1. Clinical & Scientific Overview
Lenvatinib Mesylate (TIP-MED-000571, Reference Code [ONC-22]) is classified under
Oncology & Antineoplastic Medicines as a Targeted Therapy (Multi-Kinase Anti-Angiogenic TKI) • Multi-Targeted Receptor Tyrosine Kinase Inhibitor (VEGFR1–3, FGFR1–4, PDGFR-alpha, RET, KIT).
Within the Indian regulatory and compendial framework, it is governed under Schedule H (Prescription Only — Specialist Oncology Supervision).
Lenvima (Eisai Pharmaceuticals India), Lenvatol (Cipla Ltd), Lenvakast (BDR Pharmaceuticals)
Hard Capsule: 4 mg, 10 mg
Oncology Specialisation & Cytotoxic Safety Protocol
Targeted Therapy (Multi-Kinase Anti-Angiogenic TKI)
Antineoplastic Targeted Agent
Standard Regimen & Cycle Context: HCC: 8 mg orally once daily (if body weight <60 kg) or 12 mg once daily (if >=60 kg); Thyroid Cancer: 24 mg once daily.
Signature Dose-Limiting Toxicities & Organ Monitoring: Severe treatment-emergent Hypertension (70% — control BP before starting and monitor weekly initially), proteinuria/nephrotic syndrome, palmar-plantar erythrodysaesthesia, hypothyroidism (check TSH monthly), arterial thromboembolism, GI perforation/fistula, and impaired wound healing.
Extravasation, Premedication & Safe Cytotoxic Handling: Hold Lenvatinib at least 1 week prior to elective surgery and for 2 weeks postoperatively until complete wound healing; monitor urine dipstick protein and blood pressure at every clinic visit.
3. Mechanism of Action & Pharmacodynamics
Inhibits VEGF receptors 1, 2, and 3 and FGF receptors 1, 2, 3, and 4, blocking tumour angiogenesis and fibroblast growth factor-driven escape pathways.
4. Therapeutic Indications & Evidence-Supported Uses
- Unresectable Hepatocellular Carcinoma (HCC — first-line at 8 mg or 12 mg by body weight)
- Radioiodine-refractory Differentiated Thyroid Cancer (DTC — 24 mg)
- Advanced Endometrial and Renal Cell Carcinoma (with Pembrolizumab)
🇮🇳 Jurisdiction & Indication Note: Indications and schedules reflect Indian compendial and regulatory records (CDSCO / Indian Pharmacopoeia & NFI / NLEM 2022). Where international reference labels (US FDA DailyMed / NCBI StatPearls) are cited for pharmacokinetic or mechanistic parameters, international approvals do not automatically imply CDSCO approval in India.
5. Educational Dosage Context, Formulations & Administration
Educational Dosing & Regimen Summary: Educational Oncology Regimen Context (Specialist Reference Only): HCC: 8 mg orally once daily (if body weight <60 kg) or 12 mg once daily (if >=60 kg); Thyroid Cancer: 24 mg once daily.
Administration & Meal Timing: HCC: 8 mg orally once daily (if body weight <60 kg) or 12 mg once daily (if >=60 kg); Thyroid Cancer: 24 mg once daily.
6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment
Specialist oncology pharmacokinetic profile; dosing depends on Body Surface Area (BSA in m2), Calvert GFR formula, or flat targeted dosing with strict organ-function adjustments.
Hepatic enzymatic activation/inactivation or proteolytic degradation (for monoclonal antibodies); see specific polymorphism and interaction notes.
Verify serum creatinine and eGFR before every cycle; see drug-specific renal dosing and uroprotection rules.
Check total bilirubin, AST, and ALT prior to each cycle; taxanes, anthracyclines, and TKIs require strict hepatic dose modification.
7. Contraindications, Precautions & High-Risk Warnings
- Severe hypersensitivity to Lenvatinib or formulation vehicle
- Pregnancy and lactation (potent teratogen/embryotoxic class warning unless explicitly evaluated by oncology specialist)
- Severe unrecovered bone marrow aplasia or decompensated organ failure per protocol thresholds
Key Clinical Precautions: Severe treatment-emergent Hypertension (70% — control BP before starting and monitor weekly initially), proteinuria/nephrotic syndrome, palmar-plantar erythrodysaesthesia, hypothyroidism (check TSH monthly), arterial thromboembolism, GI perforation/fistula, and impaired wound healing.
