MUROMONAB-CD3

MUROMONAB-CD3
(myoo-roe-moe'nab)
Orthoclone OKT3
Classifications: immunosuppressant; monoclonal antibody;
Therapeutic: immunosuppressant
Prototype: Cyclosporine
Pregnancy Category: C

Availability

1 mg/mL injection

Action

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.

Uses

Acute allograft rejection in kidney transplant patients.

Unlabeled Uses

Acute allograft rejection in heart and liver transplant patients.

Contraindications

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: IV ≤30 kg, 2.5 mg q.d.; >30 kg, 5 mg q.d.

Administration

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.

Intravenous

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.

Pharmacokinetics

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

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