Big Bear BRATODX Encorafenib

Product Information

• Product name: BRATODX Encorafenib as shown on package
• Manufacturer / brand: Laos BigBear Pharma
• Active ingredient: Encorafenib
• Current strength: as shown on package
• SKU: BB-ITEM-32
• Site category: BRAF V600E/V600K target, other cancer

Product Summary

BRATODX Encorafenib as shown on package is an AISTIKA-listed product supplied by Laos BigBear Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Encorafenib is the active ingredient used for this product page. Public prescribing information for Encorafenib was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

Encorafenib is a kinase inhibitor that targets BRAF V600E, as well as wild-type BRAF and CRAF in in vitro cell-free assays with IC 50 values of 0.35, 0.47, and 0.3 nM, respectively. Mutations in the BRAF gene, such as BRAF V600E, can result in constitutively activated BRAF kinases that may stimulate tumor cell growth. Encorafenib was also able to bind to other kinases in vitro including JNK1, JNK2, JNK3, LIMK1, LIMK2, MEK4, and STK36 and reduce ligand binding to these kinases at clinically achievable concentrations (≤0.9 µM).

Reference Indications

Encorafenib is a kinase inhibitor indicated: Melanoma in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-authorized test. ( 1.1 , 2.1 ) Colorectal Cancer (CRC) in combination with cetuximab and fluorouracil-based chemotherapy, for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA‑authorized test. ( 1.2 , 2.1 ) in combination with cetuximab, for the treatment of adult patients with mCRC with a BRAF V600E mutation, as detected by an FDA-authorized test, after prior therapy.

Reference Dosage and Administration

Recommended dose is 450 mg orally once daily in combination with binimetinib. Take Encorafenib with or without food.

Dose conversion must be confirmed by a physician because the reference dose may vary by indication, organ function, toxicity, or interacting medicines.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

New Primary Malignancies, cutaneous and noncutaneous : Can occur. Monitor for malignancies and perform dermatologic evaluations prior to, while on therapy, and following discontinuation of treatment. Tumor Promotion in BRAF Wild-Type Tumors : Increased cell proliferation can occur with BRAF inhibitors. Cardiomyopathy : Assess left ventricular ejection fraction (LVEF) before initiating treatment with Encorafenib and binimetinib, and after one month of treatment, then every 2 to 3 months thereafter. The safety of Encorafenib in combination with binimetinib has not been established in patients with LVEF below 50%. Hepatotoxicity : Monitor liver function tests before and during treatment with Encorafenib and binimetinib and as clinically indicated.

Common Adverse Reactions and Monitoring

BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma The safety of Encorafenib in combination with binimetinib is described in 192 patients with BRAF V600 mutation-positive unresectable or metastatic melanoma who received Encorafenib (450 mg once daily) in combination with binimetinib (45 mg twice daily) in a randomized open-label, active-controlled trial (COLUMBUS). The COLUMBUS trial excluded patients with a history of Gilbert’s syndrome, abnormal left ventricular ejection fraction, prolonged QTc (>480 ms), uncontrolled hypertension, and history or current evidence of retinal vein occlusion.

Drug Interactions and Special Populations

Strong or moderate CYP3A4 inhibitors: Avoid coadministration. If unavoidable, reduce Encorafenib dosage. ( 2.6 , 7.1 ) Strong CYP3A4 inducers: Avoid coadministration. Sensitive CYP3A4 substrates: Avoid coadministration with CYP3A4 substrates (including hormonal contraceptives) for which a decrease in plasma concentration may lead to reduced efficacy of the substrate. Transporters: Dose reductions of drugs that are substrates of OATP1B1, OATP1B3, or BCRP may be required when used concomitantly with Encorafenib. Avoid coadministration of Encorafenib with strong or moderate CYP3A4 inhibitors, including grapefruit juice. If coadministration is unavoidable, reduce the Encorafenib dose .

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: BRAFTOVI public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.