Dosing & Uses
Dosage Forms & Strengths
capsule
- 4mg
- 10mg
Differentiated Thyroid Cancer
Indicated for patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC)
24 mg (two 10 mg capsules and one 4 mg capsule) PO qDay
Renal Cell Carcinoma
Combination therapy with everolimus
- Indicated in combination with everolimus for the treatment of patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy
- Lenvatinib 18 mg (one 10 mg capsule and two 4 mg capsules) PO qDay PLUS
- Everolimus 5 mg PO qDay
- Continue until disease progression or until unacceptable toxicity
Combination therapy with pembrolizumab
- Indicated in combination with pembrolizumab for first-line treatment of patients with advanced RCC
- Lenvatinib 20 mg PO qDay, PLUS
- Pembrolizumab 200 mg IV q3Weeks OR 400 mg q6Weeks
- Continue until disease progression, unacceptable toxicity, or for pembrolizumab, up to 24 months in patients without disease progression
Hepatocellular Carcinoma
Indicated for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC)
Dose based on actual body weight
- <60 kg: 8 mg PO qDay
- ≥60 kg: 12 mg PO qDay
- Continue until disease progression or until unacceptable toxicity
Endometrial Cancer
Indicated in combination with pembrolizumab for patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation
20 mg PO qDay, PLUS pembrolizumab 200 mg IV q3weeks
Continue until disease progression or unacceptable toxicity
Refer to pembrolizumab prescribing information for recommended dosing information
Dosage Modifications
DTC dose reductions
- First occurrence: Reduce to 20 mg PO qDay
- Second occurrence: Reduce to 14 mg PO qDay
- Third occurrence: Reduce to 10 mg PO qDay
RCC or endometrial carcinoma dose reductions
- First occurrence: Reduce to 14 mg PO qDay
- Second occurrence: Reduce to 10 mg PO qDay
- Third occurrence: Reduce to 8 mg PO qDay
-
Dose modification of everolimus in RCC
- Reduce lenvatinib dose first and then the everolimus dose for adverse reactions of both lenvatinib and everolimus
- Refer to the everolimus prescribing information for additional dose modification information
-
Dose modification of pembrolizumab in endometrial carcinoma
- Interrupt one or both drugs or reduce lenvatinib when appropriate
- No dose reductions are recommended for pembrolizumab
- Refer to pembrolizumab prescribing information for additional dose modification information
HCC dose reductions
-
First occurrence
- <60 kg: Reduce to 4 mg PO qDay
- ≥60 kg: Reduce to 8 mg PO qDay
-
Second occurrence
- <60 kg: Reduce to 4 mg PO every other day
- ≥60 kg: Reduce to 4 mg PO qDay
-
Third occurrence
- <60 kg: Discontinue
- ≥60 kg: Reduce to 4 mg PO every other day
Hypertension
- Grade 3: Withhold if persists despite optimal antihypertensive therapy; resume at reduced dose when hypertension is controlled at Grade ≤2
- Grade 4: Permanently discontinue
Cardiac dysfunction
- Grade 3: Withhold until improved Grade≤1or baseline; resume at reduced dose or discontinue depending on severity and persistence of adverse reaction
- Grade 4: Permanently discontinue
Arterial thrombotic event
- Any grade: Permanently discontinue
Hepatoxicity
- Grade 3 or 4: Withhold until improved Grade ≤1 or baseline; resume at reduced dose or discontinue depending on severity and persistence of adverse reaction
- Hepatic failure: Permanently discontinue
Proteinuria
- ≥2 g/24 hr: Withhold; resume at reduced dose after resolution to <2 g/24 hr
- Nephrotic syndrome: Permanently discontinue
GI toxicity
- Grade 3 nausea, vomiting, and diarrhea: Withhold; resume at reduced dose after resolution to Grade ≤1 or baseline
- Grade 4 nausea, vomiting, and diarrhea: Permanently discontinue
- GI perforation, any grade: Permanently discontinue
- Grade 3 or 4 GI fistula: Permanently discontinue
Renal failure or impairment
- Grade 3 or 4: Withhold until improved Grade ≤1 or baseline; resume at reduced dose or discontinue depending on severity and persistence of adverse reaction
QTc prolongation
- >500 ms or >60 ms increase from baseline: Withhold; resume at reduced dose after resolution to ≤480 ms or baseline
Reversible posterior leukoencephalopathy syndrome (RPLS)
- Any grade: Withhold until fully resolved, resume at reduced dose or discontinue depending on severity and persistence of neurologic symptoms
Other adverse reactions
- Persistent or intolerable Grade 2 or 3 adverse reaction, or Grade 4 laboratory abnormality: Withhold until improves to Grade ≤1 or baseline; resume at reduced dose
- Grade 4 adverse reaction: Permanently discontinue
Renal impairment
- Mild-to-moderate (CrCl ≥30 mL/min): No dosage adjustment necessary
-
Severe (CrCl <30 mL/min)
- DTC: 14 mg PO qDay
- RCC and endometrial carcinoma: 10 mg PO qDay
- Endometrial carcinoma: 10 mg PO qDay
Hepatic impairment
- Mild-to-moderate (Child-Pugh A or B): No dosage adjustment necessary
-
Severe (Child-Pugh C)
- DTC: 14 mg PO qDay
- RCC and endometrial carcinoma: 10 mg PO qDay
- Endometrial carcinoma: 10 mg PO qDay
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- elagolix
lenvatinib will increase the level or effect of elagolix by Other (see comment). Contraindicated. Concomitant use of elagolix and strong OATP1B1 inhibitors is contraindicated.
