Multikinase inhibitors
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Lenvima Dosage

Drug Detail:Lenvima (Lenvatinib [ len-va-ti-nib ])

Generic Name: LENVATINIB 4mg

Dosage Form: capsule

Drug Class: Multikinase inhibitors VEGF/VEGFR inhibitors

Contents
Uses Warnings Before Taking Dosage Side effects Interactions FAQ

2.1 Patient Selection

​For the pMMR/not MSI-H advanced endometrial carcinoma indication, select patients for treatment with LENVIMA in combination with pembrolizumab based on MSI or MMR status in tumor specimens [see Clinical Studies (14.4)].

​Information on FDA-approved tests for patient selection is available at: http://www.fda.gov/CompanionDiagnostics .

​An FDA-approved test for the selection of patients who are not MSI-H is not currently available.

2.2 Important Dosage Information

  • Reduce the dose for certain patients with renal or hepatic impairment [see Dosage and Administration (2.8, 2.9)].
  • 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.

2.3 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.

2.4 Recommended Dosage for Renal Cell Carcinoma (RCC)

First-Line Treatment of Patients with Advanced RCC

The recommended dosage of LENVIMA is 20 mg orally once daily in combination with pembrolizumab 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or until unacceptable toxicity or up to 2 years. After completing 2 years of combination therapy, LENVIMA may be administered as a single agent until disease progression or until unacceptable toxicity.

Refer to the pembrolizumab prescribing information for other pembrolizumab dosing information.

Previously Treated 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 the everolimus prescribing information for recommended everolimus dosing information.

2.5 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.

2.6 Recommended Dosage for Endometrial Carcinoma (EC)

The recommended dosage of LENVIMA is 20 mg orally once daily, in combination with pembrolizumab 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks, until unacceptable toxicity or disease progression.

Refer to the pembrolizumab prescribing information for other pembrolizumab dosing information.

2.7 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
Endometrial Carcinoma 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

Recommended Dose Modifications for Adverse Reactions for LENVIMA in Combination with Pembrolizumab

When administering LENVIMA in combination with pembrolizumab, modify the dosage of one or both drugs as appropriate. Withhold, dose reduce, or discontinue LENVIMA as shown in Table 1. Refer to pembrolizumab prescribing information for additional dose modification information.

Recommended Dose Modifications for Adverse Reactions for LENVIMA in Combination with Everolimus

When administering LENVIMA in combination with everolimus, withhold or 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.

2.8 Dosage Modifications for Severe Renal Impairment

The recommended dosage of LENVIMA for patients with DTC, RCC, or endometrial carcinoma 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
  • Endometrial carcinoma: 10 mg orally once daily

2.9 Dosage Modifications for Severe Hepatic Impairment

The recommended dosage of LENVIMA for patients with DTC, RCC, or endometrial carcinoma 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
  • Endometrial carcinoma: 10 mg orally once daily

2.10 Capsule Administration and Preparation of Suspension for Administration

​Administration

​Oral: Capsule or Suspension

​Capsule

​• Swallow LENVIMA capsules whole at the same time each day with or without food [see Clinical Pharmacology (12.3)].

​Suspension

​• Prepare [see Preparation below] oral suspension with water or apple juice and administer at the same time each day with or without food [see Clinical Pharmacology (12.3)].

​Feeding Tube Administration

​Suspension

​• Prepare [see Preparation below] suspension for feeding tube administration with water and administer at the same time each day with or without food [see Clinical Pharmacology (12.3)].

​Preparation of Suspension

​• Place the required number of capsules, up to a maximum of 5, in a small container (approximately 20 mL capacity) or syringe (20 mL). Do not break or crush capsules.

​• Add 3 mL of liquid to the container or syringe. Wait 10 minutes for the capsule shell (outer surface) to disintegrate, then stir or shake the mixture for 3 minutes until capsules are fully disintegrated and administer the entire contents.

​• Next, add an additional 2 mL of liquid to the container or syringe using a second syringe or dropper, swirl or shake and administer. Repeat this step at least once and until there is no visible residue to ensure all of the medication is taken.

​• If 6 capsules are required for a dose, follow these instructions using 3 capsules at a time.

​If LENVIMA suspension is not used at the time of preparation, LENVIMA suspension may be stored in a refrigerator at 36ºF to 46ºF (2ºC to 8ºC) for a maximum of 24 hours in a covered container. If not administered within 24 hours, the suspension should be discarded.

​Note: Compatibility has been confirmed for polypropylene syringes and for feeding tubes of at least 5 French diameter (polyvinyl chloride or polyurethane tube) and at least 6 French diameter (silicone tube).

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