Antilymphocyte immunoglobulin (horse)

Identification

Summary

Antilymphocyte immunoglobulin (horse) is a primarily IgG immune globulin used to manage allograft rejection in renal transplant patients.

Brand Names
Atgam
Generic Name
Antilymphocyte immunoglobulin (horse)
DrugBank Accession Number
DB09312
Background

Equine anti-thymocyte globulin is composed of purified gamma globulin containing primarily IgG against human thymus lymphocytes. It is formed by inoculating a horse with an antigen (human thymoyctes) which then induces the horse immune system's B-lymphocytes to produce IgG immunoglobulins specific for that antigen. The result is polyclonal IgG that is then purified from the horse's serum to produce a usable drug product that can be used for immunosuppression. Although the exact mechanism of action is unknown, equine anti-thymocyte globulin targets a variety of immune system proteins including lymphocyte surface proteins, granulocytes, platelets, bone marrow cells, and other cell types. Equine ATG is currently indicated for the suppression of the immune system to prevent renal transplant rejection and in the treatment of aplastic anemia. Induction of T cell apoptosis and resulting T-cell lymphopenia found in vivo is credited for its therapeutic effect in these conditions.

There are currently various ATG products available, which differ in the source of inoculated animal (rabbit, horse, or pig) and in the type of antigen product used to produce immunoglobulin (thymocytes, peripheral T cells, etc.).

Type
Biotech
Groups
Approved, Investigational
Biologic Classification
Protein Based Therapies
Monoclonal antibody (mAb)
Protein Chemical Formula
Not Available
Protein Average Weight
Not Available
Sequences
Not Available
Synonyms
  • Anti-thymocyte Globulin (Equine)
  • Anti-thymocyte globulin equine
  • eATG
  • equine ATG
  • Equine thymocyte immune globulin
  • hATG
  • Horse anti-thymocyte globulin
  • Horse ATG
  • Lymphocyte immune globulin anti-thymocyte globulin (equine)
  • Lymphocyte immune globulin, anti-thymocyte globulin

Pharmacology

Indication

For prevention of renal transplant rejection and for the treatment of aplastic anemia.

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Associated Conditions
Indication TypeIndicationCombined Product DetailsApproval LevelAge GroupPatient CharacteristicsDose Form
Management ofGraft-versus-host disease••• •••••
Treatment ofHeart transplant rejection••• •••••
Prophylaxis ofHeart transplant rejection••• •••••
Treatment ofLung transplant rejection••• •••••
Prophylaxis ofLung transplant rejection••• •••••
Contraindications & Blackbox Warnings
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Pharmacodynamics

Not Available

Mechanism of action
Not Available
Absorption

Not Available

Volume of distribution

During infusion of 10 to 15 mg/kg/day, the mean peak value (n = 27 renal transplant patients) was found to be 727 ± 310 μg/mL.

Protein binding

Not Available

Metabolism
Not Available
Route of elimination

Not Available

Half-life

The half-life of equine immunoglobulin after ATGAM infusion was found to be 5.7 ± 3.0 days in one group of recipients. The range for half-life was 1.5 to 13 days.

Clearance

Not Available

Adverse Effects
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Toxicity

The most commonly reported adverse reactions (occurring in greater than 10% of patients) are pyrexia, chills, rash, thrombocytopenia, leukopenia and arthralgia.

Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
DrugInteraction
AbataceptThe risk or severity of adverse effects can be increased when Abatacept is combined with Antilymphocyte immunoglobulin (horse).
AbciximabThe risk or severity of adverse effects can be increased when Abciximab is combined with Antilymphocyte immunoglobulin (horse).
AdalimumabThe risk or severity of adverse effects can be increased when Adalimumab is combined with Antilymphocyte immunoglobulin (horse).
Adenovirus type 7 vaccine liveThe risk or severity of infection can be increased when Adenovirus type 7 vaccine live is combined with Antilymphocyte immunoglobulin (horse).
AducanumabThe risk or severity of adverse effects can be increased when Antilymphocyte immunoglobulin (horse) is combined with Aducanumab.
Food Interactions
No interactions found.

