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Kisplyx is a brand name for Lenvatinib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Kisplyx is indicated for the treatment of adults with advanced renal cell carcinoma (RCC): in combination with pembrolizumab, as first-line treatment (see section 5.1). in combination with everolimus, following one prior vascular endothelial growth factor (VEGF)-targeted therapy (see section 5.1).
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated and supervised by a healthcare professional experienced in the use of anticancer therapies. Posology Kisplyx in combination with pembrolizumab as first-line treatment The recommended dose of lenvatinib is 20 mg (two 10-mg capsules) 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.
The daily dose of lenvatinib is to be modified as needed according to the dose/toxicity management plan. Lenvatinib treatment should continue until disease 3 progression or unacceptable toxicity. Pembrolizumab should be continued until disease progression, unacceptable toxicity or the maximum duration of therapy as specified for pembrolizumab.
See the Summary of Product Characteristics (SmPC) for pembrolizumab for full pembrolizumab dosing information. Kisplyx in combination with everolimus as second-line treatment The recommended daily dose of lenvatinib is 18 mg (one 10-mg capsule and two 4-mg capsules) orally once daily in combination with 5 mg of everolimus once daily.
The daily dose of lenvatinib and, if necessary, everolimus is to be modified as needed according to the dose/toxicity management plan. See the SmPC for everolimus for full everolimus dosing information. If a patient misses a dose of lenvatinib, 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 there is clinical benefit or until unacceptable toxicity occurs. 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. 4). For toxicities thought to be related to lenvatinib (see Table 2), 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 dosea Lenvatinib dose in combination with pembrolizumab Lenvatinib dose in combination with everolimus Recommended daily dose 20 mg orally once daily (two 10-mg capsules) 18 mg orally once daily (one 10-mg capsule + two 4-mg capsules) First dose reduction 14 mg orally once daily (one 10-mg capsule + one 4-mg capsule) 14 mg orally once daily (one 10-mg capsule + one 4-mg capsule) Second dose reduction 10 mg orally once daily (one 10-mg capsule) 10 mg orally once daily (one 10-mg capsule) Third dose reduction 8 mg orally once daily (two 4-mg capsules) 8 mg orally once daily (two 4-mg capsules) a Limited data are available for doses below 8 mg When used in combination with pembrolizumab, one or both medicines should be interrupted as appropriate.
8. 8). No data for the combination of lenvatinib and everolimus are available for most of the special populations. The following information is derived from clinical experience of single agent lenvatinib in patients with differentiated thyroid cancer (DTC; see SmPC for Lenvima).
5 All patients other than those with severe hepatic or renal impairment (see below) should initiate treatment at the recommended dose of 20 mg of lenvatinib daily with pembrolizumab or 18 mg of lenvatinib with 5 mg of everolimus taken once daily as indicated, following which the dose should be further adjusted on the basis of individual tolerability.
8). Patients with hepatic impairment 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.
8). No data for the combination of lenvatinib with everolimus are available 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 in combination with the dose of everolimus recommended for patients with severe hepatic impairment in the SmPC for everolimus.
4. Grade 4 Discontinue Do not resume Proteinuria ≥ 2 gm / 24 hours Interrupt Resolves to less than 2 gm / 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 Do not resume 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. 8. 8). No data for the combination of lenvatinib and everolimus are available for most of the special populations.
The following information is derived from clinical experience of single agent lenvatinib in patients with differentiated thyroid cancer (DTC; see SmPC for Lenvima). 5 All patients other than those with severe hepatic or renal impairment (see below) should initiate treatment at the recommended dose of 20 mg of lenvatinib daily with pembrolizumab or 18 mg of lenvatinib with 5 mg of everolimus taken once daily as indicated, following which the dose should be further adjusted on the basis of individual tolerability.
8). Patients with hepatic impairment 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.
1. 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Lenvatinib in European Union.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Lenvatinib should be withheld, dose reduced, or discontinued as appropriate. Withhold or discontinue pembrolizumab in accordance with the instructions in the SmPC for pembrolizumab. No dose reductions are recommended for pembrolizumab.
For toxicities thought to be related to everolimus, treatment should be interrupted, reduced to alternate day dosing, or discontinued (see the SmPC for everolimus for dose adjustment recommendations regarding specific adverse reactions).
4 For toxicities thought to be related to both lenvatinib and everolimus, lenvatinib should be reduced (see Table 1) prior to reducing everolimus. , Grade 3). Grades are based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
Table 2 Adverse reactions requiring dose modification of lenvatinib Adverse reaction Severity Action Dose reduce and resume lenvatinib Hypertension Grade 3 (despite optimal antihypertensive therapy) Interrupt Resolves to Grade 0, 1 or 2.
See detailed guidance in Table 3 in section
Further dose adjustments may be necessary on the basis of individual tolerability. 8). Patients with renal impairment 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 or everolimus for dosing in patients with renal impairment. Further dose adjustments may be necessary based on individual tolerability.
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. 6 Body weight below 60 kg No adjustment of starting dose is required on the basis of body weight. 8). 1). Patients with a KPS (Karnofsky Performance Status) <70 were excluded from Study 307 (CLEAR). Benefit-risk in these patients has not been evaluated.
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. 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 […]
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.
8). No data for the combination of lenvatinib with everolimus are available 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 in combination with the dose of everolimus recommended for patients with severe hepatic impairment in the SmPC for everolimus.
Further dose adjustments may be necessary on the basis of individual tolerability. 8). Patients with renal impairment 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 or everolimus for dosing in patients with renal impairment. Further dose adjustments may be necessary based on individual tolerability.
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. 6 Body weight below 60 kg No adjustment of starting dose is required on the basis of body weight. 8). 1). Patients with a KPS (Karnofsky Performance Status) <70 were excluded from Study 307 (CLEAR). Benefit-risk in these patients has not been evaluated.
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. […]