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.
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.
PI-guided strategies to help manage hypertension1
Control blood pressure prior to initiating treatment
Hypertension in REFLECT protocol2
REFLECT's inclusion criteria included adequately controlled BP, with up to 3 antihypertensive agents
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:
LENVIMA was continued and antihypertensive therapy was instituted for patients not already receiving antihypertensive medication
For patients already on antihypertensive medication, dose or medication choice was modified as per the investigator
PI-guided strategies to help manage hypothyroidism1
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.
PI-guided strategies to help manage decreased appetite1
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.
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
PI-guided strategies to help manage fatigue1
CTCAE v4.0 does not define grade 4 fatigue. Permanently discontinue for grade 4 adverse reactions.
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.