Peringatan Keamanan

New primary malignancies, cutaneous and non-cutaneous, have been observed in patients treated with BRAF inhibitors and can occur with encorafenib.L12216

In COLUMBUS, a phase 3 safety and efficacy trial,L12216 cutaneous squamous cell carcinoma (cuSCC), including keratoacanthoma (KA), occurred in 2.6%, and basal cell carcinoma occurred in 1.6% of patients who received BRAFTOVI in combination with binimetinib. The median time to first occurrence of cuSCC/KA was 5.8 months (range 1 to 9 months).L12216

Tumor promotion in BRAF Wild-Type Tumors has been observed with encofarenib use.L12216

Hemorrhage, uveitis, QT interval prolongation are also other adverse events observed while taking this medication.L12216

Encorafenib, when used as a single agent, is associated with an increased risk of certain adverse reactions compared to when BRAFTOVI is used in combination with binimetinib. Grades 3 or 4 dermatologic reactions occurred in 21% of patients treated with BRAFTOVI therapy alone compared to 2% of patients treated with BRAFTOVI in combination with binimetinib.L12216

Advise females with reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with BRAFTOVI and for 2 weeks after the final dose.L12216

Carcinogenicity studies with encorafenib have not been conducted. Encorafenib was not genotoxic in studies evaluating reverse mutations in bacteria, chromosomal aberrations in mammalian cells, or micronuclei in the bone marrow of rats.L48581

No dedicated fertility studies were performed with encorafenib in animals. In a general toxicology study in rats, decreased testes and epididymis weights, tubular degeneration in testes, and oligospermia in epididymides were observed at doses approximately 13 times the human exposure at the 450 mg clinical dose based on AUC. No effects on reproductive organs were observed in either sex in any of the non-human primate toxicity studies.L48581

Since encorafenib is 86% bound to plasma proteins, hemodialysis is likely to be ineffective in the treatment of overdose with encorafenib.L48581

Encorafenib

DB11718

small molecule approved investigational

Deskripsi

Encorafenib, also known as BRAFTOVI, is a kinase inhibitor. Encorafenib inhibits BRAF gene, which encodes for B-raf protein, which is a proto-oncogene involved in various genetic mutations.L12216 This protein plays a role in regulating the MAP kinase/ERK signaling pathway, which impacts cell division, differentiation, and secretion. Mutations in this gene, most frequently the V600E mutation, are the most commonly identified cancer-causing mutations in melanoma, and have been isolated in various other cancers as well, including non-Hodgkin lymphoma, colorectal cancer, thyroid carcinoma, non-small cell lung carcinoma, hairy cell leukemia and adenocarcinoma of the lung.L3344

On June 27, 2018, the Food and Drug Administration approved encorafenib and binimetinib (BRAFTOVI and MEKTOVI, Array BioPharma Inc.) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.L12216

Struktur Molekul 2D

Berat 540.01
Wujud solid

Peta Jejaring Molekuler
Legenda: ObatTargetGenEnzim(Panah → menunjukkan arah efek / relasi)TransporterCarrier

Profil Farmakokinetik

Waktu Paruh (Half-Life) The mean (CV%) terminal half-life (t<sub>1/2</sub>) of encorafenib is 3.5 hours (17%).[L12216]
Volume Distribusi The blood-to-plasma concentration ratio is 0.58. The geometric mean (CV%) of apparent volume of distribution is 164 L (70%).[L12216]
Klirens (Clearance) The apparent clearance is 14 L/h (54%) at day 1, increasing to 32 L/h (59%) at steady-state.[L12216]