Serious - Use Alternative (48)
- amisulpride
amisulpride and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug. ECG monitoring is recommended if coadministered.
- aripiprazole
aripiprazole and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug.
- artemether
artemether and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug.
- atomoxetine
atomoxetine and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine
buprenorphine and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine buccal
buprenorphine buccal and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine subdermal implant
buprenorphine subdermal implant and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine transdermal
buprenorphine transdermal and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine, long-acting injection
buprenorphine, long-acting injection and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug.
- darolutamide
darolutamide will increase the level or effect of lenvatinib by Other (see comment). Avoid or Use Alternate Drug. Darolutamide is a BCRP inhibitor. Avoid coadministration with BCRP inhibitors. If use is unavoidable, closely monitor for adverse reactions and consider dose reduction of BCRP substrate drug (refer BCRP substrate prescribing information).
- desflurane
desflurane and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug.
- donepezil
donepezil and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug.
- doxepin
doxepin and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug.
- efavirenz
efavirenz and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug.
- eluxadoline
lenvatinib increases levels of eluxadoline by decreasing metabolism. Avoid or Use Alternate Drug. Decrease eluxadoline dose to 75 mg PO BID if coadministered with OATP1B1 inhibitors. .
- encorafenib
encorafenib and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug.
- entrectinib
lenvatinib and entrectinib both increase QTc interval. Avoid or Use Alternate Drug.
- fedratinib
lenvatinib will increase the level or effect of fedratinib by Other (see comment). Avoid or Use Alternate Drug. Avoid coadministration of fedratinib (a CYP3A4 and CYP2C19 substrate) with dual CYP3A4 and CYP2C19 inhibitor. Effect of coadministration of a dual CYP3A4 and CYP2C19 inhibitor with fedratinib has not been studied.
- fexinidazole
fexinidazole and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of fexinidazole with drugs known to block potassium channels and/or prolong QT interval.
- gadobenate
gadobenate and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug.
- gilteritinib
gilteritinib and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug.
- glasdegib
lenvatinib and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.
- hydroxyzine
hydroxyzine and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug.
- inotuzumab
inotuzumab and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.
- isoflurane
isoflurane and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug.
- itraconazole
itraconazole and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug.
- lasmiditan
lasmiditan increases levels of lenvatinib by Other (see comment). Avoid or Use Alternate Drug. Comment: Lasmiditan inhibits BCRP in vitro. Avoid coadministration of lasmiditan with BCRP substrates.
- lefamulin
lefamulin and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug.
- leniolisib
leniolisib will increase the level or effect of lenvatinib by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates
- lithium
lithium and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug.
- lonafarnib
lenvatinib will increase the level or effect of lonafarnib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration of lonafarnib (a sensitive CYP3A substrate) with weak CYP3A inhibitors is unavoidable, reduce to, or continue lonafarnib at starting dose. Closely monitor for arrhythmias and events (eg, syncope, heart palpitations) since lonafarnib effect on QT interval is unknown.
- mirtazapine
mirtazapine and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug.
- olanzapine
olanzapine and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug.
- oxaliplatin
oxaliplatin and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug.
- pacritinib
lenvatinib will decrease the level or effect of pacritinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- palifermin
palifermin increases toxicity of lenvatinib by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hr before, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.
- panobinostat
lenvatinib and panobinostat both increase QTc interval. Avoid or Use Alternate Drug. Panobinostat is known to significantly prolong QT interval. Panobinostat prescribing information states use with drugs known to prolong QTc is not recommended.
