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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:
• 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.
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)
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
• 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.
• 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.