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Dosing JEMPERLI

JEMPERLI + CP Dosing Established in the RUBY Trial

Deliver a Proven Combination Up Front, Then Continue With Single-Agent Immunotherapy1

Recommended Dosage of JEMPERLI in dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer1

Dosing schedule for JEMPERLI in combination with carboplatin and paclitaxel Dosing schedule for JEMPERLI in combination with carboplatin and paclitaxel

*Administer JEMPERLI prior to chemotherapy on the same day.1

The Q3W dosing schedule allows for more frequent patient monitoring during the 6-cycle treatment initiation phase.1

The number of infusion visits is reduced over the long term during the Q6W monotherapy phase.1

  • Additional monitoring may be required at clinical discretion1

Full receptor occupancy as measured by both the direct PD-1 binding and interleukin 2 production functional assay was maintained throughout the dosing interval at the recommended therapeutic dosing regimen.1

CP=carboplatin + paclitaxel; dMMR=mismatch repair deficient; MSI-H=microsatellite instability-high; PD-1=programmed death receptor 1; Q3W=every 3 weeks; Q6W=every 6 weeks.

JEMPERLI Monotherapy Dosing Established in the GARNET Trial

The JEMPERLI Dosing Regimen Reduces the Frequency of Dosing Visits for Your Patients After Transitioning From Q3W to Q6W Dosing1*

Recommended Dosage of JEMPERLI Monotherapy in Post-Platinum dMMR/MSI-H Recurrent or Advanced Endometrial Cancer

Dosing schedule for JEMPERLI as a single agent Dosing schedule for JEMPERLI as a single agent

*Additional monitoring may be required per clinical discretion.1

JEMPERLI Is Available in Fixed-Dose Vials for Simple Dosing1

  • For the 500-mg dose, withdraw 10 mL of JEMPERLI from a vial and transfer into an intravenous bag containing:
    -Sodium chloride 9 mg/mL (0.9%) solution for injection
    or
    -Glucose 50 mg/mL (5%) solution for injection
  • For the 1000-mg dose, withdraw 10 mL of JEMPERLI from each of two vials (withdraw 20 mL total) and transfer into an intravenous bag containing:
    -Sodium chloride 9 mg/mL (0.9%) solution for injection
    or
    -Glucose 50 mg/mL (5%) solution for injection
  • The final concentration of the diluted solution should be between 2 mg/mL and 10 mg/mL. This may require withdrawing a volume of diluent from the intravenous bag prior to adding a volume of JEMPERLI into the intravenous bag
  • Each dose of JEMPERLI is administered as a 30-minute intravenous infusion

Recommended Dose Modifications for JEMPERLI1

Management of adverse reactions*

Dose reduction is not recommended. Dosing delay or discontinuation may be required based on individual safety and tolerability. All adverse reactions are immune-related unless otherwise noted.

*Severity based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.1
†For patients with liver metastases who begin treatment with a Grade 2 increase of AST or ALT, if AST or ALT increases by ≥50% relative to baseline and lasts for at least 1 week, then treatment should be discontinued.1


ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal.

Find Out More

RUBY Trial Results

See RUBY Data

GARNET Trial Results

See GARNET Data

JEMPERLI Support and Resources

See Support and Resources

JEMPERLI Is Indicated1

  • in combination with platinum-containing chemotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/ microsatellite instability‑high (MSI‑H) primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy.
  • as monotherapy for the treatment of adult patients with dMMR/ MSI‑H recurrent or advanced EC that has progressed on or following prior treatment with a platinum‑containing regimen.

Jemperli Safety Information1

Contraindications: 
Hypersensitivity to the active substance or to any of the excipients

Adverse reactions:

Dostarlimab monotherapy:
Very common: Anaemia, Hypothyroidism, Diarrhoea, nausea, vomiting, Rash, pruritus, Arthralgia, Pyrexia and Transaminases increased

Common: Hyperthyroidism, adrenal insufficiency, Pneumonitis, Colitis , pancreatitis, gastritis, Hepatitis, Myalgia, Chills and Infusion-related reaction

Dostarlimab in combination therapy:
Very common: Hypothyroidism, Rash, dry skin, Pyrexia, Alanine aminotransferase increased and aspartate aminotransferase increased

Common: Hyperthyroidism, adrenal insufficiency, Pneumonitis and Colitis

▼ This medicine is subjected to additional monitoring. This will allow quick identification of new safety information. You may help by reporting any side effects you may get.

Reference

  1. Jemperli Local PI

For more information, please refer to the prescribing information or contact GlaxoSmithKline via gcc.medinfo@gsk.com
To report Adverse Event/s associated with the use of GSK product/s, please contact us via
gulf.safety@gsk.com
To report quality complaint/s associated with the use of GSK product/s, please contact us via
 Gulf.ProductQualityComplaints@gsk.com

Department of Pharmacovigilance & Drug Information
Drug Safety Center
Ministry of Health, Sultanate of Oman
Phone Nos. 0096822357687 / 0096822357690
Fax: 0096822358489
Email: pharma-vigil@moh.gov.om
Website: www.moh.gov.om

 دائرة التيقظ و المعلومات الدوائية
مركز سلامة الدواء
وزارة الصحة, سلطنة عمان
هاتف: 0096822357687 / 0096822357690
0096822358489 :فاكس
pharma-vigil@moh.gov.om :البريد االكتروني
www.moh.gov.om : الموقع االكتروني

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February 2025 | PM-AE-DST-WCNT-250001