Help manage your patients’ adverse reactions to KEYTRUDA
Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.
Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (eg, endocrinopathies and dermatologic reactions) are shown below.
Additional monitoring and management considerations for selected immune-mediated adverse reactions are also shown.
Severitya and Dosage Modification
Grade 2
Grade 3 or 4
Monitoring and Management
Severitya and Dosage Modification
Grade 2 or 3
Grade 4
Severitya and Dosage Modification
AST or ALT increases to more than 3 and up to 8 times ULN or total bilirubin increases to more than 1.5 and up to 3 times ULN
AST or ALT increases to more than 8 times ULN or total bilirubin increases to more than 3 times ULN
Severitya and Dosage Modification
Baseline AST or ALT is more than 1 and up to 3 times ULN and increases to more than 5 and up to 10 times ULN or baseline AST or ALT is more than 3 and up to 5 times ULN and increases to more than 8 and up to 10 times ULN
ALT or AST increases to more than 10 times ULN or total bilirubin increases to more than 3 times ULN
Monitoring and Management
Adrenal insufficiency
Hypophysitis
Thyroid disorders
Type 1 diabetes mellitus
Severitya and Dosage Modification
Grade 3 or 4
Severitya and Dosage Modification
Grade 2 or 3 increased blood creatinine
Grade 4 increased blood creatinine
Monitoring and Management
Severitya and Dosage Modification
Suspected SJS, TEN, or DRESS
Confirmed SJS, TEN, or DRESS
Severitya and Dosage Modification
Grade 2, 3, or 4
Severitya and Dosage Modification
Grade 2
Grade 3 or 4
Monitoring and Management
Monitoring and Management
Severitya and Dosage Modification
Monitoring and Management
Severitya and Dosage Modification
Grade 1 or 2
Grade 3 or 4
aBased on Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
bResume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids.
cIf AST and ALT are less than or equal to ULN at baseline, withhold or permanently discontinue KEYTRUDA based on recommendations for hepatitis with no liver involvement.
ALT = alanine aminotransferase; AST = aspartate aminotransferase; CMV = cytomegalovirus; DRESS = drug rash with eosinophilia and systemic symptoms; GVHD = graft-versus-host disease; PD-1 = programmed death receptor-1; PD-L1 = programmed death ligand 1; SJS = Stevens-Johnson syndrome; TEN = toxic epidermal necrolysis; ULN = upper limit normal; VOD = veno-occlusive disease.
Help manage your patients’ adverse reactions to LENVIMA
Capsules are not shown at actual size.
aWhen administered with KEYTRUDA.
[See Warnings and Precautions]
Monitoring and Management
Severitya and Dosage Modification
Grade 3
Grade 4
[See Warnings and Precautions]
Monitoring and Management
Severitya and Dosage Modification
Grade 3
Grade 4
[See Warnings and Precautions]
Monitoring and Management
Severitya and Dosage Modification
Any grade
[See Warnings and Precautions]
Monitoring and Management
Severitya and Dosage Modification
Grade 3 or 4
[See Warnings and Precautions]
Monitoring and Management
Severitya and Dosage Modification
Grade 3 or 4
[See Warnings and Precautions]
Monitoring and Management
Severitya and Dosage Modification
2 g or greater proteinuria in 24 hours
[See Warnings and Precautions]
Monitoring and Management
Severitya and Dosage Modification
Persistent or intolerable Grade 2 or 3 adverse reaction
Grade 4 adverse reaction
[See Warnings and Precautions]
Severitya and Dosage Modification
Any grade
[See Warnings and Precautions]
Severitya and Dosage Modification
Grade 3 or 4
[See Warnings and Precautions]
Monitoring and Management
Severitya and Dosage Modification
>500 ms or >60 ms increase from baseline
[See Warnings and Precautions]
Monitoring and Management
Severitya and Dosage Modification
Persistent or intolerable Grade 2 or 3 adverse reaction or Grade 4 laboratory abnormalities
Grade 4 adverse reaction
[See Warnings and Precautions]
Monitoring and Management
Severitya and Dosage Modification
Any grade
[See Warnings and Precautions]
Monitoring and Management
Severitya and Dosage Modification
Persistent or intolerable Grade 2 or 3 adverse reaction
Grade 4 adverse reaction
[See Warnings and Precautions]
Monitoring and Management
[See Warnings and Precautions]
Monitoring and Management
Dosage Modification
[See Warnings and Precautions]
Monitoring and Management
Severitya and Dosage Modification
[See Warnings and Precautions for Diarrhea, Hypocalcemia, and Hemorrhagic Events]
Severitya and Dosage Modification
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, version 4.0.
HCC = hepatocellular carcinoma.
Selected Safety Information for
KEYTRUDA® (pembrolizumab)
MSI-H = microsatellite instability-high; pMMR = mismatch repair proficient; ALT = alanine aminotransferase.
Before prescribing KEYTRUDA® (pembrolizumab), please read the accompanying Prescribing Information. The Medication Guide also is available.
Selected Safety Information for
LENVIMA® (lenvatinib)
Perform an oral examination prior to treatment with LENVIMA and periodically during LENVIMA treatment. Advise patients regarding good oral hygiene practices and to consider having preventive dentistry performed prior to treatment with LENVIMA and throughout treatment with LENVIMA.
Avoid invasive dental procedures, if possible, while on LENVIMA treatment, particularly in patients at higher risk. Withhold LENVIMA 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 the risk of ONJ.
Withhold LENVIMA if ONJ develops and restart based on clinical judgement of adequate resolution.
CNS = central nervous system; MRI = magnetic resonance imaging; QTc = corrected QT interval; ALT = alanine aminotransferase.
Before prescribing LENVIMA® (lenvatinib), please read the accompanying Prescribing Information and Patient Information.