Products

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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
AtgamSolution50 mgIntravenousPfizer Italia S.R.L.1998-12-04Not applicableCanada flag
AtgamInjection, solution50 mg/1mLIntravenousPharmacia & Upjohn Company LLC1981-11-17Not applicableUS flag
Atgam Sterile Solution IV 50mg/mlLiquid50 mgIntravenousPharmacia & Upjohn Inc1985-12-311999-08-12Canada flag

Categories

ATC Codes
L04AA03 — Antilymphocyte immunoglobulin (horse)
Drug Categories
Chemical TaxonomyProvided by Classyfire
Description
Not Available
Kingdom
Organic Compounds
Super Class
Organic Acids
Class
Carboxylic Acids and Derivatives
Sub Class
Amino Acids, Peptides, and Analogues
Direct Parent
Peptides
Alternative Parents
Not Available
Substituents
Not Available
Molecular Framework
Not Available
External Descriptors
Not Available
Affected organisms
Not Available

Chemical Identifiers

UNII
475247QF1Z
CAS number
Not Available

References

General References
  1. Feng X, Scheinberg P, Biancotto A, Rios O, Donaldson S, Wu C, Zheng H, Sato K, Townsley DM, McCoy JP, Young NS: In vivo effects of horse and rabbit antithymocyte globulin in patients with severe aplastic anemia. Haematologica. 2014 Sep;99(9):1433-40. doi: 10.3324/haematol.2014.106542. Epub 2014 Jun 6. [Article]
  2. Vallejo C, Montesinos P, Polo M, Cuevas B, Morado M, Rosell A, Xicoy B, Diez JL, Salamero O, Cedillo A, Martinez P, Rayon C: Rabbit antithymocyte globulin versus horse antithymocyte globulin for treatment of acquired aplastic anemia: a retrospective analysis. Ann Hematol. 2015 Jun;94(6):947-54. doi: 10.1007/s00277-015-2305-3. Epub 2015 Feb 13. [Article]
  3. Hagen P, Wagner JE, DeFor TE, Dolan M, Arora M, Warlick E, Weisdorf D, Brunstein CG: The effect of equine antithymocyte globulin on the outcomes of reduced intensity conditioning for AML. Bone Marrow Transplant. 2014 Dec;49(12):1498-504. doi: 10.1038/bmt.2014.183. Epub 2014 Sep 22. [Article]
  4. Dubey S, Nityanand S: Involvement of Fas and TNF pathways in the induction of apoptosis of T cells by antithymocyte globulin. Ann Hematol. 2003 Aug;82(8):496-9. Epub 2003 May 29. [Article]
KEGG Drug
D08808
PubChem Substance
347910436
RxNav
1011
RxList
RxList Drug Page
Wikipedia
Anti-thymocyte_globulin
FDA label
Download (4.88 MB)

