Lenvima (lenvatinib) is a receptor tyrosine kinase (RTK) inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1, as well as other RTKs that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions.
Lenvima is specifically indicated for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.
Lenvima is supplied as a capsule for oral administration. The recommended daily dose of Lenvima is 24 mg (two 10 mg capsules and one 4 mg capsule) orally taken once daily with or without food. Lenvima should be taken 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. For dose modifications in specific patients, please see drug label. Lenvima should be administered until disease progression or until unacceptable toxicity occurs.
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 of lenvatinib is 24 mg taken once daily. The daily dose is to be modified as needed according to the dose/toxicity management plan (see dose adjustment section below).
If a patient misses a dose, and it cannot be taken within 12 hours, then that dose should be skipped and the next dose should be taken at the usual time of administration. Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs.
Dose adjustment
Management of adverse reactions may require dose interruption, adjustment, or discontinuation of lenvatinib (see section 4.4). Mild to moderate adverse reactions (e.g., Grade 1 or 2) generally do not warrant interruption of lenvatinib, unless intolerable to the patient despite optimal management. Severe (e.g., Grade 3) or intolerable adverse reactions require interruption of lenvatinib until resolution or improvement of the reaction, after which treatment should be resumed at a reduced dose as suggested in Table 1. Treatment should be discontinued in case of life-threatening reactions (e.g., Grade 4) with the exception of laboratory abnormality judged to be non-life-threatening, in which case they should be managed as severe reaction (e.g., Grade 3).
Grades are based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
Optimal medical management for nausea, vomiting, and diarrhoea should be initiated prior to any interruption or dose reduction of lenvatinib. Gastrointestinal toxicity should be actively managed in order to reduce the risk of development of renal impairment or failure (see section 4.4, Renal failure and impairment).
Table 1 Dose modifications from recommended daily dose
