Trade Names:Simulect- Powder for injection 20 mg
Blocks the interleukin-2 receptor α-chain, which is a critical pathway in allograft rejection.
C max is about 7.1 mg/L (20 mg IV over 30 min).
Vd is about 8.6 L.
The t ½ is about 7.2 days. Cl is about 41 mL/h.
Distribution volume and Cl are reduced about 50% compared with adult renal transplant patients.
Prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids.
Standard considerations.
IV 20 mg within 2 h prior to transplantation surgery, followed by 20 mg 4 days after transplantation. Withhold second dose if complications such as severe hypersensitivity reactions to basiliximab or graft rejection occur.
Children/Adolescents (under 35 kg)IV 10 mg within 2 h prior to transplantation surgery, followed by 10 mg 4 days after transplantation. Withhold second dose if complications such as severe hypersensitivity reactions to basiliximab or graft rejection occur.
Children/Adolescents (35 kg or more)IV 20 mg within 2 h prior to transplantation surgery, followed by 20 mg 4 days after transplantation. Withhold second dose if complications such as severe hypersensitivity reactions to basiliximab or graft rejection occur.
Store lyophilized basiliximab under refrigerated conditions at 2° to 8°C (36° to 46°F). The reconstituted solution can be refrigerated for 24 h or at room temperature for 4 h. Discard reconstituted solution if not used in 24 h. Use the reconstituted solution immediately and dilute as directed.
None well documented.
No data available; do not add or infuse other drugs simultaneously through the same IV line.
None well documented.
Hypertension; hypotension; angina pectoris; cardiac failure; abnormal heart sounds; arrhythmia; atrial fibrillation; tachycardia; vascular disorder.
Headache; tremor; dizziness; insomnia; hypoesthesia; neuropathy; paresthesia; agitation; anxiety; depression; fatigue; malaise.
Acne; surgical wound complications; cyst; herpes simplex; herpes zoster; hypertrichosis; pruritus; rash; skin ulceration.
Constipation; nausea; diarrhea; abdominal pain; vomiting; dyspepsia; moniliasis; enlarged abdomen; flatulence; gastroenteritis; GI hemorrhage; gum hyperplasia; melena; esophagitis; ulcerative stomatitis.
Dysuria; UTI; increased nonprotein nitrogen; impotence; genital edema; albuminuria; bladder disorder; hematuria; frequent micturition; oliguria; abnormal renal function; renal tubular necrosis; ureteral disorder; urinary retention.
Anemia; hemorrhage; purpura; thrombocytopenia; thrombosis; polycythemia.
Hyperkalemia; hypokalemia; hyperglycemia; hypoglycemia; hyperuricemia; hypomagnesemia; hypophosphatemia; hypocalcemia; hypercholesterolemia; hyperlipidemia; hyperproteinemia; weight gain; acidosis; dehydration; diabetes mellitus; fluid overload.
Dyspnea; upper respiratory tract infection; coughing; rhinitis; pharyngitis; bronchitis; bronchospasm; abnormal chest sounds; pneumonia; pulmonary disorder; pulmonary edema.
Cataracts; conjunctivitis; abnormal vision; sinusitis.
Pain; chest pain; leg pain; back pain; asthenia; arthralgia; arthropathy; bone fracture; cramps; hernia; myalgia; hematoma; edema; peripheral edema; facial edema.
Category B .
Undetermined.
Safety and efficacy not established.
Safety and efficacy not established.
Although not reported, can occur following administration of proteins.
Risk of developing these complications may be increased.
Copyright © 2009 Wolters Kluwer Health.