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Brand Name :
Yervoy
(United States) [Available]Synonyms :
ipilimumab
Class :
Antineoplastics and Monoclonal Antibody
Brand Name :
Yervoy
(United States) [Available]Synonyms :
ipilimumab
Class :
Antineoplastics and Monoclonal Antibody
Dosage Forms & Strengths
Injectable solution- single dose
5mg per ml
3 mg per kg given IV over 90 minutes every three weeks for a maximum of 4 doses
Adjuvant treatment of melanoma:
10 mg per kg given IV over 90mins every three weeks for four doses, followed by 10 mg per kg given IV over 90mins every 12 weeks for up to 3yrs
ipilimumab 1 mg per kg given IV over 30 minutes every 3 weeks with nivolumab 3 mg per kg given IV over 30 minutes on the same day for 4 doses
After completing four doses of combination, nivolumab is given as a single agent
Continue the treatment until disease progression or unacceptable toxicity occurs
ipilimumab 1 mg per kg given IV over 30 minutes every 3 weeks with nivolumab 3 mg per kg given IV over 30 minutes on the same day for 4 doses
After completing four doses of combination, nivolumab is given as a single agent
Continue the therapy until disease progression or unacceptable toxicity occurs
ipilimumab 3 mg per kg given IV over 30 minutes every 3 weeks with nivolumab 1mg per kg given IV over 30 minutes on the same day for 4 doses
After completing four doses of combination, nivolumab is given as a single agent.
Continue the therapy until disease progression or unacceptable toxicity occurs.
Dosage Forms & Strengths
Injectable solution- single dose
5mg per ml
Age: >12yrs
3 mg per kg given IV over 90 minutes every three weeks for a maximum of 4 doses
Adjuvant treatment of melanoma:
10 mg per kg given IV over 90mins every three weeks for four doses, followed by 10 mg per kg given IV over 90mins every 12 weeks for up to 3yrs
Age:>12yrs
ipilimumab 1 mg per kg given IV over 30 minutes every 3 weeks with nivolumab 3 mg per kg given IV over 30 minutes on the same day for 4 doses
After completing four doses of combination, nivolumab is given as a single agent.
Continue the therapy until disease progression or unacceptable toxicity occurs.
when both drugs are combined, there may be an increased risk of adverse effects
when both drugs are combined, there may be an increased risk of adverse effects
when both drugs are combined, there may be an increased risk of adverse effects
when both drugs are combined, there may be an increased risk of adverse effects
when both drugs are combined, there may be an increased risk of adverse effects
when both drugs are combined, there may be an increased risk of adverse effects
when both drugs are combined, there may be an increased risk of adverse effects
when both drugs are combined, there may be an increased risk of adverse effects
It may enhance the immunosuppressive effects when combined with idecabtagene vicleucel
when both drugs are combined, there may be an increased risk of infection
when both drugs are combined, there may be an increased risk of infection
when both drugs are combined, there may be an increased risk of infection
when both drugs are combined, there may be an increased risk of infection
when both drugs are combined, there may be an increased risk of infection
when both drugs are combined, there may be an increased risk of infection
it may enhance the adverse effects when combined with aducanumab
It may enhance the adverse effects when combined with sotrovimab
Action
Ipilimumab is a fully human monoclonal antibody that targets cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), an immune checkpoint receptor expressed on the surface of activated T cells. Under normal physiological conditions, CTLA-4 acts as a negative regulator of T-cell activation by competing with the co-stimulatory receptor CD28 for binding to B7 ligands (CD80/CD86) on antigen-presenting cells. This mechanism helps maintain immune homeostasis and prevent autoimmunity. By binding to and inhibiting CTLA-4, ipilimumab removes this inhibitory signal, resulting in enhanced T-cell activation and proliferation. It is used to treat several advanced cancers, mainly in combination with nivolumab. It is approved for metastatic melanoma, advanced renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC), microsatellite instability-high colorectal cancer (MSI-H CRC), and hepatocellular carcinoma (HCC).
Adverse drug reactions:
>10%
Diarrhea
Dermatitis immune-mediated manifestations
Fatigue
Pruritus
Rash
1-10%
Colitis
Conjunctivitis
Immune-mediated enterocolitis
Immune-mediated hepatitis
Myocarditis
Meningitis
Pericarditis
Angiopathy
Temporal arteritis
Vasculitis
Polymyalgia rheumatica
Ipilimumab has a black box warning for severe immune-mediated side effects that can be life-threatening or fatal. These include colitis, hepatitis, dermatitis, endocrine disorders, and pneumonitis. Early detection and treatment with corticosteroids are essential, and the drug may need to be stopped based on severity.
Contraindications
Known hypersensitivity to ipilimumab or any of its components.
Patients with active autoimmune diseases or conditions where immune activation could cause severe harm, unless benefits outweigh risks (use with extreme caution).
Cautions
Use cautiously in patients with pre-existing autoimmune disorders as ipilimumab can worsen these conditions.
Monitor closely for immune-related adverse effects affecting the liver, intestines, skin, endocrine glands, lungs, and other organs.
Use caution in patients with compromised organ function or infections, as immune stimulation may exacerbate these issues.
Pregnancy warnings:
Breastfeeding warnings:
Pregnancy Categories:
Ipilimumab is a human monoclonal antibody that blocks CTLA-4, an immune checkpoint on T cells. By inhibiting CTLA-4, it boosts T-cell activation and helps the immune system attack cancer cells.
Pharmacodynamics
Ipilimumab is a fully human monoclonal antibody that targets cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), an immune checkpoint receptor expressed on the surface of activated T cells. Under normal physiological conditions, CTLA-4 acts as a negative regulator of T-cell activation by competing with the co-stimulatory receptor CD28 for binding to B7 ligands (CD80/CD86) on antigen-presenting cells. This mechanism helps maintain immune homeostasis and prevent autoimmunity. By binding to and inhibiting CTLA-4, ipilimumab removes this inhibitory signal, resulting in enhanced T-cell activation and proliferation.
Pharmacokinetics
Absorption:
The minimum plasma concentration at steady state is 19.4 mcg/mL.
Distribution:
The drug distributes primarily in the vascular and interstitial spaces.
Volume of distribution is relatively small (~7.2 L), consistent with a large monoclonal antibody.
Metabolism:
Ipilimumab is metabolized via nonspecific catabolic pathways typical for proteins, primarily by proteolytic enzymes into small peptides and amino acids.
It is not metabolized by the liver cytochrome P450 system.
Excretion and Elimination
Clearance rate is 16.8 ml/hr.
The elimination half-life is approximately 15.4 days.
Ipilimumab is given by intravenous (IV) infusion.
Infuse the diluted solution over 30 minutes through an IV line equipped with a sterile, nonpyrogenic, low-protein-binding in-line filter.
Patients should be closely monitored during and after infusion for infusion-related reactions and immune-related adverse effects.
Generic Name: ipilimumab
Pronounced: IP-i-LIM-ue-mab
Why do we use ipilimumab?
Ipilimumab is used to treat advanced cancers like metastatic melanoma, renal cell carcinoma, non-small cell lung cancer, MSI-high colorectal cancer, and hepatocellular carcinoma by boosting the immune system to attack cancer cells.
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