Brand Name
Jemperli
Generic Name
Dostarlimab
View Brand Information FDA approval date: April 22, 2021
Classification: Programmed Death Receptor-1 Blocking Antibody
Form: Injection
What is Jemperli (Dostarlimab)?
JEMPERLI is a programmed death receptor-1 –blocking antibody indicated: Endometrial Cancer in combination with carboplatin and paclitaxel, followed by JEMPERLI as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial cancer .
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Brand Information
Jemperli (dostarlimab)
1DOSAGE FORMS AND STRENGTHS
Injection: 500 mg/10 mL (50 mg/mL) clear to slightly opalescent, colorless to yellow solution in a single-dose vial for intravenous infusion after dilution.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Severe and fatal immune-mediated adverse reactions
- Infusion-related reactions
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety population described in the
Additionally, the pooled safety population described in
Primary Advanced or Recurrent Endometrial Cancer: JEMPERLI in Combination with Carboplatin and Paclitaxel
The safety of JEMPERLI in patients with primary advanced or recurrent EC was evaluated in RUBY
Serious adverse reactions occurred in 39% of patients receiving JEMPERLI in combination with carboplatin and paclitaxel; the most common serious adverse reactions were sepsis, including urosepsis (3.7%), and pulmonary embolism (3.3%). Fatal adverse reactions occurred in 1.2% of patients receiving JEMPERLI including septic shock (0.8%) and myelosuppression (0.4%).
In patients receiving JEMPERLI in combination with carboplatin and paclitaxel, JEMPERLI was permanently discontinued due to adverse reactions in 46 patients (19%). Adverse reactions that required permanent discontinuation in ≥2 patients included 3 cases (1.2%) of rash maculo-papular, and 2 cases (0.8%) each of increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), diarrhea, pancreatitis, fatigue, pneumonitis, and arthralgia.
Dosage interruptions due to an adverse reaction occurred in 37% of patients who received JEMPERLI in combination with carboplatin and paclitaxel. Adverse reactions that required dosage interruption in ≥5% of patients who received JEMPERLI in combination with carboplatin and paclitaxel were anemia, thrombocytopenia, and peripheral neuropathy.
The most common adverse reactions, including laboratory abnormalities (≥20%), were decreased hemoglobin, increased creatinine, peripheral neuropathy, decreased white blood cell count, fatigue, nausea, alopecia, decreased platelets, increased glucose, decreased lymphocytes, decreased magnesium, decreased neutrophils, increased AST, arthralgia, rash, constipation, diarrhea, increased ALT, decreased potassium, decreased albumin, decreased sodium, increased alkaline phosphatase, abdominal pain, dyspnea, decreased appetite, increased amylase, decreased phosphate, urinary tract infection, and vomiting.
Table 3 summarizes the adverse reactions that occurred in ≥20% of patients with primary advanced or recurrent EC receiving JEMPERLI in combination with carboplatin and paclitaxel in RUBY.
Clinically relevant adverse reactions in <20% of patients with primary advanced or recurrent EC who received JEMPERLI in combination with carboplatin and paclitaxel included:
Endocrine Disorders: Hypothyroidism, hyperthyroidism, thyroiditis, adrenal insufficiency.
Eye Disorders: Keratitis, uveitis.
Gastrointestinal Disorders: Colitis, pancreatitis.
Metabolism and Nutrition Disorders: Type 1 diabetes mellitus.
Musculoskeletal and Connective Tissue Disorders: Immune-mediated arthritis.
Respiratory, Thoracic, and Mediastinal Disorders: Pneumonitis.
Cardiac Disorders: Myocarditis.
Nervous System Disorders: Encephalopathy.
Vascular Disorders: Hypertension, hemorrhage.
Table 4 summarizes the laboratory abnormalities in patients with primary advanced or recurrent EC receiving JEMPERLI in combination with carboplatin and paclitaxel in RUBY.
Mismatch Repair Deficient Recurrent or Advanced Endometrial Cancer: JEMPERLI as a Single Agent
The safety of JEMPERLI was evaluated in GARNET in 150 patients with advanced or recurrent dMMR EC who received at least 1 dose of JEMPERLI
A fatal adverse reaction occurred in one patient (0.7%) who received JEMPERLI, due to concurrent immune-mediated encephalitis and urinary tract infection.
Serious adverse reactions occurred in 38% of patients receiving JEMPERLI. Serious adverse reactions in >2% of patients included urinary tract infection (4%), sepsis (3.3%), acute kidney injury (2.7%), and abdominal pain (2.7%).
JEMPERLI was permanently discontinued due to adverse reactions in 15 (10%) patients, including increased transaminases, sepsis, bronchitis, pneumonitis, rash, pruritus, pancreatitis, encephalitis, and nephritis. Dosage interruptions due to an adverse reaction occurred in 28% of patients who received JEMPERLI. Adverse reactions that required dosage interruption in >1% of patients who received JEMPERLI were anemia, diarrhea, asthenia, colitis, sepsis, and pneumonitis.
The most common adverse reactions (≥20%) were fatigue/asthenia, anemia, nausea, diarrhea, constipation, vomiting, and rash.
Table 5 summarizes the adverse reactions that occurred in ≥10% of patients with dMMR EC on JEMPERLI in GARNET.
Clinically relevant adverse reactions in <10% of patients who received JEMPERLI included:
Endocrine Disorders: Hyperthyroidism, adrenal insufficiency, hypophysitis.
Eye Disorders: Iridocyclitis, uveitis.
Gastrointestinal Disorders: Colitis, pancreatitis, enterocolitis, gastritis.
General Disorders and Administration Site Conditions: Chills.
