ATGAM® Principal Display Panel (lymphocyte immune globulin, anti-thymocyte globulin [equine]) | Pfizer Medical Information - US

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PRINCIPAL DISPLAY PANEL - 5 mL Ampule Label

NDC 0009-7224-01

5 mL

Atgam®

lymphocyte immune globulin,
anti-thymocyte globulin (equine)

250 mg protein

50 mg/mL For Intravenous use only

DOSAGE AND USE: See accompanying
prescribing information. Protect from light.

ATTENTION—May contain particles; this is
normal. Use 0.2 micron to 1.0 micron in-line
filter. See insert.

Manufactured by Pharmacia & Upjohn Co
Division of Pfizer Inc, NY, NY 10017

U.S. Govt. License No. 1216
Rx only

PAA165485

LOT / EXP

PRINCIPAL DISPLAY PANEL - 5 mL Ampule Label

PRINCIPAL DISPLAY PANEL - 5 mL Ampule Carton

NDC 0009-7224-02
Contains 5 of NDC 0009-7224-01

5–5 mL Ampoules
(single use containers)

Atgam®

lymphocyte immune globulin,
anti-thymocyte globulin (equine)

250 mg protein

50 mg/mL

ATTENTION—This product may contain a granular
or flaky deposit; this is normal. See infusion
instructions described in the enclosed product insert.

Sterile Solution For Intravenous Use Only

Pfizer Injectables
Rx only

Principal Display Panel - 5 mL Ampule Carton

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.

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Resources

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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WARNING: ANAPHYLAXIS

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

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1 INDICATIONS AND USAGE

1.1 Renal Allograft Rejection

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

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2 DOSAGE AND ADMINISTRATION

For intravenous use only.

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

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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 an anaphylactic reaction during prior administration of ATGAM or any other equine gamma...

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5 WARNINGS AND PRECAUTIONS

5.1 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

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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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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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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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 and Mutagenesis

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

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14 CLINICAL STUDIES

14.1 Renal Allograft 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...

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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:

5 – 5 mL ampoules: NDC 0009-7224-02

...

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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.

...

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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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Pfizer Safety

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.