Jemperli

Last reviewed on RxList: 7/22/2021
Jemperli Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Jemperli?

Jemperli (dostarlimab-gxly) is a programmed death receptor-1 (PD-1)–blocking antibody used to treat adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen.

What Are Side Effects of Jemperli?

Side effects of Jemperli include:

Dosage for Jemperli

Dose 1 through 4 of Jemperli is 500 mg every 3 weeks. Subsequent dosing beginning 3 weeks after dose 4 (dose 5 onwards) of Jemperli is 1,000 mg every 6 weeks.

Jemperli In Children

The safety and efficacy of Jemperli have not been established in pediatric patients.

What Drugs, Substances, or Supplements Interact with Jemperli?

Jemperli may interact with other medicines.

Tell your doctor all medications and supplements you use.

Jemperli During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Jemperli; it may harm a fetus. Females of reproductive potential are advised to use effective contraception during treatment with Jemperli and for 4 months after the last dose. It is unknown if Jemperli passes into breast milk. Because of the potential for serious adverse reactions in a breastfed child, breastfeeding is not recommended during treatment with Jemperli and for 4 months after the last dose.

Additional Information

Our Jemperli (dostarlimab-gxly) Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Pelvic Pain: What's Causing Your Pelvic Pain? See Slideshow
Jemperli Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Some side effects may occur during the injection. Tell your caregiver if you feel light-headed, chilled or feverish, itchy, or short of breath.

Dostarlimab strengthens your immune system to help it attack cancer cells, but it may also attack healthy cells and you could develop serious or fatal side effects.

Call your doctor at once if you have:

  • new or worsening cough, shortness of breath;
  • chest pain, irregular heartbeats;
  • a light-headed feeling, like you might pass out;
  • a seizure;
  • confusion, hallucinations, eye pain or redness, vision problems;
  • severe stomach pain, nausea, vomiting, diarrhea, bloody or tarry stools;
  • low red blood cells (anemia)--pale skin, tiredness, cold hands and feet;
  • kidney problems--swelling in your ankles, blood in your urine, little or no urination;
  • liver problems--right-sided upper stomach pain, loss of appetite, bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes); or
  • signs of a hormonal disorder--frequent or unusual headaches, dizziness, feeling very weak, mood or behavior changes, hoarse or deepened voice, increased hunger or thirst, increased urination, constipation, hair loss, sweating, feeling cold, weight gain or loss.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • nausea, diarrhea, constipation;
  • anemia; or
  • feeling weak or tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Jemperli (Dostarlimab-gxly Injection)

QUESTION

What is pelvic inflammatory disease (PID)? See Answer
Jemperli Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Immune-mediated adverse reactions [see WARNINGS AND PRECAUTIONS]
  • Infusion-related reactions [see WARNINGS AND PRECAUTIONS]

Clinical 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 pooled safety population described in WARNINGS AND PRECAUTIONS reflects exposure to JEMPERLI in 444 patients with advanced or recurrent solid tumors in the open-label, multicohort GARNET study including 268 patients with EC and 176 patients with other solid tumors. JEMPERLI as a single agent was administered intravenously at doses of 500 mg every 3 weeks for 4 doses followed by 1,000 mg every 6 weeks until disease progression or unacceptable toxicity. Among the 444 patients, 38% were exposed for >6 months and 12% were exposed for >1 year.

Mismatch Repair Deficient (dMMR) Endometrial Cancer

The safety of JEMPERLI was evaluated in the GARNET trial in 104 patients with advanced or recurrent dMMR EC who received at least one dose of JEMPERLI [see Clinical Studies]. Patients received JEMPERLI 500 mg every 3 weeks for 4 doses followed by 1,000 mg every 6 weeks as an intravenous infusion until disease progression or unacceptable toxicity. Among patients receiving JEMPERLI, 47% were exposed for 6 months or longer and 20% were exposed for >1 year.

Serious adverse reactions occurred in 34% of patients receiving JEMPERLI. Serious adverse reactions in >2% of patients included sepsis (2.9%), acute kidney injury (2.9%), urinary tract infection (2.9%), abdominal pain (2.9%), and pyrexia (2.9%).

JEMPERLI was permanently discontinued due to adverse reactions in 5 (4.8%) patients, including transaminases increased, sepsis, bronchitis, and pneumonitis. 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, diarrhea, increased lipase, and pyrexia.

The most common adverse reactions (≥20%) were fatigue/asthenia, nausea, diarrhea, anemia, and constipation. The most common Grade 3 or 4 adverse reactions (≥2%) were anemia and transaminases increased.

Table 2 summarizes the adverse reactions that occurred in ≥10% of patients with dMMR EC on JEMPERLI in the GARNET study.

Table 2: Adverse Reactions (≥10%) in Patients with dMMR Endometrial Cancer who Received JEMPERLI in GARNET

Adverse Reaction JEMPERLI
N = 104
All Grades % Grade 3 or 4 %
Blood and Lymphatic System
Anemiaa 24 13
Gastrointestinal
Nausea 30 0
Diarrhea 26 1.9
Constipation 20 0.9
Vomiting 18 0
General and Administration Site
Fatigueb 48 1
Infections
Urinary tract infection 13 1.9
Metabolism and Nutrition
Decreased appetite 14 0
Musculoskeletal and Connective Tissue
Myalgia 12 0
Respiratory, Thoracic, and Mediastinal
Cough 14 0
Skin and Subcutaneous Tissue
Pruritus 14 1
Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03.
a Includes anemia, hemoglobin decreased, iron deficiency, and iron deficiency anemia.
b Includes fatigue and asthenia.

Table 3 summarizes Grade 3 or 4 laboratory abnormalities worsening from baseline in ≥1% of patients with dMMR EC on JEMPERLI in the GARNET study.

Table 3: Laboratory Abnormalities that Worsened from Baseline to Grade 3 or 4 Occurring in ≥1% of Patients with dMMR EC Receiving JEMPERLI in GARNET

Laboratory Test JEMPERLI
N =104
All Gradesa% Grade 3 or 4a%
Hematology
Lymphopenia 37 9
Leukopenia 21 2.9
Chemistry
Hypoalbuminemia 30 2.9
Increased alkaline phosphatase 25 2.9
Increased creatinine 27 2.9
Hyponatremia 26 4.8
Hypercalcemia 15 1.9
Increased alanine aminotransferase 15 2.9
Hypokalemia 15 1.9
Increased aspartate aminotransferase 16 1.9
dMMR EC = Mismatch Repair Deficient Endometrial Cancer.
a Consists of new onset of laboratory abnormality or worsening of baseline laboratory abnormality.

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to dostarlimab-gxly in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.

The immunogenicity of dostarlimab was evaluated in the GARNET study. The treatment-emergent anti-drug antibodies (ADAs) against dostarlimab-gxly were detected in 2.5% of 315 patients treated with dostarlimab-gxly at the recommended therapeutic dose. Neutralizing antibodies were detected in 1.3% of patients. Because of the small number of patients who developed ADAs, the impact of immunogenicity on the efficacy and safety of dostarlimab-gxly is inconclusive.

DRUG INTERACTIONS

No Information provided

Read the entire FDA prescribing information for Jemperli (Dostarlimab-gxly Injection)

© Jemperli Patient Information is supplied by Cerner Multum, Inc. and Jemperli Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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