Lenvakin 10 mg (Capsule)
Unit Price: ৳ 1,500.00 (2 x 7: ৳ 21,000.00)
Strip Price: ৳ 10,500.00
Medicine Details
| Category | Details |
|---|---|
| Generic | Lenvatinib mesylate |
| Company | Ziska pharmaceuticals ltd |
| Also available as |
Indications
- Locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC)
- Advanced renal cell carcinoma (RCC)
- Unresectable hepatocellular carcinoma (HCC)
- Advanced endometrial carcinoma
Pharmacology
- Inhibits kinase activities of VEGFR1, VEGFR2, and VEGFR3
- Inhibits FGF receptors FGFR1, 2, 3, and 4
- Inhibits platelet-derived growth factor receptor alpha (PDGFR), KIT, and RET
- Exhibits antiproliferative activity in hepatocellular carcinoma cell lines
Absorption
- Time to peak plasma concentration (Tmax) occurs from 1 to 4 hours post-dose
- Administration with a high-fat meal does not affect extent of absorption
- Administration with a high-fat meal delays time to peak plasma concentration
Distribution
- In vitro binding to human plasma proteins ranges from 98% to 99%
- Blood-to-plasma concentration ratio ranges from 0.59 to 0.61
Metabolism
- Main metabolic pathways are enzymatic (CYP3A and aldehyde oxidase) and non-enzymatic processes
- Approximately 64% of radiolabel eliminated in feces and 25% in urine
Elimination
Terminal elimination half-life is approximately 28 hours
Dosage
- 24 mg orally once daily for differentiated thyroid cancer (DTC)
- 18 mg Lenvatinib + 5 mg Everolimus orally once daily for renal cell carcinoma (RCC)
- Dose based on actual body weight for unresectable hepatocellular carcinoma (HCC)
- 20 mg orally once daily in combination with Pembrolizumab for endometrial carcinoma
Administration
Capsules can be swallowed whole or dissolved in liquid
Interaction
Prolongs the QT/QTc interval
Contraindications
Contraindicated in patients with 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
- Can cause embryo-fetal harm in pregnancy
- Females of reproductive potential should use effective contraception during treatment
- Not known if present in human milk
- Women advised to discontinue breastfeeding during treatment
Precautions & Warnings
- Hypertension monitoring and control
- Monitoring for cardiac dysfunction
- Arterial thromboembolic event precautions
- Hepatotoxicity monitoring
- Renal failure or impairment precautions
- Proteinuria monitoring
- Diarrhea management
- Fistula formation and gastrointestinal perforation precautions
- QT interval prolongation monitoring
- Hypocalcemia precautions
- Reversible posterior leukoencephalopathy syndrome precautions
- Hemorrhagic event precautions
- Thyroid stimulating hormone suppression/thyroid dysfunction monitoring
- Wound healing complications precautions
Use in Special Populations
- Dosage modifications for severe renal impairment
- Dosage modifications for severe hepatic impairment
- Safety and effectiveness not established in pediatric patients
Overdose Effects
Not expected to be dialyzable, death due to multiorgan dysfunction reported
Storage Conditions
Store below 30°C in a dry place, protect from light, keep out of reach of children