Atgam Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Lymphocyte Ig, anti-thymocyte globulin (equine)

Indications/Uses

Management of allograft rejection in renal transplant patients. Adjunct to other immunosuppressive therapy to delay onset of 1st rejection episode. Moderate to severe aplastic anemia in patients unsuitable for bone marrow transplantation.

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Dosage/Direction for Use

Renal allograft rejection 10-15 mg/kg IV daily for 14 days. Additional alternate-day therapy up to total of 21 doses may be given. Delaying onset of allograft rejection 15 mg/kg daily for 14 days, then every other day for 14 days up to total of 21 doses in 28 days. 1st dose to be given w/in 24 hr before or after transplant. Moderate to severe aplastic anaemia 10-20 mg/kg IV daily for 8-14 days. Additional alternate-day therapy up to total of 21 doses may be given.

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Overdosage

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Contraindications

Anaphylactic reaction to lymphocyte Ig, anti-thymocyte globulin (equine) or other equine γ globulin prep.

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Warnings

For additional cautionary notes to warn of the potential risk of using the medicine... Click to view Atgam detailed prescribing information

Special Precautions

Discontinue use if anaphylaxis occurs. Infusion-associated reactions. Cytokine release syndrome; serum sickness; thrombocytopenia & neutropenia; transmissible infectious agents. Monitor patients for signs & symptoms of anaphylaxis during & for at least 24 hr after infusion; for concurrent infection. Perform skin testing prior to treatment. Monitor hepatic & renal function during treatment. Not to be administered w/ live vaccines. Not to be diluted in dextrose inj & used w/ highly acidic infusion. Women of childbearing potential & male partners should use effective contraception during & for at least 10 wk after last dose. Pregnancy & lactation. Elderly ≥65 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Pyrexia, chills, rash, thrombocytopenia, leukopenia, arthralgia.

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Drug Interactions

Development of previously masked reactions w/ reduced dose of corticosteroids & other immunosuppressants.

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Storage

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Description

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Action

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MIMS Class

Immunosuppressants

ATC Classification

J06BA02 - immunoglobulins, normal human, for intravascular adm. ; Belongs to the class of normal human immunoglobulins. Used in passive immunizations.

Regulatory Classification

Presentation/Packing

Form

Atgam inj (amp) 50 mg/mL

Packing/Price

5 mL x 5 × 1's

Atgam

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma