ATGAM® Dosage and Administration

(lymphocyte immune globulin, anti-thymocyte globulin [equine])

2 DOSAGE AND ADMINISTRATION

For intravenous use only.

Administer ATGAM intravenously and use with concomitant immunosuppressants.

2.1 Dosing Information

Renal Allograft 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.

2.2 Preparation and Administration Instructions

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 faintly brown, and may develop a slight granular or flaky deposit. 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/bag 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

Diluted ATGAM should be at 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 (not supplied) with a pore size of 0.2 to 1.0 micron. Use the in-line filter (not supplied) with all infusions of ATGAM to prevent the administration of any insoluble material that may develop in the product. Use high-flow veins to minimize the occurrence of phlebitis and thrombosis. Infuse ATGAM over a period of at least 4 hours. Monitor patients for signs and symptoms of anaphylaxis during infusion and for at least 24 hours after infusion [see Warnings and Precautions (5.1) and Adverse Reactions (6)].

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 at room temperature. The diluted solution must be infused within 24 hours (including infusion time).

Find ATGAM® medical information:

Find ATGAM® medical information:

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

ATGAM® Quick Finder

Medication Guide

Health Professional Information

Dosage and Administration

2 DOSAGE AND ADMINISTRATION

For intravenous use only.

Administer ATGAM intravenously and use with concomitant immunosuppressants.

2.1 Dosing Information

Renal Allograft 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.

2.2 Preparation and Administration Instructions

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 faintly brown, and may develop a slight granular or flaky deposit. 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/bag 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

Diluted ATGAM should be at 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 (not supplied) with a pore size of 0.2 to 1.0 micron. Use the in-line filter (not supplied) with all infusions of ATGAM to prevent the administration of any insoluble material that may develop in the product. Use high-flow veins to minimize the occurrence of phlebitis and thrombosis. Infuse ATGAM over a period of at least 4 hours. Monitor patients for signs and symptoms of anaphylaxis during infusion and for at least 24 hours after infusion [see Warnings and Precautions (5.1) and Adverse Reactions (6)].

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 at room temperature. The diluted solution must be infused within 24 hours (including infusion time).
Prescribing Information
Download Prescribing Information

Health Professional Information

Dosage and Administration

2 DOSAGE AND ADMINISTRATION

For intravenous use only.

Administer ATGAM intravenously and use with concomitant immunosuppressants.

2.1 Dosing Information

Renal Allograft 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.

2.2 Preparation and Administration Instructions

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 faintly brown, and may develop a slight granular or flaky deposit. 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/bag 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

Diluted ATGAM should be at 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 (not supplied) with a pore size of 0.2 to 1.0 micron. Use the in-line filter (not supplied) with all infusions of ATGAM to prevent the administration of any insoluble material that may develop in the product. Use high-flow veins to minimize the occurrence of phlebitis and thrombosis. Infuse ATGAM over a period of at least 4 hours. Monitor patients for signs and symptoms of anaphylaxis during infusion and for at least 24 hours after infusion [see Warnings and Precautions (5.1) and Adverse Reactions (6)].

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 at room temperature. The diluted solution must be infused within 24 hours (including infusion time).

Resources

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985*

*Contact Medical Information.9AM-5PM ET Monday to Friday; excluding holidays.

Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.