Table of contents

  • Brand Names
  • Chemistry
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Unlabeled Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Genes that may be involved
  • Drug Interactions
  • Nutrition/Nutraceutical Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics
  • Special Considerations

Brand Names


Belgium: Orthoclone OKT3; France: Orthoclone OKT3; Germany: Orthoclone OKT3; Italy: Orthoclone OKT3; Luxembourg: Orthoclone OKT3; Netherlands: Orthoclone OKT3; Portugal: Orthoclone OKT3.

North America

Canada: Orthoclone OKT3; USA: Orthoclone OKT3.

Latin America

Brazil: Orthoclone OKT3; Mexico: Ior-T3, Orthoclone OKT3.


Japan: Orthoclone OKT3.

Drug combinations


Muromonab-CD3: A biochemically purified IgG~2α~ immunoglobulin consisting of a heavy chain of approximately 50000 daltons and a light chain of approximately 25000 daltons. Manufactured by a process involving fusion of mouse myeloma cells to lymphocytes from immunized animals to produce a hybridoma which secretes antigen-specific antibodies to T3 antigen of human T-lymphocytes (1989).

Pharmacologic Category

Immunosuppressive Agents. (ATC-Code: L04AA02).

Mechanism of action

Reverses graft rejection by binding to T cells and interfering with their function by binding T-cell receptor-associated CD3 glycoprotein.

Therapeutic use

Treatment of acute allograft rejection in renal transplant patients. Treatment of acute hepatic and kidney rejection episodes resistant to conventional treatment.

Pregnancy and lactiation implications

Use with caution during pregnancy or lactation.

Unlabeled use

Treatment of acute pancreas rejection episodes resistant to conventional treatment.


Hypersensitivity to OKT3 or any murine product. Uncompensated heart failure or uncontrolled hypertension, in fluid overload or patients with >3% weight gain within 1 week prior to start of OKT3. Mouse antibody titers >1:1000. History of seizures. Known or suspected pregnancy. Breast-feeding.

Warnings and precautions

Anaphylactic and anaphylactoid reactions may occur. Acute hypersensitivity reactions (cardiovascular collapse, cardiorespiratory arrest, loss of consciousness, shock, tachycardia, tingling, angioedema, airway obstruction, bronchospasm, dyspnea, urticaria, and pruritus). CNS events (seizures, encephalopathy, cerebral edema, aseptic meningitis, and headache) reported. Contraindicated for use in history of seizures or patients predisposed to seizures. Cytokine release syndrome may occur following first couple of doses. Possible increased susceptibility to infection. Increased risk of development of lymphoproliferative disorders (particularly of skin). Severe pulmonary edema occurred with fluid overload. Arterial, venous, and capillary thrombosis of allografts and other vascular beds reported (use with caution in history of thrombosis or underlying vascular disease). May result in an increased susceptibility to infection.



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