Yervoy Side Effects

Generic name: ipilimumab

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

Some side effects of Yervoy may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to ipilimumab: intravenous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking ipilimumab (the active ingredient contained in Yervoy) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal reactions may occur during treatment with ipilimumab or months after stopping. Contact your doctor right away if you have symptoms such as:

• diarrhea, increased bowel movements, black or bloody stools, stomach tenderness;

• pain in your upper stomach, dark urine, jaundice (yellowing of the skin or eyes), easy bruising or bleeding;

• unusual muscle weakness, numbness or tingling in your hands or feet;

• unusual headaches, feeling cold or tired, weight gain, dizzy spells, mood changes, irritability, confusion;

• mouth sores, skin rash with or without itching, blistering or peeling, skin sores with bleeding; or

• eye pain, or vision problems.

Call your doctor at once if you have any of these other serious side effects:

• severe stomach pain, bloating, constipation, or vomiting;

• loss of bowel control;

• trouble with daily activities;

• feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

• urinating less than usual or not at all;

• severe upper stomach pain spreading to your back, nausea and vomiting, fast heart rate;

• fever, cough, trouble breathing; or

• chest pain, feeling short of breath (even with mild exertion), swelling, rapid weight gain.

Less serious side effects of ipilimumab may include:

• mild diarrhea; or

• mild skin rash or itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to ipilimumab: intravenous solution

General

In general, the most commonly reported adverse effects occurring in 5% or more of patients included fatigue, diarrhea, pruritus, rash, and colitis. Approximately 10% of patients discontinued ipilimumab (the active ingredient contained in Yervoy) because of adverse reactions.

Cardiovascular

Cardiovascular side effects occurring in less than 1% of patients have included immune-mediated pericarditis, myocarditis, angiopathy, temporal arteritis, and vasculitis.

Dermatologic

Dermatologic side effects have included pruritus (31%), rash (29%), urticaria (2%), and immune-mediated dermatitis (2%; including Stevens-Johnson syndrome and toxic epidermal necrolysis). Dermatologic side effects occurring in less than 1% of patients have included immune-mediated erythema multiforme and psoriasis.

Endocrine

Endocrine side effects have included immune-mediated endocrinopathy (4%), hypopituitarism (4%), hypothyroidism, and in less than 1% of patients, autoimmune thyroiditis, adrenal insufficiency, and hypogonadism.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (32%), colitis (8%), and immune-mediated enterocolitis (7%; including intestinal perforation). Gastrointestinal side effects occurring in less than 1% of patients have included large intestinal ulcer, esophagitis, and immune-mediated pancreatitis.

The incidence and severity of enterocolitis appears to be dose dependent.

Hematologic

Hematologic side effects have included immune-mediated eosinophilia (1%) and in less than 1% of patients, hemolytic anemia and leukocytoclastic vasculitis.

Hepatic

Hepatic side effects have included immune-mediated hepatitis (1%; including fatal hepatic failure and elevated transaminase and bilirubin levels).

The incidence and severity of hepatitis appears to be dose dependent.

Immunologic

Immunologic side effects have included severe and fatal immune-mediated reactions involving any organ system; most commonly enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. Anti-ipilimumab (the active ingredient contained in Yervoy) antibodies have been detected in patients receiving ipilimumab.

Nervous system

Nervous system side effects have included immune-mediated neuropathy (1%) and in less than 1% of patients, meningitis.

Ocular

Ocular side effects occurring in less than 1% of patients have included immune-mediated uveitis, iritis, conjunctivitis, blepharitis, episcleritis, and scleritis.

Other

Other side effects have included fatigue (41%).

Renal

Renal side effects have included immune-mediated nephritis (1%). Renal side effects occurring in less than 1% of patients have included renal failure.

Respiratory

Respiratory side effects occurring in less than 1% of patients have included acute respiratory distress syndrome and immune-mediated pneumonitis.

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