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Dostarlimab Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 7, 2023.

Applies to dostarlimab: intravenous solution.

Serious side effects of Dostarlimab

Along with its needed effects, dostarlimab may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking dostarlimab:

More common

Less common

Rare

Incidence not known

For Healthcare Professionals

Applies to dostarlimab: intravenous solution.

General

-The most frequently observed adverse reactions (occurring in 20% or more) were fatigue/asthenia, anemia, rash, nausea, diarrhea, constipation, and vomiting.

-The most common Grade 3 or 4 laboratory abnormalities (seen in 2% or more of patients) were decreased lymphocytes, decreased sodium, increased alanine aminotransferase, increased creatinine, decreased neutrophils, decreased albumin, and increased alkaline phosphatase.[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Myocarditis[Ref]

Dermatologic

Very common (10% or more): Rash (rash, rash maculo-papular, rash pruritic, erythema, and pemphigoid; up to 21%), pruritus (up to 19%)[Ref]

Endocrine

Very common (10% or more): Hypothyroidism (up to 11%)

Common (1% to 10%): Hyperthyroidism, adrenal insufficiency

Uncommon (0.1% to 1%): Hypophysitis, thyroiditis[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 32%), diarrhea (up to 29%), constipation (up to 23%), vomiting (up to 23%), abdominal pain (up to 15.1%)

Common (1% to 10%): Colitis, pancreatitis, gastritis

Uncommon (0.1% to 1%): Esophagitis

Frequency not reported: Enterocolitis, hemorrhage, acute pancreatitis[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (up to 19%)[Ref]

Hematologic

Very common (10% or more): Anemia (anemia, decreased hemoglobin, iron deficiency, and iron deficiency anemia; up to 35%), decreased lymphocytes (up to 46%), decreased leukocytes (up to 21%), decreased neutrophils (up to 17%)

Uncommon (0.1% to 1%): Autoimmune hemolytic anemia[Ref]

Hepatic

Very common (10% or more): Hypoalbuminemia (up to 36%), increased transaminases (increased alanine aminotransferase, increased aspartate aminotransferase, increased transaminases, and hypertransaminasemia; up to 13%), increased alkaline phosphatase (up to 31%), increased aspartate aminotransferase (up to 31%), increased alanine aminotransferase (up to 25%), increased total bilirubin (up to 7%)

Uncommon (0.1% to 1%): Hepatitis

Frequency not reported: Hepatocellular injury[Ref]

Metabolic

Very common (10% or more): Decreased appetite (up to 15%), hyponatremia (up to 29%), hypomagnesemia (up to 28%), hypokalemia (up to 22%), hypercalcemia (up to 8%), hyperkalemia (up to 14%)

Common (1% to 10%): Hypermagnesemia, hypercalcemia

Uncommon (0.1% to 1%): Type 1 diabetes mellitus, diabetic ketoacidosis[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (up to 10%), arthralgia (up to 16.6%), back pain (up to 12.3%)

Uncommon (0.1% to 1%): Immune-mediated arthritis, polymyalgia rheumatica, myositis[Ref]

Nervous system

Uncommon (0.1% to 1%): Myasthenia gravis, myasthenic syndrome, encephalitis[Ref]

Ocular

Uncommon (0.1% to 1%): Uveitis

Frequency not reported: Iridocyclitis[Ref]

Other

Very common (10% or more): Fatigue (fatigue and asthenia; up to 49%), pyrexia (up to 13%)

Common (1% to 10%): Chills, infusion-related reaction, sepsis

Uncommon (0.1% to 1%): Systemic inflammatory response syndrome[Ref]

Renal

Very common (10% or more): Increased creatinine (up to 33%)

Common (1% to 10%): Acute kidney injury

Uncommon (0.1% to 1%): Nephritis

Frequency not reported: Tubulointerstitial nephritis[Ref]

Respiratory

Very common (10% or more): Cough (up to 15%), dyspnea (up to 12.5%)

Common (1% to 10%): Pneumonitis

Frequency not reported: Interstitial lung disease[Ref]

References

1. Product Information. Jemperli (dostarlimab). GlaxoSmithKline Australia Pty Ltd. 2022.

2. Product Information. Jemperli (dostarlimab). GlaxoSmithKline. 2021.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.