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- The safety profile of dostarlimab has been evaluated in 241 patients with primary advanced or recurrent endometrial cancer who received dostarlimab in combination with carboplatin and paclitaxel in the RUBY study1
- 5.0% of patients permanently discontinued JEMPERLI due to adverse reactions1
- The most common adverse reactions (>10%) were rash (22.8%), rash maculopapular (14.1%), hypothyroidism (14.1%), alanine aminotransferase increased (12.9%), aspartate aminotransferase increased (12.0%), pyrexia (12.0%), and dry skin (10.4%)1
- Adverse reactions were serious in 5.8% of patients; most serious adverse reactions were immune-related adverse reactions1
The safety profile of JEMPERLI + CP was generally consistent with the safety profiles of the individual regimens1,2
Adverse Reactions in Patients With Primary Advanced or Recurrent Endometrial Cancer in the RUBY Study, Associated With JEMPERLI3
An adverse reaction is any adverse event or experience related to a medicine for which a reasonable causal relationship with the medicine's use is suspected.4
*One patient each from an ongoing blinded trial of dostarlimab in combination (N=760) reported myocarditis, myasthenic syndrome, immune-mediated gastritis, and vasculitis gastrointestinal; estimated frequency category.3
†Two patients in an ongoing trial of dostarlimab in combination (N=266) reported systemic inflammatory response syndrome, myositis.3
CP=carboplatin + paclitaxel.
Find Out More
RUBY Trial Results
JEMPERLI Dosing and Administration
JEMPERLI Support and Resources
JEMPERLI Is Indicated5
- 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 Information5
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.
References
- JEMPERLI Summary of Product Characteristics. GSK. 2023.
- Mirza MR, et al. N Engl J Med. 2023;388(23):2145-2158.
- Data on file. GSK.
- EUPATI Open Classroom. Accessed December 11, 2023.
- 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 |
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
