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ATGAM®(lymphocyte immune globulin, anti-thymocyte globulin [equine])

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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 OF PRESCRIBING INFORMATION

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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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1 INDICATIONS AND USAGE

1.1 Renal Allograft Rejection

Renal transplant rejection: ATGAM...

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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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3 DOSAGE FORMS AND STRENGTHS

ATGAM 50 mg/mL concentrate for solution for infusion

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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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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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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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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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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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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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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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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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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Mutagenicity and carcinogenicity studies have not been conducted on ATGAM.

...

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14 CLINICAL STUDIES

14.1 Renal Allograft Rejection

Renal Transplant Rejection

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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 acute...
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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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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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Healthcare providers should refer to labels.fda.gov or DailyMed for the most updated version of the labeling.

This product's labeling may have been updated. For the most...

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