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Lenvima Dosage

Generic name: LENVATINIB 10mg
Dosage form: capsule

Medically reviewed on August 24, 2018.

2.1 Important Dosage Information

  • Reduce the dose for certain patients with renal or hepatic impairment [see Dosage and Administration (2.6, 2.7)].
  • Take LENVIMA once daily, with or without food, at the same time each day [see Clinical Pharmacology (12.3)]. 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 Dosage for Differentiated Thyroid Cancer (DTC)

The recommended dosage of LENVIMA is 24 mg orally once daily until disease progression or until unacceptable toxicity.

2.3 Recommended Dosage for Renal Cell Carcinoma (RCC)

The recommended dosage of LENVIMA is 18 mg in combination with 5 mg everolimus orally once daily until disease progression or until unacceptable toxicity.

Refer to everolimus prescribing information for recommended everolimus dosing information.

2.4 Recommended Dosage for Hepatocellular Carcinoma (HCC)

The recommended dosage of LENVIMA is based on actual body weight:

• 12 mg for patients greater than or equal to 60 kg or

• 8 mg for patients less than 60 kg.

Take LENVIMA orally once daily until disease progression or until unacceptable toxicity.

2.5 Dosage Modifications for Adverse Reactions

Recommendations for LENVIMA dose interruption, reduction and discontinuation for adverse reactions are listed in Table 1. Table 2 lists the recommended dosage reductions of LENVIMA for adverse reactions.

Table 1. Recommended Dosage Modifications for LENVIMA for Adverse Reactions
Adverse Reaction Severity a Dosage Modifications for LENVIMA
Hypertension [see Warnings and Precautions (5.1)]
Grade 3
  • Withhold for Grade 3 that persists despite optimal antihypertensive therapy.
  • Resume at reduced dose when hypertension is controlled at less than or equal to Grade 2.
Grade 4
  • Permanently discontinue.
Cardiac Dysfunction [see Warnings and Precautions (5.2)]
Grade 3
  • Withhold until improves to Grade 0 to 1 or baseline.
  • Resume at a reduced dose or discontinue depending on the severity and persistence of adverse reaction.
Grade 4
  • Permanently discontinue.
Arterial Thromboembolic Event [see Warnings and Precautions (5.3)] Any Grade
  • Permanently discontinue.
Hepatotoxicity [see Warnings and Precautions (5.4)] Grade 3 or 4
  • Withhold until improves to Grade 0 to 1 or baseline.
  • Either resume at a reduced dose or discontinue depending on severity and persistence of hepatotoxicity.
  • Permanently discontinue for hepatic failure.
Renal Failure or Impairment [see Warnings and Precautions (5.5)] Grade 3 or 4
  • Withhold until improves to Grade 0 to 1 or baseline.
  • Resume at a reduced dose or discontinue depending on severity and persistence of renal impairment.
Proteinuria [see Warnings and Precautions (5.6)] 2 g or greater proteinuria in 24 hours
  • Withhold until less than or equal to 2 grams of proteinuria per 24 hours.
  • Resume at a reduced dose.
  • Permanently discontinue for nephrotic syndrome.
Gastrointestinal Perforation [see Warnings and Precautions (5.8)] Any Grade
  • Permanently discontinue.
Fistula Formation [see Warnings and Precautions (5.8)] Grade 3 or 4
  • Permanently discontinue.
QT Prolongation [see Warnings and Precautions (5.9)] Greater than 500 ms or greater than 60 ms increase from baseline
  • Withhold until improves to less than or equal to 480 ms or baseline.
  • Resume at a reduced dose.
Reversible Posterior Leukoencephalopathy Syndrome [see Warnings and Precautions (5.11)] Any Grade
  • Withhold until fully resolved.
  • Resume at a reduced dose or discontinue depending on severity and persistence of neurologic symptoms.
Other Adverse Reactions [see Warnings and Precautions (5.7, 5.10, 5.12)]
Persistent or intolerable Grade 2 or 3 adverse reaction
Grade 4 laboratory abnormality
  • Withhold until improves to Grade 0 to 1 or baseline.
  • Resume at reduced dose.
Grade 4 adverse reaction
  • Permanently discontinue.
a National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.
Table 2: Recommended Dosage Reductions of LENVIMA for Adverse Reactions
Indication First Dosage Reduction To Second Dosage Reduction To Third Dosage Reduction To
DTC 20 mg
once daily
14 mg
once daily
10 mg
once daily
RCC 14 mg
once daily
10 mg
once daily
8 mg
once daily
HCC
  • Actual weight 60 kg or greater
8 mg
once daily
4 mg
once daily
4 mg
every other day
  • Actual weight less than 60 kg
4 mg
once daily
4 mg
every other day
Discontinue

When administering LENVIMA in combination with everolimus for the treatment of renal cell carcinoma, reduce the LENVIMA dose first and then the everolimus dose for adverse reactions of both LENVIMA and everolimus. Refer to the everolimus prescribing information for additional dose modification information.

2.6 Dosage Modifications for Severe Renal Impairment

The recommended dosage of LENVIMA for patients with DTC and RCC and severe renal impairment (creatinine clearance less than 30 mL/min calculated by Cockcroft-Gault equation using actual body weight) is [see Warnings and Precautions (5.5), Use in Specific Populations (8.6)]:

  • Differentiated thyroid cancer: 14 mg orally once daily
  • Renal cell carcinoma: 10 mg orally once daily

2.7 Dosage Modifications for Severe Hepatic Impairment

The recommended dosage of LENVIMA for patients with DTC or RCC and severe hepatic impairment (Child-Pugh C) is [see Warnings and Precautions (5.4), Use in Specific Populations (8.7)]:

  • Differentiated thyroid cancer: 14 mg taken orally once daily
  • Renal cell carcinoma: 10 mg taken orally once daily

2.8 Preparation and Administration

LENVIMA capsules can be swallowed whole or dissolved in a small glass of liquid. To dissolve in liquid, put capsules into 1 tablespoon of water or apple juice without breaking or crushing the capsules. Leave the capsules in the water or apple juice for at least 10 minutes. Stir for at least 3 minutes. After drinking the mixture, add 1 tablespoon of water or apple juice to the glass, swirl the contents a few times and swallow the water or apple juice.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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