- pitolisant
lenvatinib and pitolisant both increase QTc interval. Avoid or Use Alternate Drug.
- ponesimod
ponesimod, lenvatinib. Either increases effects of the other by QTc interval. Avoid or Use Alternate Drug. Consult cardiologist if considering treatment. Generally, should not be initiated in patients who are concurrently taking QT prolonging drugs with known arrhythmogenic properties, such as HR-lowering calcium channel blockers (eg, verapamil, diltiazem).
- primaquine
primaquine and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug.
- sertraline
sertraline and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug.
- sevoflurane
sevoflurane and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug.
- siponimod
siponimod and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug.
- solifenacin
solifenacin and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug.
- sotorasib
sotorasib will decrease the level or effect of lenvatinib by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If use is unavoidable, refer to the prescribing information of the P-gp substrate for dosage modifications.
- tacrolimus
tacrolimus and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug.
- tepotinib
tepotinib will increase the level or effect of lenvatinib by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If concomitant use unavoidable, reduce the P-gp substrate dosage if recommended in its approved product labeling.
- vorinostat
vorinostat and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug.
Monitor Closely (132)
- acalabrutinib
acalabrutinib increases levels of lenvatinib by Other (see comment). Use Caution/Monitor. Comment: Acalabrutinib may increase exposure to coadministered BCRP substrates by inhibition of intestinal BCRP.
- albuterol
albuterol and lenvatinib both increase QTc interval. Use Caution/Monitor.
- alfuzosin
alfuzosin and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- amiodarone
amiodarone and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- anagrelide
anagrelide and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- apalutamide
apalutamide will decrease the level or effect of lenvatinib by increasing elimination. Use Caution/Monitor. Apalutamide weakly induces BCRP and may decrease systemic exposure of drugs that are BCRP substrates.
- apomorphine
apomorphine and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- arformoterol
arformoterol and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- arsenic trioxide
arsenic trioxide and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- artemether/lumefantrine
artemether/lumefantrine and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- asenapine
asenapine and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- asenapine transdermal
asenapine transdermal and lenvatinib both increase QTc interval. Use Caution/Monitor.
- avapritinib
lenvatinib will increase the level or effect of avapritinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- azithromycin
azithromycin and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- bedaquiline
bedaquiline and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- berotralstat
berotralstat will increase the level or effect of lenvatinib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor or titrate P-gp substrate dose if coadministered.
- bosutinib
bosutinib and lenvatinib both increase QTc interval. Use Caution/Monitor.
- capecitabine
capecitabine and lenvatinib both increase QTc interval. Use Caution/Monitor.
- ceritinib
ceritinib and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- chloroquine
chloroquine and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- chlorpromazine
chlorpromazine and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- ciprofloxacin
ciprofloxacin and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- citalopram
citalopram and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- clarithromycin
clarithromycin and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- clozapine
clozapine and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- crizotinib
crizotinib and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- dabrafenib
dabrafenib and lenvatinib both increase QTc interval. Use Caution/Monitor.
- dasatinib
dasatinib and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- degarelix
degarelix and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- deutetrabenazine
deutetrabenazine and lenvatinib both increase QTc interval. Use Caution/Monitor. At the maximum recommended dose, deutetrabenazine does not prolong QT interval to a clinically relevant extent. Certain circumstances may increase risk of torsade de pointes and/or sudden death in association with drugs that prolong the QTc interval (eg, bradycardia, hypokalemia or hypomagnesemia, coadministration with other drugs that prolong QTc interval, presence of congenital QT prolongation).
- dichlorphenamide
dichlorphenamide and lenvatinib both decrease serum potassium. Use Caution/Monitor.
- disopyramide
disopyramide and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- dofetilide
dofetilide and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- dolasetron
dolasetron and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- dronedarone
dronedarone and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- droperidol
droperidol and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- elagolix
elagolix will increase the level or effect of lenvatinib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- eliglustat
eliglustat and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- eluxadoline
eluxadoline increases levels of lenvatinib by decreasing metabolism. Use Caution/Monitor. Eluxadoline may increase the systemic exposure of coadministered OATP1B1 or BCRP substrates.
- encorafenib
encorafenib will increase the level or effect of lenvatinib by Other (see comment). Modify Therapy/Monitor Closely. Encorafenib (a BCRP inhibitor) may increase the concentration and toxicities of BCRP substrates. Closely monitor for signs and symptoms of increased exposure and consider adjusting the dose of these substrates.
