lenvatinib (Rx)

Brand and Other Names:Lenvima

Dosing & Uses

AdultPediatric

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

Next:

Interactions

Interaction Checker

and lenvatinib

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            Contraindicated (2)

            • 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.

            • fezolinetant

              lenvatinib will increase the level or effect of fezolinetant by affecting hepatic enzyme CYP1A2 metabolism. Contraindicated. Fezolinetant AUC and peak plasma concentration are increased if coadministered with drugs that are weak, moderate, or strong CYP1A2 inhibitors

            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 (130)

            • 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.

            • 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.

            • 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.

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            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
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            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
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            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.

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            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

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            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)

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            Images

            No images available for this drug.
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            Patient Handout

            Patient Education
            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 frequently 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 stopping treatment. 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 November 2022. 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.

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
            Additional Offers
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.