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JEMPERLI is indicated 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) who are candidates for systemic therapy.

DOSING IN COMBINATION WITH CHEMOTHERAPY

JEMPERLI is indicated 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.

DOSING AS JEMPERLI MONOTHERAPY

Dosing in Combination

Dosage of JEMPERLI in combination with platinum-containing chemotherapy for dMMR/MSI-H primary advanced or recurrent endometrial cancer1

The recommended dose of JEMPERLI in combination with platinum-containing chemotherapy is 500mg every 3 weeks for 6 cycles followed by 1000mg every 6 weeks thereafter

Dosing as combination therapy Dosing as combination therapy
  • Administration of JEMPERLI should continue according to the recommended schedule until disease progression or unacceptable toxicity, or for a duration of up to 3 years
  • JEMPERLI should be administered by intravenous infusion using an intravenous infusion pump over 30 minutes by a healthcare practitioner
  • JEMPERLI must not be administered as an intravenous push or bolus injection
  • Do not co-administer other drugs through the same infusion line
  • A 0.2 or 0.22 micron in-line polyethersulfone (PES) filter must be used during administration of JEMPERLI

*For the dosage or recommended dose modifications of concomitantly used chemotherapeutic agents, refer to the product information for these medicinal products

Please refer to the JEMPERLI SmPC for further information

DOWNLOAD THE DOSING AND ADMINISTRATION GUIDE

Dosing as Monotherapy

Recommended Monotherapy Dosing for dMMR/ MSI-H recurrent or advanced EC that has progressed on or following prior treatment with a platinum-containing regimen1

The recommended dose for JEMPERLI monotherapy is 500mg Q3W for 4 cycles followed by 1,000mg Q6W thereafter

Dosing as monotherapy Dosing as monotherapy
  • JEMPERLI should be administered by intravenous infusion using an intravenous infusion pump over 30 minutes by a healthcare practitioner.
  • JEMPERLI must not be administered as an intravenous push or bolus injection
  • Do not co-administer other drugs through the same infusion line.
  • A 0.2 or 0.22 micron in-line polyethersulfone (PES) filter must be used during administration of JEMPERLI

Please refer to the JEMPERLI SmPC for further information

DOWNLOADING THE DOSING AND ADMINISTRATION GUIDE

Dose Modification and Therapy Discontinuation1

Listed adverse reactions below are immune related events unless otherwise noted. This is not an exhaustive list. Please consult the JEMPERLI Summary of Product Characteristics for further information on the management of adverse reactions associated with dostarlimab treatment.

  • Colitis

    Grade 2 or 3: Withhold dose. Restart dosing when toxicity resolves to grade 0 or 1

    Grade 4: Permanently discontinue

  • Hepatitis

    Grade 2 with AST or ALT >3 and up to 5x ULN or total bilirubin > 1.5 and up to 3 × ULN
    Withhold dose. Restart dosing when toxicity resolves to grade 0 or 1

    Grade ≥ 3 with AST or ALT > 5 x ULN or total bilirubin > 3 x ULN:
    Permanently discontinue (See exceptions below*)

    *For patients with liver metastases who begin treatment with 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)

  • Type 1 Diabetes Mellitus (T1DM)

    Grade 3 or 4 (hyperglycaemia):
    Withhold dose. Restart dosing in appropriately managed, clinically and metabolically stable patients.

  • Hypophysitis or Adrenal Insufficiency

    Grade 2, 3 or 4:
    Withhold dose. Restart dosing when toxicity resolves to grade 0 or 1. Permanently discontinue for recurrence or worsening while on adequate hormonal therapy.

  • Hypothyroidism or Hyperthyroidism

    Grade 3 or 4:
    Withhold dose. Restart dosing when toxicity resolves to grade 0 or 1.

  • Pneumonitis

    Grade 2:
    Withhold dose. Restart dosing when toxicity resolves to grade 0 or 1. If grade 2 recurs, permanently discontinue.

    Grade 3 or 4:
    Permanently discontinue.

  • Nephritis

    Grade 2:
    Withhold dose. Restart dosing when toxicity resolves to grade 0 or 1.

    Grade 3 or 4:
    Permanently discontinue.

  • Exfoliative dermatologic conditions (e.g. SJS, TEN, DRESS)

    Suspected:
    Withhold dose for any grade. Restart dosing if not confirmed and when toxicity resolves to grade 0 or 1.

    Confirmed:
    Permanently discontinue.

  • Myocarditis

    Grade 2, 3 or 4:
    Permanently discontinue.

  • Severe neurological toxicities

    Myasthenic syndrome/ myasthenia gravis, Guillain-Barre syndrome, encephalitis, transverse myelitis

    Grade 2, 3 or 4:
    Permanently discontinue.

  • Other Immune-Related Adverse Reactions

    Including but not limited to myositis, sarcoidosis, autoimmune haemolytic anaemia, pancreatitis, iridocyclitis, uveitis, diabetic ketoacidosis arthralgia, solid organ transplant rejection, graft-versus-host-disease

    Grade 3:
    Withhold dose. Restart dosing when toxicity resolves to grade 0 or 1.

    Grade 4:
    Permanently discontinue.

  • Recurrence of immune-related adverse reactions after resolution to ≤ grade 1

    Except for pneumonitis, see above.

    Grade 3 or 4:
    Permanently discontinue.

  • Infusion-related Adverse Reactions

    Grade 2:
    Withhold dose. If resolved within one hour of stopping, may be restarted at 50% of the original infusion rate, or restart when symptoms resolve with premedication. If grade 2 recurs with adequate premedication, permanently discontinue.

    Grade 3 or 4:
    Permanently discontinue.

Trial Icon

The RUBY Trial

JEMPERLI + CP demonstrates a statistically significant (p<0.0001) and clinically meaningful PFS benefit vs placebo + CP in dMMR/MSI-H primary advanced or recurrent EC2

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Safety Profile Icon

JEMPERLI Safety Profile

JEMPERLI + CP offers a manageable safety profile consistent with the known profiles of its individual components after 2 years of follow-up1,2

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Indications

JEMPERLI is indicated 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) who are candidates for systemic therapy.

JEMPERLI is indicated 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.

Footnotes

ALT, alanine aminotransferase; AST, aspartate aminotransferase; CP, carboplatin/paclitaxel; dMMR, mismatch repair deficient; DRESS, Drug Reaction with Eosinophilia and Systemic Symptoms Syndrome; MSI-H, microsatellite instability-high; PFS, progression free survival; SJS, Stevens-Johnson Syndrome; TEN, Toxic epidermal necrolysis; ULN, upper limit of normal

References

  1. Jemperli (dostarlimab) Summary of Product Characteristics Great Britain Accessed December 2023.
  2. Mirza MR, et al. Dostarlimab for primary advanced or recurrent endometrial cancer. N Engl J Med. 2023;388(23):2145-2158.

Adverse events should be reported. Reporting forms and information can be found at: https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App store.

Adverse events should also be reported to GlaxoSmithKline on 0800 221 441 or uksafety@gsk.com

© 2022 GSK Group of Companies or its licensor. Trademarks are the property of their respective owners.

December 2023 ӏ PM-GB-DST-WCNT-230020 (V0.6)