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a murine monoclonal antibody to the CD3 antigen of human T cells, functioning as an immunosuppressant in treatment of acute rejection of renal, hepatic, and cardiac transplants.
Miller-Keane Encyclopedia and Dictionary of Medicine, Nursing, and Allied Health, Seventh Edition. © 2003 by Saunders, an imprint of Elsevier, Inc. All rights reserved.


Orthoclone OKT3

Pharmacologic class: Murine monoclonal antibody

Therapeutic class: Immunosuppressant

Pregnancy risk category C

FDA Box Warning

• Give under supervision of physician experienced in immunosuppressive therapy and management of solid-organ transplant patients, in facility equipped for cardiopulmonary resuscitation where patient can be monitored closely based on health status.

• Drug may cause anaphylactic and anaphylactoid reactions and occasionally life-threatening or lethal systemic, cardiovascular, and CNS reactions. Monitor patient's fluid status closely before and during therapy. Methylprednisolone pretreatment is recommended to minimize symptoms of cytokine release syndrome.


Binds to and blocks function of T lymphocytes responsible for antigen recognition, thereby reversing graft rejection


Injection: 1 mg/1 ml in 5-ml ampules

Indications and dosages

Acute allograft rejection in kidney transplant patients; steroid-resistant acute allograft rejection in heart and liver transplant patients

Adults and children weighing more than 30 kg (66 lb): 5 mg/day I.V. for 10 to 14 days

Children weighing 30 kg (66 lb) or less: 2.5 mg/day I.V. for 10 to 14 days


• Hypersensitivity to drug or other murine products

• Uncompensated heart failure

• Uncontrolled hypertension

• Predisposition to or history of seizures

• Antimouse antibody titer of 1:1000 or higher

• Pregnancy or breastfeeding


Use cautiously in:

• fever

• children younger than age 2.


• In kidney transplant patients, know that therapy should start as soon as acute kidney rejection is diagnosed. In heart and liver transplant patients, therapy should start when physician determines that steroid therapy hasn't reversed allograft rejection.

Know that drug must be given in facility equipped and staffed to treat cardiopulmonary arrest.

• For I.V. bolus injection, draw solution into syringe through low-protein-binding 0.2- or 0.22-micron filter. Discard filter and attach needle-free adapter.

• Administer bolus over less than 1 minute.

• Give antipyretics to decrease fever and corticosteroids to reduce allergic response, as prescribed.

Adverse reactions

CNS: fatigue, headache, weakness, tremors, hallucinations, aseptic meningitis, cerebral edema, seizures, encephalopathy

CV: chest pain, hypertension, hypotension, heart failure, tachycardia, cardiac arrest, shock

EENT: vision loss, blurred vision, conjunctivitis, photophobia, tinnitus, otitis media

GI: nausea, vomiting, diarrhea

GU: oliguria, anuria

Respiratory: dyspnea, wheezing, severe pulmonary edema, adult respiratory distress syndrome (ARDS)

Skin: flushing

Other: fever, chills, flulike symptoms, infection, anaphylaxis, cytokine release syndrome


Drug-drug. Indomethacin: increased muromonab blood level, encephalopathy and other adverse CNS effects

Live-virus vaccines: increased viral replication and effects

Other immunosuppressants: increased risk of infection

Drug-diagnostic tests. Blood urea nitrogen, creatinine: increased levels

Drug-herbs. Astragalus, echinacea, melatonin: interference with immunosuppressant effect

Patient monitoring

• Evaluate vital signs and cardiovascular status. Monitor ECG closely.

Stay alert for signs and symptoms of cytokine release syndrome, including fever up to 41.6 °C (107 °F), chills, rigor, nausea, vomiting, abdominal pain, diarrhea, malaise, joint and muscle pain, headache, and tremors.

Be aware that most adverse reactions occur within 30 minutes to 6 hours of first dose.

• Monitor temperature closely. Stay alert for fever and other signs and symptoms of infection.

Assess neurologic status and respiratory status closely. Evaluate for evidence of aseptic meningitis, encephalopathy, cerebral edema, pulmonary edema, and ARDS.

Patient teaching

• Inform patient that drug can cause serious adverse reactions. Reassure him that he will be monitored closely and will receive interventions to relieve these reactions. Teach him which signs and symptoms to report immediately.

• Reassure patient that adverse reactions will subside as treatment progresses.

• Advise female patient to avoid becoming pregnant or breastfeeding during therapy.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above.

McGraw-Hill Nurse's Drug Handbook, 7th Ed. Copyright © 2013 by The McGraw-Hill Companies, Inc. All rights reserved
References in periodicals archive ?
However, on presentation with initial symptoms, our patient seemed to have a low risk of developing PTLD and presence of latent EBV infection as opposed to a primary one; the type of organ transplanted was the kidney, being the least likely to result in PTLD; induction therapy was by basiliximab as opposed to muromonab-CD3 (OKT3) or thymoglobulin; he had no prior rejection episodes and was neither CMV nor Hepatitis C Virus (HCV) positive.
Although PCAR without ABMR has no consensus therapy today, induction therapy for PCAR without ABMR commonly consists of not only steroid but also multiple immunosuppressant including deoxyspergualin (DSG) and Muromonab-CD3 (OKT3) [5, 6].
[11] mPSL, PEX, IVIG, Rit Stable Our case mPSL improved Diffuse infiltration of PCAR was defined as score i3 in Banff classification or described as "Diffuse." By contrast, less than i2 was described as "Focal." ND: no data; VR: vascular rejection; RTx: renal transplantation; TG: transplant glomerulitis; DSA: donor-specific antibody; ABMR: antibody-mediated rejection; mPSL: methylprednisolone; PEX: plasma exchange; IVIG: intravenous immunoglobulin; Rit: Rituximab; OKT3: Muromonab-CD3; DSG: deoxyspergualin.
Current practice includes the use of various combinations of immunosuppressive agents such as cyclosporine with steroids, azathioprine, or muromonab-CD3, (4) in conjunction with mechanical support devices, if needed.
Muromonab-CD3 (Orthoclone OKT3[R]), an all murine monoclonal antibody has been used in the U.S.