Lenvatinib
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From MedlinePlus, U.S. National Library of Medicine
Specialty pharmacy: therapy management checklist, storage and cold chain, dosing calendar, Medicare Part D coverage.
Handling and access
NIOSH hazardous drug
Table 2NIOSH lists lenvatinib as a hazardous drug. AHFS class: 10:00 antineoplastic agents.
- Meets the NIOSH definition of a hazardous drug (carcinogenicity, developmental or reproductive toxicity, organ toxicity at low doses, or genotoxicity) without MSHI or a Group 1 or 2A carcinogen classification.
- Only a developmental and/or reproductive hazard: precautions matter most for workers who are pregnant, breastfeeding, or trying to conceive.
Handle with the precautions your facility uses for hazardous drugs (USP <800>). NIOSH's Managing Hazardous Drug Exposures lists controls by drug form and activity.
Kinase Inhibitor
Dosing in kidney impairment
Renal Impairment No dose adjustment is recommended for patients with mild (CLcr 60-89 mL/min) or moderate (CLcr 30-59 mL/min) renal impairment. Lenvatinib concentrations may increase in patients with DTC, RCC, or endometrial carcinoma and severe (CLcr 15-29 mL/min) renal impairment. Reduce the dose of LENVIMA for patients with RCC, DTC, or endometrial carcinoma and severe renal impairment [see Dosage and Administration] .
There is no recommended dose of LENVIMA for patients with HCC and severe renal impairment. LENVIMA has not been studied in patients with end stage renal disease [ see Warnings and Precautions , Clinical Pharmacology ] .
| 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. | ||
Dosing in liver impairment
Hepatic Impairment No dose adjustment is recommended for patients with HCC and mild hepatic impairment (Child-Pugh A). There is no recommended dose for patients with HCC with moderate or severe hepatic impairment. No dose adjustment is recommended for patients with DTC, RCC, or endometrial carcinoma and mild or moderate hepatic impairment (Child-Pugh A or B).
Lenvatinib concentrations may increase in patients with DTC, RCC, or endometrial carcinoma and severe hepatic impairment (Child-Pugh C). Reduce the dose of lenvatinib for patients with DTC, RCC, or endometrial carcinoma and severe hepatic impairment [see Dosage and Administration , Clinical Pharmacology ] .
| 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. | ||
Preparation and administration
Prepare this dose
Your numbers for lenvatinib. Take vial strength, diluent, and limits from the label below.
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2 DOSAGE AND ADMINISTRATION Single Agent Therapy: DTC: The recommended dosage is 24 mg orally once daily. HCC: The recommended dosage is based on actual body weight: 12 mg orally once daily for patients greater than or equal to 60 kg or 8 mg orally once daily for patients less than 60 kg. Combination Therapy: EC: The recommended dosage is 20 mg orally once daily in combination with pembrolizumab 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks.
RCC: The recommended dosage is: 20 mg orally once daily with pembrolizumab 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks. 18 mg orally once daily with everolimus 5 mg orally once daily. Modify the recommended daily dose for certain patients with renal or hepatic impairment. ( 2.8 , 2.9 ) 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 MMR or MSI status in tumor specimens [see Clinical Studies].
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 Dos ag e 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) F irst- L ine 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.
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.
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).
Drug interactions
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- Lenvatinib
Label text (2 paragraphs)
7 DRUG INTERACTIONS
7.1 Drugs That Prolong the QT Interval LENVIMA has been reported to prolong the QT/QTc interval. Avoid coadministration of LENVIMA with medicinal products with a known potential to prolong the QT/QTc interval [ see Warnings and Precaution s ( 5.9 ) ] .
Contraindications
None. None. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
DLikelihood score D: Possible cause of clinically apparent liver injury.
Lenvatinib is orally available multi-kinase inhibitor and antineoplastic agent that is used in treatment of advanced, metastatic medullary thyroid cancer and refractory renal cell carcinoma. Lenvatinib is associated with a modest rate of serum enzyme elevations during treatment and has been implicated to rare instances of clinically apparent, acute liver injury some of which have been fatal.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action, LENVIMA can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . In animal reproduction studies, oral administration of lenvatinib during organogenesis at doses below the recommended human doses resulted in embryotoxicity, fetotoxicity, and teratogenicity in rats and rabbits ( see Data ) . There are no available human data informing the drug-associated risk. Advise pregnant women of the potential risk to a fetus. In the U.S.
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryofetal development study, daily oral administration of lenvatinib mesylate at doses ≥0.3 mg/kg [approximately 0.14 times the recommended clinical dose of 24 mg based on body surface area (BSA)] to pregnant rats during organogenesis resulted in dose-related decreases in mean fetal body weight, delayed fetal ossifications, and dose-related increases in fetal external (parietal edema and tail abnormalities), visceral, and skeletal anomalies.
Greater than 80% post-implantation loss was observed at 1.0 mg/kg/day (approximately 0.5 times the recommended clinical dose of 24 mg based on BSA). Daily oral administration of lenvatinib mesylate to pregnant rabbits during organogenesis resulted in fetal external (short tail), visceral (retroesophageal subclavian artery), and skeletal anomalies at doses greater than or equal to 0.03 mg/kg (approximately 0.03 times the recommended clinical dose of 24 mg based on BSA). At the 0.03 mg/kg dose, increased post-implantation loss, including 1 fetal death, was also observed.
Lenvatinib was abortifacient in rabbits, resulting in late abortions in approximately one-third of the rabbits treated at a dose level of 0.5 mg/kg/day (approximately 0.5 times the recommended clinical dose of 24 mg based on BSA).
Breastfeeding (LactMed)
No information is available on the clinical use of lenvatinib during breastfeeding. Because lenvatinib is more than 98% bound to plasma proteins, the amount in milk is likely to be low. However, its half-life is about 28 hours, and it might accumulate in the infant. The manufacturer recommends that breastfeeding be discontinued during lenvatinib therapy and for at least 1 week after the last dose. If it is used with other agents, breastfeeding should not resume for the longest post-treatment duration recommended for the individual agent(s).
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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