Active Ingredient: Lenvatinib
Lenvatinib is indicated as monotherapy for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hรผrthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).
For this indication, competent medicine agencies globally authorize below treatments:
Oral
24 - 24 mg
From 24 To 24 mg once every day
The recommended daily dose of lenvatinib is 24 mg once daily. The daily dose is to be modified as needed according to the dose/toxicity management plan.
Management of adverse reactions may require dose interruption, adjustment, or discontinuation of lenvatinib therapy. 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 improvement of the reaction to Grade 0-1 or baseline.
For lenvatinib related toxicities, upon resolution/improvement of an adverse reaction to Grade 0-1 or baseline, treatment should be resumed at a reduced dose of lenvatinib as suggested in the following table.
Dose modifications from recommended lenvatinib daily dose in DTC patientsa:
| Dose level | Daily dose | Number of capsules |
|---|---|---|
| Recommended daily dose | 24 mg orally once daily | Two 10 mg capsules plus one 4 mg capsule |
| First dose reduction | 20 mg orally once daily | Two 10 mg capsules |
| Second dose reduction | 14 mg orally once daily | One 10 mg capsule plus one 4 mg capsule |
| Third dose reduction | 10 mg orally once dailya | One 10 mg capsule a: Further dose reductions should be considered on an individual patient basis as limited data are available for doses below 10 mg. |
a Further dose reductions should be considered on an individual patient basis as limited data are available for doses below 10 mg.
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).
Lenvatinib should be taken at about the same time each day, with or without food.
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