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LENVIMA
Bladder, kidney, and other urologic cancers
Colorectal and other GI cancers
Pancreatic, thyroid, and other endocrine cancers
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Drug Name:

LENVIMA Rx

Generic Name and Formulations:
Lenvatinib 4mg, 10mg; caps.

Company:
Eisai Pharmaceuticals

Therapeutic Use:

Indications for LENVIMA:

In combination with everolimus, for treatment of advanced renal cell carcinoma, following one prior anti-angiogenic therapy.

Adult:

Swallow whole or may dissolve capsule contents into liquid. 18mg (in combination with everolimus 5mg) once daily until disease progression or unacceptable toxicity. Severe renal impairment (CrCl <30mL/min) or severe hepatic impairment (Child-Pugh C): 10mg once daily. Dose modifications for adverse reactions or lab abnormalities: see full labeling.

Children:

Not established.

Warnings/Precautions:

Control BP prior to treatment; monitor after 1 week, every 2 weeks for the first 2 months, and then at least monthly thereafter during therapy. Permanently discontinue if Grade 4 hypertension or cardiac dysfunction, arterial thrombotic event, hepatic failure, nephrotic syndrome, GI perforation, Grade 3 or 4 fistula, severe and persistent neurologic symptoms, or other Grade 4 reactions (eg, diarrhea, hemorrhage, hypocalcemia) occur. Withhold if Grade 3 hypertension persists despite therapy, Grade 3 cardiac dysfunction, Grade 3 or 4 liver/renal impairment, ≥2g of proteinuria/24hrs, QT prolongation >500ms, reversible posterior leukoencephalopathy syndrome (RPLS), other persistent/intolerable Grade 2 or 3 reactions, or Grade 4 lab abnormality occurs. Monitor for signs/symptoms of cardiac dysfunction. Monitor liver function prior to treatment, every 2 weeks for the first 2 months, then at least monthly during treatment. Monitor for proteinuria prior to, and periodically during treatment. Monitor for dehydration and treat if diarrhea develops. Hypovolemia. Congenital long QT syndrome, CHF, bradyarrhythmias, or those taking Class Ia or III antiarrhythmic drugs; monitor ECGs. Monitor and correct electrolyte abnormalities. Monitor blood calcium levels at least monthly; replace as needed during treatment. Monitor thyroid function prior to initiation and at least monthly thereafter; treat hypothyroidism as needed. Withhold for at least 6 days before surgery; permanently discontinue if would healing complications occur. ESRD. Embryo-fetal toxicity. Pregnancy: avoid. Females of reproductive potential should use effective contraception during and for at least 30 days after last dose. Nursing mothers: not recommended.

Pharmacological Class:

Kinase inhibitor.

Interactions:

Avoid concomitant QT-prolonging drugs.

Adverse Reactions:

Hypertension, fatigue, diarrhea, arthralgia/myalgia, decreased appetite, weight decreased, nausea, stomatitis, headache, vomiting, proteinuria, palmar-plantar erythrodysesthesia syndrome, abdominal pain, dysphonia, peripheral edema, cough, dyspnea, rash, hemorrhagic events, hypothyroidism.

Generic Availability:

NO

How Supplied:

Blister cards—6

Indications for LENVIMA:

First-line treatment of unresectable hepatocellular carcinoma (HCC).

Adult:

Swallow whole or may dissolve capsule contents into liquid. <60kg: 8mg once daily. ≥60kg: 12mg once daily. Continue until disease progression or unacceptable toxicity. Dose modifications for adverse reactions or lab abnormalities: see full labeling.

Children:

Not established.

Warnings/Precautions:

