Jemperli Dosage

Generic name: DOSTARLIMAB 50mg in 1mL
Dosage form: injection
Drug class: Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors)

Medically reviewed by Drugs.com. Last updated on Mar 4, 2024.

Patient Selection

Combination Therapy

For use of JEMPERLI in combination with carboplatin and paclitaxel, select patients for treatment with JEMPERLI based on dMMR/MSI-H status in tumor specimens [see Clinical Studies (14.1)].

Single Agent

Select patients for treatment with JEMPERLI as a single agent based on the presence of dMMR in tumor specimens in:

•: recurrent or advanced endometrial cancer [see Clinical Studies (14.1)].
•: recurrent or advanced solid tumors [see Clinical Studies (14.2)].

Information on FDA-approved tests for the detection of dMMR status is available at https://www.fda.gov/companiondiagnostics.

•: An FDA-approved test for the detection of MSI-H is not currently available [see Clinical Studies (14.1)].

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 for JEMPERLI is presented in Table 1.

Table 1. Recommended Dosage of JEMPERLI
dMMR = Mismatch Repair Deficient; MSI-H = Microsatellite Instability-High; EC = endometrial cancer.
a First 6 doses are administered in combination with carboplatin and paclitaxel. Refer to the Prescribing Information for the agents administered in combination with JEMPERLI, as appropriate.
b 30-minute intravenous infusion.
Indication	Recommended Dosage	Duration/Timing of Treatment
Combination Therapy
Adults with dMMR/MSI-H primary advanced or recurrent EC	500 mgb every 3 weeks for 6 dosesa followed by 1,000 mgb monotherapy every 6 weeks Administer JEMPERLI prior to carboplatin and paclitaxel when given on the same day.	Until disease progression, unacceptable toxicity, or up to 3 years.
Monotherapy
Adults with dMMR recurrent or advanced EC and dMMR recurrent or advanced solid tumors	500 mgb every 3 weeks for 4 doses followed by 1,000 mgb every 6 weeks	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 2.

Table 2. 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
Pneumonitis	Grade 3 or 4 or recurrent Grade 2	Permanently discontinue
Colitis	Grade 2 or 3	Withholdb
Colitis	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
Hepatitis with no tumor involvement of the liver	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
Hepatitis with tumor involvement of the liverc	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
Nephritis with renal dysfunction	Grade 4 increased blood creatinine	Permanently discontinue
Exfoliative dermatologic conditions	Suspected SJS, TEN, or DRESS	Withholdb
Exfoliative dermatologic conditions	Confirmed SJS, TEN, or DRESS	Permanently discontinue
Myocarditis	Grade 2, 3, or 4	Permanently discontinue
Neurological toxicities	Grade 2	Withholdb
Neurological toxicities	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.