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Avelumab Side Effects

For the Consumer

Applies to avelumab: intravenous solution

Along with its needed effects, avelumab 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 avelumab:

More Common

  • Abdominal or stomach pain
  • back pain
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • chills
  • confusion
  • cough
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • feeling of warmth
  • fever
  • headache
  • hives or welts, itching, or skin rash
  • hoarseness
  • irritation
  • joint pain, stiffness, or swelling
  • nervousness
  • pounding in the ears
  • rapid weight gain
  • redness of the face, neck, arms, and occasionally, upper chest
  • redness of the skin
  • slow or fast heartbeat
  • sweating
  • swelling of the eyelids, face, lips, hands, or feet
  • tightness in the chest
  • tingling of the hands or feet
  • troubled breathing or swallowing
  • unusual tiredness or weakness
  • unusual weight gain or loss

Less Common

  • Chest pain
  • constipation
  • depressed mood
  • dry skin and hair
  • feeling cold
  • general feeling of discomfort or illness
  • hair loss
  • muscle cramps and stiffness
  • stomach cramps
  • thickening of bronchial secretions
  • watery or bloody diarrhea
  • weight gain

Rare

  • Blistering, peeling, or loosening of the skin
  • bloody or cloudy urine
  • chest discomfort
  • dark urine
  • darkening of the skin
  • diarrhea
  • drowsiness
  • dry mouth
  • fainting
  • flushed, dry skin
  • fruit-like breath odor
  • increased hunger
  • increased thirst
  • increased urination
  • light-colored stools
  • loss of appetite
  • loss of consciousness
  • muscle pain
  • nausea or vomiting
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • sensitivity to heat
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • stomachache
  • trouble sleeping
  • unexplained weight loss
  • unusual tiredness or weakness
  • upper right abdominal or stomach pain
  • weight loss
  • yellow eyes and skin

Some side effects of avelumab 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

  • Decreased appetite

For Healthcare Professionals

Applies to avelumab: intravenous solution

Cardiovascular

Very common (10% or more): Hypotension (25%), hypertension (13%)

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

Dermatologic

Very common (10% or more): Urticaria (25%), rash (e.g., maculopapular, erythema, dermatitis bullous) (22%), pruritus (10%)

Uncommon (0.1% to 1%): Psoriasis, arthritis, exfoliative dermatitis, pemphigoid, Stevens Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), histiocytic necrotizing lymphadenitis, vasculitis, hypophysitis[Ref]

Endocrine

Common (1% to 10%): Immune-mediated thyroid disorders (hypothyroidism/hyperthyroidism)

Uncommon (0.1% to 1%): Adrenal insufficiency, hypopituitarism, hypophysitis[Ref]

Gastrointestinal

Very common (10% or more): Abdominal pain (25%), diarrhea (23%), nausea (22%), constipation (17%)

Common (1% to 10%): Immune-mediated colitis

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

Hematologic

Very common (10% or more): Lymphopenia (49%), anemia (35%), thrombocytopenia (27%)

Common (1% to 10%): Neutropenia

Rare (0.01% to 0.1%): Hemolytic anemia[Ref]

Hepatic

Very common (10% or more): Increased aspartate aminotransferase (AST) (34%), increased alanine aminotransferase (ALT) (20%)

Common (1% to 10%): Increased bilirubin

Uncommon (0.1% to 1%): Immune-mediated hepatitis[Ref]

Immunologic

Common (1% to 10%): Immunogenicity[Ref]

Local

Very common (10% or more): Anorexia (20%), weight loss (15%), increased lipase (14%)

Common (1% to 10%): Increased amylase[Ref]

Metabolic

Very common (10% or more): Anorexia (20%), weight loss (15%), increased lipase (14%)

Common (1% to 10%): Increased amylase[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (32%), back pain (25%), arthralgia (16%)

Common (1% to 10%):

Uncommon (0.1% to 1%): Myositis, rhabdomyolysis, myasthenia gravis[Ref]

Nervous system

Very common (10% or more): Dizziness (14%), headache (10%)

Uncommon (0.1% to 1%): Guillain-Barre syndrome, demyelination, encephalitis[Ref]

Respiratory

Very common (10% or more): Couth (18%), dyspnea (11%)

Common (1% to 10%): Immune-mediated pneumonitis, wheezing[Ref]

Renal

Rare (less than 0.1%): Immune-mediated nephritis[Ref]

Other

Very common (10% or more): Fatigue (50%), pyrexia (25%), chills (25%), flushing (25%), peripheral edema (20%)[Ref]

Ocular

Uncommon (0.1% to 1%): Uveitis, iritis[Ref]

References

1. "Product Information. Bavencio (avelumab)." EMD Serono Inc, Rockland, MA.

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.

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