Orthoclone OKT3
Classifications: immunosuppressant; monoclonal antibody;
Therapeutic: immunosuppressant

Prototype: Cyclosporine
Pregnancy Category: C


1 mg/mL injection


Murine monoclonal antibody (purified IgG2). Specifically targets the T3 (CD3) molecule in the antigenic recognition site of the human T-cell membrane. Following this antigenic challenge, CD3-positive T-cells are rapidly removed from circulation, and T-lymphocyte action leading to renal inflammation and destruction is blocked, thus reversing graft rejection.

Therapeutic Effect

CD3-positive T-lymphocyte immunosuppressive activity results in reversing graft rejection of a transplanted kidney.


Acute allograft rejection in kidney transplant patients.

Unlabeled Uses

Acute allograft rejection in heart and liver transplant patients.


Intolerance to any product of murine origin; patient with fluid overload; weight gain of more than 3% within week prior to treatment; infection: chickenpox (existing, recent, including recent exposure), seizure disorders; herpes zoster; pregnancy (category C), lactation.

Cautious Use

Recent MI; ischemic cardiac disease, CAD; pulmonary edema; repeated courses.

Route & Dosage

Transplant Rejection
Adult: IV 5 mg/d for 10–14 d
Child: IV30 kg, 2.5 mg q.d.; >30 kg, 5 mg q.d.


Note: Only persons experienced with immunosuppressive therapy and management of kidney transplant patients should administer muromonab-CD3 and only in an area equipped with staff and facilities to deal with cardiac resuscitation.

  • Note: Verify correct rate of IV injection for administration to infants or children with physician.
  • Administer IV methylprednisolone sodium succinate before and IV hydrocortisone sodium succinate 30 min after muromonab-CD3 to decrease incidence of first dose reaction.
  • Be aware that concomitant maintenance immunosuppressive therapy is reduced or discontinued during drug therapy with muromonab-CD3 and resumed about 3 d prior to end of therapy.

PREPARE: Direct: Give undiluted. Do not shake ampule. Draw sterile solution into syringe through a low protein-binding 0.2- or 0.22-micron filter. Discard filter; attach syringe to an appropriate needle for IV bolus injection.  

ADMINISTER: Direct: Give by rapid (bolus) injection. Do not give by IV infusion or in conjunction with other drug solutions.  

  • Store at 2°–8° C (36°–46° F) unless otherwise stipulated. Avoid freezing.

Adverse Effects (≥1%)

All: Especially during first 2 d of therapy. GI: Nausea, vomiting, diarrhea. Respiratory: Severe pulmonary edema, dyspnea, chest pain, wheezing. Body as a Whole: Fever, chills, malaise, tremor, increased susceptibility to cytomegalovirus, herpes simplex, Pneumocystis carinii, Legionella, Cryptococcus, Serratia organisms, and gram-negative bacteria. CV: Tachycardia.


Onset: The number of circulating CD3-positive T-cells decreases within minutes. Peak: 2–7 d. Duration: 7 d.

Nursing Implications

Assessment & Drug Effects

  • Monitor patient's response closely for 48 h for first dose reaction (occurs within 45–60 min after first dose and lasts several hours). It may occur (less severe) after second dose; then usually does not occur with subsequent doses. Symptoms: Chills, dyspnea, malaise, high fever.
  • Assess and monitor vital signs. If temperature rises above 37.8° C (100° F), suspect infection (commonly observed in first 45 d of therapy). Take temperature before treatment and several hours after drug administration to detect first signs of infection.
  • Consult physician if patient has a fever exceeding 37.8° C (100° F) before treatment. Make immediate attempts to lower temperature to at least 37.8° C (100° F) with antipyretics before muromonab-CD3 is administered.
  • Be alert to susceptibility of patient with pretreatment fluid over-load to acute pulmonary edema (may be fatal). Be prepared for prompt intubation, oxygenation, and corticosteroid drug administration should it occur.
  • Lab tests: periodic WBC with differential, CD3 T cells, LFTs, kidney function tests.

Patient & Family Education

  • Report any of the following to physician: Chest pain, difficulty breathing, wheezing, nausea and vomiting, significant weight gain, an infection, or fever.
  • Use an effective method of birth control for 12 wk following the end of therapy.

Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug

© 2006-2022 Last Updated On: 12/04/2022 (0)
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