HIGHLIGHTS OF PRESCRIBING INFORMATIONThese 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 |
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)
- 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)
- 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)
- 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 REACTIONSThe 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.
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)
- Previously masked reactions to ATGAM may appear following reduced doses of immunosuppressants. (7)
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 12/2020