Absorpsi

The pharmacokinetics of encorafenib were studied in healthy subjects and patients with solid tumors, including advanced and unresectable or metastatic cutaneous melanoma harboring a BRAF V600E or V600K mutation, BRAF V600E mutation-positive metastatic CRC. After a single dose, systemic exposure of encorafenib was dose-proportional over the dose range of 50 mg to 700 mg (0.1 to 1.6 times the maximum recommended dose of 450 mg). After once-daily dosing, systemic exposure of encorafenib was less than dose-proportional over the dose range of 50 mg to 800 mg (0.1 to 1.8 times the maximum recommended dose of 450 mg). Steady-state was reached within 15 days, with exposure being 50% lower compared to Day 1; intersubject variability (CV%) of AUC ranged from 12% to 69%.L48581 After oral administration, the median Tmax of encorafenib is 2 hours. At least 86% of the dose is absorbed.L48581 Following administration of a single dose of encorafenib 100 mg (0.2 times the maximum recommended dose of 450 mg) with a high-fat, high-calorie meal (consisting of approximately 150 calories from protein, 350 calories from carbohydrates, and 500 calories from fat) the mean maximum encorafenib concentration (Cmax) decreased by 36% and there was no effect on AUC.L48581

Metabolisme

Encorafenib is primarily metabolized by CYP3A4 (83%) and to a lesser extent by CYP2C19 (16%) and CYP2D6 (1%).L48581

Rute Eliminasi

Following a single oral dose of 100 mg radiolabeled encorafenib, 47% (5% unchanged) of the administered dose was recovered in the feces and 47% (2% unchanged) was recovered in the urine.L12216

Interaksi Makanan

3 Data
  • 1. Avoid grapefruit products. Grapefruit inhibits CYP3A metabolism, which may increase the serum concentration of encorafenib.
  • 2. Exercise caution with St. John's Wort. This herb induces CYP3A metabolism, which may reduce serum levels of encorafenib.
  • 3. Take with or without food.