Clinical Trials

Clinical Trials
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PhaseStatusPurposeConditionsCountStart DateWhy Stopped100+ additional columns
Not AvailableActive Not RecruitingOtherSevere Aplastic Anemia (SAA)1somestatusstop reasonjust information to hide
Not AvailableCompletedTreatmentAccelerated Phase Chronic Myelogenous Leukemia (CML) / Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome / Adult Acute Lymphoblastic Leukemia in Remission / Adult Acute Myeloid Leukemia in Remission / Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities / Adult Acute Myeloid Leukemia With Del(5q) / Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) / Adult Acute Myeloid Leukemia With T(15;17)(q22;q12) / Adult Acute Myeloid Leukemia With T(16;16)(p13;q22) / Adult Acute Myeloid Leukemia With T(8;21)(q22;q22) / Adult Nasal Type Extranodal NK/T-Cell Lymphoma / Anaplastic Large Cell Lymphoma / Angioimmunoblastic T-cell Lymphoma (AITL) / Aplastic Anemia / Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative / B-cell Small Lymphocytic Lymphoma Recurrent / Childhood Acute Lymphoblastic Leukemia in Remission / Childhood Acute Myeloid Leukemia in Remission / Childhood Chronic Myelogenous Leukemia / Childhood Diffuse Large B -Cell Lymphoma / Childhood Immunoblastic Large Cell Lymphoma / Childhood Myelodysplastic Syndromes / Childhood Nasal Type Extranodal NK/T-cell Lymphoma / Chronic Eosinophilic Leukemia / Chronic Myelomonocytic Leukemia / Chronic Phase Chronic Myeloid Leukemia / Extranodal marginal zone B-cell lymphoma (MALT type) / Fanconi's Anemia / Juvenile chronic myelomonocytic leukaemia / Leukemia, Neutrophilic, Chronic / Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable / Nodal marginal zone B-cell lymphomas / Noncontiguous Stage II Adult Burkitt Lymphoma / Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma / Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma / Noncontiguous Stage II Adult Lymphoblastic Lymphoma / Noncontiguous Stage II Mantle Cell Lymphoma / Noncontiguous Stage II Marginal Zone Lymphoma / Noncontiguous Stage II Small Lymphocytic Lymphoma / Paroxysmal Nocturnal Hemoglobinuria (PNH) / Previously treated Myelodysplastic Syndromes (MDS) / Primary Myelodysplastic Syndromes (MDS) / Primary Myelofibrosis (PMF) / Recurrent Adult Acute Lymphoblastic Leukemia (ALL) / Recurrent Adult Acute Myeloid Leukemia / Recurrent Adult Burkitt Lymphoma / Recurrent Adult Diffuse Large Cell Lymphoma / Recurrent Adult Diffuse Mixed Cell Lymphoma / Recurrent Adult Diffuse Small Cleaved Cell Lymphoma / Recurrent Adult Grade III Lymphomatoid Granulomatosis / Recurrent Adult Hodgkin's Lymphoma / Recurrent Adult Immunoblastic Large Cell Lymphoma / Recurrent Adult Lymphoblastic Lymphoma / Recurrent Adult T-Cell Leukemia/Lymphoma / Recurrent Childhood Acute Lymphoblastic Leukemia / Recurrent Childhood Acute Myeloid Leukemia / Recurrent Childhood Anaplastic Large Cell Lymphoma / Recurrent Childhood Grade III Lymphomatoid Granulomatosis / Recurrent Childhood Lymphoblastic Lymphoma / Recurrent Childhood Small Noncleaved Cell Lymphoma / Recurrent Cutaneous T-Cell Non-Hodgkin Lymphoma / Recurrent Grade 1 Follicular Lymphoma / Recurrent Grade 2 Follicular Lymphoma / Recurrent Grade 3 Follicular Lymphoma / Recurrent Mantle Cell Lymphoma / Recurrent Marginal Zone Lymphoma / Recurrent Mycosis Fungoides and Sezary Syndrome / Recurrent/Refractory Childhood Hodgkin Lymphoma / Refractory Chronic Lymphocytic Leukemia (CLL) / Refractory Multiple Myeloma / Relapsing Chronic Myelogenous Leukemia / Secondary Acute Myeloid Leukemia (Secondary AML, sAML) / Secondary Myelodysplastic Syndromes / Splenic Marginal Zone Lymphoma / Stage II Grade 1 Non-Contiguous Follicular Lymphoma / Stage II Grade 2 Non-Contiguous Follicular Lymphoma / Stage II Grade 3 Non-Contiguous Follicular Lymphoma / Stage II Non-Contiguous Adult Diffuse Large Cell Lymphoma / Stage II Non-Contiguous Adult Diffuse Mixed Cell Lymphoma / Stage III Adult Diffuse Small Cleaved Cell Lymphoma / Stage III Adult Immunoblastic Large Cell Lymphoma / Stage III Adult Lymphoblastic Lymphoma / Stage III B-cell small lymphocytic lymphoma / Stage III Grade 1 Follicular Lymphoma / Stage III Grade 2 Follicular Lymphoma / Stage III Grade 3 Follicular Lymphoma / Stage III Mantle Cell Lymphoma / Stage III Marginal Zone Lymphoma / Stage IV Adult Burkitt Lymphoma / Stage IV Adult Diffuse Small Cleaved Cell Lymphoma / Stage IV Adult Immunoblastic Large Cell Lymphoma / Stage IV Adult Lymphoblastic Lymphoma / Stage IV Grade 1 Follicular Lymphoma / Stage IV Grade 2 Follicular Lymphoma / Stage IV Grade 3 Follicular Lymphoma / Stage IV Mantle Cell Lymphoma / Stage IV Marginal Zone Lymphoma / Stage IV Small Lymphocytic Lymphoma / Waldenström's Macroglobulinemia (WM)1somestatusstop reasonjust information to hide
Not AvailableEnrolling by InvitationNot AvailableSevere Aplastic Anemia (SAA)1somestatusstop reasonjust information to hide
Not AvailableTerminatedTreatmentAcute Lymphocytic Leukemia (ALL) / Acute Myeloid Leukemia / Chronic Lymphocytic Leukemia / Chronic Myeloid Leukemia (CML) / Hodgkins Disease (HD) / Juvenile chronic myelomonocytic leukaemia / Multiple Myeloma (MM) / Myelodysplastic Syndrome / Non-Hodgkin's Lymphoma (NHL)1somestatusstop reasonjust information to hide
4CompletedTreatmentKidney Diseases1somestatusstop reasonjust information to hide

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Injection, solutionIntravenous50 mg/1mL
SolutionIntravenous50 mg
Injection, solutionIntravenous50 mg/ml
InjectionIntravenous50 mg/ml
LiquidIntravenous50 mg
InjectionParenteral
Injection, solution, concentrateIntravenous50 MG/ML
Injection, solution, concentrateIntravenous20 MG/ML
Prices
Not Available
Patents
Not Available

Properties

State
Solid
Experimental Properties
Not Available

Drug created at November 16, 2015 22:18 / Updated at November 03, 2024 19:35