ATGAM PACKAGE INSERT PDF
ATGAM is the purified, concentrated and sterile gamma globulin, primarily During processing, the drug is adsorbed with human erythrocyte stroma and with . Globulin [Equine] Sterile Solution. Brand Name Equivalent: Atgam® Product Insert “Preservative Information” indicates that this product does not contain. Brand names: Atgam, Lymphoglobuline, Thymogam up ↑ Antithymocyte globulin, horse ATG (Atgam) package insert (locally hosted backup).
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Randomized clinical trial of antithymocyte globulin in cadaver renal allograft recipients: For full prescribing information, please visit www. In addition, immunosuppression may be mediated by the binding of antibodies to lymphocytes which results in partial activation and induction of T lymphocyte anergy.
Because thrombocytopenia can be associated with the administration of ATGAM, patients receiving it for the treatment of aplastic anemia may need prophylactic platelet transfusions to maintain platelets at clinically acceptable levels. Adverse reactions in both groups were comparable and included rash, chills, gastrointestinal disturbances, and joint pain during ATGAM infusion, as well as symptoms of serum sickness in all patients. The most clinically significant adverse reactions are anaphylaxis, infection, thrombocytopenia, leukopenia, arthralgia, edema, bradycardia, and abnormal renal and liver function tests.
Abdominal pain, Gastrointestinal hemorrhage, Gastrointestinal perforation, Nisert pain Skin and subcutaneous tissue disorders: Reversal of acute renal allograft rejection with adjunctive ATG therapy.
Inform patients that ATGAM may cause serious allergic reactions, infection or abnormal liver or renal function.
HIGHLIGHTS OF PRESCRIBING INFORMATION
Kidney enlargement, Kidney rupture, Renal failure acute Congenital, familial and genetic disorders: A total of 53 patients 3 to 76 years of age participated in this randomized, placebo-controlled, double-blind study to determine if androgens add to the efficacy of ATGAM in providing favorable hematologic response rates in patients with moderate to severe aplastic anemia.
Do not use highly acidic infusion solutions since these solutions may contribute to physical instability over time.
Transplantation ; 31 2: Study 2 A randomized double-blind, placebo prospective, controlled study was conducted to compare the safety and efficacy of ATGAM and androgen oxymetholone; OXY immunosuppressive therapy with the combination of ATGAM, androgen OXY and an infusion of HLA mismatched bone marrow in patients with severe aplastic anemia who were not candidates for bone marrow transplantation.
Because reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In this patient, the administration of ATGAM was not associated with any signs of acute intoxication or late sequelae. For storage conditions of diluted solution, see Dosage and Administration 2. There is insufficient information to fully define the extent of the risk, or the period of time during which the risk exists.
Antithymocyte globulin, horse ATG (Atgam) | – A Hematology Oncology Wiki
In embryo-fetal toxicity studies, ATGAM was administered to rats and cynomolgus monkeys for 11 and 16 days, respectively during organogenesis. The safety of ATGAM has been evaluated in patients with renal transplant and patients with aplastic anemia.
Patients were enrolled at the time of first rejection episode and randomized among three treatment groups: Always keep appropriate resuscitation equipment at the patient’s bedside while ATGAM is being administered. Use of ATG for reversal of acute allograft rejection. ATGAM should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Discuss the risks and benefits of therapy with patients before initiating treatment [see Warnings and Precautions 5.
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Hepatitis viral, Localized infection, Systemic infection Blood and lymphatic system disorders: Renal and urinary disorders: Dyskinesia, Syncope, Tremor Cardiac disorders: Efficacy was evaluated as sustained improvement in peripheral blood counts within 3 months of entry into the study.
ATGAM is composed of antibodies that bind a wide variety of proteins on the surface of lymphocytes.
Allocation to treatment group was based on the availability of mismatched bone marrow donors. Use only if the potential benefit justifies the risk.
Use of ATG in treatment of steroid-resistant rejection. Also, skin testing done as atgm above will not predict for later development of serum sickness. General disorders and administration site conditions: Use the in-line filter with all infusions of ATGAM to prevent the administration of any insoluble material that may develop in the product during storage. Therefore, this toxicity is not considered relevant to human fetal development. Inseft in immunosuppression for kidney transplantation.
The effect of ATGAM when administered in conjunction with standard therapy at the time of diagnosis of the first rejection episode was studied under two different protocols with cadaveric and living related renal transplant patients.
The use of ATGAM for the treatment of moderate to severe aplastic anemia in patients who are unsuitable for bone marrow transplantation is based on data from three controlled studies. Compatibility and Stability Once diluted, ATGAM has been shown to be physically and chemically stable for up to 24 hours at concentrations of up to 4 mg per mL in the following diluents: