Basiliximab

 Action Blocks the interleukin-2 receptor a-chain, which is a critical pathway in allograft rejection.

 Indications Prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids. Prophylaxis of solid organ rejection.

 Contraindications Standard considerations.

 Route/Dosage

ADULTS: IV 20 mg within 2 hr prior to transplantation surgery, followed by 20 mg 4 days after transplantation.

CHILDREN (2 to 15 yr): IV 12 mg/m2 (max 20 mg/m2) within 2 hr prior to transplantation surgery, followed by same dose 4 days after transplantation.

 Interactions

None well documented.

No data available; do not add or infuse other drugs simultaneously through the same IV line.

 Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Hypertension; hypotension; angina pectoris; cardiac failure; abnormal heart sounds; arrhythmia; atrial fibrillation; tachycardia; vascular disorder. RESPIRATORY: Dyspnea; upper respiratory tract infection; coughing; rhinitis; pharyngitis; bronchitis; bronchospasm; abnormal chest sounds; pneumonia; pulmonary disorder; pulmonary edema. CNS: Headache; tremor; dizziness; insomnia; hypoesthesia; neuropathy; paresthesia; agitation; anxiety; depression; fatigue; malaise. EENT: Cataracts; conjunctivitis; abnormal vision; sinusitis. GI: Constipation; nausea; diarrhea; abdominal pain; vomiting; dyspepsia; moniliasis; enlarged abdomen; flatulence; gastroenteritis; GI hemorrhage; gum hyperplasia; melena; esophagitis; ulcerative stomatitis. GU: Dysuria; urinary tract infection; increased nonprotein nitrogen; impotence; genital edema; albuminuria; bladder disorder; hematuria; frequent micturition; oliguria; abnormal renal function; renal tubular necrosis; ureteral disorder; urinary retention. HEMATOLOGIC: Anemia; hemorrhage; purpura; thrombocytopenia; thrombosis; polycythemia. DERMATOLOGIC: Acne; surgical wound complications; cyst; herpes simplex; herpes zoster; hypertrichosis; pruritus; rash; skin ulceration. METABOLIC: Hyperkalemia; hypokalemia; hyperglycemia; hypoglycemia; hyperuricemia; hypomagnesemia; hypophosphatemia; hypocalcemia; hypercholesterolemia; hyperlipidemia; hyperproteinemia; weight gain; acidosis; dehydration; diabetes mellitus; fluid overload. OTHER: Pain; chest pain; leg pain; back pain; asthenia; arthralgia; arthropathy; bone fracture; cramps; hernia; myalgia; hematoma; edema; peripheral edema; facial edema.

 Precautions

Pregnancy: Category B. Lactation: Undetermined. Children: Safety and efficacy not established. Elderly: Safety and efficacy not established. Opportunistic Infections/Lymphoproliferative Disorders: Risk of developing these complications may be increased. Hypersensitivity: Although not reported, can occur following administration of proteins.

 Administration/Storage

• Store lysophilized basiliximab under refrigerated conditions at 2° to 8°C (36° to 46°F). The reconstituted solution can be refrigerated for 24 hr or at room temperature for 4 hr. Discard reconstituted solution if not used in 24 hr. Use the reconstituted solution immediately and dilute as directed
• Inspect the bag for particulate matter or solution discoloration, and if present do not use.
• Administer with care to assure sterility as the solution contains no antimicrobial preservatives.
• Do not administer or add other drug substances to the same bag or infuse simultaneously through the same IV line.
• Do not shake solution; invert bag gently to avoid foaming.
• Administer diluted solution through central or peripheral IV only over 20 to 30 min using sterile technique.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Monitor for signs of hypersensitivity. Have medications for the treatment of severe hypersensitivity available for immediate use.
• Discontinue infusion immediately if signs of hypersensitivity are present; keep IV line open, follow institution emergency protocol, and notify health care provider
• Monitor for adverse reactions.
• Maintain sterility and monitor infusion site, IV rate, and patient during infusion.

 Patient/Family Education

• Instruct patient or family to monitor for signs and symptoms of adverse events and report immediately to primary health care provider.
• Instruct family or patient to monitor for signs and symptoms of infections and transplant rejection including fever, pain, and urinary tract infections. Report these symptoms immediately to primary care provider.
• Advise women to notify health care provider immediately if pregnant, planning to become pregnant, or planning to breastfeed.
• Instruct women of childbearing potential to use effective contraception before beginning therapy, during therapy, and for 2 mo after the completion of therapy.
• Nursing mothers should discontinue nursing prior to using the drug.
• Stress the importance of regular exams and laboratory work.
• Encourage patient to comply with the treatment regimen.