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Lenvima is a brand name for Lenvatinib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Differentiated Thyroid Carcinoma (DTC) LENVIMA as monotherapy 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). Hepatocellular Carcinoma (HCC) LENVIMA as…
Verbatim from this product's EMA label. Tap a section to expand.
LENVIMA treatment should be initiated and supervised by a healthcare professional experienced in the use of anticancer therapies. 4). Posology 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. Differentiated thyroid cancer (DTC) The recommended daily dose of lenvatinib is 24 mg (two 10-mg capsules and one 4-mg capsule) once daily.
The daily dose is to be modified as needed according to the dose/toxicity management plan. 4). , Grade 1 or 2) generally do not warrant interruption of lenvatinib, unless intolerable to the patient despite optimal management. , 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 (see Table 4), 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 in Table 1. Table 1 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.
, Grade 3). Hepatocellular Carcinoma The recommended daily dose of lenvatinib is 8 mg (two 4 mg capsules) once daily for patients with a body weight of < 60 kg and 12 mg (three 4 mg capsules) 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 4 during treatment. The daily dose is to be modified, as needed, according to the dose/toxicity management plan. Dose adjustments and Discontinuation for HCC Management of some adverse reactions may require dose interruption, adjustment, or discontinuation of lenvatinib therapy.
, Grade 1 or 2) generally do not warrant interruption of lenvatinib, unless intolerable to the patient despite optimal management. For lenvatinib-related toxicities, see Table 4. Details for monitoring, dose adjustment and discontinuation are provided in Table 2.
8. HCC In the patient populations enrolled in the HCC study no dose adjustments were required on the basis of hepatic function in those patients who had mild hepatic impairment (Child-Pugh A). The available very limited data are not sufficient to allow for a dosing recommendation for HCC patients with moderate hepatic impairment (Child-Pugh B).
2). Lenvatinib has not been studied in patients with severe hepatic impairment (Child-Pugh C) and is not recommended for use in these patients. EC Limited data are available for the combination of lenvatinib with pembrolizumab in patients with hepatic impairment.
No adjustment of starting dose of the combination 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, the recommended starting dose of lenvatinib is 10 mg taken once daily.
Please refer to the SmPC for pembrolizumab for dosing in patients with hepatic impairment. Further dose adjustments may be necessary on the basis of individual tolerability. Patients with renal impairment DTC No adjustment of starting dose is required on the basis of renal function in patients with mild or moderate renal impairment.
In patients with severe renal impairment, the recommended starting dose is 14 mg taken once daily. Further dose adjustments may be necessary based on individual tolerability. 8). HCC No dose adjustments are required on the basis of renal function in patients with mild or moderate renal impairment.
The available data do not allow for a dosing recommendation for patients with HCC and severe renal impairment. EC No adjustment of starting dose is required on the basis of renal function in patients with mild or moderate renal impairment.
In patients with severe renal impairment, the recommended starting dose is 10 mg of lenvatinib taken once daily. Please refer to the SmPC for pembrolizumab for dosing in patients with renal impairment. Further dose adjustments may be necessary based on individual tolerability.
4. Grade 4 Discontinue Do not resume. Proteinuria ≥ 2 g / 24 hours Interrupt Resolves to less than 2 g / 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. 6 Table 4 Adverse reactions requiring dose modification of lenvatinib Adverse reaction Severity Action Dose reduce and resume lenvatinib Posterior reversible encephalopathy syndrome (PRES)/reversible posterior leukoencephalopathy syndrome (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 Do not resume.
Gastrointestinal perforation or fistula Grade 3 Interrupt Resolves to Grade 0-1 or baseline. Grade 4 Discontinue Do not resume. Non-gastrointestinal 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 3). 8). 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.
HCC Patients ≥75 years, of white race or female sex or those with worse baseline hepatic impairment (Child-Pugh A score of 6 compared to score of 5) appear to have reduced tolerability to lenvatinib. HCC patients other than those with moderate and severe hepatic impairment or severe renal impairment should initiate treatment at the recommended starting dose of 8 mg (two 4-mg capsules) for body weight < 60 kg and 12 mg (three 4-mg capsules) for body weight ≥ 60 kg, following which the dose should be further adjusted on the basis of individual tolerability.
1. 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Table 2 Dose modifications from recommended lenvatinib daily dose in HCC patients Starting Dose ≥60 kg BW 12 mg (three 4-mg capsules orally once daily) <60 kg BW 8 mg (two 4-mg capsules orally once daily) Persistent and Intolerable Grade 2 or Grade 3 Toxicitiesa Adverse Reaction Modification Adjusted Doseb (≥60 kg BW) Adjusted Doseb (<60 kg BW) First occurrence c Interrupt until resolved to Grade 0-1 or baselined 8 mg (two 4-mg capsules) orally once daily 4 mg (one 4-mg capsule) orally once daily Second occurrence (same reaction or new reaction) Interrupt until resolved to Grade 0-1 or baselined 4 mg (one 4-mg capsule) orally once daily 4 mg (one 4-mg capsule) orally every other day Third occurrence (same reaction or new reaction) Interrupt until resolved to Grade 0-1 or baselined 4 mg (one 4-mg capsule) 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 2 g/24 hours.
e: Excluding laboratory abnormalities judged to be nonlife-threatening, which should be managed as Grade 3. Grades are based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). 1). Refer to the Summary of Product Characteristics (SmPC) for pembrolizumab for additional dosing information.
