Ipilimumab

Ipilimumab
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gloria Picoy [2]

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Black Box Warning

Immune-mediated adverse reactions See full prescribing information for complete Boxed Warning. YERVOY can result in severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY. Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions. Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests and thyroid function tests at baseline and before each dose.

Overview

Ipilimumab is an antineoplastic Agent that is FDA approved for the treatment of unresectable or metastatic melanoma. There is a Black Box Warning for this drug as shown here. Common adverse reactions include pruritus, colitis, fatigue.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Ipilimumab FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ipilimumab in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ipilimumab in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Ipilimumab FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ipilimumab in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ipilimumab in pediatric patients.

Contraindications

There is limited information regarding Ipilimumab Contraindications in the drug label.

Warnings

Immune-mediated adverse reactions See full prescribing information for complete Boxed Warning. YERVOY can result in severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY. Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions. Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests and thyroid function tests at baseline and before each dose.

There is limited information regarding Ipilimumab Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Ipilimumab Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Ipilimumab Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Ipilimumab Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Ipilimumab in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ipilimumab in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Ipilimumab during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Ipilimumab in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Ipilimumab in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Ipilimumab in geriatric settings.

Gender

There is no FDA guidance on the use of Ipilimumab with respect to specific gender populations.

Race

There is no FDA guidance on the use of Ipilimumab with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Ipilimumab in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Ipilimumab in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Ipilimumab in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Ipilimumab in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Ipilimumab Administration in the drug label.

Monitoring

There is limited information regarding Ipilimumab Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Ipilimumab and IV administrations.

Overdosage

There is limited information regarding Ipilimumab overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Ipilimumab Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Ipilimumab Mechanism of Action in the drug label.

Structure

There is limited information regarding Ipilimumab Structure in the drug label.

Pharmacodynamics

There is limited information regarding Ipilimumab Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Ipilimumab Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Ipilimumab Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Ipilimumab Clinical Studies in the drug label.

How Supplied

There is limited information regarding Ipilimumab How Supplied in the drug label.

Storage

There is limited information regarding Ipilimumab Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Ipilimumab Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Ipilimumab interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Ipilimumab Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Ipilimumab Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

WikiDoc Resources for Ipilimumab
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Evidence Based Medicine
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Clinical Trials
Ongoing Trials on Ipilimumab at Clinical Trials.gov Trial results on Ipilimumab Clinical Trials on Ipilimumab at Google
Guidelines / Policies / Govt
US National Guidelines Clearinghouse on Ipilimumab NICE Guidance on Ipilimumab NHS PRODIGY Guidance FDA on Ipilimumab CDC on Ipilimumab
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News
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Definitions
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Patient Resources / Community
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Healthcare Provider Resources
Symptoms of Ipilimumab Causes & Risk Factors for Ipilimumab Diagnostic studies for Ipilimumab Treatment of Ipilimumab
Continuing Medical Education (CME)
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International
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Experimental / Informatics
List of terms related to Ipilimumab

Overview

Ipilimumab (also known as MDX-010) is a human monoclonal antibody being developed by Bristol-Myers Squibb and Medarex. It is intended to be used as a drug to activate the immune system. Ipilimumab is undergoing clinical trials for the treatment of melanoma.

Ipilimumab is a fully human antibody that binds to CTLA-4 (cytotoxic T lymphocyte-associated antigen 4), a molecule on T-cells that is believed to play a critical role in regulating natural immune responses. The absence or presence of CTLA-4 can augment or suppress the immune system's T-cell response in fighting disease. Ipilimumab is designed to block the activity of CTLA-4, thereby sustaining an active immune response in its attack on cancer cells.

As of October 2007 there are two fully human anti CTLA-4 [3] monoclonal antibodies in advanced clinical trials. Ipilimumab, which is an IgG1 isotype, and Tremelimumab (from Pfizer) which is an IgG2 isotype.

References

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