1. Ingredients

Ingredients:
LegaLenva 4&10mg contains:

• Lenvatinib 4&10mg
• Other excipients q.s. per capsule.

Dosage form: Hard capsule.

2. Effects and Indications of LegaLenva 10mg

LegaLenva 10mg Original
LegaLenva 10mg is used as a monotherapy treatment for adults with:

• Progressive or metastatic differentiated thyroid cancer refractory to radioactive iodine treatment.
• Unresectable or advanced hepatocellular carcinoma (HCC).
• Renal cell carcinoma (RCC).
• Advanced endometrial carcinoma.

3. Dosage and Administration of LegaLenva 4&10mg

4. Contraindications

Do not use LegaLenva 10mg in patients who:

• Are hypersensitive to any ingredient of the drug.
• Are taking strong CYP3A4 inducers.

5. Side Effects of LegaLenva 10mg

Patients taking LegaLenva 10mg may experience the following side effects:

• Cardiovascular: Hypertension, arterial thromboembolism, cardiac dysfunction.
• Gastrointestinal: Constipation, nausea, dysgeusia, diarrhea.
• Headache, muscle pain.
• Weight loss.
• Hepatic and renal function impairment.
• Hypocalcemia.
• Thyroid dysfunction.

6. Drug Interactions

Potential interactions when LegaLenva 10mg is used with:

• Leuprolide, Goserelin, Octreotide: May prolong QT interval.
• Cyclosporine: Increased metabolism of Cyclosporine.
• Choline: Increased Choline levels.

7. Precautions and Storage

7.1 Precautions and Warnings

• Monitor liver and kidney function indicators during treatment.
• Regularly check body weight when treating unresectable hepatocellular carcinoma to manage issues timely.
• Consult a physician for antiemetic medication if nausea occurs.
• Monitor blood pressure regularly; evaluate QT interval.
• Control blood pressure before starting LegaLenva 10mg in hypertensive patients.

7.2 Use in Pregnancy and Lactation

• Pregnant women: Only use if the potential benefits justify the risks; consult a physician carefully.
• Breastfeeding women: Although little LegaLenva enters breast milk, it may accumulate in infants. Mothers should stop breastfeeding for at least one week during treatment.

7.3 Caution for Drivers and Machine Operators

Use with caution.

7.4 Overdose Management

Currently, no cases of LegaLenva overdose have been reported.

7.5 Storage

• Store in a dry place.
• Avoid direct exposure to light.
• Store below 30°C.

8. Alternative Products

• LegaSora 200mg containing Sorafenib Tosylate, used for treating hepatocellular carcinoma and renal cell carcinoma. Produced by Legacuis Pharma Co., Ltd., packaged as 6 blisters × 10 tablets
• Tecentriq containing Atezolizumab, used for metastatic non-small cell lung cancer. Produced by Roche Products Limited, packaged as 1 vial × 20ml,

9. General Information

• Registration number: Updating
• Manufacturer: Legacius Pharma
• Registrant company: Legacius Pharma
• Packaging: Box of 1 bottle × 30 capsules.

10. Mechanism of Action

10.1 Pharmacodynamics

Lenvatinib, a multi-targeted tyrosine kinase inhibitor (TKI), has emerged as a first-line therapy for hepatocellular carcinoma (HCC). Its use has shifted the landscape previously dominated by sorafenib for over a decade.
Preclinical studies have demonstrated lenvatinib’s anti-proliferative and immunomodulatory activities. Compared to sorafenib, lenvatinib is non-inferior regarding overall survival (OS) and superior in several secondary efficacy endpoints.
Lenvatinib inhibits immune checkpoints and targets VEGF receptors 1–3, FGF receptors 1–4, PDGF receptor alpha, RET, and KIT, making it a key agent in HCC treatment.
It is often combined with everolimus to enhance therapeutic outcomes.

10.2 Pharmacokinetics

Lenvatinib is rapidly absorbed after oral administration, with a high plasma protein binding rate (almost 100%). The volume of distribution (Vd) is 97L.
It is metabolized primarily in the liver via oxidation by aldehyde oxidase or conjugation with GSH and demethylation. The elimination half-life (t½) is approximately 28 hours.

11. Advantages

• LegaLenva contains Lenvatinib, effectively treating hepatocellular carcinoma, renal cell carcinoma, and differentiated thyroid cancer. [1]
• Manufactured by Everest Pharmaceuticals, a company with strong experience in oncology drug production, ensuring quality.
• Numerous studies have evaluated the cancer treatment efficacy of Lenvatinib, including comparisons with sorafenib in first-line therapy for unresectable hepatocellular carcinoma.