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ATGAM®(lymphocyte immune globulin, anti-thymocyte globulin [equine])
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
ATGAM® Quick Finder
Highlights
Boxed Warning
WARNING: ANAPHYLAXIS
Antithymocyte globulins can cause anaphylaxis when injected intravenously. Although ATGAM is processed to reduce the level of antibodies that will react to non-T cells, physicians...
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Indications and Usage
1 INDICATIONS AND USAGE
1.1 Renal Allograft Rejection
Renal transplant rejection: ATGAM...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
ATGAM is intended for intravenous use only.
ATGAM is used with concomitant immunosuppressants. During repeat courses of ATGAM, observe patients for signs of allergic reactions...
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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 a systemic reaction (e.g., anaphylactic reaction) during prior administration of ATGAM or any other equine gamma globulin preparation...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity
Serious immune-mediated reactions have been reported with the use of ATGAM. Clinical signs associated with 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
Previously masked reactions to ATGAM may appear when the dose of corticosteroids and other immunosuppressants is being reduced.
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
ATGAM was not teratogenic in rats or monkeys at a dose up to 20 mg/kg. However, 20 mg/kg/day ATGAM for 16 days during...
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Overdosage
10 OVERDOSAGE
The maximum tolerated dose of ATGAM Sterile Solution would be 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 a...
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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, Mutagenesis, Impairment of Fertility
Mutagenicity and carcinogenicity studies have not been conducted on ATGAM.
...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Renal Allograft Rejection
Renal Transplant Rejection
...
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References
15 REFERENCES
- Hardy MA, Nowygrod R, Elberg A, Appel G. Use of ATG in treatment of steroid-resistant rejection. Transplantation 1980; 29(2):162–4.
- Nowygrod R, Appel G, Hardy MA. Use of ATG for reversal of acute...
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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:
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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.
Inform patients that ATGAM may...
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Report Adverse Event
To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.
If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at https://vaers.hhs.gov or call (800) 822-7967.