Usual Adult Dose for Renal Transplant

10 to 15 mg/kg/day IV for 14 days; additional alternating day therapy can be administered for up to 21 doses

Comments:

• This drug is used with concomitant immunosuppressants. During repeat courses, observe patients for signs of allergic reactions.

Use: For the management of allograft rejection in renal transplant patients; when administered with conventional therapy at the time of rejection this drug increases the frequency of resolution of the acute rejection episode

Usual Adult Dose for Aplastic Anemia

10 to 20 mg/kg/day IV for 8 to 14 days; additional alternating day therapy can be administered for up to a total of 21 doses

Comments:

• This drug is used with concomitant immunosuppressants. During repeat courses, observe patients for signs of allergic reactions.
• Because thrombocytopenia can be associated with the administration of this drug, patients receiving it for the treatment of aplastic anemia may need prophylactic platelet transfusions to maintain platelets at clinically acceptable levels.

Use: For the treatment of moderate to severe aplastic anemia in patients unsuitable for bone marrow transplantation

Usual Pediatric Dose for Renal Transplant

Experience with children has been limited. This drug has been administered safely to a small number of pediatric renal allograft recipients at dosage levels comparable to those in adults.

1 year and older:
10 to 15 mg/kg/day IV for 14 days; additional alternating day therapy can be administered for up to 21 doses

Comments:

• This drug is used with concomitant immunosuppressants. During repeat courses, observe patients for signs of allergic reactions.

Use: For the management of allograft rejection in renal transplant patients; when administered with conventional therapy at the time of rejection this drug increases the frequency of resolution of the acute rejection episode

Usual Pediatric Dose for Aplastic Anemia

Experience with children has been limited. This drug has been administered safely to a small number of pediatric aplastic anemia patients at dosage levels comparable to those in adults.

1 year and older:
10 to 20 mg/kg/day IV for 8 to 14 days; additional alternating day therapy can be administered for up to a total of 21 doses

Comments:

• This drug is used with concomitant immunosuppressants. During repeat courses, observe patients for signs of allergic reactions.
• Because thrombocytopenia can be associated with the administration of this drug, patients receiving it for the treatment of aplastic anemia may need prophylactic platelet transfusions to maintain platelets at clinically acceptable levels.

Use: For the treatment of moderate to severe aplastic anemia in patients unsuitable for bone marrow transplantation

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNINGS:
ANAPHYLAXIS:

• Antithymocyte globulins can cause anaphylaxis when injected IV. Although this drug 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 during the infusion.

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients

Safety and efficacy have not been established in patients younger than 1 year.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Allow the diluted drug to reach room temperature before infusion.
• Administer 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 this drug 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.
• Infuse over at least 4 hours.
• Keep resuscitation equipment at the bedside while this drug is being administered.
• Observe the patient for allergic reactions throughout the infusion.

Reconstitution/preparation techniques:

• Visually inspect for particulate matter and discoloration prior to administration.
• Because this drug 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 this drug (diluted or undiluted) because excessive foaming and/or denaturation of the protein may occur.
• Dilute for IV infusion in an inverted bottle of sterile vehicle so the undiluted drug does not contact the air inside.
• Add the total daily dose of this drug to the sterile vehicle; do not exceed a concentration of 4 mg/mL.
• Gently rotate or swirl the diluted solution to mix.
• When diluted, this drug is physically and chemically stable for up to 24 hours at concentrations of up to 4 mg/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 this drug in dextrose injection, 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).

Storage requirements:

• Store in a refrigerator at 2C to 8C (36F to 46F). Do not freeze.

Patient advice:

• Discontinue this drug and seek immediate medical attention if any signs/symptoms of an allergic or immune reaction occur.