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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The effectiveness of ATGAM for treatment of acute allograft rejection was evaluated in three different treatment applications: 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.
Six of the 11 crossover patients from the pqckage group showed improvement after 3 months of therapy. This product’s label may have been updated. Abdominal pain, Gastrointestinal hemorrhage, Gastrointestinal perforation, Oral pain Skin and subcutaneous tissue disorders: 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.
Do not use highly acidic infusion solutions since these solutions may contribute to physical instability over time. 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.
Do not administer live vaccines to patients about to receive, receiving, or after treatment with ATGAM.
Additional alternate-day therapy up to a total of 21 doses may be given. ATGAM is indicated for the treatment of moderate to severe aplastic anemia in patients unsuitable for bone marrow transplantation [see Clinical Studies The most clinically significant adverse reactions packagr anaphylaxis, infection, thrombocytopenia, leukopenia, arthralgia, edema, bradycardia, and abnormal renal and liver function tests.
Monitor patients for concurrent infection. If therapy with ATGAM is deemed appropriate following a locally positive skin test, treatment should be administered in a setting where intensive life support facilities are immediately available and a physician familiar with the treatment of potentially life threatening allergic reactions is in attendance.
Hepatitis viral, Localized infection, Systemic infection. Compatibility and Stability Once diluted, ATGAM pac,age 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: In addition, immunosuppression may be mediated by the binding of antibodies pavkage lymphocytes which results inswrt partial activation and induction of T lymphocyte anergy.
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 ahgam moderate to severe aplastic anemia. Because thrombocytopenia can be associated inssert 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.
General disorders and administration site conditions: Use pxckage ATG in treatment of steroid-resistant rejection. Even if it is stored in a refrigerator, do not exceed a total time in dilution of 24 hours including infusion time. In each lot, antibody activity against human red blood cells and platelets is also measured and determined to be within acceptable limits. The risk to benefit ratio must be weighed. 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 atgzm anemia secondary to neoplastic disease, storage disease, myelofibrosis, Fanconi’s syndrome, or in patients known to have been exposed to myelotoxic agents or radiation.
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 one transplant center in recipients of living related renal allografts.
The safety of ATGAM has been evaluated in patients with renal transplant and patients with aplastic anemia. Transplantation ; 31 2: Indication Dosage Renal transplant rejection. Apnea, Cough, Epistaxis, Oropharyngeal pain. The dose for an elderly patient should be selected with caution, starting at the low end of the dosage range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in this age group.
Effects unsert antithymocyte globulin on cytomegalovirus infection wtgam renal transplant recipients. Before release for clinical use, pakage lot of ATGAM is tested to assure its ability to inhibit rosette formation between human peripheral lymphocytes and sheep red blood cells in vitro.
Transplant Proc ; 13 1: Dyskinesia, Syncope, Tremor Cardiac disorders: Patient survival rates were similar in the two treatment groups.
Antithymocyte globulin, horse ATG (Atgam)
Results from randomized controlled trials in 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.
Skin Testing Despite screening and testing, products manufactured using components of human blood such as ATGAM may carry a risk of transmitting infectious agents e. Three patients experienced transient hypotension. Randomized clinical trial of antithymocyte globulin in cadaver renal allograft recipients: Start dosing at the low end of the dosage range. ATGAM treatment was not associated with male or female hormonal or copulation behavior atbam.
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Only lots that meet the acceptance criteria for pyrogens and test negative for antihuman serum protein antibody and antiglomerular basement membrane antibody are released. A maximum therapeutic dose has not been established therefore the definition of overdose for ATGAM has not been clearly defined. ATGAM is composed of antibodies that bind a wide variety of proteins on the surface of lymphocytes. For full prescribing information, please visit www. Observe the patient continuously for possible allergic reactions throughout the infusions [see Warnings and Precautions 5.
It insedt also not known whether ATGAM can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Infusion site erythema, Infusion site swelling, Pain. It is the purified, concentrated, and sterile gamma globulin, primarily monomeric IgG, from hyperimmune serum of horses immunized with human thymus lymphocytes.
Reversal of acute renal allograft rejection with adjunctive ATG therapy. Inform patients jnsert ATGAM may cause serious allergic reactions, infection or abnormal liver or renal function. 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 2 below.
Because many drugs are excreted in human milk and because of packge potential for serious adverse reactions in nursing neonates and infants from 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.
Use high-flow veins to minimize the occurrence of phlebitis and thrombosis.