- eribulin
eribulin and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- erythromycin base
erythromycin base and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- erythromycin ethylsuccinate
erythromycin ethylsuccinate and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- erythromycin lactobionate
erythromycin lactobionate and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- erythromycin stearate
erythromycin stearate and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- escitalopram
escitalopram and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- etrasimod
etrasimod, lenvatinib. Either increases effects of the other by QTc interval. Modify Therapy/Monitor Closely. Transient decrease in heart rate and AV conduction delays may occur when initiating etrasimod. Owing to potential of additive effect on heart rate, etrasimod may increase risk of QT prolongation and Torsades de Pointes when coadministered with Class Ia or Class III antiarrhythmic drugs, or other drugs that prolong the QT interval. .
- ezogabine
ezogabine and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- finerenone
lenvatinib will increase the level or effect of finerenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Monitor serum potassium during initiation and dosage adjustment of either finererone or weak CYP3A4 inhibitors. Adjust finererone dosage as needed.
- fingolimod
fingolimod and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- flecainide
flecainide and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- flibanserin
lenvatinib will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Increased flibanserin adverse effects may occur if coadministered with multiple weak CYP3A4 inhibitors.
- floxuridine
floxuridine and lenvatinib both increase QTc interval. Use Caution/Monitor.
- fluconazole
fluconazole and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- fluoxetine
fluoxetine and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- formoterol
formoterol and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- fostamatinib
fostamatinib will increase the level or effect of lenvatinib by Other (see comment). Use Caution/Monitor. Concomitant use of fostamatinib may increase concentrations of P-gp/BCRP substrate drugs. Monitor for toxicities of P-gp/BCRP substrate drug that may require dosage reduction when given concurrently with fostamatinib.
- fostemsavir
fostemsavir will increase the level or effect of lenvatinib by Other (see comment). Modify Therapy/Monitor Closely. Fostemsavir inhibits BCRP transporters. If possible, avoid coadministration or modify dose of BCRP substrate coadministered with fostemsavir.
lenvatinib and fostemsavir both increase QTc interval. Use Caution/Monitor. QTc prolongation reported with higher than recommended doses of fostemsavir. - gemifloxacin
gemifloxacin and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- gemtuzumab
lenvatinib and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- glecaprevir/pibrentasvir
glecaprevir/pibrentasvir will increase the level or effect of lenvatinib by Other (see comment). Use Caution/Monitor. Glecaprevir/pibrentasvir may increase plasma concentration of P-gp and BCRP substrates.
- goserelin
goserelin and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- granisetron
granisetron and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- haloperidol
haloperidol and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- histrelin
histrelin and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- ibutilide
ibutilide and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- iloperidone
iloperidone and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- indacaterol, inhaled
indacaterol, inhaled and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- isavuconazonium sulfate
lenvatinib will increase the level or effect of isavuconazonium sulfate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- istradefylline
istradefylline will increase the level or effect of lenvatinib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of P-gp substrates in clinical trials. Consider dose reduction of sensitive P-gp substrates.
- lapatinib
lapatinib and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- lemborexant
lenvatinib will increase the level or effect of lemborexant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Lower nightly dose of lemborexant recommended if coadministered with weak CYP3A4 inhibitors. See drug monograph for specific dosage modification.
- letermovir
lenvatinib increases levels of letermovir by decreasing metabolism. Use Caution/Monitor. Coadminstration of letermovir, an OATP1B1/3 substrate, with OATP1B1/3 inhibitors may increase letermovir plasma concentrations.
- leuprolide
leuprolide and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- levofloxacin
levofloxacin and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- lonafarnib
lonafarnib will increase the level or effect of lenvatinib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Lonafarnib is a weak P-gp inhibitor. Monitor for adverse reactions if coadministered with P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities. Reduce P-gp substrate dose if needed.
- lopinavir
lopinavir and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- mavacamten
lenvatinib will increase the level or effect of mavacamten by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely. Inititiation of weak CYP2C19 inhibitors may require decreased mavacamten dose.
- methadone
methadone and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- midazolam intranasal
lenvatinib will increase the level or effect of midazolam intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of mild CYP3A4 inhibitors with midazolam intranasal may cause higher midazolam systemic exposure, which may prolong sedation.
- mifepristone
mifepristone and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- momelotinib
lenvatinib increases toxicity of momelotinib by Other (see comment). Use Caution/Monitor. Comment: OATP1B1/B3 inhibitor increases momelotinib (OATP1B1/B3 subtrate) plasma concentrations, which may increase the risk of adverse reactions with momelotinib.
momelotinib increases toxicity of lenvatinib by plasma protein binding competition. Modify Therapy/Monitor Closely. Momelotinib (BCRP inhibitor) may increase exposure of BCRP substrates, which may increase the risk of BCRP substrate adverse reactions. Dose adjustment of other BCRP substrates may necessary. - moxifloxacin
moxifloxacin and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- nilotinib
nilotinib and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- ofloxacin
ofloxacin and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- ondansetron
ondansetron and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- osilodrostat
osilodrostat and lenvatinib both increase QTc interval. Use Caution/Monitor.
