Big Bear DABRADX Dabrafenib 75mg

Product Information

• Product name: DABRADX Dabrafenib 75mg
• Manufacturer / brand: Laos BigBear Pharma
• Active ingredient: Dabrafenib
• Current strength: 75mg
• SKU: BB-ITEM-36
• Site category: BRAF V600E/V600K target, BRAF V600E target, other cancer

Product Summary

DABRADX Dabrafenib 75mg 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

Dabrafenib is the active ingredient used for this product page. Public prescribing information for Dabrafenib 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

Dabrafenib is an inhibitor of some mutated forms of BRAF kinases with in vitro IC 50 values of 0.65, 0.5, and 1.84 nM for BRAF V600E, BRAF V600K, and BRAF V600D enzymes, respectively. Dabrafenib also inhibits wild-type BRAF and CRAF kinases with IC 50 values of 3.2 and 5.0 nM, respectively, and other kinases, such as SIK1, NEK11, and LIMK1 at higher concentrations. Some mutations in the BRAF gene, including those that result in BRAF V600E, can result in constitutively activated BRAF kinases that may stimulate tumor cell growth .

Reference Indications

Dabrafenib is a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. ( 1.1 , 2.1 ) Dabrafenib is indicated, in combination with trametinib , for: the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. ( 1.2 , 2.1 ) the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. ( 1.3 , 2.1 ) the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.

Reference Dosage and Administration

Recommended dosage of Dabrafenib in adult patients is 150 mg (two 75 mg capsules) orally twice daily. Take Dabrafenib at least 1 hour before or 2 hours after a meal.

With this 75mg product, that corresponds to 2 x 75mg tablets when that reference dose is clinically appropriate.

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 Non-Cutaneous : Can occur when Dabrafenib is administered as a single agent or with trametinib. Monitor patients for new malignancies prior to, or while on therapy, and following discontinuation of treatment. ( 5.1 , 2.4 ) Tumor Promotion in BRAF Wild-type Tumors : Increased cell proliferation can occur with BRAF inhibitors. ( 5.2 , 2.1 ) Hemorrhage : Major hemorrhagic events can occur in patients receiving Dabrafenib with trametinib. Monitor for signs and symptoms of bleeding. Cardiomyopathy : Assess left ventricular ejection fraction (LVEF) before treatment with Dabrafenib and trametinib, after one month of treatment, then every 2 to 3 months thereafter. ( 5.4 , 2.4 ) Uveitis : Perform ophthalmological evaluation for any visual disturbances.

Common Adverse Reactions and Monitoring

Refer to the trametinib prescribing information for additional information. Adjuvant treatment of melanoma: pyrexia, fatigue, nausea, headache, rash, chills, diarrhea, vomiting, arthralgia, and myalgia. NSCLC: pyrexia, fatigue, nausea, vomiting, diarrhea, dry skin, decreased appetite, edema, rash, chills, hemorrhage, cough, and dyspnea. Adult patients with solid tumors: pyrexia, fatigue, nausea, rash, chills, headache, hemorrhage, cough, vomiting, constipation, diarrhea, myalgia, arthralgia, and edema.

Drug Interactions and Special Populations

Avoid concurrent administration of strong inhibitors of CYP3A4 or CYP2C8. Concomitant use with agents that are sensitive substrates of CYP3A4, CYP2C8, CYP2C9, CYP2C19, or CYP2B6 may result in loss of efficacy of these agents. Substitution of strong inhibitors of CYP3A4 or CYP2C8 is recommended during treatment with Dabrafenib. Monitor international normalized ratio (INR) levels more frequently in patients receiving warfarin during initiation or discontinuation of dabrafenib. Coadministration of Dabrafenib with other substrates of these enzymes, including dexamethasone or hormonal contraceptives , can result in decreased concentrations and loss of efficacy . Substitute for these medications or monitor patients for loss of efficacy if use of these medications is unavoidable. Lactation : Do not breastfeed.

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: Tafinlar 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.