Lucius LuciVemu Vemurafenib 240mg

Product Information

• Product name: LuciVemu Vemurafenib 240mg
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Vemurafenib
• Current strength: 240mg
• SKU: LU-ITEM-125
• Site category: BRAF V600E/V600K target, other cancer

Product Summary

LuciVemu Vemurafenib 240mg is an AISTIKA-listed product supplied by Laos Lucius 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

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

Vemurafenib is a low molecular weight, orally available inhibitor of some mutated forms of BRAF serine- threonine kinase, including BRAF V600E. Vemurafenib also inhibits other kinases in vitro such as CRAF, ARAF, wild-type BRAF, SRMS, ACK1, MAP4K5, and FGR at similar concentrations. Some mutations in the BRAF gene including V600E result in constitutively activated BRAF proteins, which can cause cell proliferation in the absence of growth factors that would normally be required for proliferation.

Reference Indications

Vemurafenib ® is a kinase inhibitor indicated 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 ) Vemurafenib ® is indicated for the treatment of patients with Erdheim- Chester Disease with BRAF V600 mutation. ( 1.2 , 2.1 ) Limitation of Use: Vemurafenib is not indicated for treatment of patients with wild-type BRAF melanoma ( 2.1 , 5.2 ) 1.1 Unresectable or Metastatic Melanoma Vemurafenib ® is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. Limitation of Use: Vemurafenib is not indicated for treatment of patients with wild-type BRAF melanoma .

Reference Dosage and Administration

Recommended dose: 960 mg orally twice daily taken approximately 12 hours apart with or without a meal.

With this 240mg product, that corresponds to 4 x 240mg 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 Cutaneous Malignancies: Perform dermatologic evaluations prior to initiation of therapy, every 2 months while on therapy, and for up to 6 months following discontinuation of Vemurafenib. Manage with excision and continue treatment without dose adjustment. New Non-Cutaneous Squamous Cell Carcinoma: Evaluate for symptoms or clinical signs of new non-cutaneous SCC before initiation of treatment and periodically during treatment. Other Malignancies: Monitor patients receiving Vemurafenib closely for signs or symptoms of other malignancies . Tumor Promotion in BRAF Wild-Type Melanoma: Increased cell proliferation can occur with BRAF inhibitors .

Common Adverse Reactions and Monitoring

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not predict the rates observed in a broader patient population in clinical practice. Unresectable or Metastatic Melanoma with BRAF V600E Mutation This section describes adverse drug reactions (ADRs) identified from analyses of Trial 1 and Trial 2 . Trial 1 randomized (1:1) 675 treatment-naive patients with unresectable or metastatic melanoma to receive Vemurafenib 960 mg orally twice daily or dacarbazine 1000 mg/m 2 intravenously every 3 weeks.

Drug Interactions and Special Populations

Avoid concomitant administration of Vemurafenib with strong CYP3A4 inhibitors or inducers. CYP1A2 Substrates: Vemurafenib can increase concentrations of CYP1A2 substrates. Avoid concomitant use of Vemurafenib with CYP1A2 substrates with a narrow therapeutic window. If coadministration cannot be avoided, monitor closely for toxicities and consider dose reduction of CYP1A2 substrates. Avoid coadministration of Vemurafenib with strong CYP3A4 inhibitors. If coadministration of a strong CYP3A4 inhibitor is unavoidable, consider dose reduction of Vemurafenib, if clinically indicated. Strong CYP3A4 Inducers Coadministration of Vemurafenib with rifampin, a strong CYP3A4 inducer, decreased vemurafenib plasma concentrations and may result in decreased efficacy.

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: ZELBORAF 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.