Equine thymocyte immune globulin
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: ANAPHYLAXIS Antithymocyte globulins can cause anaphylaxis when injected intravenously. Although ATGAM is processed to reduce the level of antibodies that will react to non-T cells, physicians should be prepared for the potential risk of anaphylaxis and monitor patients for signs and symptoms during infusion. WARNING: ANAPHYLAXIS See full prescribing information for complete boxed warning . Antithymocyte globulins can cause anaphylaxis when injected intravenously. Although ATGAM is processed to reduce the level of antibodies that will react to non-T cells, physicians should be prepared for the potential risk of anaphylaxis and monitor patients for signs and symptoms during infusion.
Immunoglobulin G
Dosing in kidney impairment
Dose Renal Allograft Recipients Renal transplant rejection: The recommended dose is 10 to 15 mg/kg daily intravenously for 14 days. Additional alternate-day therapy up to a total of 21 doses may be given. Aplastic Anemia (Moderate to Severe) The recommended dose is 10 to 20 mg/kg daily intravenously for 8 to 14 days. Additional alternate-day therapy up to a total of 21 doses may be given.
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. Geriatric population (≥65 years of age) Select the dose for an elderly patient with caution, starting at the low end of the dosage range [see Use in Specific Populations ] .
| Indication | Dosage |
|---|---|
| Renal transplant rejection | 10 to 15 mg/kg daily intravenously for 14 days; additional alternate-day therapy up to a total of 21 doses may be given. (2.1) |
| Aplastic anemia | 10 to 20 mg/kg daily intravenously for 8 to 14 days; additional alternate-day therapy up to a total of 21 doses may be given. (2.1) |
Preparation and administration
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Preparation and Administration Preparation of Solution Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. 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.
Do not shake ATGAM (diluted or undiluted) because excessive foaming and/or denaturation of the protein may occur. Dilute ATGAM for intravenous infusion in an inverted bottle of sterile vehicle so the undiluted ATGAM does not contact the air inside. Add the total daily dose of ATGAM to the sterile vehicle (see Compatibility and Stability ) .
Do not exceed a concentration of 4 mg of ATGAM per mL. Gently rotate or swirl the diluted solution to effect thorough mixing. Administration Allow the diluted ATGAM to reach room temperature before infusion. 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 0.2 to 1.0 micron.
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. Use high-flow veins to minimize the occurrence of phlebitis and thrombosis. Do not infuse a dose of ATGAM in less than 4 hours. Always keep appropriate resuscitation equipment at the patient's bedside while ATGAM is being administered.
Observe the patient continuously for possible allergic reactions throughout the infusions [see Warnings and Precautions and Adverse Reactions ] . 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: 0.9% Sodium Chloride Injection, 5% Dextrose and 0.225% Sodium Chloride Injection, and 5% Dextrose and 0.45% Sodium Chloride Injection.
Do not dilute ATGAM in Dextrose Injection, USP, as low salt concentrations may cause precipitation. Do not use highly acidic infusion solutions since these solutions may contribute to physical instability over time. Store diluted ATGAM in a refrigerator if it is prepared prior to the time of infusion. Even if it is stored in a refrigerator, do not exceed a total time in dilution of 24 hours (including infusion time).
Drug interactions
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- Equine thymocyte immune globulin
Label text (1 paragraph)
Previously masked reactions to ATGAM may appear when the dose of corticosteroids and other immunosuppressants is being reduced. Previously masked reactions to ATGAM may appear following reduced doses of immunosuppressants. ( 7 )
Contraindications
Do not administer ATGAM to a patient who has had a systemic reaction (e.g., anaphylactic reaction) during prior administration of ATGAM or any other equine gamma globulin preparation [see Warnings and Precautions (5.1) ]. Systemic reaction (e.g., anaphylactic reaction) during prior administration of ATGAM or any other equine gamma globulin preparation. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for equine thymocyte immune globulin. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy ATGAM was not teratogenic in rats or monkeys at a dose up to 20 mg/kg. However, 20 mg/kg/day ATGAM for 16 days during organogenesis in cynomolgus monkeys was fetotoxic. No fetal or maternal toxicity was seen with 10 mg/kg/day ATGAM administered for 16 days during organogenesis [see Nonclinical Toxicology (13.1) ] . 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.
Lactation
8.3 Nursing Mothers In animal studies, a single dose of ATGAM up to 40 mg/kg was not detected at the limit of quantification in the milk of lactating cynomolgus monkeys. 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.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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