Levagen 10 mg (Capsule)
Medicine Details
| Category | Details |
|---|---|
| Generic | Lenvatinib mesylate |
| Company | General pharmaceuticals ltd |
| Also available as |
Title
Levagen
Categories
- Medicine
- Pharmaceutical
Description
Levagen is a kinase inhibitor indicated for the treatment of differentiated thyroid cancer, renal cell carcinoma, hepatocellular carcinoma, and endometrial carcinoma. It inhibits VEGF receptors and other kinases implicated in angiogenesis, tumor growth, and cancer progression. Dosage varies for different types of cancer, and dosage modifications are recommended for patients with severe renal or hepatic impairment. Lenvatinib should be taken once daily and can be administered with or without food. It is contraindicated in patients with known hypersensitivity to Lenvatinib or any component of the formulation. Specific precautions and warnings are provided for managing side effects such as hypertension, cardiac dysfunction, arterial thromboembolic events, hepatotoxicity, and others. It is important to store Levagen below 30°C in a dry place and protect it from light.
Indications
- Locally recurrent or metastatic, radioactive iodine-refractory differentiated thyroid cancer (DTC)
- Advanced renal cell carcinoma (RCC)
- Unresectable hepatocellular carcinoma (HCC)
- Advanced endometrial carcinoma
Pharmacology
- Mechanism Of Action: Inhibition of VEGF receptors (VEGFR1, VEGFR2, and VEGFR3) and other kinases (FGFR1, FGFR2, FGFR3, FGFR4, PDGFR, KIT, RET) involved in angiogenesis, tumor growth, and cancer progression
- Absorption: Peak plasma concentration typically occurs 1 to 4 hours post-dose, delayed to 4 hours with high-fat meal
- Distribution: In vitro binding to human plasma proteins ranged from 98% to 99%, blood-to-plasma concentration ratio ranged from 0.59 to 0.61
- Metabolism: Mainly by enzymatic (CYP3A, aldehyde oxidase) and non-enzymatic processes
- Excretion: Approximately 64% eliminated in feces and 25% in urine after ten days
Dosage
- Differentiated Thyroid Cancer (DTC): 24 mg orally once daily
- Renal Cell Carcinoma (RCC) with Everolimus: 18 mg orally with 5 mg Everolimus once daily
- Hepatocellular Carcinoma (HCC): 12 mg for patients ≥60 kg, 8 mg for patients <60 kg, orally once daily
- Endometrial Carcinoma with Pembrolizumab: 20 mg orally once daily with 200 mg Pembrolizumab every 3 weeks
Administration
- Capsules can be swallowed whole or dissolved in liquid
- If dissolved, capsules should be placed in 1 tablespoon of water or apple juice, stirred for 3 minutes, and then consumed
Interaction
- Avoid coadministration with drugs that prolong the QT interval
Contraindications
- Known hypersensitivity to Lenvatinib or any component of the formulation
Side Effects
- Hypertension
- Cardiac dysfunction
- Arterial thromboembolic events
- Hepatotoxicity
- Renal failure and impairment
- Proteinuria
- Diarrhea
- Fistula formation and gastrointestinal perforation
- QT Interval Prolongation
- Hypocalcemia
- Reversible posterior leukoencephalopathy syndrome
- Hemorrhagic events
- Impairment of thyroid stimulating hormone suppression/thyroid dysfunction
- Wound healing complications
Pregnancy & Lactation
- Use in Pregnancy: Can cause embryo-fetal harm, effective contraception advised
- Use in Lactation: Discontinue breastfeeding during treatment and for at least 1 week after the last dose
Precautions & Warnings
- Hypertension monitoring and management
- Cardiac dysfunction monitoring
- Arterial thromboembolic events precautions
- Hepatotoxicity monitoring
- Renal failure or impairment precautions
- Proteinuria monitoring
- Diarrhea management
- Fistula formation and gastrointestinal perforation precautions
- QT Interval Prolongation monitoring
- Hypocalcemia management
- Reversible Posterior Leukoencephalopathy Syndrome precautions
- Hemorrhagic events risk assessment
- Impairment of thyroid stimulating hormone suppression/thyroid dysfunction monitoring
- Wound healing precautions
Use in Special Populations
- Dosage Modifications for Severe Renal Impairment:
- Differentiated Thyroid Cancer: 14 mg orally once daily
- Renal Cell Carcinoma: 10 mg orally once daily
- Endometrial Carcinoma: 10 mg orally once daily
- Dosage Modifications for Severe Hepatic Impairment:
- Differentiated Thyroid Cancer: 14 mg orally once daily
- Renal Cell Carcinoma: 10 mg orally once daily
- Endometrial Carcinoma: 10 mg orally once daily
- Pediatric Use: Safety and effectiveness not established
Overdose Effects
Not expected to be dialyzable, death occurred with a single dose of 120 mg orally
Storage Conditions
Store below 30°C in a dry place, protect from light, keep out of the reach of children