Lenvima(Lenvatinib Capsules)
LENVIMA™ (lenvatinib) is indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC).
Lenvima 4mg and 10mg hard capsules
1. Name of the medicinal product
LENVIMA 4 mg hard capsules
LENVIMA 10 mg hard capsules
2. Qualitative and quantitative composition
Each 4mg hard capsule contains 4 mg of lenvatinib (as mesilate).
Each 10mg hard capsule contains 10 mg of lenvatinib (as mesilate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard capsule.
4mg capsule:
A yellowish-red body and yellowish-red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 4 mg” on the body.
10mg capsule:
A yellow body and yellowish-red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 10 mg” on the body.
4. Clinical particulars
4.1 Therapeutic indications
LENVIMA is indicated for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).
4.2 Posology and method of administration
LENVIMA treatment should be initiated and supervised by a health care professional experienced in the use of anticancer therapies.
Posology
The recommended daily dose o