LENVIMA 4 mg hard capsules
LENVIMA 10 mg hard capsules
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.
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.
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).
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
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Dose level
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Daily dose
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Number of capsules
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Recommended daily dose
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24 mg orally once daily
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Two 10 mg capsules plus one 4 mg capsule
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|
First dose reduction
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20 mg orally once daily
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Two 10 mg capsules
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|
Second dose reduction
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14 mg orally once daily
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One 10 mg capsule plus one 4 mg capsule
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|
Third dose reduction
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10 mg orally once dailya
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One 10 mg capsule
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|
a: Further dose reductions should be considered on an individual patient basis as limited data are available for doses below 10 mg.
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Special populations
Patients of age ≥75 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 (see section 4.8, Other special populations). 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.
Patients with hypertension
Blood pressure should be well controlled prior to treatment with lenvatinib, and should be regularly monitored during treatment (see section 4.4).
Patients with hepatic impairment
No adjustment of starting dose is required on the basis of hepatic function in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment. In patients with severe (Child-Pugh C) hepatic impairment,
