- Bladder, kidney, and other urologic cancers
- Colorectal and other GI cancers
- Gynecologic cancers
- Pancreatic, thyroid, and other endocrine cancers
Bladder, kidney, and other urologic cancers:
Indications for: LENVIMA
In combination with pembrolizumab, for the first-line treatment of advanced renal cell carcinoma (RCC). In combination with everolimus, for treatment of advanced RCC following one prior anti-angiogenic therapy.
Adult Dosage:
Swallow whole or may dissolve capsule contents into liquid. First-line treatment: 20mg once daily (in combination with pembrolizumab 200mg IV every 3 weeks) until disease progression or unacceptable toxicity, or up to 2yrs. After 2yrs completion, may give lenvatinib as a single-agent until disease progression or unacceptable toxicity. Previously treated: 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: see full labeling.
Children Dosage:
Not established.
LENVIMA 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. Concomitant exposure to other risk factors (eg, bisphosphonates, denosumab, dental disease/invasive procedures) may increase the risk of osteonecrosis of the jaw (ONJ); withhold Lenvima for ≥1 week prior to scheduled dental surgery/invasive procedures or for development of ONJ until resolution. Impaired wound healing: withhold for ≥1 week prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. ESRD. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Advise females of reproductive potential to use effective contraception during and for ≥30 days after the last dose. Nursing mothers: not recommended (during and for ≥1 week after the last dose).
LENVIMA Classification:
Kinase inhibitor.
LENVIMA 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 Drug Availability:
NO
How Supplied:
Caps—6 (cards)
Colorectal and other GI cancers:
Indications for: LENVIMA
First-line treatment of unresectable hepatocellular carcinoma (HCC).
Adult Dosage:
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: see full labeling.
Children Dosage:
Not established.
LENVIMA 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. Concomitant exposure to other risk factors (eg, bisphosphonates, denosumab, dental disease/invasive procedures) may increase the risk of osteonecrosis of the jaw (ONJ); withhold Lenvima for ≥1 week prior to scheduled dental surgery/invasive procedures or for development of ONJ until resolution. Impaired wound healing: withhold for ≥1 week prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. ESRD. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Advise females of reproductive potential to use effective contraception during and for ≥30 days after the last dose. Nursing mothers: not recommended (during and for ≥1 week after the last dose).
LENVIMA Classification:
Kinase inhibitor.
LENVIMA 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 Drug Availability:
NO
How Supplied:
Caps—6 (cards)
Gynecologic cancers:
Indications for: LENVIMA
In combination with pembrolizumab, for patients with advanced endometrial carcinoma that is mismatch repair deficient (dMMR) or not microsatellite instability-high (MSI-H), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
Adult Dosage:
Swallow whole or may dissolve capsule contents into liquid. 20mg once daily (in combination with pembrolizumab 200mg IV over 30mins every 3 weeks) 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: see full labeling.
Children Dosage:
Not established.
LENVIMA 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. Concomitant exposure to other risk factors (eg, bisphosphonates, denosumab, dental disease/invasive procedures) may increase the risk of osteonecrosis of the jaw (ONJ); withhold Lenvima for ≥1 week prior to scheduled dental surgery/invasive procedures or for development of ONJ until resolution. Impaired wound healing: withhold for ≥1 week prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. ESRD. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Advise females of reproductive potential to use effective contraception during and for ≥30 days after the last dose. Nursing mothers: not recommended (during and for ≥1 week after the last dose).
LENVIMA Classification:
Kinase inhibitor.
LENVIMA 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 Drug Availability:
NO
How Supplied:
Caps—6 (cards)
Pancreatic, thyroid, and other endocrine cancers:
Indications for: LENVIMA
Locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.
Adult Dosage:
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: see full labeling.
Children Dosage:
Not established.
LENVIMA 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. Concomitant exposure to other risk factors (eg, bisphosphonates, denosumab, dental disease/invasive procedures) may increase the risk of osteonecrosis of the jaw (ONJ); withhold Lenvima for ≥1 week prior to scheduled dental surgery/invasive procedures or for development of ONJ until resolution. Impaired wound healing: withhold for ≥1 week prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. ESRD. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Advise females of reproductive potential to use effective contraception during and for ≥30 days after the last dose. Nursing mothers: not recommended (during and for ≥1 week after the last dose).
LENVIMA Classification:
Kinase inhibitor.
LENVIMA 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 Drug Availability:
NO
How Supplied:
Caps—6 (cards)