- oteseconazole
oteseconazole will increase the level or effect of lenvatinib by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.
- oxaliplatin
oxaliplatin will increase the level or effect of lenvatinib by Other (see comment). Use Caution/Monitor. Monitor for ECG changes if therapy is initiated in patients with drugs known to prolong QT interval.
- paliperidone
paliperidone and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- panobinostat
panobinostat and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- pasireotide
pasireotide and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- pazopanib
pazopanib and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- pentamidine
pentamidine and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- perflutren
perflutren and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- pimozide
pimozide and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- posaconazole
posaconazole and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- procainamide
procainamide and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- propafenone
propafenone and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- quetiapine
quetiapine and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- quinidine
quinidine and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- ranolazine
ranolazine and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- regorafenib
regorafenib will increase the level or effect of lenvatinib by Other (see comment). Modify Therapy/Monitor Closely. Regorafenib likely inhibits BCRP (ABCG2) transport. Coadministration with a BCRP substrate may increase systemic exposure to the substrate and related toxicity.
- romidepsin
romidepsin and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- safinamide
safinamide will increase the level or effect of lenvatinib by Other (see comment). Use Caution/Monitor. Safinamide and its major metabolite may inhibit intestinal BCRP. Monitor BCRP substrates for increased pharmacologic or adverse effects.
- salmeterol
salmeterol and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- saquinavir
saquinavir and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- sarecycline
sarecycline will increase the level or effect of lenvatinib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor for toxicities of P-gp substrates that may require dosage reduction when coadministered with P-gp inhibitors.
- siponimod
siponimod and lenvatinib both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- sodium sulfate/?magnesium sulfate/potassium chloride
sodium sulfate/?magnesium sulfate/potassium chloride increases toxicity of lenvatinib by QTc interval. Use Caution/Monitor. Consider predose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias. .
- sodium sulfate/potassium sulfate/magnesium sulfate
sodium sulfate/potassium sulfate/magnesium sulfate increases toxicity of lenvatinib by QTc interval. Use Caution/Monitor. Consider predose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias. .
- sofosbuvir/velpatasvir
sofosbuvir/velpatasvir will increase the level or effect of lenvatinib by Other (see comment). Use Caution/Monitor. Velpatasvir is an inhibitor of the drug transporter BCRP. Coadministration may increase systemic exposure of drugs that are BCRP substrates.
- sorafenib
sorafenib and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- sotalol
sotalol and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- stiripentol
stiripentol will increase the level or effect of lenvatinib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing the dose of P-glycoprotein (P-gp) substrates, if adverse reactions are experienced when administered concomitantly with stiripentol.
stiripentol will increase the level or effect of lenvatinib by Other (see comment). Modify Therapy/Monitor Closely. Stiripentol is a BCRP transport inhibitor. Consider dosage reduction for BCRP substrates if adverse effects are experienced when coadministered. - sunitinib
sunitinib and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- tafamidis
tafamidis will increase the level or effect of lenvatinib by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- tafamidis meglumine
tafamidis meglumine will increase the level or effect of lenvatinib by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- telavancin
telavancin and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- tetrabenazine
tetrabenazine and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- thioridazine
thioridazine and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- tinidazole
lenvatinib will increase the level or effect of tinidazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- toremifene
toremifene and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- trazodone
trazodone and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- triclabendazole
triclabendazole and lenvatinib both increase QTc interval. Use Caution/Monitor.
- triptorelin
triptorelin and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- tucatinib
tucatinib will increase the level or effect of lenvatinib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Consider reducing the dosage of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities.
- valbenazine
valbenazine and lenvatinib both increase QTc interval. Use Caution/Monitor.
- vandetanib
vandetanib and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- vemurafenib
vemurafenib and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- voriconazole
voriconazole and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- ziprasidone
ziprasidone and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
Minor (1)
- atogepant
lenvatinib will increase the level or effect of atogepant by Other (see comment). Minor/Significance Unknown. Recommended dosage of atogepant (an OATP1B1 substrate) with concomitant use of OATP inhibitors is 10 mg or 30 mg qDay.
