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Prescribing Information

Let Their Light Shine With JEMPERLI (dostarlimab)¹

The first immunotherapy in combination with platinum-containing chemotherapy approved in dMMR/MSI-H primary advanced or recurrent endometrial cancer.¹

See the PFS results from the dMMR/MSI-H subgroup of the RUBY trial along with OS, ORR, and DOR.

Discover RUBY Data

See the ORR and DOR results from the GARNET monotherapy trial of JEMPERLI.

Discover GARNET Data

See the PFS results from the dMMR/MSI-H subgroup of the RUBY trial along with OS, ORR, and DOR.

Discover RUBY Data

See the ORR and DOR results from the GARNET monotherapy trial of JEMPERLI.

Discover GARNET Data

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.

dMMR=mismatch repair deficient; DOR=duration of response; MSI-H=microsatellite instability-high; ORR=objective response rate; OS=overall survival; PFS=progression-free survival.

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

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