Control BP prior to treatment; monitor after 1 week, every 2 weeks for the first 2 months, and then at least monthly thereafter during therapy. Permanently discontinue if Grade 4 hypertension or cardiac dysfunction, arterial thrombotic event, hepatic failure, nephrotic syndrome, GI perforation, Grade 3 or 4 fistula, severe and persistent neurologic symptoms, or other Grade 4 reactions (eg, diarrhea, hemorrhage, hypocalcemia) occur. Withhold if Grade 3 hypertension persists despite therapy, Grade 3 cardiac dysfunction, Grade 3 or 4 liver/renal impairment, ≥2g of proteinuria/24hrs, QT prolongation >500ms, reversible posterior leukoencephalopathy syndrome (RPLS), other persistent/intolerable Grade 2 or 3 reactions, or Grade 4 lab abnormality occurs. Monitor for signs/symptoms of cardiac dysfunction. Monitor liver function prior to treatment, every 2 weeks for the first 2 months, then at least monthly during treatment. Monitor for proteinuria prior to, and periodically during treatment. Monitor for dehydration and treat if diarrhea develops. Hypovolemia. Congenital long QT syndrome, CHF, bradyarrhythmias, or those taking Class Ia or III antiarrhythmic drugs; monitor ECGs. Monitor and correct electrolyte abnormalities. Monitor blood calcium levels at least monthly; replace as needed during treatment. Monitor thyroid function prior to initiation and at least monthly thereafter; treat hypothyroidism as needed. Withhold for at least 6 days before surgery; permanently discontinue if would healing complications occur. ESRD. Embryo-fetal toxicity. Pregnancy: avoid. Females of reproductive potential should use effective contraception during and for at least 30 days after last dose. Nursing mothers: not recommended.

Pharmacological Class:

Kinase inhibitor.

Interactions:

Avoid concomitant QT-prolonging drugs.

Adverse Reactions:

Hypertension, fatigue, diarrhea, arthralgia/myalgia, decreased appetite, weight decreased, nausea, stomatitis, headache, vomiting, proteinuria, palmar-plantar erythrodysesthesia syndrome, abdominal pain, dysphonia, peripheral edema, cough, dyspnea, rash, hemorrhagic events, hypothyroidism.

Generic Availability:

NO

How Supplied:

Blister cards—6

Indications for LENVIMA:

Treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.

Adult:

Swallow whole or may dissolve capsule contents into liquid. 24mg once daily until disease progression or unacceptable toxicity. Severe renal impairment (CrCl <30mL/min) or severe hepatic impairment (Child-Pugh C): 14mg once daily. Dose modifications for adverse reactions or lab abnormalities: see full labeling.

Children:

Not established.

Warnings/Precautions:

Control BP prior to treatment; monitor after 1 week, every 2 weeks for the first 2 months, and then at least monthly thereafter during therapy. Permanently discontinue if Grade 4 hypertension or cardiac dysfunction, arterial thrombotic event, hepatic failure, nephrotic syndrome, GI perforation, Grade 3 or 4 fistula, severe and persistent neurologic symptoms, or other Grade 4 reactions (eg, diarrhea, hemorrhage, hypocalcemia) occur. Withhold if Grade 3 hypertension persists despite therapy, Grade 3 cardiac dysfunction, Grade 3 or 4 liver/renal impairment, ≥2g of proteinuria/24hrs, QT prolongation >500ms, reversible posterior leukoencephalopathy syndrome (RPLS), other persistent/intolerable Grade 2 or 3 reactions, or Grade 4 lab abnormality occurs. Monitor for signs/symptoms of cardiac dysfunction. Monitor liver function prior to treatment, every 2 weeks for the first 2 months, then at least monthly during treatment. Monitor for proteinuria prior to, and periodically during treatment. Monitor for dehydration and treat if diarrhea develops. Hypovolemia. Congenital long QT syndrome, CHF, bradyarrhythmias, or those taking Class Ia or III antiarrhythmic drugs; monitor ECGs. Monitor and correct electrolyte abnormalities. Monitor blood calcium levels at least monthly; replace as needed during treatment. Monitor thyroid function prior to initiation and at least monthly thereafter; treat hypothyroidism as needed. Withhold for at least 6 days before surgery; permanently discontinue if would healing complications occur. ESRD. Embryo-fetal toxicity. Pregnancy: avoid. Females of reproductive potential should use effective contraception during and for at least 30 days after last dose. Nursing mothers: not recommended.

Pharmacological Class:

Kinase inhibitor.

Interactions:

Avoid concomitant QT-prolonging drugs.

Adverse Reactions:

Hypertension, fatigue, diarrhea, arthralgia/myalgia, decreased appetite, weight decreased, nausea, stomatitis, headache, vomiting, proteinuria, palmar-plantar erythrodysesthesia syndrome, abdominal pain, dysphonia, peripheral edema, cough, dyspnea, rash, hemorrhagic events, hypothyroidism.

Generic Availability:

NO

How Supplied:

Blister cards—6

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