Adverse Effects
>10%
Percentages are for all grades of adverse effects unless otherwise noted
Hypertension (73%)
Diarrhea (67%)
Fatigue (67%)
Arthralgia/myalgia (62%)
Decreased appetite (54%)
Weight decreased (51%)
Nausea (47%)
Hypertension, grades 3-4 (44%)
Stomatitis (41%)
Headache (38%)
Vomiting (36%)
Proteinuria (34%)
Palmar-plantar erythrodysesthesia (32%)
Abdominal pain (31%)
Dysphonia (31%)
Constipation (29%)
Oral pain (25%)
Cough (24%)
Peripheral edema (21%)
Rash (21%)
Dysgeusia (18%)
Dry mouth (17%)
Dizziness (15%)
Dyspepsia (13%)
Alopecia (12%)
Epistaxis (12%)
Insomnia (12%)
Urinary tract infection (11%)
1-10%
Percentages are for all grades of adverse effects unless otherwise noted
Dental infections (10%)
Hypotension (9%)
Diarrhea, grades 3-4 (9%)
Dehydration (9%)
Prolonged QT interval (9%)
Hypocalcemia (9%)
Decreased appetite, grades 3-4 (7%)
Hyperkeratosis (7%)
Hypokalemia (6%)
AST increased (5%)
ALT increased (4%)
Lipase increased (4%)
Creatinine increased (3%)
Nausea, grades 3-4 (2%)
Platelet count decreased (2%)
Postmarketing Reports
Pancreatitis
Amylase increased
Cholecystitis
Impaired wound healing
Fistula
Aortic dissection
Nephrotic syndrome
Arterial (including aortic) aneurysms, dissections, and rupture
Coadministration with pembrolizumab
- Pneumonia, acute kidney injury, acute myocardial infarction, colitis, decreased appetite, intestinal perforation, lower gastrointestinal hemorrhage, malignant gastrointestinal obstruction, multiple organ dysfunction syndrome, myelodysplastic syndrome, pulmonary embolism, and right ventricular dysfunction, asthenia, palmar-plantar erythrodysesthesia syndrome
Warnings
Contraindications
None
Cautions
Serious and fatal cardiac dysfunction may occur; Grade ≥3 cardiac dysfunction (including cardiomyopathy, left or right ventricular dysfunction, congestive heart failure [CHF], cardiac failure, ventricular hypokinesia, or decrease in left or right ventricular EF >20% from baseline) reported; monitor for symptoms or signs of cardiac decompensation and/or dysfunction; withhold and resume at reduced dose when hypertension controlled or permanently discontinue based on severity
Arterial thromboembolic events reported; permanently discontinue therapy following a thromboembolic event; safety of resuming after an arterial thromboembolic event not established om patients who had an arterial thromboembolic event within the previous 6 months
Monitor liver function prior to initiating therapy, then every 2 weeks for the first 2months, and at least monthly thereafter during treatment; serious hepatic adverse reactions reported; monitor patients with HCC closely for signs of hepatic failure, including hepatic encephalopathy; withhold and resume at a reduced dose upon recovery or permanently discontinue therapy based on severity; increased ALT and/or AST observed; rare reports of hepatic failure, including fatalities, were also reported
Proteinuria reported; monitor for proteinuria before initiation and during treatment; if urine dipstick proteinuria ≥2+ is detected, obtain a 24-hr urine protein; withhold and resume at a reduced dose upon recovery or permanently discontinue therapy on severity
Serious including fatal renal failure or impairment can occur; initiate prompt management of diarrhea or dehydration/hypovolemia; withhold and resume at a reduced dose upon recovery or permanently discontinue therapy for renal failure or impairment based on severity; primary risk factor for severe renal impairment was dehydration/hypovolemia due to diarrhea and vomiting; initiate active management of diarrhea and any other gastrointestinal symptoms Grade 1 events
Diarrhea may occur; initiate prompt medical management for diarrhea; monitor for dehydration; interrupt therapy for Grade 3 or 4 diarrhea
Gastrointestinal (GI) perforation or fistula reported; discontinue if patient develops a GI perforation or life-threatening fistula; permanently discontinue therapy in patients who develop gastrointestinal perforation of any severity or Grade 3 or 4 fistula
Hypocalcemia reported; monitor blood calcium levels at least monthly and replace calcium as necessary during treatment; withhold and resume at reduced dose upon recovery or permanently discontinue therapy depending on severity and persistence of neurologic symptoms
Reversible posterior leukoencephalopathy syndrome (RPLS) reported rarely; confirm diagnosis of RPLS with magnetic resonance imaging
Impairs exogenous thyroid suppression; monitor TSH levels monthly and adjust thyroid replacement medication as needed; monitor thyroid function before initiating therapy and at least monthly during treatment; treat hypothyroidism according to standard medical practice
May cause fetal harm when administered to pregnant females
Impaired wound healing reported in patients who received therapy; withhold therapy for at least 1 week prior to elective surgery; do not administer for at least 2 weeks following major surgery and until adequate wound healing; safety of resumption of therapy after resolution of wound healing complications not established; permanently discontinue drug in patients with wound healing complications
Hemorrhagic events
- Hemorrhagic events occurred; consider risk of severe or fatal hemorrhage associated with tumor invasion or infiltration of major blood vessels (eg, carotid artery)