Musculoskeletal and Connective Tissue Disorders: Immune-mediated myositis, immune-mediated arthritis.
Nervous System Disorders: Encephalitis.
Renal and Urinary Disorders: Nephritis.
Respiratory, Thoracic, and Mediastinal Disorders: Pneumonitis, interstitial lung disease.
Table 6 summarizes laboratory abnormalities worsening from baseline to Grade 3 or 4 in ≥1% of patients with dMMR EC on JEMPERLI in GARNET.
Mismatch Repair Deficient Recurrent or Advanced Solid Tumors
The safety of JEMPERLI was investigated in 267 patients with recurrent or advanced dMMR solid tumors enrolled in GARNET
Serious adverse reactions occurred in 34% of patients receiving JEMPERLI. Serious adverse reactions in >2% of patients included abdominal pain (3.7%), sepsis (2.6%), and acute kidney injury (2.2%). Fatal adverse reaction occurred in 1 patient who received JEMPERLI due to respiratory failure.
JEMPERLI was permanently discontinued due to adverse reactions in 9% patients; the most common adverse reaction (≥1%) leading to discontinuation was increased alanine aminotransferase (1.1%).
Dosage interruptions due to an adverse reaction occurred in 23% of patients who received JEMPERLI. Adverse reactions that required dosage interruption in ≥1% of patients who received JEMPERLI were anemia, pneumonitis, diarrhea, adrenal insufficiency, increased alanine aminotransferase, and increased aspartate aminotransferase.
The most common adverse reactions (≥20%) were fatigue/asthenia, anemia, diarrhea, and nausea.
Table 7 summarizes the adverse reactions that occurred in ≥10% of patients with dMMR recurrent or advanced solid tumors in GARNET.
Clinically relevant adverse reactions in <10% of patients who received JEMPERLI included:
Endocrine Disorders: Hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis, autoimmune thyroiditis.
Eye Disorders: Uveitis.
Gastrointestinal Disorders: Colitis, enterocolitis, enterocolitis hemorrhage, pancreatitis, acute pancreatitis.
General Disorders and Administration Site Conditions: Chills.
Injury, Poisoning, and Procedural Complications: Infusion related reaction.
Hepatobiliary Disorders: Hepatocellular injury.
Musculoskeletal and Connective Tissue Disorders: Myalgia.
Renal and Urinary Disorders: Nephritis, tubulointerstitial nephritis.
Respiratory, Thoracic, and Mediastinal Disorders: Pneumonitis, interstitial lung disease.
Table 8 summarizes laboratory abnormalities worsening from baseline to Grade 3 or 4 in ≥1% of patients with dMMR recurrent or advanced solid tumors in GARNET.
4DESCRIPTION
Dostarlimab-gxly is a programmed death receptor-1 (PD-1)–blocking IgG
JEMPERLI (dostarlimab-gxly) injection is a sterile, clear to slightly opalescent, colorless to yellow solution essentially free from visible particles. It is supplied as single-dose vials.
Each vial contains 500 mg of JEMPERLI in 10 mL of solution with a pH of 6. Each mL of solution contains 50 mg of dostarlimab-gxly, citric acid monohydrate (0.48 mg), L-arginine hydrochloride (21.07 mg), polysorbate 80 (0.2 mg), sodium chloride (1.81 mg), trisodium citrate dihydrate (6.68 mg), and Water for Injection, USP.
5HOW SUPPLIED/STORAGE AND HANDLING
JEMPERLI (dostarlimab-gxly) injection is a clear to slightly opalescent, colorless to yellow solution supplied in a carton containing one 500 mg/10 mL (50 mg/mL), single-dose vial (NDC 0173-0898-03).
Store vial refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze or shake.
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Immune-Mediated Adverse Reactions
Inform patients of the risk of immune-mediated adverse reactions that may be severe or fatal, may occur after discontinuation of treatment, and may require corticosteroid or other treatment and interruption or discontinuation of JEMPERLI. These reactions may include:
- Pneumonitis: Advise patients to contact their healthcare provider immediately for new or worsening cough, chest pain, or shortness of breath
- Colitis: Advise patients to contact their healthcare provider immediately for diarrhea or severe abdominal pain
- Hepatitis: Advise patients to contact their healthcare provider immediately for jaundice, severe nausea or vomiting, or easy bruising or bleeding
- Immune-mediated endocrinopathies: Advise patients to contact their healthcare provider immediately for signs or symptoms of hypothyroidism, hyperthyroidism, thyroiditis, adrenal insufficiency, hypophysitis, or type 1 diabetes mellitus
- Nephritis: Advise patients to contact their healthcare provider immediately for signs or symptoms of nephritis
- Severe skin reactions: Advise patients to contact their healthcare provider immediately for any signs or symptoms of severe skin reactions, SJS, TEN, or DRESS
- Other immune-mediated adverse reactions:
Infusion-Related Reactions
- Advise patients to contact their healthcare provider immediately for signs or symptoms of infusion-related reactions
Complications of Allogeneic HSCT
- Advise patients of the risk of post-allogeneic hematopoietic stem cell transplantation complications
Embryo-Fetal Toxicity
- Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy
- Advise females of reproductive potential to use effective contraception during treatment with JEMPERLI and for 4 months after the last dose
Lactation
- Advise women not to breastfeed during treatment with JEMPERLI and for 4 months after the last dose
Trademarks are owned by or licensed to the GSK group of companies.
Manufactured by:
GlaxoSmithKline LLC
Philadelphia, PA 19104
U.S. License No. 1727
Distributed by:
GlaxoSmithKline
Durham, NC 27701
©2025 GSK group of companies or its licensor.
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