Classifications: immunosuppressant; monoclonal antibody; Therapeutic: immunosuppressant
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.
CD3-positive T-lymphocyte immunosuppressive activity results in reversing graft rejection of a transplanted kidney.
Acute allograft rejection in kidney transplant patients.
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.
Recent MI; ischemic cardiac disease, CAD; pulmonary edema; repeated courses.
Route & Dosage
Adult: IV 5 mg/d for 1014 d
Child: IV ≤30 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:
The number of circulating CD3
-positive T-cells decreases within minutes. Peak:
27 d. Duration:
Assessment & Drug Effects
- Monitor patient's response closely for 48 h for first dose reaction (occurs within 4560 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.