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HomeEfficacyEfficacyAplastic AnemiaRenal Allograft RejectionSafetyDosing & Administration
Prescribing Information, including BOXED WARNINGIndications
Renal Allograft Rejection EfficacyRenal Allograft Rejection EfficacyATGAM in conjunction with standard therapy at the time of diagnosis of the first rejection episode1The effectiveness of ATGAM for treatment of acute allograft rejection was evaluated in 3 different treatment applications.1The effectiveness of ATGAM for treatment of acute allograft rejection was evaluated in 3 different treatment applications.1 ATGAM as a substitute for standard therapy1 ATGAM as a substitute for standard therapy1

In 1 study of ATGAM as a substitute for standard therapy for treatment of the first acute rejection episode, all patients in the ATGAM group achieved resolution. Patient survival was similar in the 2 treatment groups.

Resolution of first rejection

Functional graft survival rate at 1 year

Patient survival rate

Study design

A randomized controlled trial of the use of ATGAM as a substitute for standard therapy for treatment of the first acute rejection episode was conducted at 1 transplant center in recipients of living related renal allografts. A total of 22 patients were studied; 11 in each of the 2 treatment groups [ATGAM versus standard therapy (bolus doses of Solu-Medrol®)]. Patients randomized to the ATGAM group received 14–21 doses of ATGAM therapy, starting on the day the rejection was diagnosed. ATGAM was administered daily according to a dose-by-rosette regimen which resulted in a mean daily dose of approximately 15 mg/kg. Patients randomized to the control group received 
Solu-Medrol® at a dosage of 15 mg/kg starting on the day the rejection was diagnosed, administered either daily or on alternate days for 3 to 7 doses to complete a maximum total dose of 5,000 mg for the course of the rejection episode.1

ATGAM in conjunction with standard therapy at the time of diagnosis of the first rejection episode1ATGAM in conjunction with standard therapy at the time of diagnosis of the first rejection episode1In cadaveric renal allograft rejection patients, the addition of ATGAM to standard rejection therapy (methylprednisolone sodium succinate) resulted in an increased frequency of resolution of the first acute rejection episode, which was statistically significant.

There was a statistically significant improvement in functional graft survival favoring the ATGAM group (P<0.01), and a statistically significant steroid sparing effect during the first rejection episode among patients in the ATGAM group. There was no difference in the patient survival rate between the 2 treatment groups.

In a study conducted at 5 different transplant centers, the addition of ATGAM to standard rejection therapy for treatment of acute rejection in recipients of living related renal transplants resulted in an increased frequency of rejection resolution and improvement in functional graft survival.† Marginal statistical significance was demonstrated in rejection reversal rate and intravenous steroid sparing among ATGAM patients (P=0.10 and P=0.07). Patient survival rates were similar in the 2 treatment groups.

†Due to the small sample size, the difference between the ATGAM group and the control group in functional graft survival rate did not achieve statistical significance.

Study design

The effect of ATGAM when administered in conjunction with standard therapy at the time of diagnosis of the first rejection episode was studied under 2 different protocols with cadaveric and living related renal allograft rejection patients.1

Study 1 was a randomized controlled, 2 center trial of ATGAM use for treatment of acute rejection in cadaveric renal allograft rejection patients, with an addition of ATGAM to standard rejection therapy (methylprednisolone sodium succinate).1

Study 2 was a randomized controlled trial conducted at 5 different transplant centers. In this study, ATGAM was added to standard rejection therapy (bolus doses of Solu-Medrol®) for treatment of acute rejection in recipients of living related renal transplants.1

 ATGAM in conjunction with standard therapy in steroid resistant rejection episodes1 ATGAM in conjunction with standard therapy in steroid resistant rejection episodes1

In trials with patients with first acute renal allograft rejection episodes refractory to conventional steroid therapy have demonstrated that ATGAM, when administered in conjunction with standard therapy, yields efficacy results superior to those of standard therapy alone.

One study investigated 2 different regimens of ATGAM; immediate and delayed therapy:

  • Results favored the 2 ATGAM groups (and particularly the immediate ATGAM group) in both outcome of first rejection and functional graft survival
     
  • ​​​​​There was statistically significant improvement in functional graft survival (P=0.05) and statistically significant difference in patient survival rate favoring the ATGAM-treated groups (P=0.02)
Study design

Randomized controlled trials have been conducted in patients with first acute renal allograft rejection episodes refractory to conventional steroid therapy.1

