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Jemperli Dosage

Generic name: DOSTARLIMAB 50mg in 1mL
Dosage form: injection
Drug class: Anti-PD-1 monoclonal antibodies

Medically reviewed by Drugs.com. Last updated on Apr 28, 2022.

Patient Selection

Mismatch Repair Deficient Recurrent or Advanced Endometrial Cancer or Mismatch Repair Deficient Recurrent or Advanced Solid Tumors

Select patients for treatment with JEMPERLI based on the presence of dMMR in tumor specimens [see Clinical Studies (14)]. Information on FDA-approved tests for the detection of dMMR status is available at https://www.fda.gov/companiondiagnostics.

Because the effect of prior chemotherapy on test results for dMMR in patients with high-grade gliomas is unclear, it is recommended to test for this marker in the primary tumor specimen obtained prior to initiation of temozolomide chemotherapy in patients with high-grade gliomas.

Recommended Dosage

The recommended dosage of JEMPERLI is:

Dose 1 through Dose 4: 500 mg every 3 weeks
Subsequent dosing beginning 3 weeks after Dose 4 (Dose 5 onwards): 1,000 mg every 6 weeks

Administer JEMPERLI as an intravenous infusion over 30 minutes. Treat patients until disease progression or unacceptable toxicity.

Dosage Modifications for Adverse Reactions

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 in Table 1.

Table 1. Recommended Dosage Modifications for Adverse Reactions
AST = aspartate aminotransferase, ALT = alanine aminotransferase, ULN = upper limit of normal, SJS = Stevens-Johnson syndrome, TEN = toxic epidermal necrolysis, DRESS = drug rash with eosinophilia and systemic symptoms.
a Based on National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0.
b 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/day (or equivalent) within 12 weeks of initiating steroids.
c 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.

Adverse Reaction

Severitya

Dosage Modification

Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1)]

Pneumonitis

Grade 2

Withholdb

Grade 3 or 4 or recurrent Grade 2

Permanently discontinue

Colitis

Grade 2 or 3

Withholdb

Grade 4

Permanently discontinue

Hepatitis with no tumor involvement of the liver

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

Withholdb

AST or ALT increases to more than 8 times ULN

or

Total bilirubin increases to more than 3 times ULN

Permanently discontinue

Hepatitis with tumor involvement of the liverc

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

Withholdb

AST or ALT increases to more than 10 times ULN

or

Total bilirubin increases to more than 3 times ULN

Permanently discontinue

Endocrinopathies

Grade 2, 3, or 4

Withhold until clinically stable or permanently discontinue, depending on severityb

Nephritis with renal dysfunction

Grade 2 or 3 increased blood creatinine

Withholdb

Grade 4 increased blood creatinine

Permanently discontinue

Exfoliative dermatologic conditions

Suspected SJS, TEN, or DRESS

Withholdb

Confirmed SJS, TEN, or DRESS

Permanently discontinue

Myocarditis

Grade 2, 3, or 4

Permanently discontinue

Neurological toxicities

Grade 2

Withholdb

Grade 3 or 4

Permanently discontinue

Other Adverse Reactions

Infusion-related reactions [see Warnings and Precautions (5.2)]

Grade 1 or 2

Interrupt or slow the rate of infusion

Grade 3 or 4

Permanently discontinue

Preparation and Administration

Preparation for Intravenous Infusion

Visually inspect the solution for particulate matter and discoloration. The solution is clear to slightly opalescent, colorless to yellow. Discard the vial if visible particles are observed.
Do not shake.
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 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 di(2-ethylhexyl) phthalate (DEHP).
For the 1,000-mg dose, withdraw 10 mL from each of 2 vials (withdraw 20 mL total) and dilute into an intravenous 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).
Mix diluted solution by gentle inversion. Do not shake.
Discard any unused portion left in the vial.

Storage of Infusion Solution

Store in the original carton until time of preparation in order to protect from light. The prepared dose may be stored either:

At room temperature for no more than 6 hours from the time of preparation until the end of infusion.
Under refrigeration at 2°C to 8°C (36ºF to 46ºF) for no more than 24 hours from time of preparation until end of infusion. If refrigerated, allow the diluted solution to come to room temperature prior to administration.

Discard after 6 hours at room temperature or after 24 hours under refrigeration.

Do not freeze.

Administration

Administer infusion solution intravenously over 30 minutes through an intravenous line using tubing made of polyvinyl chloride or platinum cured silicon; fittings made of polyvinyl chloride or polycarbonate; and a sterile, non-pyrogenic, low‑protein binding, 0.2-micron, in-line or add-on filter.

JEMPERLI must not be administered as an intravenous push or bolus injection. Do not co‑administer other drugs through the same infusion line.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.