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.

Pharmacology
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Associated Conditions
Contraindications & Blackbox Warnings
Contraindications
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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
Adverseeffects
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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.
AldesleukinThe risk or severity of adverse effects can be increased when Aldesleukin is combined with Antilymphocyte immunoglobulin (horse).
AlefaceptThe risk or severity of adverse effects can be increased when Alefacept is combined with Antilymphocyte immunoglobulin (horse).
AlemtuzumabThe risk or severity of adverse effects can be increased when Alemtuzumab is combined with Antilymphocyte immunoglobulin (horse).
AlirocumabThe risk or severity of adverse effects can be increased when Alirocumab is combined with Antilymphocyte immunoglobulin (horse).
Allogeneic processed thymus tissueThe therapeutic efficacy of Allogeneic processed thymus tissue can be decreased when used in combination with Antilymphocyte immunoglobulin (horse).
Interactions
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Food Interactions
No interactions found.

Products

Products2
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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
AtgamSolution50 mgIntravenousPfizer1998-12-04Not 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
PhaseStatusPurposeConditionsCount
4CompletedTreatmentKidney Diseases1
3CompletedTreatmentAplastic Anemia1
3CompletedTreatmentSevere Aplastic Anemia (SAA)1
2Active Not RecruitingTreatmentAplastic Anemia1
2Active Not RecruitingTreatmentNon-Hodgkin's Lymphoma (NHL)1
2Active Not RecruitingTreatmentNon-Hodgkin's Lymphoma, Relapsed / Refractory Non-Hodgkin's lymphoma1
2Active Not RecruitingTreatmentScleroderma, Systemic1
2CompletedTreatmentAccelerated Phase Chronic Myelogenous Leukemia (CML) / 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) / Childhood Acute Myeloid Leukemia in Remission / Childhood Chronic Myelogenous Leukemia / Childhood Myelodysplastic Syndromes / Chronic Myelogenous Leukemia, Blastic Phase / Chronic Phase Phase Chronic Myelogenous Leukemia (CML) / De Novo Myelodysplastic Syndromes / Hematopoietic/Lymphoid Cancer / Myelodysplastic Syndromes, Previously Treated / Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable / Recurrent Acute Myeloid Leukemia, Adult / Recurrent Childhood Acute Myeloid Leukemia / Relapsing Chronic Myelogenous Leukemia1
2CompletedTreatmentAcute Myeloid Leukemia (AML) / Chronic Lymphocytic Leukemia (CLL) / Lymphoma, B-Cell, Non-Hodgkin's Lymphoma / Lymphoma, Hodgkins / Lymphomas non-Hodgkin's T-cell / Myelodysplastic Syndromes (MDS) / Myeloproliferative Neoplasms (MPNs)1
2CompletedTreatmentAcute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome / Adult Acute Lymphoblastic Leukemia in Remission / Adult Acute Megakaryoblastic Leukemia (M7) / Adult Acute Minimally Differentiated Myeloid Leukemia (M0) / Adult Acute Monoblastic Leukemia (M5a) / Adult Acute Monocytic Leukemia (M5b) / Adult Acute Myeloid Leukemia in Remission / Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities / Adult Acute Myeloid Leukemia With T(16;16)(p13;q22) / Adult Erythroleukemia (M6a) / Adult Nasal Type Extranodal NK/T-Cell Lymphoma / Adult Pure Erythroid Leukemia (M6b) / B-cell Adult Acute Lymphoblastic Leukemia (ALL) / B-cell Childhood Acute Lymphoblastic Leukemia / Burkitt Lymphoma (BL)) / Childhood Acute Erythroleukemia (M6) / Childhood Acute Lymphoblastic Leukemia in Remission / Childhood Acute Megakaryocytic Leukemia (M7) / Childhood Acute Minimally Differentiated Myeloid Leukemia (M0) / Childhood Acute Monoblastic Leukemia (M5a) / Childhood Acute Monocytic Leukemia (M5b) / Childhood Acute Myeloid Leukemia in Remission / Childhood Chronic Myelogenous Leukemia / Childhood Diffuse Large Cell Lymphoma / Childhood Immunoblastic Large Cell Lymphoma / Childhood Myelodysplastic Syndromes / Childhood Nasal Type Extranodal NK/T-cell Lymphoma / Chronic Lymphocytic Leukemia (CLL) - Refractory / Chronic Myelogenous Leukemia, Blastic Phase / Chronic Myelomonocytic Leukemia (CMML) / Chronic Phase Phase Chronic Myelogenous Leukemia (CML) / Cutaneous B-Cell Non-Hodgkin Lymphoma / De Novo Myelodysplastic Syndromes / Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue / Juvenile Myelomonocytic Leukaemias (JMML) / Myelodysplastic Syndromes, Previously Treated / Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable / Nodal marginal zone B-cell lymphomas / Prolymphocytic Leukaemia (PLL) / Recurrent Acute Myeloid Leukemia, Adult / Recurrent Adult Acute Lymphoblastic Leukemia (ALL) / 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 Immunoblastic Large Cell Lymphoma / Recurrent Adult Lymphoblastic 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 Large Cell Lymphoma / 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/Sezary Syndrome / Recurrent Small Lymphocytic Lymphoma / Relapsing Chronic Myelogenous Leukemia / Secondary Acute Myeloid Leukemia (Secondary AML, sAML) / Secondary Myelodysplastic Syndromes / Secondary Myelofibrosis / Splenic Marginal Zone Lymphoma / Stage I Chronic Lymphocytic Leukemia / Stage II Chronic Lymphocytic Leukemia / Stage III Chronic Lymphocytic Leukemia / Stage IV Chronic Lymphocytic Leukemia / T-cell Adult Acute Lymphoblastic Leukemia (ALL) / T-cell Childhood Acute Lymphoblastic Leukemia / T-Cell Large Granular Lymphocyte Leukemia / Waldenström's Macroglobulinemia (WM)1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Injection, solutionIntravenous50 mg/1mL
SolutionIntravenous50 mg
Injection, solutionIntravenous
InjectionIntravenous50 mg/ml
LiquidIntravenous50 mg
InjectionParenteral
Injection, solution, concentrateIntravenous
Prices
Not Available
Patents
Not Available

Properties

State
Solid
Experimental Properties
Not Available

Drug created at November 16, 2015 22:18 / Updated at December 04, 2021 10:27