One study investigated 2 different regimens of ATGAM; immediate and delayed therapy. Patients were enrolled at the time of first rejection episode and randomized among 3 treatment groups: control (no ATGAM), immediate ATGAM, and delayed ATGAM. Patients in all 3 treatment groups received standard rejection therapy in the form of bolus doses of Solu-Medrol® 15 mg/kg/day IV, while patients in the 2 ATGAM groups received ATGAM therapy in addition to Solu-Medrol®. In the immediate ATGAM group, ATGAM administration started at the time of diagnosis of rejection (concurrent with standard therapy). In the delayed ATGAM group, ATGAM administration started on rejection day 4 (following the first 3 doses of Solu-Medrol®). Patients in both of the treated groups received from 10 to 21 doses of ATGAM.1

Reference:ATGAM [prescribing information]. New York, NY: Pfizer Inc., May 2023.ATGAM Efficacy Explore ATGAM Safety Safety Loading Learn About ATGAM Dosing & Administration
Dosing & Administration
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ATGAM® (lymphocyte immune globulin, anti-thymocyte globulin [equine]) INDICATIONS

ATGAM is indicated for:
 
  • Management of allograft rejection in renal transplant patients; when administered with conventional therapy at the time of rejection ATGAM increases the frequency of resolution of the acute rejection episode.
  • Treatment of moderate to severe aplastic anemia in patients unsuitable for bone marrow transplantation.

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.

Please see full Prescribing Information, including BOXED WARNING.
IMPORTANT SAFETY INFORMATION WARNING: ANAPHYLAXIS

Anaphylaxis has been reported with the use of ATGAM. ATGAM can cause potentially life-threatening anaphylaxis when injected intravenously. Monitor patients for signs and symptoms of anaphylaxis during infusion and for at least 24 hours after infusion.

Contraindications
Do not administer ATGAM to a patient who has had an anaphylactic reaction during prior administration of ATGAM or any other equine gamma globulin preparation.

Warnings and Precautions

Anaphylaxis: Discontinue ATGAM if anaphylaxis occurs.
  • Skin testing: To identify those at greatest risk, skin testing before treatment is strongly recommended.
  • Monitoring and Management of Anaphylaxis: Administer ATGAM in a healthcare facility where a physician familiar with the treatment of potentially life-threatening allergic reactions is in attendance. Monitor patients for signs and symptoms of anaphylaxis during infusion and for at least 24 hours after infusion of ATGAM.
Cytokine Release Syndrome: Monitor patients for signs and symptoms of cytokine release syndrome and manage according to relevant clinical guidelines. 

Infusion-Associated Reactions: Monitor patients for signs and symptoms of infusion-associated reactions and manage according to relevant clinical guidelines.


Serum Sickness: Monitor patients for signs and symptoms of serum sickness and manage according to relevant clinical guidelines.
 

Transmissible Infectious Agents: Because ATGAM is made from equine and human blood components, it may carry a risk of transmitting infectious agents. Report any infection suspected to have been transmitted by this product to Pfizer Inc. at 1-800-438-1985. 

  • Infections: Monitor patients carefully for concurrent infection, including cytomegalovirus, Epstein-Barr virus, and herpes simplex virus infection.

  • Immunizations: Do not administer live vaccines to patients about to receive, receiving, or after treatment with ATGAM.
  • Thrombocytopenia and Neutropenia: If thrombocytopenia occurs, consider platelet transfusions to maintain platelets at clinically acceptable levels. Consider discontinuing ATGAM if severe and unremitting thrombocytopenia or neutropenia occurs.

Hepatic and Renal Function Tests: Monitor liver and renal functions as clinically indicated and manage according to relevant clinical guidelines. 

Adverse Reactions

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

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 bacterial, viral, and fungal infections. The severity of the infections such as septicemia may be masked, and their clinical presentations may be atypical.

Monitor patients receiving ATGAM and immunosuppressive agents such as corticosteroids when the dose of corticosteroids and other immunosuppressants is being reduced, since this adjustment of dose may result in reduced immunosuppression and lead to development of previously masked reactions to ATGAM.

Use in Specific Populations

Pregnancy: Use only if the potential benefit to the mother justifies the potential risk.

Lactation: Discontinue breast-feeding during treatment with ATGAM or discontinue ATGAM treatment.

Contraception: Advise females of reproductive potential to use effective contraception during treatment with ATGAM and for at least 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.

Geriatric: Start dosing at the low end of the dosing range.

Please see full Prescribing Information, including BOXED WARNING.INDICATIONSATGAM is indicated for:
  • Management of allograft rejection in renal transplant patients; when administered with conventional therapy at the time of rejection ATGAM increases the frequency of resolution of the acute rejection episode.
  • Treatment of moderate to severe aplastic anemia in patients unsuitable for bone marrow transplantation.

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.Please see full Prescribing Information, including BOXED WARNING.