5 Dose adjustments and Discontinuation for EC For lenvatinib-related toxicities see Table 4. When administering LENVIMA in combination with pembrolizumab, interrupt, dose reduce, or discontinue LENVIMA as appropriate (see Table 3). Withhold or discontinue pembrolizumab in accordance with the instructions in the SmPC for pembrolizumab.
No dose reductions are recommended for pembrolizumab. Table 3 Dose modifications from recommended lenvatinib daily dose in EC patientsa Starting Dose in combination with pembrolizumab 20 mg orally once daily (two 10-mg capsules) Persistent and Intolerable Grade 2 or Grade 3 Toxicities […]
Patients with end-stage renal disease have not been studied, therefore the use of lenvatinib in these patients is not recommended. 8 Elderly population No adjustment of starting dose is required on the basis of age. 8). Paediatric population The safety and efficacy of lenvatinib in children aged 2 to <18 years have not been established.
2 but no recommendation on a posology can be made. 3). 2). 8). Method of administration Lenvatinib is for oral use. 2). Caregivers should not open the capsule, in order to avoid repeated exposure to the contents of the capsule. Lenvatinib capsules can be swallowed whole with water or administered as a suspension prepared by dispersing the whole capsule(s) in water, apple juice, or milk.
The suspension may be administered orally or via a feeding tube. 6 for preparation and administration of suspension). If not used at the time of preparation, lenvatinib suspension may be stored in a covered container and must be refrigerated at 2ºC to 8ºC for a maximum of 24 hours.
After removal from the refrigerator the suspension should be shaken for approximately 30 seconds before use. If not administered within 24 hours, the suspension should be discarded. For use in combination with pembrolizumab, refer to the SmPC for pembrolizumab.
1. 6). 8). Blood pressure (BP) should be well controlled prior to treatment with lenvatinib and, if patients are known to be hypertensive, they should be on a stable dose of antihypertensive therapy for at least 1 week prior to treatment with lenvatinib.
Serious complications of poorly controlled hypertension, including aortic dissection, have been reported. The early detection and effective management of hypertension are important to minimise the need for lenvatinib dose interruptions and reductions.
Antihypertensive agents should be started as soon as elevated BP is confirmed. BP should be monitored after 1 week of treatment with lenvatinib, then every 2 weeks for the first 2 months, and monthly thereafter. The choice of antihypertensive treatment should be individualised to the patient’s clinical circumstances and follow standard medical practice.
For previously normotensive subjects, monotherapy with one of the classes of antihypertensives should be 9 started when elevated BP is observed. For those patients already on an antihypertensive medicinal product, the dose of the current agent may be increased, if appropriate, or one or more agents of a different class of antihypertensive should be added.
When necessary, manage hypertension as recommended in Table
8). Patients with hepatic impairment DTC 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, the recommended starting dose is 14 mg taken once daily.
Further dose adjustments may be necessary on the basis of individual tolerability. 8. HCC In the patient populations enrolled in the HCC study no dose adjustments were required on the basis of hepatic function in those patients who had mild hepatic impairment (Child-Pugh A).
The available very limited data are not sufficient to allow for a dosing recommendation for HCC patients with moderate hepatic impairment (Child-Pugh B). 2). Lenvatinib has not been studied in patients with severe hepatic impairment (Child-Pugh C) and is not recommended for use in these patients.
EC Limited data are available for the combination of lenvatinib with pembrolizumab in patients with hepatic impairment. No adjustment of starting dose of the combination 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, the recommended starting dose of lenvatinib is 10 mg taken once daily. Please refer to the SmPC for pembrolizumab for dosing in patients with hepatic impairment. Further dose adjustments may be necessary on the basis of individual tolerability.
Patients with renal impairment DTC No adjustment of starting dose is required on the basis of renal function in patients with mild or moderate renal impairment. In patients with severe renal impairment, the recommended starting dose is 14 mg taken once daily.
Further dose adjustments may be necessary based on individual tolerability. 8). HCC No dose adjustments are required on the basis of renal function in patients with mild or moderate renal impairment. The available data do not allow for a dosing recommendation for patients with HCC and severe renal impairment.
EC No adjustment of starting dose is required on the basis of renal function in patients with mild or moderate renal impairment. In patients with severe renal impairment, the recommended starting dose is 10 mg of lenvatinib taken once daily.
Please refer to the SmPC for pembrolizumab for dosing in patients with renal impairment. Further dose adjustments may be necessary based on individual tolerability. Patients with end-stage renal disease have not been studied, therefore the use of lenvatinib in these patients is not recommended.
8 Elderly population No adjustment of starting dose is required on the basis of age. 8). Paediatric population The safety and efficacy of lenvatinib in children aged 2 to <18 years have not been established. 2 but no recommendation on a posology can be made.
Lenvatinib should not be used […]