Medical Information
United States
 

In order to provide you with relevant and meaningful content we need to know more about you.

Please choose the category that best describes you.

This content is intended for U.S. Healthcare Professionals. Would you like to proceed?

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our medical information is accurate, up to date, and scientifically balanced.

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 medical information is accurate, up to date, and scientifically balanced.

ATGAM® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
Did you find an answer to your question? Yes No

WARNING: ANAPHYLAXIS

Anaphylaxis has been reported with the use of ATGAM. ATGAM can cause potentially life‑...

Did you find an answer to your question? Yes No

1 INDICATIONS AND USAGE

1.1 Renal Allograft Rejection

ATGAM is indicated for the management of allograft rejection...

Did you find an answer to your question? Yes No

2 DOSAGE AND ADMINISTRATION

For intravenous use only.

Administer ATGAM intravenously and use with concomitant immunosuppressants....

Did you find an answer to your question? Yes No

3 DOSAGE FORMS AND STRENGTHS

ATGAM 50 mg/mL concentrate for solution for infusion

Did you find an answer to your question? Yes No

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...

Did you find an answer to your question? Yes No

5 WARNINGS AND PRECAUTIONS

5.1 Anaphylaxis

...

Did you find an answer to your question? Yes No

6 ADVERSE REACTIONS

The most clinically significant adverse reactions are anaphylaxis, infection, thrombocytopenia, leukopenia, arthralgia, edema, bradycardia, and abnormal renal and liver function tests.

...
Did you find an answer to your question? Yes No

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...

Did you find an answer to your question? Yes No

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no adequate and well-controlled studies in pregnant women....

Did you find an answer to your question? Yes No

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...

Did you find an answer to your question? Yes No

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...

Did you find an answer to your question? Yes No

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,...

Did you find an answer to your question? Yes No

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis and Mutagenesis

Carcinogenicity and pre-/post-natal development studies have not been conducted on ATGAM.

Did you find an answer to your question? Yes No

14 CLINICAL STUDIES

14.1 Renal Allograft Rejection

...

Did you find an answer to your question? Yes No

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...
Did you find an answer to your question? Yes No

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

...
Did you find an answer to your question? Yes No

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.

...
Did you find an answer to your question? Yes No

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...

Did you find an answer to your question? Yes No
Did you find an answer to your question? Yes No
Didn’t find what you were looking for? Contact us.
Report Adverse Event