Lenvatinib 4 mg & 10 mg
LENVAXEN 4 capsules: Each capsule contains Lenvatinib Mesylate INN equivalent to Lenvatinib 4 mg.
LENVAXEN 10 capsules Each capsule conlains Lenvatinib Mesylate INN equivalent to Lenvatinib 10 mg.
INDICATIONS AND USAGE
Lenvatinib is indicated as monotherapy for the treatment of adult patients with progressive, IocaIIy advanced or metastatic, differenliated (papillary/foIIicuIar/Hürthle cell) thyroid carcino- ma (DTC), refractory to radioactiva iodine (RAI). Lenvatinib is indicated as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy.
DOSAGE AND ADMINISTRATION
Recommended Dosage for Ditferentiated Thyroid Cancer (DTC)
The recommended dosage of lenvatinib is 24 mg orally once daily until disease progression or until unacceptable toxicity.
Recommended Dosage for Renal Cell Carcinoma (RCC) The recommended dosage of lenvatinib is 18 mg in combina- tion wilh 5 mg everolimus orally once daily until disease progression or until inacceptable toxicity.
Refer to everolimus prescribing information for recommended everolimus dosing intormation.
Recommended Dosage for Hepatocellular Carcinoma
The recommended dosage of lenvatinib is based on actual body weight, 12 mg for patients greater than or equal to 60 kg or 8 mg for patients less than 60 kg. Take lenvatinib orally once daily until disease progression or until unacceptable toxicity.
Reduce the dose for certain patients with renal or hepatic impairment. Take lenvatinib once daily, with or without food, at the same time each day. If a dose is missed and cannot be taken within 12 hours, skip that dose and take the next dose at the usual time of administration.
LENVAXEN 10 capsules: Each Child-resistant HDPE container contains 30 capsules (each capsule contains Lenvatinib Mesylale INN equivalent to Lenvatinib 10 mg).
Everest Pharmaceuticals Ltd.