ATGAM PACKAGE INSERT PDF

Mijin Gently rotate or swirl the diluted solution to effect thorough mixing. Advise patients receiving ATGAM that they will be monitored in a facility equipped and staffed with adequate laboratory and supportive medical resources. To identify those at greatest risk, skin testing before treatment is strongly recommended. The effectiveness of ATGAM for reversal of acute renal allograft rejection was also demonstrated in other controlled studies performed in various medical centers. Because clinical trials are conducted under widely varying conditions, inset 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.

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Mijin Gently rotate or swirl the diluted solution to effect thorough mixing. Advise patients receiving ATGAM that they will be monitored in a facility equipped and staffed with adequate laboratory and supportive medical resources.

To identify those at greatest risk, skin testing before treatment is strongly recommended. The effectiveness of ATGAM for reversal of acute renal allograft rejection was also demonstrated in other controlled studies performed in various medical centers.

Because clinical trials are conducted under widely varying conditions, inset 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. Flank pain, Muscle rigidity, Myalgia, Pain in extremity. 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.

Dyskinesia, Syncope, Tremor Cardiac disorders: Allocation to treatment group was based on the availability of mismatched bone marrow donors. Use high-flow veins to minimize the occurrence of phlebitis and thrombosis. Antithymocyte globulins can cause anaphylaxis when injected intravenously. Previously masked reactions to ATGAM may appear when the dose of corticosteroids and other immunosuppressants is being reduced. Experience with children has been limited. Use of ATG for reversal of acute allograft rejection.

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. There are no adequate and well-controlled studies in pregnant women.

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.

The risk to benefit ratio must be weighed. The predictive value of this test has not been proven clinically. ATGAM is indicated for the management of allograft rejection in renal transplant patients; when administered with conventional therapy at the time of rejection ATGAM increases the frequency of resolution of the acute rejection episode [see Clinical Studies Effects of antithymocyte globulin on cytomegalovirus infection in renal transplant recipients. ATGAM is used with concomitant immunosuppressants.

Digital Security 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. 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.

Observe the patient continuously for possible allergic reactions throughout the infusions [see Warnings and Precautions 5. Five patients had asymptomatic sinus bradycardia; six patients required antihypertensive therapy. Published data indicate that the primary mechanism is the depletion of circulating lymphocytes, with greatest effect on T lymphocytes.

Additional alternate-day therapy up to a total xtgam 21 doses may be given. Abdominal pain, Gastrointestinal hemorrhage, Gastrointestinal perforation, Oral pain. Some renal transplant patients have received up to 50 doses in 4 months, and others have received day courses of 21 doses followed by as many as 3 more courses for the treatment of acute rejection. For storage conditions of diluted solution, see Dosage and Administration 2.

Infusion site erythema, Infusion site swelling, Pain. Transplantation ; 29 2: ATGAM is indicated for the treatment atgwm moderate to severe aplastic anemia in patients unsuitable for bone marrow transplantation [see Clinical Studies 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.

Indication Dosage Renal transplant rejection. It is the purified, concentrated, and sterile gamma globulin, primarily monomeric IgG, from packzge serum of horses immunized with human thymus lymphocytes. 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.

Trends in immunosuppression for kidney transplantation. ATGAM is composed of antibodies that bind a wide variety of proteins on the surface of lymphocytes. 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.

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. 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.

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Kazrara Advise patients receiving ATGAM that they will be monitored in a facility aygam and staffed with adequate laboratory and supportive medical resources. The most clinically significant adverse reactions are anaphylaxis, infection, thrombocytopenia, leukopenia, arthralgia, edema, bradycardia, and abnormal renal and liver function tests. Even if it is stored in a refrigerator, do not exceed a total time in dilution of 24 hours including infusion time. Deep vein thrombosis, Vasculitis Respiratory, thoracic and mediastinal disorders: Do not administer live vaccines to patients about to receive, receiving, or after treatment with 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. However, because ATGAM is a gamma globulin product, it can be transparent to slightly opalescent, colorless to faintly pink or brown, and may develop a slight granular or flaky deposit during storage.

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Meshicage In addition, immunosuppression may be mediated by the binding of antibodies to lymphocytes which results in partial activation and induction of T lymphocyte anergy. Randomized clinical trial of antithymocyte globulin in cadaver renal allograft recipients: 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. It is also not known whether ATGAM can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Select the dose for an elderly patient with caution, starting at the low end of the dosage range [see Use in Specific Populations 8. There was no difference in the patient survival rate between the two treatment groups. Monitor patients for concurrent infection. Additional alternate-day therapy up to a total of 21 doses may be given.

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ATGAM PACKAGE INSERT PDF

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. There are no adequate and well-controlled studies in pregnant women. It is also not known whether Atgam can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Atgam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Atgam is excreted in human milk. Because many drugs are excreted in human milk and because of the 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. Pediatric Use Experience with children has been limited.

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For full prescribing information, please visit www. Apnea, Cough, Epistaxis, Oropharyngeal pain. 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. The effectiveness of ATGAM for treatment of acute allograft rejection was evaluated in three different treatment applications: The maternal and fetal deaths were attributed to maternal anemia due to red blood cell antigen that humans do not share. Only lots that meet the acceptance criteria for pyrogens and test negative for antihuman serum protein antibody and antiglomerular basement membrane antibody are released. To identify those at greatest risk of systemic anaphylaxis, skin testing potential recipients is strongly recommended before commencing treatment.

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