No

Monoclonal Antibody

Prophylaxis of acute organ rejection in renal transplantation

B - per Manufacturer

IL-2 receptors play an important role in the development of the immune system. Use in pregnant women only when benefit exceeds potential risk to the fetus. Women of childbearing potential should use effective contraceptive measures before beginning treatment and for 2 months after completion of therapy with this agent.

Known hypersensitivity to murine proteins or any component of this product

To be used as a component of immunosuppressive regimen which includes cyclosporine and corticosteroids. Only physicians experienced in transplantation and immunosuppression should prescribe, and patients should receive the drug in a facility with adequate equipment and staff capable of providing the laboratory and medical support required for transplantation.

Administration of basiliximab did not appear to increase the incidence or severity of adverse effects in clinical trials. Adverse events were reported in 99% of both the placebo and basiliximab groups.

Cardiovascular: Edema, peripheral edema, hypertension

Central nervous system: Fever, headache, dizziness, insomnia

Dermatologic: Wound complications, acne

Endocrine and metabolic: Hypokalemia, hyperkalemia, hyperglycemia, hyperuricemia, hypophosphatemia, hypocalcemia, hypercholesterolemia, acidosis

Gastrointestinal: Constipation, nausea, diarrhea, abdominal pain, vomiting, dyspepsia, moniliasis, weight gain

Genitourinary: Dysuria, urinary tract infection

Hematologic: Anemia

Neuromuscular and skeletal: Leg pain, back pain, tremor

Respiratory: Dyspnea, infection (upper respiratory), coughing, rhinitis, pharyngitis

Miscellaneous: Viral infection, asthenia

3% to 10%:

Cardiovascular: Chest pain, cardiac failure, hypotension, arrhythmia, tachycardia, vascular disorder, generalized edema

Central nervous system: Hypoesthesia, neuropathy, agitation, anxiety, depression, malaise, fatigue, rigors

Dermatologic: Cyst, herpes infection, hypertrichosis, pruritus, rash, skin disorder, skin ulceration

Endocrine and metabolic: Dehydration, diabetes mellitus, fluid overload, hypercalcemia, hyperlipidemia, hypoglycemia, hypomagnesemia

Gastrointestinal: Flatulence, gastroenteritis, GI hemorrhage, gingival hyperplasia, melena, esophagitis, stomatitis

Genitourinary: Impotence, genital edema, albuminuria, bladder disorder, hematuria, urinary frequency, oliguria, abnormal renal function, renal tubular necrosis, ureteral disorder, urinary retention

Hematologic: Hematoma, hemorrhage, purpura, thrombocytopenia, thrombosis, polycythemia

Neuromuscular and skeletal: Arthralgia, arthropathy, cramps, fracture, hernia, myalgia, paresthesia

Ocular: Cataract, conjunctivitis, abnormal vision

Renal: Increased BUN

Respiratory: Bronchitis, bronchospasm, pneumonia, pulmonary edema, sinusitis

Miscellaneous: Accidental trauma, facial edema, sepsis, infection, increased glucocorticoids

There have been no reports of overdose

Basiliximab is an immunoglobulin; specific drug interactions have not been evaluated, but are not anticipated

Store intact vials under refrigeration 2°C to 8°C (36°F to 46°F). Reconstitute 20 mg vials with 5 mL of sterile water for injection, USP. Shake the vial gently to dissolve. It is recommended that after reconstitution, the solution should be used immediately. If not used immediately, it can be stored at 2°C to 8°C for up to 24 hours or at room temperature for up to 4 hours. Discard the reconstituted solution within 24 hours. Further dilute reconstituted solution to a volume of 50 mL with 0.9% sodium chloride or dextrose 5% in water. When mixing the solution, gently invert the bag to avoid foaming. Do not shake.

Chimeric (murine/human) monoclonal antibody which blocks the alpha-chain of the interleukin-2 (IL-2) receptor complex; this receptor is expressed on activated T lymphocytes and is a critical pathway for activating cell-mediated allograft rejection

Duration: Mean: 36 days (determined by IL-2R alpha saturation)

Distribution, mean: V_d: Children: 5.2 ± 2.8 L; V_d: Adults: 8.6 L

Metabolism: Children: 20 mL/hour; Adults: Clearance (mean): 41 mL/hour

Half-life: Children: 9.4 days; Adults: Mean: 7.2 days

I.V.:

Adults: 20 mg within 2 hours prior to transplant surgery, followed by a second 20 mg dose 4 days after transplantation

Dosing adjustment/comments in renal or hepatic impairment: No specific dosing adjustment recommended

Signs and symptoms of acute rejection

Dizziness, headache, and insomnia are common. May cause agitation, anxiety, depression, malaise, or fatigue

Side effects mimic depressive symptoms; effects of benzodiazepines and antidepressants may be altered

No information available to require special precautions

Causes gingival hypertrophy (GH) similar to that caused by cyclosporine; early reported indicate that frequency/incidence of basiliximab-induced GH not as high as cyclosporine-induced GH

This medication, which may help to reduce transplant rejection, can only be given by infusion. You will be monitored and assessed closely during infusion and thereafter, however, it is important that you report any changes or problems for evaluation. You will be susceptible to infection; avoid crowds or infected persons or persons with contagious diseases. Frequent mouth care and small frequent meals may help counteract any GI effects you may experience and will help maintain adequate nutrition and fluid intake. Report any changes in urination; unusual bruising or bleeding; chest pain or palpitations; acute dizziness; respiratory difficulty; fever or chills; changes in cognition; rash; feelings of pain or numbness in extremities; severe GI upset or diarrhea; unusual back or leg pain or muscle tremors; vision changes; or any sign of infection (chills, fever, sore throat, easy bruising or bleeding, mouth sores, unhealed sores, vaginal discharge). Breast-feeding precautions: Breast-feeding is not recommended.

Powder for injection: 20 mg