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Pharmacologic class: Monoclonal antibody
Therapeutic class: Immunosuppressant
Pregnancy risk category B
FDA Box Warning
• Give under supervision of physician experienced in immunosuppressive therapy and management of organ transplant recipients, in facility with adequate diagnostic and treatment resources.
Blocks specific interleukin-2 (IL-2) receptor sites on activated T lymphocytes. Specific binding competitively inhibits IL-2-mediated activation and differentiation of lymphocytes responsible for cell-mediated immunity. Also impairs immunologic response to antigenic challenges.
Powder for injection: 10 mg, 20 mg in single-use vials
Indications and dosages
➣ Prevention of acute organ rejection in kidney transplantation
Adults and children weighing 35 kg (77 lb) or more: 20 mg I.V. 2 hours before transplantation surgery, then 20 mg I.V. 4 days after surgery. Withhold second dose if complications, hyper-sensitivity reaction, or graft loss occurs.
Children weighing less than 35 kg (77 lb): 10 mg I.V. 2 hours before transplantation surgery, then 10 mg I.V. 4 days after surgery. Withhold second dose if complications, hypersensitivity reaction, or graft loss occurs.
• Hypersensitivity to drug
• Pregnancy or breastfeeding
Use cautiously in:
• elderly patients
• females of childbearing age.
☞ Give by central or peripheral I.V. route only.
• Reconstitute by adding 5 ml of sterile water for injection to vial for bolus injection, or dilute with normal saline solution or dextrose 5% in water to a volume of 50 ml and infuse over 20 to 30 minutes. Discard any remaining product after preparing each dose.
• Don't infuse other drugs simultaneously through same I.V. line.
• Know that drug should be used only as part of regimen that includes cyclosporine and corticosteroids.
CNS: headache, insomnia, paresthesia, dizziness, drowsiness, tremor, anxiety, confusion, coma, seizures
CV: palpitations, edema, chest pain, ECG abnormalities, hypotension, hypertension, prolonged QT interval
EENT: blurred vision, eye irritation, tinnitus, earache, epistaxis, nasopharyngitis, sinusitis
GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, anorexia, oral blisters, oral candidiasis, GI hemorrhage
GU: urinary incontinence, intermenstrual bleeding, oliguria, renal failure
Hematologic: anemia, disseminated intravascular coagulation, hemorrhage, neutropenia, thrombocytopenia Metabolic: hypokalemia, hypomagnesemia, hyperglycemia, acidosis, hypoglycemia, hyperkalemia
Musculoskeletal: bone, back, neck, or limb pain
Respiratory: dyspnea, cough, hypoxia, tachypnea, hemoptysis, upper respiratory tract infection, pleural effusions
Skin: bruising, pruritus, dermatitis, skin lesions, diaphoresis, night sweats, erythema, hyperpigmentation, urticaria
Other: fever, lymphadenopathy, facial edema, bacterial infection, herpes simplex infection, injection site erythema, hypersensitivity reaction, sepsis
Drug-drug. Immunosuppressants: additive immunosuppression
Drug-diagnostic tests. Calcium, glucose, potassium: increased or decreased levels
Hemoglobin, neutrophils, platelets: decreased values
Triglycerides: increased levels
White blood cells: decreased levels
Drug-herbs. Astragalus, echinacea, melatonin: interference with immunosuppressant action
☞ Watch for signs and symptoms of hypersensitivity reaction. Keep emergency drugs at hand in case these occur.
• Monitor vital signs and observe patient frequently during I.V. infusion.
• Monitor laboratory values and drug blood level.
• Teach patient about purpose of therapy. Explain that drug decreases the risk of acute organ rejection.
• Tell patient he may be more susceptible to infection because of drug's immunosuppressant effect.
• Inform patient that he'll need lifelong immunosuppressant drug therapy.
• Advise women of childbearing age to use reliable contraception before, during, and for 2 months after 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.