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
- Bladder pain
- bloody or cloudy urine
- constipation
- depression
- difficult, burning, or painful urination
- dry skin and hair
- feeling cold
- frequent urge to urinate
- hair loss
- hoarseness or husky voice
- loss of appetite
- lower back or side pain
- muscle cramps and stiffness
- pale skin
- slow heartbeat
- sore tongue
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- weight gain
Less common
- Agitation
- chest pain or tightness
- chills
- coma
- confusion
- cough
- cough producing mucus
- decreased urine output
- diarrhea
- dizziness
- fever
- general feeling of discomfort or illness
- headache
- hostility
- irritability
- lethargy
- muscle twitching
- nausea
- nervousness
- rapid weight gain
- seizures
- sensitivity to heat
- stomach cramps, tenderness, or pain
- stupor
- sweating
- swelling of the face, feet, lower legs, ankles, or hands
- thickening of bronchial secretions
- trouble sleeping
- watery or bloody diarrhea
- weight loss
Rare
- Anxiety
- back or leg pain
- black, tarry stools
- bleeding gums
- bloating
- blood in the stools
- blue or pale skin
- blurred vision
- burning, tingling, numbness, or pain in the hands, arms, feet, or legs
- burning feeling in the chest or stomach
- change in vision
- chest pain, possibly moving to the left arm, neck, or shoulder
- dark urine
- darkening of the skin
- drowsiness
- dry mouth
- eye pain
- fainting
- fast heartbeat
- general body swelling
- inability to move the arms and legs
- indigestion
- joint pain
- light-colored stools
- lightheadedness
- loss of consciousness
- loss of strength or energy
- muscle aches, pain, tenderness, or weakness
- nosebleeds
- numbness or tingling in the fingers, face, or feet
- pains in the stomach, side, or abdomen, possibly radiating to the back
- partial or slight paralysis
- pinpoint red spots on the skin
- rapid, shallow breathing
- redness of the eye
- sensation of pins and needles
- sensitivity of the eye to light
- severe headache
- skin rash, redness, soreness, or itching
- sores, welting, or blisters
- stabbing pain
- stiff neck or back
- stomach discomfort or upset
- sudden numbness and weakness in the arms and legs
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- tearing
- upper right abdominal or stomach pain
- vomiting
- yellow eyes and skin
Incidence not known
- Blistering, peeling, or loosening of the skin
- cracks in the skin
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased thirst
- increased urination
- loss of heat from the body
- red irritated eyes
- red skin lesions, often with a purple center
- red, swollen skin
- scaly skin
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
Other side effects of Dostarlimab
Some side effects of dostarlimab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Constipation
For Healthcare Professionals
Applies to dostarlimab: intravenous solution.
Hematologic
Very common (10% or more): Lymphopenia (37%), anemia (e.g., anemia, hemoglobin decreased, iron deficiency, iron deficiency anemia) (24%), leukopenia (21%)
Uncommon (0.1% to 1%): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, immune thrombocytopenia[Ref]
Hypersensitivity
Very common (10% or more): Increased alkaline phosphatase (25%)[Ref]
Immunologic
Common (1% to 10%): Immunogenicity
Uncommon (0.1% to 1%): Systemic inflammatory response syndrome
Frequency not reported: Cytomegalovirus infection/reactivation[Ref]
Local
Uncommon (0.1% to 1%): Immune-related reactions[Ref]
Musculoskeletal
Very common (10% or more): Myalgia (12%)
Uncommon (0.1% to 1%): Myositis/polymyositis, rhabdomyolysis, arthritis, polymyalgia rheumatica[Ref]
Ocular
Uncommon (0.1% to 1%): Uveitis, iritis, other ocular inflammatory toxicities, retinal detachment, various grades of visual impairment, blindness, Vogt-Koyanagi-Harada syndrome[Ref]
Metabolic
Very common (10% or more): Hyponatremia (26%), hypercalcemia (15%), hypokalemia (15%), anorexia (14%)
Frequency not reported: Type 1 diabetes mellitus, ketoacidosis[Ref]
Genitourinary
Very common (10% or more): Urinary tract infection (13%)[Ref]
Hepatic
Very common (10% or more): Hypoalbuminemia (30%), Increased aspartate aminotransferase (16%), increased alanine aminotransferase (15%)
Uncommon (0.1% to 1%): Immune-mediated hepatitis[Ref]
Respiratory
Very common (10% or more): Cough (14%)
Common (1% to 10%): Immune-related pneumonitis[Ref]
Other
Very common (10% or more): Fatigue/asthenia (48%)
Uncommon (0.1% to 1%): Histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, solid organ transplant rejection[Ref]
Nervous system
Uncommon (0.1% to 1%): Meningitis, encephalitis, myelitis, demyelination, myasthenic syndrome/myasthenia gravis, Guillain-Barre syndrome, nerve paresis, autoimmune neuropathy[Ref]
Renal
Very common (10% or more): Increased creatinine (27%)
Uncommon (0.1% to 1%): Immune-related nephritis[Ref]
Cardiovascular
Uncommon (0.1% to 1%): Myocarditis, pericarditis, vasculitis[Ref]
Dermatologic
Very common (10% or more): Pruritus (14%)
Frequency not reported: Immune-mediated rash/dermatitis, bullous and exfoliative dermatitis, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug rash with eosinophilia and systemic symptoms (DRESS), non-bullous/exfoliative rashes[Ref]
Endocrine
Uncommon (0.1% to 1%): Adrenal insufficiency, hypophysitis (e.g., headache, photophobia, visual field cuts), hypopituitarism, thyroid disorders (e.g., thyroiditis, hypothyroidism, hyperthyroidism)[Ref]
Gastrointestinal
Very common (10% or more): Nausea (30%), diarrhea (26%), constipation (20%), vomiting (18%)
Common (1% to 10%): Immune-related colitis
Uncommon (0.1% to 1%): Pancreatitis, increases in serum amylase and lipase levels, gastritis, duodenitis[Ref]
