BASILIXIMAB 
Pronounciation
- (bah-zih-LIX-ih-mab)
Trade Name(s)
- Simulect
Baseline studies indicated; see Monitor.
Basiliximab should only be administered once it has been determined that the patient will receive the graft and concomitant immunosuppression. Patients who have received a previous course of basiliximab should only be re-exposed to a subsequent course of therapy with extreme caution. Used concurrently with cyclosporine (Sandimmune) and corticosteroids.
Organ rejection prophylaxis in renal transplant:
2 doses of 20 mg each as an infusion. Administer the first dose within 2 hours before transplantation. Give the second dose 4 days after transplantation. Withhold the second dose if complications such as severe hypersensitivity reactions to basiliximab or graft loss occur.
2 doses of 10 mg each (discard remaining product after each dose).
2 doses of 20 mg each.
In all pediatric patients, administer the first dose within 2 hours before transplantation. Give the second dose 4 days after transplantation. See Actions and Maternal/Child. Withhold second dose if complications occur (e.g., hypersensitivity reactions or graft loss).
Reconstitute each single 20-mg vial with 5 mL of SWFI. Reconstitute each 10-mg vial with 2.5 mL SWFI. Shake gently to dissolve powder. After reconstitution, may be given as an IV injection or may be further diluted to 50 mL with NS or D5W. When mixing, gently invert to avoid foaming; do not shake.
Store unopened vials in the refrigerator (2° to 8° C [36° to 46° F]). Should be used within 4 hours of reconstitution. If necessary, may be refrigerated for up to 24 hours. Discard prepared solution after 24 hours.
Manufacturer states, “Other drug substances should not be added or infused simultaneously through the same IV line.” No incompatibilities observed with polyvinyl chloride bags and administration sets.
May be given through a peripheral or central vein.
May be given as a bolus injection over 30 to 60 seconds. Incidence of N/V and local reaction including pain increased.
A single dose properly diluted over 20 to 30 minutes.
A chimeric (murine/human) monoclonal antibody produced by recombinant DNA technology. Functions as an immunosuppressant. Specifically binds to and blocks the interleukin-2 receptor alpha chain (IL-2Rα, also known as CD25 antigen), thereby inhibiting IL-2 driven proliferation of activated T-cells, which play a key role in organ rejection. Reduces/minimizes acute rejection. IL-2Rα is expressed selectively on activated, but not resting, T-cells. This selectivity prevents the profound generalized immunosuppression seen with other immunosuppressants used in organ transplantation and may decrease the risk of infection and development of lymphoproliferative disorders. Two 20-mg doses block the receptor for 4 to 6 weeks posttransplantation, the critical risk period for acute organ rejection. Has reduced the incidence of biopsy-confirmed acute rejections while minimizing side effects seen with other immunosuppressants. Clinical benefit demonstrated in a broad range of patients, regardless of age, gender, race, donor type, or history of diabetes mellitus as long as serum levels exceed 0.2 mg/mL (by ELISA). Mean half-life is 4 to 10.4 days. Half-life is increased (5.2 to 17.8 days) and distribution volume and clearance are decreased by approximately 50% in pediatric patients 2 to 11 years of age. Crosses the placental barrier. May be secreted in breast milk.
Prophylaxis of acute organ rejection in patients receiving renal transplants. Used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids. Dosing regimen may also include either azathioprine or mycophenolate (CellCept IV).
Known hypersensitivity to basiliximab or any of its components (composite of human and murine antibodies).
Usually administered by or under the direction of a physician experienced in immunosuppressive therapy and management of organ transplant patients. Adequate laboratory and supportive medical resources must be available.
■ Severe acute (onset within 24 hours) hypersensitivity reactions including anaphylaxis have been reported both with initial exposure and/or following re-exposure after several months. Emergency equipment and drugs for the treatment of severe hypersensitivity reactions must be readily available. Withhold the second dose of basiliximab if a hypersensitivity reaction occurs.
■ Readministration after an initial course of therapy has not been studied in humans, but other monoclonal antibodies have precipitated anaphylactoid reactions.
■ Potential for causing lymphoproliferative disorders, cytomegalovirus (CMV), and other opportunistic infections is unknown.
■ Use with caution in patients with infections or malignancies.
■ It is not known whether basiliximab use will have a long-term effect on the ability of the immune system to respond to antigens first encountered during induced immunosuppression.
■ Low titers of anti-idiotype antibodies and human antimurine antibodies (HAMA) to basiliximab have been detected in some patients during treatment; no adverse effects have been noted.
Obtain baseline CBC with differential and platelets and baseline renal and liver tests if not already completed for other immunosuppressant agents.
■ Monitor vital signs.
■ Observe closely for signs of infection (fever, sore throat, tiredness) or unusual bleeding or bruising.
■ Prophylactic antibiotics may be indicated pending results of C/S in a febrile immunosuppressed patient.
■ Symptoms of cytokine release syndrome (e.g., chills, fever, dyspnea, and malaise) have not been reported but may occur; observe carefully.
■ See Drug/Lab Interactions.
Immediately report difficulty in breathing or swallowing, rapid heartbeat, rash, or itching.
■ Report swelling of lower extremities and weakness.
■ Avoid pregnancy; females with childbearing potential should use effective contraception before beginning basiliximab therapy, during therapy, and for 2 months after completion.
■ See Appendix D.
Category B: use during pregnancy only if benefits justify the potential risk to the fetus. Avoid pregnancy; effective contraception required; see Patient Education.
■ Discontinue breast-feeding.
■ Has been used in pediatric patients from 2 to 15 years of age. No adequate or well-controlled studies completed. See differences in Actions. Most frequent side effects were fever and urinary infections.
Age-related dosing not required. Adverse events similar to younger adults. Use caution when giving immunosuppressive drugs to the elderly.
Has been administered concurrently with anti-lymphocyte globulin (ALG), anti-thymocyte globulin, azathioprine, corticosteroids, cyclosporine, muromonab CD3, and mycophenolate; no additional adverse reactions noted.
■ May increase or decrease numerous lab values, including serum calcium and potassium and fasting blood glucose.
Basiliximab did not appear to alter the pattern, frequency, or severity of known side effects associated with the use of immunosuppressive drugs. Abdominal pain, anemia, constipation, diarrhea, edema, fever, headache, hyperkalemia, hypersensitivity reactions (including anaphylaxis, bronchospasm, capillary leak syndrome, cardiac failure, cytokine release syndrome, dyspnea, hypotension, pruritus, pulmonary edema, rash, respiratory failure, sneezing, tachycardia, urticaria, wheezing), hypertension, hypokalemia, insomnia, nausea, pain, peripheral edema, upper respiratory infections, urinary tract infections. Incidence of N/V and local reaction including pain increased with bolus injection. Severe hypersensitivity reactions (including anaphylaxis), capillary leak syndrome, and cytokine release syndrome have been reported. Incidence of infections, lymphomas, or other malignancies similar to placebo groups in studies.
Notify physician of all side effects. Most will be treated symptomatically. Basiliximab may be discontinued or alternate immunosuppressive agents substituted. Discontinue immediately if anaphylaxis occurs, and treat with oxygen, epinephrine, corticosteroids, and/or antihistamines. Resuscitate as necessary.