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

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ATGAM safely and effectively. See full prescribing information for ATGAM.

ATGAM® (lymphocyte immune globulin, anti-thymocyte globulin [equine]), sterile solution for intravenous use only
Initial U.S. Approval: 1981

WARNING: ANAPHYLAXIS

See full prescribing information for complete boxed warning.

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 should be prepared for the potential risk of anaphylaxis and monitor patients for signs and symptoms during infusion.

INDICATIONS AND USAGE

ATGAM is an immunoglobulin G indicated for:

  • Renal transplant rejection. (1.1)
  • Aplastic anemia (moderate to severe) in patients unsuitable for bone marrow transplantation. (1.2)
  • Limitations of Use: The usefulness of ATGAM has not been demonstrated in patients with aplastic anemia who are suitable candidates for bone marrow transplantation or in patients with aplastic anemia secondary to neoplastic disease, storage disease, myelofibrosis, Fanconi's syndrome, or in patients known to have been exposed to myelotoxic agents or radiation. (1.2)

DOSAGE AND ADMINISTRATION

Intravenous use only.

Indication Dosage
Renal transplant rejection 10 to 15 mg/kg daily intravenously for 14 days; additional alternate-day therapy up to a total of 21 doses may be given. (2.1)
Aplastic anemia 10 to 20 mg/kg daily intravenously for 8 to 14 days; additional alternate-day therapy up to a total of 21 doses may be given. (2.1)

DOSAGE FORMS AND STRENGTHS

  • ATGAM 50 mg/mL concentrate for solution for infusion. (3)

CONTRAINDICATIONS

  • Systemic reaction (e.g., anaphylactic reaction) during prior administration of ATGAM or any other equine gamma globulin preparation. (4)

WARNINGS AND PRECAUTIONS

  • Discontinue ATGAM if anaphylaxis occurs. (5.1)
  • Serious immune-mediated reactions, including anaphylaxis, have been reported. To identify those at greatest risk, skin testing before treatment is strongly recommended. (5.1)
  • Monitor patients for concurrent infection, including cytomegalovirus. (5.2)
  • Do not administer live vaccines to patients about to receive, receiving, or after treatment with ATGAM due to a potential of uncontrolled viral replication in the immunosuppressed patient. (5.3)

ADVERSE REACTIONS

The most common (>10%) adverse reactions are pyrexia, chills, rash, thrombocytopenia, leukopenia and arthralgia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

  • Previously masked reactions to ATGAM may appear following reduced doses of immunosuppressants. (7)

USE IN SPECIFIC POPULATIONS

  • Pregnancy: Use only if the potential benefit justifies the risk. (8.1)
  • Nursing Mothers: Discontinue nursing when administering ATGAM. (8.3)
  • Geriatric: Start dosing at the low end of the dosage range. (8.5)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 5/2018

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Report Adverse Event

Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: (800) 438-1985

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch