Recommended dose and dose modifications1
Interrupt, reduce, and/or discontinue LENVIMA based on the type and/or severity (grade) of the adverse reaction
Treatment discontinuation due to ARs occurred in 20% of patients taking LENVIMA1
In REFLECT, the most common ARs (≥5%) resulting in dose reduction or interruption of LENVIMA were fatigue (9%), decreased appetite (8%), diarrhea (8%), proteinuria (7%), hypertension (6%), and hand-foot skin reaction (5%)1
The median time to first dose reduction was 10 weeks with LENVIMA and 3.7 weeks with sorafenib2
Limitation: this is a post hoc exploratory analysis for descriptive purposes only; no conclusions can be drawn
The most common ARs (≥1%) resulting in discontinuation of LENVIMA were fatigue (1%), hepatic encephalopathy (2%), hyperbilirubinemia (1%), and hepatic failure (1%)1
AR=adverse reaction; REFLECT=A Multicenter, Randomized, Open-Label, Phase 3 Trial to Compare the EFficacy and Safety of LEnvatinib (E7080) Versus Sorafenib in First-Line Treatment of Subjects With UnreseCtable HepaTocellular Carcinoma.
For the management of specific adverse reactions, please see the AR management section below.
AR management
Help manage ARs with PI-guided strategies
Click on the bar of each AR for PI-guided strategies. For the complete list of ARs, see full Prescribing Information.
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Hypertension
PI-guided strategies to help manage hypertension1
Control blood pressure prior to initiating treatment
Hypertension in REFLECT protocol2
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REFLECT's inclusion criteria included adequately controlled BP, with up to 3 antihypertensive agents
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Based on the study protocol, the following guidelines were used for the management of systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg confirmed on repeat measurements after 1 hour:
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LENVIMA was continued and antihypertensive therapy was instituted for patients not already receiving antihypertensive medication
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For patients already on antihypertensive medication, dose or medication choice was modified as per the investigator
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Hypothyroidism
PI-guided strategies to help manage hypothyroidism1
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Hand-foot skin reaction
PI-guided strategies to help manage hand-foot skin reaction1
CTCAE v4.0 does not define grade 4 HFSR. Permanently discontinue for grade 4 adverse reactions.
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Decreased appetite
PI-guided strategies to help manage decreased appetite1
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Decreased weight
PI-guided strategies to help manage decreased weight1
CTCAE v4.0 does not define grade 4 decreased weight. Permanently discontinue for grade 4 adverse reactions.
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Diarrhea
PI-guided strategies to help manage diarrhea1
Promptly initiate management of diarrhea. Withhold and resume at a reduced dose upon recovery, or permanently discontinue LENVIMA based on severity.1
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Fatigue
PI-guided strategies to help manage fatigue1
CTCAE v4.0 does not define grade 4 fatigue. Permanently discontinue for grade 4 adverse reactions.
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Proteinuria
PI-guided strategies to help manage proteinuria1
AR=adverse reaction; PI=Prescribing Information; BP=blood pressure; CTCAE=Common Terminology Criteria for Adverse Events; HFSR=hand-foot skin reaction.