8. Adverse Effects Profile
- Severe treatment-emergent Hypertension (70% — control BP before starting and monitor weekly initially), proteinuria/nephrotic syndrome, palmar-plantar erythrodysaesthesia, hypothyroidism (check TSH monthly), arterial thromboembolism, GI perforation/fistula, and impaired wound healing.
- Severe treatment-emergent Hypertension (70% — control BP before starting and monitor weekly initially), proteinuria/nephrotic syndrome, palmar-plantar erythrodysaesthesia, hypothyroidism (check TSH monthly), arterial thromboembolism, GI perforation/fistula, and impaired wound healing.
9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions
- Severe treatment-emergent Hypertension (70% — control BP before starting and monitor weekly initially), proteinuria/nephrotic syndrome, palmar-plantar erythrodysaesthesia, hypothyroidism (check TSH monthly), arterial thromboembolism, GI perforation/fistula, and impaired wound healing.
- Avoid live-attenuated vaccines during immunosuppressive chemotherapy; verify CYP3A4, UGT1A1, DPD, and QTc interactions before each cycle.
10. Clinical Monitoring, Patient Counselling & Storage
Clinical & Laboratory Monitoring: Hold Lenvatinib at least 1 week prior to elective surgery and for 2 weeks postoperatively until complete wound healing; monitor urine dipstick protein and blood pressure at every clinic visit.
Pharmacist Patient Counselling Points:
- Hold Lenvatinib at least 1 week prior to elective surgery and for 2 weeks postoperatively until complete wound healing; monitor urine dipstick protein and blood pressure at every clinic visit.
- Report fever >=38.0°C (100.4°F) immediately (medical emergency: possible febrile neutropenia).
- Follow strict reproductive contraception and safe cytotoxic oral handling instructions.
Storage, Stability & Dispensing Safeguards: Hold Lenvatinib at least 1 week prior to elective surgery and for 2 weeks postoperatively until complete wound healing; monitor urine dipstick protein and blood pressure at every clinic visit.
11. Visual Pharmacology & Mechanism Diagram (svg-v339-01-adme-12-step-journey)
12. Authoritative References, Regulatory Sources & Editorial Disclaimer
Primary Compendial & Guideline Reference: National Cancer Grid (NCG) India Consensus Guidelines; NLEM 2022 Antineoplastic Section; Indian Pharmacopoeia (IP) & CDSCO Approved Oncology Prescribing Information.
Official Verification Portals: National Cancer Grid (NCG) India — Evidence-Based Oncology Guidelines • CDSCO — Central Drugs Standard Control Organization Approved Drug Data • Indian Pharmacopoeia Commission (IPC)
Last Medically & Pharmaceutically Reviewed: 2026-11-10 • Verification Status: VERIFIED_EDUCATIONAL_CONTENT
Educational & Clinical Disclaimer: This reference profile is published solely for pharmacy education, academic study, and professional clinical reference. It does not substitute for patient-specific clinical judgement, qualified specialist oncology/medical supervision, or official CDSCO/IP prescribing information. Never self-medicate with prescription, Schedule H/H1/X, NDPS, or oncology medicines.
13. Related Reference Monographs, Educational Guides & Visual Concept
💊 Related Pharmacological / Category Profiles
- [ONC-21] Osimertinib Mesylate — Targeted Therapy (EGFR TKI) • Third-Generation Mutant-Selective I
- [ONC-23] Ibrutinib — Targeted Therapy (BTK Inhibitor) • First-in-Class Irreversible Br
- [ONC-24] Palbociclib — Targeted Therapy (CDK4/6 Cell-Cycle Inhibitor) • Reversible Selec
- [ONC-25] Bortezomib — Targeted Therapy (Proteasome Inhibitor) • Reversible Dipeptidyl B
