JEMPERLI offers fixed dosing1

Dosing regimen for patients treated with JEMPERLl1

Graph: Jemperli Dosing

JEMPERLI is available in fixed-dose vials1

  • For the 500-mg dose, withdraw 10 mL of JEMPERLI from a vial using a disposable sterile syringe made of polypropylene and dilute into an intravenous infusion bag*
  • For the 1000-mg dose, withdraw 10 mL from each of two vials (withdraw 20 mL total) and dilute into an intravenous bag
  • JEMPERLI doses are administered in a 30-minute intravenous infusion

*Infusion bag containing 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP to a final concentration between 2 to 10 mg/mL (maximum 250 mL). JEMPERLI is compatible with an infusion bag made of polyolefin, ethylene vinyl acetate, or polyvinyl chloride with DEHP.

Infusion bag containing 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP to a final concentration between 4 to 10 mg/mL (maximum 250 mL).

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JEMPERLI provides sustained target engagement throughout the dosing interval at the recommended dose1‡

As measured by direct PD-1 binding and stimulation of IL-2 production throughout the dosing interval at the recommended dose.

Learn about dose preparation and administration: Download Guide Now

Recommended dose modifications

No dose reductions of JEMPERLI are recommended. In general, withhold JEMPERLI for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue JEMPERLI for life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive treatment, or an inability to reduce corticosteroid dose to 10 mg or less of prednisone equivalent per day within 12 weeks of initiating steroids. Dosage modifications for JEMPERLI for adverse reactions that require management different from these general guidelines are summarized below.

  • Pneumonitis

    Grade 2: Withhold||

    Grade 3 or 4 or recurrent Grade 2: Permanently discontinue

  • Colitis

    Grade 2 or 3: Withhold||

    Grade 4: Permanently discontinue

  • Hepatitis with no tumor involvement of the liver

    AST or ALT >3 and ≤8 times the ULN, or total bilirubin >1.5 and ≤3 times the ULN: Withhold||

    AST or ALT >8 times the ULN or total bilirubin >3 times the ULN: Permanently discontinue

  • Hepatitis with tumor involvement of the liver

    Baseline AST or ALT >1 and ≤3 times ULN and increases to >5 and ≤10 times ULN or Baseline AST or ALT is >3 and ≤5 times ULN and increases to >8 and ≤10 times ULN: Withhold||

    AST or ALT increases to >10 times ULN or Total bilirubin increases to >3 times ULN: Permanently discontinue

  • Endocrinopathies

    Grade 2, 3, 4: Withhold until clinically stable or permanently discontinue, depending on severity||

  • Nephritis with renal dysfunction

    Grade 2 or 3 increased blood creatinine: Withhold||

    Grade 4 increased blood creatinine: Permanently discontinue

  • Exfoliative dermatologic conditions

    Suspected SJS, TEN, or DRESS: Withhold||

    Confirmed SJS, TEN, or DRESS: Permanently discontinue

  • Myocarditis

    Grade 2, 3, or 4: Permanently discontinue

  • Neurological toxicities

    Grade 2: Withhold||

    Grade 3 or 4: Permanently discontinue

  • Infusion-related reactions

    Grade 1 or 2: Interrupt or slow the rate of infusion

    Grade 3 or 4: Permanently discontinue

ALT=alanine aminotransferase; AST=aspartate aminotransferase; DRESS=drug rash with eosinophilia and systemic symptoms;

SJS=Stevens-Johnson syndrome; TEN=toxic epidermal necrolysis; ULN=upper limit of normal.

§Based on National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0.

||Resume 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 less than 10 mg per day (or equivalent) within 12 weeks of initiating steroids.

If AST and ALT are less than or equal to ULN at baseline in patients with liver involvement, withhold or permanently discontinue JEMPERLI based on recommendations for hepatitis with no liver involvement.

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