Interaksi Obat

1325 Data
Ivabradine The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Ivabradine.
Mirabegron The serum concentration of Encorafenib can be increased when it is combined with Mirabegron.
Dofetilide The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Dofetilide.
Anagrelide The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Anagrelide.
Disopyramide The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Disopyramide.
Ibutilide The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Ibutilide.
Grepafloxacin The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Grepafloxacin.
Toremifene The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Toremifene.
Trovafloxacin The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Trovafloxacin.
Arsenic trioxide The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Arsenic trioxide.
Sparfloxacin The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Sparfloxacin.
Lithium cation The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Lithium cation.
Temafloxacin The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Temafloxacin.
Vandetanib The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Vandetanib.
Romidepsin The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Romidepsin.
Asenapine The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Asenapine.
Artemether The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Artemether.
Glasdegib The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Glasdegib.
Macimorelin The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Macimorelin.
Terodiline The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Terodiline.
Citalopram The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Citalopram.
Clemastine The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Clemastine.
Mifepristone The serum concentration of Mifepristone can be decreased when it is combined with Encorafenib.
Cocaine The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Cocaine.
Bepridil The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Bepridil.
Eliglustat The metabolism of Eliglustat can be decreased when combined with Encorafenib.
Imatinib The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Imatinib.
Vemurafenib The serum concentration of Encorafenib can be increased when it is combined with Vemurafenib.
Domperidone The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Domperidone.
Paliperidone The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Paliperidone.
Zuclopenthixol The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Zuclopenthixol.
Tetrabenazine The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Tetrabenazine.
Iloperidone The metabolism of Iloperidone can be decreased when combined with Encorafenib.
Deutetrabenazine The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Deutetrabenazine.
Valproic acid The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Valproic acid.
Leuprolide The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Leuprolide.
Goserelin The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Goserelin.
Moxifloxacin The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Moxifloxacin.
Sulfisoxazole The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Sulfisoxazole.
Sulpiride The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Sulpiride.
Nimodipine The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Nimodipine.
Droperidol The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Droperidol.
Oxaliplatin The risk or severity of QTc prolongation can be increased when Oxaliplatin is combined with Encorafenib.
Fluorouracil The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Fluorouracil.
Perflutren The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Perflutren.
Atropine The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Atropine.
Adenosine The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Adenosine.
Gadobenic acid The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Gadobenic acid.
Carbinoxamine The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Carbinoxamine.
Nalidixic acid The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Nalidixic acid.
Cinoxacin The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Cinoxacin.
Granisetron The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Granisetron.
Levosimendan The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Levosimendan.
Desloratadine The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Desloratadine.
Lomefloxacin The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Lomefloxacin.
Dimenhydrinate The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Dimenhydrinate.
Papaverine The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Papaverine.
Levofloxacin The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Levofloxacin.
Gemifloxacin The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Gemifloxacin.
Ofloxacin The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Ofloxacin.
Levacetylmethadol The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Levacetylmethadol.
Probucol The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Probucol.
Aceprometazine The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Aceprometazine.
Terlipressin The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Terlipressin.
Prenylamine The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Prenylamine.
Fluspirilene The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Fluspirilene.
Azimilide The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Azimilide.
Pracinostat The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Pracinostat.
Technetium Tc-99m ciprofloxacin The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Technetium Tc-99m ciprofloxacin.
Garenoxacin The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Garenoxacin.
Tedisamil The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Tedisamil.
Tucidinostat The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Tucidinostat.
Telavancin The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Telavancin.
Nemonoxacin The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Nemonoxacin.
Antazoline The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Antazoline.
Bedaquiline The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Bedaquiline.
Fendiline The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Fendiline.
Eperisone The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Eperisone.
Butriptyline The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Butriptyline.
Amifampridine The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Amifampridine.
Mocetinostat The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Mocetinostat.
Entinostat The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Entinostat.
CUDC-101 The risk or severity of QTc prolongation can be increased when Encorafenib is combined with CUDC-101.
Simendan The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Simendan.
Ricolinostat The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Ricolinostat.
Abexinostat The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Abexinostat.
Oxatomide The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Oxatomide.
Sitafloxacin The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Sitafloxacin.
Sultopride The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Sultopride.
Otilonium The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Otilonium.
Nizofenone The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Nizofenone.
Bunaftine The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Bunaftine.
Lorcainide The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Lorcainide.
Penfluridol The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Penfluridol.
Dexverapamil The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Dexverapamil.
Emedastine The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Emedastine.
Pazopanib The serum concentration of Pazopanib can be increased when it is combined with Encorafenib.
Diltiazem The serum concentration of Encorafenib can be increased when it is combined with Diltiazem.
Promazine The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Promazine.
Prochlorperazine The risk or severity of QTc prolongation can be increased when Encorafenib is combined with Prochlorperazine.

Target Protein

Serine/threonine-protein kinase B-raf BRAF
G1/S-specific cyclin-D1 CCND1
RAF proto-oncogene serine/threonine-protein kinase RAF1
Mitogen-activated protein kinase 8 MAPK8
Mitogen-activated protein kinase 9 MAPK9
Mitogen-activated protein kinase 10 MAPK10
LIM domain kinase 1 LIMK1
LIM domain kinase 2 LIMK2
Dual specificity mitogen-activated protein kinase kinase 4 MAP2K4
Serine/threonine-protein kinase 36 STK36

Contoh Produk & Brand

Produk: 8 • International brands: 0
Produk
  • Braftovi
    Capsule • 50 mg/1 • Oral • US
  • Braftovi
    Capsule • 75 mg/1 • Oral • US • Approved
  • Braftovi
    Capsule • 50 mg/1 • Oral • US • Approved
  • Braftovi
    Capsule • 75 mg • Oral • Canada • Approved
  • Braftovi
    Capsule • 50 mg • Oral • EU • Approved
  • Braftovi
    Capsule • 75 mg • Oral • EU • Approved
  • Braftovi
    Capsule • 50 mg • Oral • EU • Approved
  • Braftovi
    Capsule • 75 mg • Oral • EU • Approved

Sekuens Gen/Protein (FASTA)

Sekuens dimuat saat dibutuhkan agar halaman tetap ringan.
© 2025 Digital Pharmacy Research - Universitas Esa Unggul