For patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation.
Recommended dosage reductions for LENVIMA for adverse reaction managementa
Recommended dosage reductions for LENVIMA for adverse reaction managementa
How LENVIMA is supplied
Recommended dose
20 mg orally once daily
First dose reduction
14 mg orally once daily
Second dose reduction
10 mg orally once daily
Third dose reduction
8 mg orally once daily
Capsules may not be shown at actual size.
LENVIMA capsules are supplied in cartons of 6 cards; each card is a 5-day blister card.
Grade 3
Grade 4
Grade 3
Grade 4
Any grade
Grade 3 or 4
Grade 3 or 4
≥2 g proteinuria in 24 hours
Any grade
Grade 3 or 4
>500 ms or >60 ms increase from baseline
Any grade
Diarrhea
Hypocalcemia
Hemorrhagic events
Persistent or intolerable Grade 2 or 3 adverse reaction or Grade 4 laboratory abnormalities
Grade 4 adverse reaction
aNational Cancer Institute-Common Terminology Criteria for Adverse Events v4.0.
HCC = unresectable hepatocellular carcinoma.
Grade 2
Grade 3 or 4 or recurrent Grade 2
Grade 2 or 3
Grade 4
AST or ALT >3 but no more than 5 times the ULN or total bilirubin >1.5 but no more than 3 times the ULN
In patients without liver metastases, AST or ALT >5 times ULN or total bilirubin >3 times ULN
In patients with liver metastasis and Grade 2 AST or ALT at baseline, with an increase in AST or ALT of ≥50% relative to baseline that persists for at least 1 week
Grade 2 adrenal insufficiency or hypophysitis
Grade 3 or 4 adrenal insufficiency or hypophysitis
Grade 3 or 4 hyperthyroidism
Severe hyperglycemia
Grade 2
Grade 3 or 4
Grade 3 or suspected SJS or TEN
Grade 4 or confirmed SJS or TEN
Grade 2 or 3 based on the severity and type of reaction
Grade 3 based on the severity and type of reaction or Grade 4
Recurrent Grade 2 pneumonitis
Recurrent Grade 3 or 4
Requirement for 10 mg per day or greater prednisone or equivalent for more than 12 weeks after last dose of KEYTRUDA
Grade 2 or 3 adverse reactions lasting 12 weeks or longer after last dose of KEYTRUDA
Grade 1 or 2
Grade 3 or 4
aToxicity was graded per National Cancer Institute-Common Terminology Criteria for Adverse Events v4.0.
bResume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper.
cPlease refer to the dose modifications section of the Prescribing Information for specific guidance for patients with hepatocellular carcinoma.
ALT = alanine aminotransferase; AST = aspartate aminotransferase; HSCT = hematopoietic stem cell transplantation; GVHD = graft-versus-host disease; ULN = upper limit of normal; VOD = veno-occlusive disease.
Selected Safety Information for
KEYTRUDA® (pembrolizumab)
PD-1 = programmed death receptor-1; PD-L1 = programmed death ligand 1
Before prescribing KEYTRUDA® (pembrolizumab), please read the accompanying Prescribing Information. The Medication Guide also is available.
Selected Safety Information for
LENVIMA® (lenvatinib)
Adverse reactions led to dose reduction or interruption in 88% of patients receiving LENVIMA. The most common adverse reactions (≥5%) resulting in dose reduction or interruption of LENVIMA were fatigue (32%), hypertension (26%), diarrhea (18%), nausea (13%), palmar-plantar erythrodysesthesia (13%), vomiting (13%), decreased appetite (12%), musculoskeletal pain (11%), stomatitis (9%), abdominal pain (7%), hemorrhages (7%), renal impairment (6%), decreased weight (6%), rash (5%), headache (5%), increased lipase (5%), and proteinuria (5%).
Fatal adverse reactions occurred in 3% of patients receiving LENVIMA + KEYTRUDA, including gastrointestinal perforation, RPLS with intraventricular hemorrhage, and intracranial hemorrhage.
Serious adverse reactions occurred in 52% of patients receiving LENVIMA + KEYTRUDA. Serious adverse reactions in ≥3% of patients were hypertension (9%), abdominal pain (6%), musculoskeletal pain (5%), hemorrhage (4%), fatigue (4%), nausea (4%), confusional state (4%), pleural effusion (4%), adrenal insufficiency (3%), colitis (3%), dyspnea (3%), and pyrexia (3%).
Permanent discontinuation due to adverse reaction (grade 1-4) occurred in 21% of patients who received LENVIMA + KEYTRUDA. The most common adverse reactions (>2%) resulting in discontinuation of LENVIMA were gastrointestinal perforation or fistula (2%), muscular weakness (2%), and pancreatitis (2%).
QTc = corrected QT interval; MRI = magnetic resonance imaging; CNS = central nervous system.
Before prescribing LENVIMA® (lenvatinib), please read the accompanying Prescribing Information and Patient Information.