Active Ingredient: Lenvatinib
Lenvatinib in combination with pembrolizumab is indicated for the treatment of adult patients with advanced or recurrent endometrial carcinoma (EC) who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and are not candidates for curative surgery or radiation.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 20 milligrams lenvatinib, once daily.
The recommended dosage of lenvatinib is 20 mg orally once daily, in combination with pembrolizumab either 200 mg every 3 weeks or 400 mg every 6 weeks, administered as an intravenous infusion over 30 minutes, until unacceptable toxicity or disease progression.
Refer to the Summary of Product Characteristics (SmPC) for pembrolizumab for additional dosing information.
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.
When administering lenvatinib in combination with pembrolizumab, interrupt, dose reduce, or discontinue lenvatinib as appropriate. Withhold or discontinue pembrolizumab in accordance with the instructions in the SmPC for pembrolizumab. No dose reductions are recommended for pembrolizumab.
Dose modifications from recommended lenvatinib daily dose in EC patients:
| Starting Dose in combination with pembrolizumab | 20 mg orally once daily (two 10-mg capsules) | |
| Persistent and Intolerable Grade 2 or Grade 3 Toxicities | ||
| Adverse Reaction | Modification | Adjusted Dose |
| First occurrence | Interrupt until resolved to Grade 0-1 or baseline | 14 mg orally once daily (one 10-mg capsule + one 4-mg capsule) |
| Second occurrence (same reaction or new reaction) | Interrupt until resolved to Grade 0-1 or baseline | 10 mg orally once daily (one 10-mg capsule) |
| Third occurrence (same reaction or new reaction) | Interrupt until resolved to Grade 0-1 or baseline | 8 mg orally once daily (two 4-mg capsules) |
| Life-threatening toxicities (Grade 4): Discontinueb | ||
a Limited data are available for doses below 8 mg.
b 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).
No adjustment of starting dose is required on the basis of age. Limited data are available on use in patients aged ≥75 years.
Lenvatinib should be taken at about the same time each day, with or without food.
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