TLPH Lyvioni Lenvatinib 10mg

Product Information

• Product name: Lyvioni Lenvatinib 10mg
• Manufacturer / brand: Laos TLPH Pharma
• Active ingredient: Lenvatinib
• Current strength: 10mg
• SKU: AM-ITEM-43
• Site category: endometrial cancer, general medicines, kidney cancer, liver cancer, thyroid cancer

Product Summary

Lyvioni Lenvatinib 10mg is an AISTIKA-listed product supplied by Laos TLPH 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

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

Lenvatinib is a kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). Lenvatinib inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1, 2, 3, and 4; platelet derived growth factor receptor alpha (PDGFRA), KIT, and RET.

Reference Indications

Lenvatinib is a kinase inhibitor that is indicated: Differentiated Thyroid Cancer (DTC) For the treatment of adult patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). Renal Cell Carcinoma (RCC) In combination with pembrolizumab, for the first line treatment of adult patients with advanced renal cell carcinoma (RCC). Hepatocellular Carcinoma (HCC) For the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).

Reference Dosage and Administration

Recommended dosage is 24 mg orally once daily. administered as an intravenous infusion over 30 minutes every 3 weeks.

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

Hypertension : Control blood pressure prior to treatment and monitor during treatment. Withhold for Grade 3 hypertension despite optimal antihypertensive therapy. Discontinue for Grade 4 hypertension. ( 2.7 , 5.1 ) Cardiac Dysfunction : Monitor for clinical symptoms or signs of cardiac dysfunction. Withhold or discontinue for Grade 3 cardiac dysfunction. Discontinue for Grade 4 cardiac dysfunction. ( 2.7 , 5.2 ) Arterial Thromboembolic Events : Discontinue following an arterial thromboembolic event. ( 2.7 , 5.3 ) Hepatotoxicity : Monitor liver function prior to treatment and periodically during treatment. Withhold or discontinue for Grade 3 or 4 hepatotoxicity. Discontinue for hepatic failure. ( 2.7 , 5.4 ) Renal Failure or Impairment : Withhold or discontinue for Grade 3 or 4 renal failure or impairment.

Common Adverse Reactions and Monitoring

Among the 1823 patients who received Lenvatinib as a single agent, the median age was 61 years (20 to 89 years), the dose range was 0.2 mg to 32 mg daily, and the median duration of exposure was 5.6 months. The data below reflect exposure to Lenvatinib in 1557 patients enrolled in randomized, active-controlled trials (REFLECT; Study 205; CLEAR; Study 309), and a randomized, placebo-controlled trial (SELECT). The median duration of exposure to Lenvatinib across these five studies ranged from 6 to 16 months. The demographic and exposure data for each clinical trial population are described in the subsections below.

Drug Interactions and Special Populations

Avoid coadministration of Lenvatinib with medicinal products with a known potential to prolong the QT/QTc interval . Lactation: Advise not to breastfeed. There are no available human data informing the drug-associated risk. Advise pregnant women of the potential risk to a fetus. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

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: Lenvima 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.