Lenvatinib Application Scope

• Differentiated thyroid cancer (DTC) refractory to radioactive iodine therapy
• Advanced renal cell carcinoma (RCC) in combination with everolimus
• Unresectable hepatocellular carcinoma (HCC)
• Advanced endometrial carcinoma in combination with pembrolizumab

Lenvatinib Characteristics

Ingredients: Lenvatinib mesylate
Properties: Oral, small molecule multi-kinase inhibitor
Packaging Specification: 4 mg, 10 mg, or 20 mg capsules; typically packaged as 28 capsules per box
Storage: Store at room temperature, 20°C to 25°C (68°F to 77°F). Protect from moisture and light.
Expiry Date: See package labeling (generally 24 months)
Executive Standard: Compliant with FDA and EMA regulations
Approval Number: Example (U.S.): NDA 208573
Date of Revision: August 2025 (or latest available)
Manufacturer: Eisai Co., Ltd.

Guidelines for the Use of Lenvima

Dosage and Administration:
- Recommended Dose:
  - Differentiated thyroid cancer: 24 mg orally once daily
  - Renal cell carcinoma: 18 mg orally once daily (in combination with everolimus)
  - Hepatocellular carcinoma: 12 mg (bodyweight ≥60 kg) or 8 mg (bodyweight <60 kg) orally once daily
  - Endometrial carcinoma: 20 mg orally once daily (in combination with pembrolizumab)
- Administration: Swallow capsules whole with water, with or without food. Take at the same time daily.
- Missed Dose: If a dose is missed, take as soon as possible on the same day. Do not double dose the next day.
Adverse Reactions:
- Common Adverse Reactions (≥5% and >3% higher than placebo):
  - - Hypertension
    - Diarrhea
    - Fatigue
    - Decreased appetite
    - Nausea
    - Weight loss
    - Proteinuria
    - Palmar-plantar erythrodysesthesia syndrome (hand-foot syndrome)
- Serious Adverse Reactions:
  - - Hepatotoxicity
    - Cardiac dysfunction (including heart failure)
    - Gastrointestinal perforation or fistula
    - Severe hypertension
    - Hemorrhage
Contraindications:Hypersensitivity to lenvatinib or any component of the formulation
Precautions:
- - Hypertension:
    Monitor blood pressure regularly and manage accordingly.
  - Hepatic Impairment:
    Use with caution in patients with liver dysfunction.
  - Cardiac Function:
    Monitor for signs of cardiac dysfunction.
  - Pregnancy and Lactation:
    Not recommended during pregnancy; advise effective contraception. Unknown if excreted in breast milk; avoid breastfeeding.

Lenvatinib Interactions

CYP3A4 Inducers/Inhibitors:
Co-administration may affect lenvatinib plasma levels; monitor for efficacy and toxicity.
Anticoagulants:
Use caution due to increased bleeding risk.
Other Tyrosine Kinase Inhibitors or Anti-hypertensives:
Monitor for additive adverse effects.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.