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.
Pharmacologic: monoclonal antibodies
Time/action profile (effect on immune function)
|IV||2 hr||unknown||36 days|
Adverse Reactions/Side EffectsNoted for patients receiving corticosteroids and cyclosporine in addition to basiliximab
Central nervous system
- dizziness (most frequent)
- headache (most frequent)
- insomnia (most frequent)
- weakness (most frequent)
Ear, Eye, Nose, Throat
- abnormal vision
- coughing (most frequent)
- heart failure (life-threatening)
- edema (most frequent)
- hypertension (most frequent)
- abdominal pain (most frequent)
- constipation (most frequent)
- diarrhea (most frequent)
- dyspepsia (most frequent)
- moniliasis (most frequent)
- nausea (most frequent)
- vomiting (most frequent)
- GI bleeding
- gingival hyperplasia
- acne (most frequent)
- wound complications (most frequent)
- hyperglycemia (most frequent)
- hypoglycemia (most frequent)
Fluid and Electrolyte
- acidosis (most frequent)
- hypercholesterolemia (most frequent)
- hyperkalemia (most frequent)
- hyperuricemia (most frequent)
- hypocalcemia (most frequent)
- hypokalemia (most frequent)
- hypophosphatemia (most frequent)
- coagulation abnormalities
- back pain (most frequent)
- leg pain (most frequent)
- tremor (most frequent)
- hypersensitivity reactions including anaphylaxis (life-threatening)
- infection (most frequent)
- weight gain (most frequent)
Drug-Drug interactionImmunosuppression may be ↑ with other immunosuppressants.Concommitant use with echinacea and melatonin may interfere with immunosuppression.
- Monitor for signs of anaphylactic or hypersensitivity reactions (hypotension, tachycardia, cardiac failure, dyspnea, wheezing, bronchospasm, pulmonary edema, respiratory failure, urticaria, rash, pruritus, sneezing) at each dose. Onset of symptoms is usually within 24 hr. Resuscitation equipment and medications for treatment of severe hypersensitivity should be readily available. If a severe hypersensitivity reaction occurs, basiliximab therapy should be permanently discontinued. Patients who have previously received basiliximab should only receive subsequent therapy with extreme caution.
- Monitor for infection (fever, chills, rash, sore throat, purulent discharge, dysuria). Notify physician immediately if these symptoms occur; may necessitate discontinuation of therapy.
- Lab Test Considerations: May cause ↑ or ↓ hemoglobin, hematocrit, serum glucose, potassium, and calcium concentrations.
- May cause ↑ serum cholesterol levels.
- May cause ↑ BUN, serum creatinine, and uric acid concentrations.
- May cause ↓ serum magnesium, phosphate, and platelet levels.
Potential Nursing DiagnosesRisk for infection (Side Effects)
- pH: Near Neutrality.
- Basiliximab is usually administered concurrently with cyclosporine and corticosteroids.
- Reconstitute with 2.5 mL or 5 mL of sterile water for injection for the 10 mg or 20 mg vial, respectively. Shake gently to dissolve powder.
- Diluent: May be administered undiluted. Bolus administration may be associated with nausea, vomiting, and local reactions (pain).Concentration: 4 mg/mL.
- Rate: Administer over 20–30 min via peripheral or central line.
- Intermittent Infusion: Diluent: Dilute further with 25–50 mL of 0.9% NaCl or D5W. Gently invert bag to mix; do not shake, to avoid foaming. Solution is clear to opalescent and colorless; do not administer solutions that are discolored or contain particulate matter. Discard unused portion. Administer within 4 hr or may be refrigerated for up to 24 hr. Discard after 24 hr.Concentration: 0.08–0.16 mg/mL.
- Rate: Administer over 20–30 min via peripheral or central line.
- Additive Incompatibility: Do not admix; do not administer in IV line containing other medications.
- Explain purpose of medication to patient. Explain that patient will need to resume lifelong therapy with other immunosuppressive drugs after completion of basiliximab course.
- May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response is known.
- Instruct patient to continue to avoid crowds and persons with known infections, because basiliximab also suppresses the immune system.
- Prevention of acute organ rejection in patients receiving renal transplantation.