muromonab-CD3


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muromonab-CD3

 [mu″ro-mo´nab]
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.

muromonab-CD3

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.

Action

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

Availability

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

Contraindications

• 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

Precautions

Use cautiously in:
• fever
• children younger than age 2.

Administration

• 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

Interactions

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.

muromonab-CD3

/mu·ro·mo·nab-CD3/ (mu″ro-mo´nab) a murine monoclonal antibody to the CD3 antigen of human T cells that functions as an immunosuppressant in the treatment of acute allograft rejection of renal, hepatic, and cardiac transplants.

muromonab-Cd3

[myo̅o̅′rəmon′ab]
a parenteral immunosuppressant drug, a monoclonal antibody that interferes with the function of the T cell antigen recognition receptors.
indications It is used to control acute renal transplant rejection, and to control liver or pancreas rejection or graft-versus-host disease when conventional methods are unsuccessful.
contraindications Hypersensitivity to muromonab-CD3 or any other murine products, patients in fluid over or those with greater than 3% weight gain over the past week, uncontrolled hypertension, or uncompensated heart failure.
adverse effects It causes a first-dose effect within 1 to 3 hours that ranges from mild flu-like symptoms to a life-threatening anaphylaxis. Pulmonary edema, fever, chills, breathing difficulty, chest pain, vomiting, nausea, diarrhea, and tremors are among the adverse effects associated with each administration.
References in periodicals archive ?
The transplant was complicated by cellular rejection of the kidney in March 2009 treated with Solu-Medrol and biopsy-proven pancreas rejection treated with 10 doses of muromonab-CD3.
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.
1-3) Risk factors are a high degree of immunosuppression, use of muromonab-CD3 (OKT3), need for retransplantation, history of smoking, and renal insufficiency.
The intensity of immunosuppression, including the use of muromonab-CD3 (OKT3) or antithymocyte globulin induction therapy, plays a paramount role in triggering PTLD (3).