Lenvima Dosage

2.1 Recommended Dose for DTC

The recommended daily dose of LENVIMA is 24 mg (two 10 mg capsules and one 4 mg capsule) orally taken once daily with or without food [see Clinical Pharmacology (12.3)]. Continue LENVIMA until disease progression or until unacceptable toxicity.

Take LENVIMA at the same time each day. If a dose is missed and cannot be taken within 12 hours, skip that dose and take the next dose at the usual time of administration.

2.2 Recommended Dose for RCC

​The recommended daily dose of LENVIMA is 18 mg (one 10 mg capsule and two 4 mg capsules) in combination with 5 mg everolimus orally taken once daily with or without food [see Clinical Pharmacology (12.3)]. Continue LENVIMA plus everolimus until disease progression or until unacceptable toxicity.

​Take LENVIMA and everolimus at the same time each day. If a dose is missed and cannot be taken within 12 hours, skip that dose and take the next dose at the usual time of administration.

2.3 Administration Instructions

​LENVIMA capsules should be swallowed whole. Alternatively, the capsules can be dissolved in a small glass of liquid. Measure 1 tablespoon of water or apple juice and put the capsules into the liquid without breaking or crushing them. Leave the capsules in the liquid for at least 10 minutes. Stir for at least 3 minutes. Drink the mixture. After drinking, add the same amount (1 tablespoon) of water or apple juice to the glass. Swirl the contents a few times and swallow the additional liquid.

2.4 Dose Modifications for DTC and RCC

1 Grade 3 despite optimal anti-hypertensive therapy
2 Initiate prompt medical management for nausea, vomiting or diarrhea. Permanently discontinue for Grade 4 vomiting and diarrhea despite medical management

Manage other adverse reactions according to the instructions in Table 2 for DTC or Table 3 for RCC.

​Recommendations for Dose Modifications in DTC

a Initiate medical management for nausea, vomiting, or diarrhea prior to interruption or dose reduction of LENVIMA
b Reduce dose in succession based on the previous dose level (24 mg, 20 mg, or 14 mg per day)
c Refers to the same or a different adverse reaction that requires dose modification

Severe Renal or Hepatic Impairment in DTC

For patients with DTC, the recommended dose of LENVIMA is 14 mg taken orally once daily in patients with severe renal impairment (creatinine clearance [CLcr] less than 30 mL/min calculated by the Cockcroft-Gault equation) or severe hepatic impairment (Child-Pugh C) [see Warnings and Precautions (5.4, 5.6), Use in Specific Populations (8.6, 8.7)].

​Recommendations for Dose Modifications in RCC

​a Initiate medical management for nausea, vomiting, or diarrhea prior to interruption or dose reduction of LENVIMA
b Reduce dose in succession based on the previous dose level (18 mg, 14 mg, 10 mg, or 8 mg per day)
c Refers to the same or a different adverse reaction that requires dose modification

​Recommendations for Dose Modification of Everolimus in RCC

​Review the Full Prescribing Information for everolimus for recommended dose modifications. For toxicities thought to be related to everolimus alone, discontinue, interrupt, or use alternate day dosing. For toxicities thought to be related to both LENVIMA and everolimus, first reduce LENVIMA and then everolimus.

​Severe Renal or Hepatic Impairment in RCC

​For patients with RCC, the recommended dose of LENVIMA is 10 mg taken orally once daily in patients with severe renal impairment (CLcr less than 30 mL/min calculated by the Cockcroft-Gault equation) or severe hepatic impairment (Child-Pugh C) [see Warnings and Precautions (5.4, 5.6), Use in Specific Populations (8.6, 8.7)].