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 allograft 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 STRENGTHSATGAM 50 mg/mL concentrate for solution for infusion. (3)
ATGAM 50 mg/mL concentrate for solution for infusion. (3)
CONTRAINDICATIONSAnaphylactic reaction during prior administration of ATGAM or any other equine gamma globulin preparation. (4)
Anaphylactic reaction during prior administration of ATGAM or any other equine gamma globulin preparation. (4)
WARNINGS AND PRECAUTIONS- •
- Anaphylaxis, which can be life-threatening, has been reported. To identify those at greatest risk, skin testing before treatment is strongly recommended. Discontinue ATGAM if anaphylaxis occurs. (5.1)
- •
- Monitor patients for signs and symptoms of cytokine release syndrome. (5.2)
- •
- Monitor patients for signs and symptoms of infusion-associated reactions. (5.3)
- •
- Monitor patients for signs and symptoms of serum sickness. (5.4)
- •
- Monitor and report any infection suspected to have been transmitted. (5.5)
- •
- Monitor patients for concurrent infection, including cytomegalovirus, Epstein-Barr virus, and herpes simplex virus infection. (5.6)
- •
- 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. (5.7)
- •
- Consider discontinuing therapy if severe and unremitting thrombocytopenia or neutropenia occurs. (5.8)
- •
- Monitor liver and renal function as clinically indicated and manage according to relevant clinical guidelines. (5.9)
- •
- Anaphylaxis, which can be life-threatening, has been reported. To identify those at greatest risk, skin testing before treatment is strongly recommended. Discontinue ATGAM if anaphylaxis occurs. (5.1)
- •
- Monitor patients for signs and symptoms of cytokine release syndrome. (5.2)
- •
- Monitor patients for signs and symptoms of infusion-associated reactions. (5.3)
- •
- Monitor patients for signs and symptoms of serum sickness. (5.4)
- •
- Monitor and report any infection suspected to have been transmitted. (5.5)
- •
- Monitor patients for concurrent infection, including cytomegalovirus, Epstein-Barr virus, and herpes simplex virus infection. (5.6)
- •
- 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. (5.7)
- •
- Consider discontinuing therapy if severe and unremitting thrombocytopenia or neutropenia occurs. (5.8)
- •
- Monitor liver and renal function as clinically indicated and manage according to relevant clinical guidelines. (5.9)
ADVERSE REACTIONSThe most common (incidence >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 (incidence >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 INTERACTIONSPreviously 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- •
- Pregnancy: Use only if the potential benefit justifies the risk. (8.1)
- •
- Lactation: Discontinue breast-feeding during treatment with ATGAM or discontinue ATGAM treatment. (8.2)
- •
- Contraception: Advise females of reproductive potential to use effective contraception during treatment with ATGAM and for up to 10 weeks after cessation of therapy. Advise males with a female partner of reproductive potential to use effective contraception during treatment with ATGAM and for at least 10 weeks after cessation of therapy. (8.3)
- •
- Geriatric: Start dosing at the low end of the dosage range. (8.5)
- •
- Pregnancy: Use only if the potential benefit justifies the risk. (8.1)
- •
- Lactation: Discontinue breast-feeding during treatment with ATGAM or discontinue ATGAM treatment. (8.2)
- •
- Contraception: Advise females of reproductive potential to use effective contraception during treatment with ATGAM and for up to 10 weeks after cessation of therapy. Advise males with a female partner of reproductive potential to use effective contraception during treatment with ATGAM and for at least 10 weeks after cessation of therapy. (8.3)
- •
- Geriatric: Start dosing at the low end of the dosage range. (8.5)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 8/2023