Lenva 4 mg (Capsule)

Indications

• Treatment of differentiated thyroid cancer
• Treatment of renal cell carcinoma in combination with Everolimus
• First-line treatment of unresectable hepatocellular carcinoma
• Treatment of advanced endometrial carcinoma in combination with Pembrolizumab

Pharmacology

• Inhibition of VEGF receptors VEGFR1, VEGFR2, and VEGFR3
• Inhibition of FGF receptors FGFR1, FGFR2, FGFR3, and FGFR4
• Activity in hepatocellular carcinoma cell lines dependent on activated FGFR signaling

Dosage

• Recommended dosage for differentiated thyroid cancer is 24 mg orally once daily
• Recommended dosage for renal cell carcinoma in combination with Everolimus is 18 mg orally once daily
• Recommended dosage for hepatocellular carcinoma based on actual body weight
• Recommended dosage for endometrial carcinoma is 20 mg orally once daily in combination with Pembrolizumab

Administration

• Can be swallowed whole or dissolved in liquid
• Instructions for dissolving capsules in water or apple juice

Interaction

• Reported prolongation of the QT/QTc interval
• Coadministration avoidance with drugs known to prolong the QT/QTc interval

Contraindications

• Contraindicated in patients with known hypersensitivity to Lenvatinib or its components

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

• Potential embryo-fetal harm
• Need for effective contraception during treatment
• Discontinuation of breastfeeding during treatment

Precautions & Warnings

• Hypertension monitoring and control
• Monitoring for symptoms or signs of cardiac dysfunction
• Permanently discontinuing Lenva following arterial thrombotic events
• Liver function monitoring
• Monitoring for renal failure or impairment
• Proteinuria monitoring
• Diarrhea management
• Discontinuing Lenva for certain gastrointestinal complications
• Monitoring and correcting electrolyte abnormalities
• Monitoring for hypothyroidism and thyroid dysfunction
• Managing wound healing complications

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
• Reported death due to multiorgan dysfunction in an overdose case

Storage Conditions

• Store below 30°C in a dry place
• Protection from light
• Keep out of the reach of children

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