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Important Dosage Information: Reduce the dose for certain patients with renal or hepatic impairment [see Dosage Modifications for Severe Renal Impairment and Dosage Modifications for Severe Hepatic Impairment as follows; Renal Impairment and Hepatic Impairment under Precautions].
Take LENVIMA once daily, with or without food, at the same time each day [see Pharmacology: Pharmacokinetics under Actions]. 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.
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.
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 everolimus prescribing information for recommended everolimus dosing information.
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.
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.
Dosage Modifications for Adverse Reactions: Recommendations for LENVIMA dose interruption, reduction and discontinuation for adverse reactions are listed in Table 7. Table 8 lists the recommended dosage reductions of LENVIMA for adverse reactions. (See Tables 7 and 8.)
Click on icon to see table/diagram/image
Click on icon to see table/diagram/imageRecommended 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 7. 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.
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 as follows [see Renal Failure or Impairment and Renal Impairment under Precautions].
Differentiated thyroid cancer: 14 mg orally once daily.
Renal cell carcinoma: 10 mg orally once daily.
Endometrial carcinoma: 10 mg orally once daily.
Hepatocellular carcinoma: see Renal Impairment under Precautions.
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 as follows [see Hepatotoxicity and Hepatic Impairment under Precautions].
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.
Hepatocellular carcinoma: see Hepatic Impairment under Precautions.
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.
