Lenvaxen 10 mg, containing the active ingredient Lenvatinib, is a targeted cancer therapy indicated for the treatment of multiple advanced malignancies:

• Differentiated Thyroid Cancer (DTC): For patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory disease.

• Renal Cell Carcinoma (RCC): In combination with Everolimus for advanced RCC following one prior anti-angiogenic therapy.

• Hepatocellular Carcinoma (HCC): As first-line treatment for patients with unresectable disease.

• Endometrial Carcinoma: In combination with Pembrolizumab, for advanced disease that is not MSI-H or dMMR, after prior systemic therapy, and in patients not candidates for curative surgery or radiation.

Lenvaxen offers a precision approach by inhibiting tumor growth and pathological angiogenesis in multiple solid tumors.

Description

Lenvaxen 10 mg is an oral receptor tyrosine kinase (RTK) inhibitor that blocks the activity of kinases involved in cancer progression. It targets VEGFR1, VEGFR2, VEGFR3, as well as FGFR1-4, PDGFRα, KIT, and RET, reducing angiogenesis, tumor proliferation, and metastasis. By interfering with these signaling pathways, Lenvaxen suppresses tumor growth and progression in various cancers.

Pharmacology

• Mechanism of Action: Lenvatinib binds to the ATP-binding site of VEGFR2 and nearby regions, inhibiting kinase activity. It disrupts VEGF and FGF signaling, which are critical for angiogenesis and tumor growth.

• Absorption: Tmax occurs 1–4 hours post-dose; high-fat meals delay absorption but do not affect the extent.

• Distribution: 98–99% plasma protein binding; blood-to-plasma ratio 0.59–0.61.

• Metabolism: Primarily via CYP3A and aldehyde oxidase and non-enzymatic pathways.

• Excretion: 64% in feces, 25% in urine; terminal half-life ~28 hours.

Dosage & Administration

• Differentiated Thyroid Cancer (DTC): 24 mg orally once daily.

• Renal Cell Carcinoma (RCC): 18 mg orally once daily with 5 mg Everolimus.

• Hepatocellular Carcinoma (HCC): ≥60 kg: 12 mg daily; <60 kg: 8 mg daily.

• Endometrial Carcinoma: 20 mg orally once daily with Pembrolizumab 200 mg IV every 3 weeks.

Administration: Capsules can be swallowed whole or dissolved in water/apple juice. Take at the same time each day, with or without food. If a dose is missed and >12 hours have passed, skip and continue next dose as scheduled.

Drug Interactions

• Avoid co-administration with drugs that prolong the QT interval.

• Avoid strong CYP3A inducers or inhibitors unless dose adjustments are made.

Contraindications

• Hypersensitivity to Lenvatinib or any component of the formulation.

Side Effects

Common and serious adverse effects include:

• Cardiovascular: Hypertension, cardiac dysfunction, arterial thromboembolic events.

• Hepatic & Renal: Hepatotoxicity, renal failure or impairment.

• Gastrointestinal: Diarrhea, fistula formation, gastrointestinal perforation.

• Other: Proteinuria, QT interval prolongation, hypocalcemia, reversible posterior leukoencephalopathy syndrome, hemorrhage, thyroid dysfunction, wound healing complications.

Pregnancy & Lactation

• Pregnancy: Lenvatinib can cause fetal harm; effective contraception recommended during treatment and for at least 30 days after the last dose.

• Lactation: Breastfeeding should be avoided during treatment and for at least one week after the last dose.

Special Populations

• Pediatric Use: Safety and efficacy not established.

• Renal Impairment: Dose reduction required for severe impairment.

• Hepatic Impairment: Dose reduction required for severe hepatic dysfunction.

• Geriatric Use: Close monitoring recommended due to higher risk of adverse effects.

Therapeutic Class

Targeted Cancer Therapy

Storage Conditions

Store below 30°C in a dry place, protected from light. Keep out of reach of children.