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ATGAM® (lymphocyte immune globulin, anti-thymocyte globulin [equine])
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Our medical information is accurate, up to date, and scientifically balanced.
ATGAM® Quick Finder
Highlights
Boxed Warning
WARNING: ANAPHYLAXIS
Anaphylaxis has been reported with the use of ATGAM. ATGAM can cause potentially life‑...
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Indications and Usage
1 INDICATIONS AND USAGE
1.1 Renal Allograft Rejection
ATGAM is indicated for the management of allograft rejection...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
For intravenous use only.
Administer ATGAM intravenously and use with concomitant immunosuppressants....
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
ATGAM 50 mg/mL concentrate for solution for infusion
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Contraindications
4 CONTRAINDICATIONS
Do not administer ATGAM to a patient who has had an anaphylactic reaction during prior administration of ATGAM or any other equine gamma...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Anaphylaxis
...
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Adverse Reactions
6 ADVERSE REACTIONS
The most clinically significant adverse reactions are anaphylaxis, infection, thrombocytopenia, leukopenia, arthralgia, edema, bradycardia, and abnormal renal and liver function tests.
...
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Drug Interactions
7 DRUG INTERACTIONS
A potential pharmacodynamic interaction concerns the concomitant administration of ATGAM with corticosteroids and other immunosuppressants, which are associated with an increased susceptibility to...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
There are no adequate and well-controlled studies in pregnant women....
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Overdosage
10 OVERDOSAGE
The maximum tolerated dose of ATGAM Sterile Solution is expected to vary from patient to patient due to the biological nature of the product. The largest single daily dose known to be administered to one...
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Description
11 DESCRIPTION
ATGAM Sterile Solution contains lymphocyte immune globulin, anti-thymocyte globulin [equine]. It is the purified, concentrated, and sterile gamma globulin, primarily monomeric IgG, from hyperimmune serum of...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
ATGAM is composed of antibodies that bind a wide variety of proteins on the surface of lymphocytes. In addition,...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis and Mutagenesis
Carcinogenicity and pre-/post-natal development studies have not been conducted on ATGAM.
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Clinical Studies
14 CLINICAL STUDIES
14.1 Renal Allograft Rejection
...
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References
15 REFERENCES
- 1.
- Hardy MA, Nowygrod R, Elberg A, Appel G. Use of ATG in treatment of steroid-resistant rejection. Transplantation 1980; 29(2):162–4.
- 2.
- Nowygrod R, Appel G, Hardy MA. Use of ATG for reversal of...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
ATGAM Sterile Solution, containing 50 mg/mL lymphocyte immune globulin, anti-thymocyte globulin [equine], is supplied as follows:
5 – 5 mL ampoules: NDC 0009-7224-02
...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Advise patients receiving ATGAM that they will be monitored in a facility equipped and staffed with adequate laboratory and supportive medical resources.
...
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