LENVIMA® for first-line unresectable hepatocellular carcinoma

Recommended dose and dose modifications1

Interrupt, reduce, and/or discontinue LENVIMA based on the type and/or severity (grade) of the adverse reaction

Recommended dose reductions for 8-mg and 12-mg daily dose of LENVIMA Recommended dose reductions for 8-mg and 12-mg daily dose of LENVIMA mobile

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.

  • Hypertension

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    PI-guided strategies to help manage hypertension1

    Control blood pressure prior to initiating treatment

    PI-guided strategies to manage hypertension when taking LENVIMA for unresectable HCC

    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

  • Hypothyroidism

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    PI-guided strategies to help manage hypothyroidism1

    PI-guided strategies to manage hypothyroidism when taking LENVIMA for unresectable HCC
  • Hand-foot skin reaction

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    PI-guided strategies to help manage hand-foot skin reaction1

    PI-guided strategies to manage hand-foot skin reaction when taking LENVIMA for unresectable HCC

    CTCAE v4.0 does not define grade 4 HFSR. Permanently discontinue for grade 4 adverse reactions.

  • Decreased appetite

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    PI-guided strategies to help manage decreased appetite1

    PI-guided-strategies to manage decreased appetite when taking LENVIMA for unresectable HCC
  • Decreased weight

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    PI-guided strategies to help manage decreased weight1

    PI-guided-strategies to manage decreased weight when taking LENVIMA for unresectable HCC

    CTCAE v4.0 does not define grade 4 decreased weight. Permanently discontinue for grade 4 adverse reactions.

  • Diarrhea

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    PI-guided strategies to help manage diarrhea1

    PI-guided-strategies to manage diarrhea when taking LENVIMA for unresectable HCC

    Promptly initiate management of diarrhea. Withhold and resume at a reduced dose upon recovery, or permanently discontinue LENVIMA based on severity.1

  • Fatigue

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    PI-guided strategies to help manage fatigue1

    PI-guided strategies to manage fatigue when taking LENVIMA for unresectable HCC

    CTCAE v4.0 does not define grade 4 fatigue. Permanently discontinue for grade 4 adverse reactions.

  • Proteinuria

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    PI-guided strategies to help manage proteinuria1

    PI-guided strategies to manage proteinuria when taking LENVIMA for unresectable HCC

AR=adverse reaction; PI=Prescribing Information; BP=blood pressure; CTCAE=Common Terminology Criteria for Adverse Events; HFSR=hand-foot skin reaction.

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Download the LENVIMA AR Management Guide