum of Hormonal Contraceptives
nafcillin will decrease the effect of action of encorafenib by affecting enzyme CYP3A4 metabolism.
QTc interval increases on taking encorafenib and lenvatinib together. Avoid or take an alternate drug
the effect of encorafenib is decreased by lorlatinib, by altering intestinal or hepatic CYP3A4 enzyme metabolism
when both drugs are combined, both increase the QTC interval   
both lapatinib and encorafenib increase the QTc interval
may increase the QT-prolonging effect and enhance the risk of bradycardia, hypokalemia
when both drugs are combined, there may be an increased QTC interval  
when both drugs are combined, there may be an increased QTC interval  
CYP3A strong enhancers of the small intestine may reduce the bioavailability of encorafenib
encorafenib decreases the effect of fedratinib by altering the intestinal/hepatic CYP3A4 enzyme metabolism
CYP3A4 inducers decrease the concentration of encorafenib in serum
it decreases the concentration of hormonal contraceptives in serum
when used together, encorafenib and albuterol both increase the QTc interval
encorafenib, in combination with the dengue vaccine, shows immunosuppression. It decreases the effect of the dengue vaccine
encorafenib increases the level of digoxin in the body
encorafenib increases the toxicity of efavirenz and decreases its effectiveness by altering intestinal/hepatic CYP3A4 enzyme metabolism
encorafenib increases the toxicity of erlotinib and decreases its effectiveness by altering intestinal/hepatic CYP3A4 enzyme metabolism
encorafenib increases the toxicity of esterified estrogens and decreases its effectiveness by altering intestinal/hepatic CYP3A4 enzyme metabolism
mifepristone decreases the effect of encorafenib by altering the intestinal or hepatic CYP3A4 enzyme metabolism
may decrease the serum concentration of encorafenib
may decrease the serum concentration of encorafenib
may decrease the serum concentration of encorafenib
may decrease the serum concentration of encorafenib
may decrease the serum concentration of encorafenib
it may diminish the metabolism when combined with azelastine
it may diminish the metabolism when combined with tiotropium
When encorafenib is used together with adenosine, this leads to enhanced risk or seriousness of QTc prolongation
When indisulam is used together with encorafenib, this leads to a reduction in encorafenib metabolism
co-administration of both the drugs result in higher toxicity.
decrease the metabolism of daunorubicin and increase serum levels
encorafenib and ixazomib alter the intestinal/hepatic CYP3A4 enzyme metabolism when used simultaneously
decrease the metabolism of idarubicin and increase serum levels
may enhance the serum concentration
may have a decrease in excretion when combined with encorafenib
When encorafenib is used together with lomitapide, this leads to an enhancement in lomitapide’s metabolism
When encorafenib is aided by hesperetin, it reduces hesperetin’s metabolism
encorafenib decreases the effect of erdafitinib by altering the intestinal or hepatic CYP3A4 enzyme metabolism
on interacting with each other, encorafenib increases the level of nitrofurantoin
Actions and Spectrum
Actions:
The primary action of encorafenib is the inhibition of BRAF, a protein that plays a key role in cell signaling pathways that regulate cell growth and survival. encorafenib inhibits the mutant form of BRAF known as BRAF V600E, which is commonly found in melanoma tumors.
encorafenib has also been shown to inhibit other proteins in the same signaling pathway as BRAF, including MEK, which is downstream of BRAF and is also frequently mutated in melanoma.
Spectrum:
The spectrum of encorafenib is primarily limited to the treatment of melanoma with the BRAF V600E mutation, as this is the target of the drug’s action. encorafenib is often used in combination with another drug, binimetinib, which targets the MEK protein, to provide more comprehensive inhibition of the signaling pathway that drives melanoma growth.
Frequency defined:Â Â
>10%Â
Fatigue Â
Nausea Â
Vomiting Â
Abdominal pain Â
Arthralgia Â
Myopathy Â
Hyperkeratosis Â
Rash Â
Headache Â
Hemorrhage Â
Pyrexia Â
Dry skin Â
Dizziness Â
Alopecia Â
Pruritus Â
Peripheral neuropathy Â
Extreme painÂ
1%-10%:Â
Fatigue Â
Increased alkaline phosphatase Â
Abdominal pain (4%)Â
Hypokalemia Â
Diarrhea Â
Hyponatremia Â
Hemorrhage Â
Peripheral neuropathy Â
Increased ASTÂ
Dermatitis acneiform Â
Arthralgia Â
Myopathy Â
Decreased appetite Â
Vomiting Â
Nausea Â
Pyrexia Â
Frequency not defined:Â Â
–Â
Â
Contraindication/Cautions:
Â
Pregnancy consideration: As per the mechanism of action of encorafenib, it is rendered unsafe for the fetus. Pregnant women are advised to know about the potential risks.Â
Lactation: No data available regarding the excretion of encorafenib in breast milk. Hence, potential adverse effects and potential benefits should be compared and considered.Â
Pregnancy category:Â
Pharmacology
encorafenib is a small molecule inhibitor of BRAF kinase that exerts its pharmacological effects by selectively binding to the ATP-binding site of BRAF V600E and inhibiting its activity. BRAF V600E is a mutant form of the BRAF protein that is commonly found in certain types of cancer, particularly melanoma.
By inhibiting BRAF V600E, encorafenib blocks the activation of downstream signaling pathways, including the MAPK/ERK pathway, which leads to the inhibition of cancer cell proliferation, invasion, and survival.
Pharmacodynamics
The pharmacodynamics of encorafenib primarily involve the inhibition of the BRAF V600E mutant protein and downstream signaling pathways that promote cancer cell growth and survival.
Pharmacokinetics
Absorption:
encorafenib is rapidly absorbed after oral administration, with peak plasma concentrations occurring within 2 hours. The absolute bioavailability of encorafenib is not known, but it is assumed to be high based on its pharmacokinetic properties.
Distribution:
encorafenib is highly bound to plasma proteins (>99%), primarily to albumin. The volume of distribution is approximately 429 L, indicating extensive tissue distribution.
Metabolism:
encorafenib is extensively metabolized in the liver by cytochrome P450 enzymes, primarily CYP3A4, to form metabolites that are less active than the parent drug. The major metabolite, M8, is formed by oxidative metabolism and is about 3 times less potent than encorafenib in inhibiting BRAF kinase activity.
Excretion/Elimination
The elimination half-life of encorafenib is approximately 41 hours. The drug is primarily eliminated in the feces (81%) with a minor amount (7%) being eliminated in the urine.
Administration:
encorafenib is available as capsules for oral administration. The capsules should be swallowed whole with water, and should not be opened, crushed, or chewed. The recommended dose of encorafenib for the treatment of unresectable or metastatic melanoma with BRAF V600E mutation is 450 mg (three 150 mg capsules) once daily, taken on an empty stomach, at least one hour before or two hours after a meal.
If a dose is missed, it should be taken as soon as possible on the same day, and the next dose should be taken at the usual time the following day. However, if a dose is missed for more than 12 hours, the missed dose should be skipped, and the next dose should be taken at the usual time the following day.
Patient information leaflet
Generic Name: encorafenib
Pronounced: en-koe-RAF-e-nib
Why do we use encorafenib?
encorafenib is used to treat patients with unresectable or metastatic melanoma that has a BRAF V600E or V600K mutation.
encorafenib is often used in combination with another drug, binimetinib, which targets the MEK protein, to provide more comprehensive inhibition of the signaling pathway that drives melanoma growth.
The combination of encorafenib and binimetinib has been shown to further improve outcomes in patients with unresectable or metastatic melanoma that has a BRAF V600E or V600K mutation.
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