ATGAM PACKAGE INSERT PDF

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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Effects of antithymocyte globulin on cytomegalovirus infection in renal transplant recipients. The effectiveness of the ATGAM therapy in the studies described below was evaluated by the hematological response and survival rates Table 3.

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. Hepatitis viral, Localized infection, Systemic infection Blood and lymphatic system disorders: 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.

Dyskinesia, Syncope, Tremor Cardiac disorders: ATGAM treatment was not associated with male or female hormonal or copulation behavior changes.

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

The range for half-life was 1. This product’s label may have been updated. It may appear colorless to faintly pink or brown and is nearly odorless. Six of the 11 crossover patients from the control group showed improvement after 3 months of therapy.

Kidney enlargement, Kidney rupture, Renal failure acute. General disorders and administration site conditions: Abdominal pain, Gastrointestinal hemorrhage, Gastrointestinal perforation, Oral pain Skin and subcutaneous tissue disorders: ATGAM is used with concomitant immunosuppressants.

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Randomized clinical trial of antithymocyte globulin in cadaver 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.

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A conservative, conventional approach would first employ epicutaneous prick testing with undiluted ATGAM. Trends in immunosuppression for kidney transplantation.

ATGAM is appropriately administered into a vascular shunt, arterial venous fistula, or a high-flow central vein using an in-line filter with a pore size of 0. Hepatitis viral, Localized infection, Systemic infection. Improved cadaveric renal transplant outcome in children.

HIGHLIGHTS OF PRESCRIBING INFORMATION

Aplasia General disorders pacage administration site conditions: Serum sickness occurred in all patients within 6 to 18 days of ATGAM initiation atgaam was well-controlled with standard therapy. Study 2 was a randomized controlled trial conducted at five different transplant centers. 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.

The usefulness of ATGAM has insegt 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.

Patients were enrolled at the time of first rejection episode and randomized among three treatment groups: The risk to benefit ratio must be weighed. Gently rotate or swirl the diluted solution to effect thorough mixing.

Inform patients that ATGAM may cause serious allergic reactions, infection or abnormal wtgam or renal function. Healthcare providers should refer to labels. Discuss the risks and benefits of therapy with patients before initiating treatment [see Warnings and Precautions 5.

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Also, skin testing done as described above will not predict for later development iinsert serum sickness.

Therefore, this toxicity is not considered relevant to human fetal development. 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. Atgma alternate-day therapy up to a total of 21 doses may be given. Efficacy was evaluated as sustained improvement in peripheral blood counts within 3 months of entry into the study.

Patient survival rates were similar in the two treatment groups. It is also not known whether ATGAM can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Infusion atagm erythema, Infusion site swelling, Pain. A maximum therapeutic dose has not been established therefore the definition of overdose for ATGAM has not been clearly defined.

Use of antithymocyte globulin for reversal of acute allograft rejection. Clinical signs associated with anaphylaxis, other infusion associated reactions, and serum sickness have been reported.

Transplantation ; 31 2: For storage conditions of diluted solution, see Dosage and Administration 2. Some studies have suggested an increase in the incidence of cytomegalovirus infection in patients receiving ATGAM. 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.