Active Ingredient: Lenvatinib
Lenvatinib as monotherapy is indicated 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:
For:
Oral, 24 milligrams lenvatinib, once daily.
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.
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.
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 to 1 or baseline.
For lenvatinib-related toxicities, upon resolution/improvement of an adverse reaction to Grade 0 to 1 or baseline, treatment should be resumed at a reduced dose of lenvatinib as suggested inthe 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.
Treatment should be discontinued in case of life-threatening reactions (e.g., Grade 4) with the exception of laboratory abnormalities judged to be non-life-threatening, in which case they should be managed as severe reactions (e.g., Grade 3).
Patients of age โฅ75 years, of Asian race, with comorbidities (such as hypertension, and hepatic or renal impairment), or body weight below 60 kg appear to have reduced tolerability to lenvatinib. All patients other than those with severe hepatic or renal impairment (see below) should initiate treatment at the recommended 24-mg dose, following which the dose should be further adjusted on the basis of individual tolerability.
Lenvatinib should be taken at about the same time each day, with or without food.
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