- Serious tumor-related bleeds, including fatal hemorrhagic events, reported in clinical trials and in the post-marketing setting; in post-marketing surveillance, serious and fatal carotid artery hemorrhages were seen more frequently in patients with anaplastic thyroid carcinoma (ATC) than in other tumor types; safety and effectiveness of this drug in patients with ATC not demonstrated in clinical trials
- Consider risk of severe or fatal hemorrhage associated with tumor invasion or infiltration of major blood vessels (eg, carotid artery); withhold and resume at reduced dose upon recovery or permanently discontinue based on severity
Hypertension
- Hypertension reported
- Control blood pressure (BP) before treatment; monitor BP after 1 week, then q2weeks for the first 2 months, and then at least monthly thereafter
- Serious complications of poorly controlled hypertension reported
- Withhold and resume at reduced dose when hypertension controlled or permanently discontinue based on severity
Osteonecrosis of the jaw
- Osteonecrosis of the Jaw (ONJ) reported; concomitant exposure to other risk factors, such as bisphosphonates, denosumab, dental disease, or invasive dental procedures, may increase risk of ONJ
- Perform an oral examination prior to treatment and periodically during treatment; advise patients regarding good oral hygiene practices; avoid invasive dental procedures, if possible, while on treatment, particularly in patients at higher risk
- Withhold therapy for at least 1 week prior to scheduled dental surgery or invasive dental procedures, if possible
- For patients requiring invasive dental procedures, discontinuation of bisphosphonate treatment may reduce risk of ONJ; withhold therapy if ONJ develops and restart based on clinical judgment of adequate resolution
QT prolongation
- QT prolongation reported
- Monitor ECG in patients with congenital long QT syndrome, CHF, bradyarrhythmias, or those who are taking drugs known to prolong the QT interval, including class Ia and III antiarrhythmics
- Monitor and correct electrolyte abnormalities in all patients; withhold and resume at reduced dose upon recovery based on severity
- Monitor electrocardiograms in patients with congenital long QT syndrome; CHF, bradyarrhythmias, or those who are taking drugs known to prolong QT interval, including Class Ia and III antiarrhythmics
Pregnancy & Lactation
Pregnancy
Based on its mechanism of action and data from animal reproduction studies, lenvatinib can cause fetal harm when administered to a pregnant woman; verify the pregnancy status of females of reproductive potential prior to initiating
In animal reproduction studies, oral administration during organogenesis at doses below the recommended human dose (approximately 0.14 times the recommended human dose based on body surface area) resulted in embryotoxicity, fetotoxicity, and teratogenicity in rats and rabbits
There are no available human data informing the drug-associated risk
Advise pregnant women of the potential risk to a fetus
Contraception
- Advise females of reproductive potential to use effective contraception during treatment and for at least 30 days after last dose
Infertility
- Females: May result in reduced fertility in females of reproductive potential
- Males: May result in damage to male reproductive tissues, leading to reduced fertility of unknown duration
Lactation
Unknown if distributed in human breast milk; because of the potential for serious adverse reactions in nursing infants, advise women to discontinue breastfeeding during treatment and for at least 1 week after last dose
Lenvatinib and its metabolites are excreted in rat milk at concentrations higher than in maternal plasma (~2 times higher [based on AUC]) in milk compared with maternal plasma
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Receptor tyrosine kinase (RTK) inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4)
Also inhibits other RTKs that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1, 2, 3, and 4; the platelet-derived growth factor receptor alpha (PDGFR-alpha), KIT, and RET
Absorption
Peak plasma time: 1-4 hr after PO administration
Administration with food does not affect the extent of absorption but can delay the mean peak plasma time from 2 hr to 4 hr
Distribution
Protein bound: 98-99%
Substrate of P-gp and BCRP
Metabolism
Metabolized by the CYP3A enzymes and aldehyde oxidase
Elimination
Half-life: 28 hr
Excretion (10 days after single dose): 64% feces; 25% urine
Administration
Oral Administration
Swallow capsule whole
May take with or without food
Take at the same time each day
Missed dose: If a dose is missed and cannot be taken within 12 hr, skip that dose and take the next dose at the usual time of administration
If unable to swallow capsule
- 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, and then 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
Storage
Store at room temperature, between 68-77°F (20-25°C)
Images
Patient Handout
lenvatinib oral
LENVATINIB - ORAL
(len-VA-ti-nib)
COMMON BRAND NAME(S): Lenvima
USES: This medication is used to treat cancer. Lenvatinib belongs to a class of drugs known as tyrosine kinase inhibitors. It works by slowing or stopping the growth of cancer cells.
