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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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. The safety of ATGAM has been evaluated in patients with renal transplant and patients with aplastic anemia.

Allocation to treatment group was based on the atgqm of mismatched bone marrow donors. 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 wtgam severe aplastic anemia who were not candidates for bone marrow transplantation.

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In this study, ATGAM was at least effective as standard therapy for treatment of acute allograft rejection. Reversal of acute renal allograft rejection with adjunctive ATG therapy. Transplantation ; 29 2: 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.

Randomized clinical trial of antithymocyte globulin in cadaver renal allograft recipients: Even if it is stored in a refrigerator, do not exceed a total time in dilution of 24 hours including infusion time. Clinical signs associated with anaphylaxis, other infusion associated reactions, and serum sickness have been reported.

Previously masked reactions to ATGAM may appear when the dose of corticosteroids and other immunosuppressants is being reduced. Musculoskeletal and connective tissue disorders: Also, skin testing done as described above will not predict for later development of serum sickness.

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

ATGAM has been administered safely to a small number of pediatric renal allograft recipients and pediatric aplastic anemia patients at dosage levels comparable to those in adults. Before release for clinical use, each lot of ATGAM is tested to assure its ability to inhibit rosette formation between human peripheral lymphocytes and sheep red blood cells in vitro.

Because ATGAM is pavkage from equine and human blood components, it may carry a risk of transmitting infectious agents, e. A total of 41 patients with moderate or severe aplastic anemia ages 6 to 69 years, who were not candidates for bone marrow transplantation were enrolled in a randomized controlled study.

The dose for an elderly patient should be selected packxge 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. Hyperhidrosis Musculoskeletal and connective tissue disorders: Dyskinesia, Syncope, Tremor Cardiac disorders: 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 pacckage clinically acceptable levels.

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.

ATGAM treatment was not associated with male or female hormonal or copulation behavior changes. Discuss the risks and benefits of therapy with patients before initiating treatment [see Warnings and Precautions 5. A ahgam reaction such as a generalized rash, tachycardia, dyspnea, hypotension, or anaphylaxis precludes any additional administration of ATGAM.

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The effectiveness of ATGAM for reversal of acute renal allograft rejection was also demonstrated in other controlled studies performed in various medical centers. There are no adequate and well-controlled studies in pregnant women. Allergic reactions such as anaphylaxis have occurred in patients whose skin test is negative.

Antithymocyte globulin, horse ATG (Atgam) | – A Hematology Oncology Wiki

Six of the 11 crossover patients from the control group showed improvement after 3 months of therapy. In embryo-fetal toxicity studies, ATGAM was administered to rats and cynomolgus monkeys for 11 and 16 days, respectively during organogenesis.

Infusion site erythema, Infusion site swelling, Pain. For storage conditions of diluted solution, see Dosage and Administration 2.

In this patient, the administration of ATGAM was not associated with any signs of acute intoxication or late sequelae.

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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. The effectiveness of the ATGAM therapy in the studies described below was evaluated by the hematological response and survival rates Table 3. Transplantation ; 31 2: Observe the patient continuously for possible allergic reactions throughout the infusions [see Warnings and Precautions 5.

Improved cadaveric renal transplant outcome in children. Use of ATG for reversal of acute allograft rejection. Patients were enrolled at the time of first rejection episode and randomized among three treatment groups: Kidney enlargement, Kidney rupture, Renal failure acute. Flank pain, Muscle rigidity, Myalgia, Pain in extremity Renal and urinary disorders: ATGAM is a transparent to slightly opalescent aqueous protein solution.