"This week the U.S. Food and Drug Administration approved Mekinist (trametinib) in combination with Tafinlar (dabrafenib) to treat patients with advanced melanoma that is unresectable (cannot be removed by surgery) or metastatic (late-stage)."...
Yervoy Side Effects Center
Medical Editor: Melissa Conrad Stöppler, MD
Yervoy (ipilimumab) is a monoclonal antibody used to treat late-stage, metastatic melanoma, a deadly skin cancer. Yervoy is thought to work by allowing the body's immune system to recognize, target, and attack cells in these tumors. Patients with metastatic melanoma are shown to live longer when treated with Yervoy. Side effects of Yervoy can include enterocolitis, decreased liver function, and dermatitis.
Yervoy is administered intravenously over 90 minutes every 3 weeks for a total of four doses. It is not known whether Yervoy is secreted in human milk. Breastfeeding mothers should carefully consider the potential for serious adverse reactions in nursing infants. A decision should be made to discontinue nursing or to discontinue Yervoy. Safety and effectiveness of YERVOY have not been established in pediatric patients.
Our Yervoy (ipilimumab) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Yervoy in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: 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 may include:
- mild diarrhea; or
- mild skin rash or itching.
Read the entire detailed patient monograph for Yervoy (Ipilimumab Injection)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Yervoy Overview - Patient Information: Side Effects
Tiredness, nausea, or vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication have serious side effects.
A very serious allergic reaction to this drug is unlikely. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Read the entire patient information overview for Yervoy (Ipilimumab Injection)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Yervoy FDA Prescribing Information: Side Effects
The following adverse reactions are discussed in greater detail in other sections of the labeling.
- Immune-mediated enterocolitis [see WARNINGS AND PRECAUTIONS].
- Immune-mediated hepatitis [see WARNINGS AND PRECAUTIONS].
- Immune-mediated dermatitis [see WARNINGS AND PRECAUTIONS].
- Immune-mediated neuropathies [see WARNINGS AND PRECAUTIONS].
- Immune-mediated endocrinopathies [see WARNINGS AND PRECAUTIONS].
- Other immune-mediated adverse reactions, including ocular manifestations [see WARNINGS AND PRECAUTIONS].
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared with rates in other clinical trials or experience with therapeutics in the same class and may not reflect the rates observed in clinical practice.
The clinical development program excluded patients with active autoimmune disease or those receiving systemic immunosuppression for organ transplantation. Exposure to YERVOY 3 mg/kg for 4 doses given by intravenous infusion in previously treated patients with unresectable or metastatic melanoma was assessed in a randomized, double-blind clinical study (Study 1). [See Clinical Studies] One hundred thirty-one patients (median age 57 years, 60% male) received YERVOY as a single agent, 380 patients (median age 56 years, 61% male) received YERVOY with an investigational gp100 peptide vaccine (gp100), and 132 patients (median age 57 years, 54% male) received gp100 peptide vaccine alone. Patients in the study received a median of 4 doses (range: 1-4 doses). YERVOY was discontinued for adverse reactions in 10% of patients.
Table 1 presents selected adverse reactions from Study 1, which occurred in at least 5% of patients in the YERVOY-containing arms and with at least 5% increased incidence over the control gp100 arm for all-grade events and at least 1% incidence over the control group for Grade 3-5 events.
Table 1: Selected Adverse Reactions in Study 1
|System Organ Class/ Preferred Term||Percentage (%) of Patientsa|
|YERVOY 3 mg/kg
|YERVOY 3 mg/kg + gp100
|Any Grade||Grade 3-5||Any Grade||Grade 3-5||Any Grade||Grade 3-5|
|Skin and Subcutaneous Tissue Disorders|
|General Disorders and Administration Site Conditions|
|a Incidences presented in this table are based on reports of adverse events regardless of causality.|
Table 2 presents the per-patient incidence of severe, life-threatening, or fatal immune-mediated adverse reactions from Study 1.
Table 2: Severe to Fatal
Immune-mediated Adverse Reactions in Study 1
|Percentage (%) of Patients|
|Any Immune-mediated Adverse Reaction||15||12|
|a Including fatal outcome.
bIncluding intestinal perforation.
c Underlying etiology not established.
Across clinical studies that utilized YERVOY doses ranging from 0.3 to 10 mg/kg, the following adverse reactions were also reported (incidence less than 1% unless otherwise noted): urticaria (2%), large intestinal ulcer, esophagitis, acute respiratory distress syndrome, renal failure, and infusion reaction.
Based on the experience in the entire clinical program for melanoma, the incidence and severity of enterocolitis and hepatitis appear to be dose dependent.
In clinical studies, 1.1% of 1024 evaluable patients tested positive for binding antibodies against ipilimumab in an electrochemiluminescent (ECL) based assay. This assay has substantial limitations in detecting anti-ipilimumab antibodies in the presence of ipilimumab. Infusion-related or peri-infusional reactions consistent with hypersensitivity or anaphylaxis were not reported in these 11 patients nor were neutralizing antibodies against ipilimumab detected.
Because trough levels of ipilimumab interfere with the ECL assay results, a subset analysis was performed in the dose cohort with the lowest trough levels. In this analysis, 6.9% of 58 evaluable patients, who were treated with 0.3 mg/kg dose, tested positive for binding antibodies against ipilimumab.
Immunogenicity assay results are highly dependent on several factors including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to YERVOY with the incidences of antibodies to other products may be misleading.
Read the entire FDA prescribing information for Yervoy (Ipilimumab Injection)
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