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Libtayo Side Effects

Generic name: cemiplimab

Medically reviewed by Drugs.com. Last updated on Sep 14, 2020.

Note: This document contains side effect information about cemiplimab. Some of the dosage forms listed on this page may not apply to the brand name Libtayo.

For the Consumer

Applies to cemiplimab: intravenous solution

Side effects requiring immediate medical attention

Along with its needed effects, cemiplimab (the active ingredient contained in Libtayo) 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 cemiplimab:

More common

  • Chills
  • cough
  • diarrhea
  • fever
  • hoarseness
  • itching, skin rash
  • lower back or side pain
  • painful or difficult urination

Less common

  • Bladder pain
  • bloody or cloudy urine
  • blurred vision
  • chest pain or discomfort
  • confusion
  • dark urine
  • dizziness
  • fainting
  • frequent urge to urinate
  • general feeling of discomfort or illness
  • general tiredness and weakness
  • headache
  • light-colored stools
  • lightheadedness
  • muscle or bone pain
  • muscle weakness
  • nausea
  • nervousness
  • pain, redness, swelling, tenderness, or warmth on the skin
  • pale skin
  • pounding in the ears
  • rapid, shallow breathing
  • slow or fast heartbeat
  • sneezing
  • sore throat
  • stiff neck or back
  • thickening of bronchial secretions
  • tightness in the chest
  • trouble breathing
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • upper right abdominal pain
  • vomiting
  • yellow eyes and skin

Side effects not requiring immediate medical attention

Some side effects of cemiplimab 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

For Healthcare Professionals

Applies to cemiplimab: intravenous solution

Ocular

Uncommon (0.1% to 1%): Uveitis, iritis, retinal detachment, visual impairment, blindness[Ref]

Cardiovascular

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

Dermatologic

Very common (10% or more): Rash (e.g., maculopapular rash, dermatitis, generalized rash, dermatitis bullous, drug eruption, erythema, erythematous rash, macular rash, pruritic rash, skin reaction) (25%), pruritus (15%)[Ref]

Endocrine

Common (1% to 10%): Hypothyroidism, hyperthyroidism

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

Gastrointestinal

Very common (10% or more): Diarrhea/colitis (22%), nausea (19%), constipation (12%)

Uncommon (0.1% to 1%): Colitis, pancreatitis[Ref]

Immunologic

Common (1% to 10%): Immunogenicity

Uncommon (0.1% to 1%): Sjogren's syndrome, immune thrombocytopenic purpura[Ref]

Local

Uncommon (0.1% to 1%): Infusion-related reactions[Ref]

Metabolic

Very common (10% or more): Decreased appetite (10%)

Uncommon (0.1% to 1%): Type 1 diabetes mellitus, myositis, rhabdomyolysis, arthritis, polymyalgia rheumatica[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (e.g., back pain, myalgia, neck pain, pain in extremity (17%)

Common (1% to 10%: Arthralgia, arthritis, muscular weakness[Ref]

Nervous system

Uncommon (0.1% to 1%): Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis, Guillain-Barre syndrome, nerve paresis, autoimmune neuropathy, central nervous system inflammation, neuropathy peripheral, chronic inflammatory demyelinating polyradiculoneuropathy, Myasthenia gravis[Ref]

Other

Very common (10% or more): Fatigue/asthenia (29%)[Ref]

Respiratory

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

Hepatic

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

Renal

Uncommon (0.1% to 1%): Nephritis, renal failure[Ref]

References

1. "Product Information. Libtayo (cemiplimab)." Regeneron Pharmaceuticals Inc, Tarrytown, NY.

Frequently asked questions

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.