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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Use of antithymocyte globulin for reversal of acute allograft rejection. Randomized clinical trial of antithymocyte globulin in cadaver renal allograft recipients: Transplantation ; 28 6: Transplantation ; 31 2: For storage conditions of diluted solution, see Dosage and Administration 2.
Isnert full prescribing information, please visit www. The most clinically atga adverse reactions are anaphylaxis, infection, thrombocytopenia, leukopenia, arthralgia, edema, bradycardia, and abnormal renal and liver function tests. It is the purified, concentrated, and sterile gamma globulin, primarily monomeric IgG, from hyperimmune serum of horses immunized with human thymus lymphocytes.
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. Antithymocyte globulins can cause anaphylaxis when injected intravenously. Apnea, Cough, Epistaxis, Oropharyngeal pain. Indication Dosage Renal transplant rejection. A inesrt 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.
The effect of ATGAM when administered in conjunction with standard atgxm at the time of diagnosis of the first rejection episode was studied under two different protocols with cadaveric and living related renal transplant patients. Select the dose for an elderly patient with caution, starting at the low end of the dosage range [see Use in Specific Populations 8. In addition, immunosuppression may be mediated by the binding of antibodies to lymphocytes which results in partial activation and induction of T lymphocyte anergy.
In embryo-fetal toxicity studies, ATGAM was administered to rats and cynomolgus monkeys for 11 insret 16 days, respectively during organogenesis. The most commonly reported adverse events were rash, fever, arthralgias, chills, headache, myalgia and pruritus. Results from randomized controlled trials in patients with first acute renal allograft rejection episodes refractory agam conventional steroid therapy have demonstrated that ATGAM, when administered in conjunction with standard therapy, yields efficacy results superior to those of standard therapy alone.
Trends in immunosuppression for kidney transplantation. To identify those at greatest risk of systemic anaphylaxis, skin atgxm potential recipients is strongly recommended before commencing treatment. Always keep appropriate resuscitation equipment at the patient’s bedside while ATGAM is being administered. 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: Kidney enlargement, Kidney rupture, Renal failure acute Congenital, familial and genetic disorders: In this study, ATGAM was at least effective as standard therapy for treatment of acute allograft rejection.
Respiratory, thoracic and mediastinal disorders: Because many insfrt are excreted in human milk and because of the potential for serious adverse reactions in nursing neonates and infants packaye ATGAM, a decision should be made whether to discontinue nursing or to discontinue the drug taking into account the importance of the drug to the mother.
HIGHLIGHTS OF PRESCRIBING INFORMATION
There are no adequate and well-controlled studies atgma pregnant women. Do not use highly acidic infusion solutions since these solutions may contribute to physical instability over time. The incidence of toxicologic manifestations did not increase with any of these regimens; however, close monitoring of the patient is recommended.
Blood and lymphatic system disorders: Although ATGAM is atam 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.
Skin Testing Despite screening and testing, products manufactured using components of packkage blood inserrt as ATGAM may carry a risk of transmitting infectious agents e. There was no difference in the patient survival rate between the two treatment groups.
The maximum tolerated dose of ATGAM Sterile Solution would be expected to vary from patient to patient due to the biological nature of the product. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The objective of this study was to determine the efficacy of ATGAM as a single agent, in restoring hematopoiesis in patients with moderate to severe aplastic anemia.
Patient survival rates were similar in the two treatment groups. The renal transplantation and aplastic anemia patients received a similar dosing regimen, and these data were pooled to obtain the frequencies listed in Tables 1 and insdrt below.
All infections suspected by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Pfizer, Inc. 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.
Renal and urinary disorders: The maternal and fetal deaths were attributed to maternal anemia due to red blood cell antigen that humans do not share. The results from these studies demonstrate the efficacy associated with the addition of ATGAM to standard therapy for treatment of the first rejection episode in renal allograft recipients.
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.
While the etiology of this toxicity is uncertain, it may be attributed to hemolytic anemia due to cross-reactivity of ATGAM to a monkey red blood antigen.
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.
Even if it is stored in a refrigerator, do not exceed a total time in dilution of 24 hours including infusion time. Inxert Testing To identify those at greatest risk of systemic anaphylaxis, skin testing potential recipients is strongly recommended before commencing treatment. Flank pain, Muscle rigidity, Myalgia, Pain in extremity. Kidney Int ; 13 Suppl 8: Improved cadaveric renal transplant outcome packagee children. Also, skin testing done as described above will not predict for later development of serum sickness.
If the subject does not show a wheal ten minutes after pricking, proceed to intradermal testing with 0. Use high-flow veins to minimize the occurrence of phlebitis and thrombosis.