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking lenvatinib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow the capsules whole. Do not crush or chew the capsules. If you have trouble swallowing the capsules whole, you may mix the capsules with water or apple juice. The amount of liquid will depend on your dose. Consult your doctor or pharmacist for more detailed instructions.If you are giving this medication through a feeding tube, ask your health care professional for detailed instructions on how to properly mix and give it.Lenvatinib may have different packaging and different dosage instructions based on your medical condition. To prevent dosage errors, ask your pharmacist about proper use. The dosage is also based on your response to treatment and lab tests. For the treatment of liver cancer, the dosage is also based on your weight.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.
SIDE EFFECTS: Dry mouth, hoarseness, nose bleeds, tiredness, weight loss, headache, muscle/joint pain, trouble sleeping, change in taste, diarrhea, constipation, upset stomach, nausea, vomiting, or loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Vomiting or diarrhea that doesn't stop may result in dehydration. Contact your doctor promptly if you notice any symptoms of dehydration, such as unusual dry mouth/thirst, dizziness, or lightheadedness.To relieve dry mouth, suck (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.Pain or sores in the mouth and throat may occur. Brush your teeth carefully/gently, avoid using mouthwash that contains alcohol, and rinse your mouth often with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.Temporary hair loss may occur. Normal hair growth should return after treatment has ended.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Your doctor may control your blood pressure with medication.Lenvatinib may cause low blood calcium levels. Your doctor will check lab tests during treatment, and may direct you to take calcium and vitamin D.Tell your doctor right away if you have any serious side effects, including: signs of new or worsening kidney problems (such as change in the amount of urine, frothy urine), signs of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain), signs of an underactive thyroid (such as weight gain, cold intolerance, slow heartbeat), muscle spasms, redness/pain/swelling/blisters on the palms of your hands or soles of your feet, easy bleeding/bruising, slow wound healing.Get medical help right away if you have any very serious side effects, including: symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), signs of a stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion), signs of stomach/intestinal problems (such as bloody/black/tarry stools, stomach/abdominal pain, bloody vomit, vomit that looks like coffee grounds), sudden/severe back pain, fast/irregular heartbeat, severe dizziness, fainting.Lenvatinib may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.Lenvatinib may rarely cause a serious brain condition called RPLS (reversible posterior leukoencephalopathy syndrome). Get medical help right away if you have any symptoms of RPLS, including: headaches that don't go away, seizures, sudden vision changes, mental/mood changes (such as confusion).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking lenvatinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, high blood pressure, history of heart attack/stroke, blood vessel problems (such as an aneurysm or a tear/break in the aorta or other blood vessels), dehydration.Lenvatinib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using lenvatinib, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using lenvatinib safely.Some people taking lenvatinib may have serious jawbone problems. Your doctor should check your mouth before you start this medication. Tell your dentist that you are taking this medication before you have any dental work done. To help prevent jawbone problems, have regular dental exams and learn how to keep your teeth and gums healthy. If you have jaw pain, tell your doctor and dentist right away.Before having surgery (especially dental procedures), tell your doctor or dentist about this medication and all other products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication may cause wounds to heal slowly or poorly. Before having surgery, talk with your doctor about the risks and benefits of this medication. Your doctor may tell you to temporarily stop treatment with this medication at least 1 week before surgery. Ask your doctor for specific instructions about when to stop and when to restart treatment with lenvatinib. Tell your doctor right away if you have wounds that are not healing well.Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using lenvatinib. Lenvatinib may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for at least 30 days after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for at least 1 week after stopping treatment. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as blood pressure, EKG, urine protein, kidney/liver/thyroid function, mineral levels in the blood) should be done before and while you are taking this medication. Keep all medical and lab appointments.
MISSED DOSE: If you miss a dose and it is more than 12 hours until the next dose, take it as soon as you remember. If it is less than 12 hours until the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised August 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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Adding plans allows you to:
- View the formulary and any restrictions for each plan.
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- Compare formulary status to other drugs in the same class.
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