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Atgam Generic Name & Formulations
Legal Class
Rx
General Description
Lymphocyte immune globulin, anti-thymocyte globulin [equine] 50mg/mL; soln for IV infusion after dilution.
Pharmacological Class
Immune globulin.
How Supplied
Ampules (5mL)—5
Manufacturer
Atgam Indications
Indications
Treatment of moderate to severe aplastic anemia in patients who are unsuitable for bone marrow transplantation.
Atgam Dosage and Administration
Adult
Perform intradermal test dose before initiating therapy (see literature). Do not dilute in dextrose injection or highly acidic infusion solutions. Give by IV infusion over >4hrs. 10–20mg/kg daily for 8–14 days. Additional alternate-day therapy up to a total of 21 doses can be administered. May need prophylactic platelet transfusions to maintain platelets.
Children
Limited experience (see literature).
Atgam Contraindications
Not Applicable
Atgam Boxed Warnings
Not Applicable
Atgam Warnings/Precautions
Warnings/Precautions
To be administered by physicians with experience in immunosuppressive therapy and in facilities equipped with adequate lab and supportive medical resources. Discontinue if symptoms of anaphylaxis develop. Contains human plasma; monitor for possible infection transmission. Monitor for leukopenia, thrombocytopenia, or infection esp. with concomitant corticosteroids and antimetabolites. Pregnancy (Cat.C): not recommended. Nursing mothers.
Atgam Pharmacokinetics
See Literature
Atgam Interactions
Interactions
Previously masked reactions may occur when corticosteroids and other immunosuppressant doses are reduced.
Atgam Adverse Reactions
Adverse Reactions
Fever, skin reactions, chills, arthralgia, headache, myalgia, GI upset, chest pain, phlebitis, diaphoresis, joint stiffness, edema, muscle ache, vomiting, agitation/lethargy, listlessness, light-headedness, seizures, bradycardia, myocarditis, cardiac irregularity, hepatosplenomegaly, possible encephalitis or post viral encephalopathy, hypotension, CHF, hypertension, burning soles/palms, foot sole pain, lymphadenopathy, post-cervical lymphadenopathy, tender lymph nodes, bilateral pleural effusion, respiratory distress, anaphylactic reaction, proteinuria, abnormal LFTs and renal function, serum sickness.
Atgam Clinical Trials
See Literature
Atgam Note
Not Applicable
Atgam Patient Counseling
See Literature
Atgam Generic Name & Formulations
Legal Class
Rx
General Description
Lymphocyte immune globulin, anti-thymocyte globulin [equine] 50mg/mL; soln for IV infusion after dilution.
Pharmacological Class
Immune globulin.
How Supplied
Ampules (5mL)—5
Manufacturer
Atgam Indications
Indications
Management of allograft rejection in renal transplant patients.
Atgam Dosage and Administration
Adult
Perform intradermal test dose before initiating therapy (see literature). Do not dilute in dextrose injection or highly acidic infusion solutions. Give by IV infusion over >4hrs. Usual range: 10–30mg/kg daily. Delaying onset of allograft rejection: fixed dose of 15mg/kg daily for 14 days, then every other day for 14 days for a total of 21 doses in 28 days. Give first dose within 24 hours before or after transplant. Treatment of rejection: first dose can be delayed until diagnosis of first rejection episode. 10–15mg/kg daily for 14 days; additional alternate-day therapy up to a total of 21 doses can be given.
Children
Limited experience. 5–25mg/kg daily.
Atgam Contraindications
Not Applicable
Atgam Boxed Warnings
Not Applicable
Atgam Warnings/Precautions
Warnings/Precautions
To be administered by physicians with experience in immunosuppressive therapy and in facilities equipped with adequate lab and supportive medical resources. Discontinue if symptoms of anaphylaxis, or severe and unremitting thrombocytopenia or leukopenia develop. Contains human plasma; monitor for possible infection transmission. Monitor for leukopenia, thrombocytopenia, or infection esp. with concomitant corticosteroids and antimetabolites. Pregnancy (Cat.C): not recommended. Nursing mothers.
Atgam Pharmacokinetics
See Literature
Atgam Interactions
Interactions
Previously masked reactions may occur when corticosteroids and other immunosuppressant doses are reduced.
Atgam Adverse Reactions
Adverse Reactions
Fever, chills, leukopenia, thrombocytopenia, dermatologic reactions, arthralgia, chest or back pain, clotted A/V fistula, diarrhea, dyspnea, headache, hypotension, nausea, vomiting, night sweats, pain at infusion site, peripheral thrombophlebitis, stomatitis.
Atgam Clinical Trials
See Literature
Atgam Note
Not Applicable
Atgam Patient Counseling
See Literature
