Active Ingredient: Lenvatinib
Lenvatinib is indicated as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
8 - 12 mg
From 8 To 12 mg once every day
The recommended daily dose of lenvatinib is 8 mg once daily for patients with a body weight of <60 kg and 12 mg once daily for patients with a body weight of ≥60 kg. Dose adjustments are based only on toxicities observed and not on body weight changes during treatment. The daily dose is to be modified, as needed, according to the dose/toxicity management plan.
Management of some 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. Details for monitoring, dose adjustment and discontinuation are provided in the following table.
Dose modifications from recommended lenvatinib daily dose in HCC patients:
| Starting Dose | ≥60 kg BW 12 mg | <60 kg BW 8 mg | |
|---|---|---|---|
| Persistent and Intolerable Grade 2 or Grade 3 Toxicitiesa | |||
| Adverse Reaction | Modification | Adjusted Doseb (≥60 kg BW) | Adjusted Doseb (<60 kg BW) |
| First occurrencec | Interrupt until resolved to Grade 0-1 or baselined | 8 mg orally once daily | 4 mg orally once daily |
| Second occurrence (same reaction or new reaction) | Interrupt until resolved to Grade 0-1 or baselined | 4 mg orally once daily | 4 mg orally every other day |
| Third occurrence (same reaction or new reaction) | Interrupt until resolved to Grade 0-1 or baselined | 4 mg orally every other day | Discontinue |
| Life-threatening toxicities (Grade 4): Discontinuee | |||
a Initiate medical management for nausea, vomiting, or diarrhoea prior to interruption or dose reduction.
b Reduce dose in succession based on the previous dose level (12 mg, 8 mg, 4 mg or 4 mg every other day).
c Haematologic toxicity or proteinuria-no dose adjustment required for first occurrence.
d For haematologic toxicity, dosing can restart when resolved to Grade 2; proteinuria, resume when resolves to less than 2g/24 hours.
e Excluding laboratory abnormalities judged to be nonlife-threatening, which should be managed as Grade 3
Adverse reactions requiring dose modification of lenvatinib in DTC and HCC:
| Adverse reaction | Severity | Action | Dose reduce and resume lenvatinib |
|---|---|---|---|
| Hypertension | Grade 3 (despite optimal antihypertensive therapy) | Interrupt | Resolves to Grade 0, 1 or 2. |
| Grade 4 | Discontinue | Do not resume | |
| Proteinuria | ≥2g/24 hours | Interrupt | Resolves to less than 2g/24 hours. |
| Nephrotic syndrome | ------- | Discontinue | Do not resume |
| Renal impairment or failure | Grade 3 | Interrupt | Resolves to Grade 0-1 or baseline. |
| Grade 4* | Discontinue | Do not resume | |
| Cardiac dysfunction | Grade 3 | Interrupt | Resolves to Grade 0-1 or baseline. |
| Grade 4 | Discontinue | Do not resume | |
| PRES/RPLS | Any grade | Interrupt | Consider resuming at reduced dose if resolves to Grade 0-1. |
| Hepatotoxicity | Grade 3 | Interrupt | Resolves to Grade 0-1 or baseline. |
| Grade 4* | Discontinue | Do not resume | |
| Arterial thromboembolisms | Any grade | Discontinue | Do not resume |
| Haemorrhage | Grade 3 | Interrupt | Resolves to Grade 0-1. |
| Grade 4 | Discontinue | Μην αρχίζετε εκ νέου τη θεραπεία | |
| GI perforation or fistula | Grade 3 | Interrupt | Resolves to Grade 0-1 or baseline. |
| Grade 4 | Discontinue | Do not resume | |
| Non-GI fistula | Grade 4 | Discontinue | Do not resume |
| QT interval prolongation | >500 ms | Interrupt | Resolves to <480 ms or baseline |
| Diarrhoea | Grade 3 | Interrupt | Resolves to Grade 0-1 or baseline. |
| Grade 4 (despite medical management) | Discontinue | Do not resume |
* Grade 4 laboratory abnormalities judged to be non-life-threatening, may be managed as severe reactions (e.g., Grade 3)
Lenvatinib should be taken at about the same time each day, with or without food.
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