basiliximab

basiliximab /bas·i·lix·i·mab/ (bas″ĭ-lik´sĭ-mab) a chimeric monoclonal antibody that is an interleukin-2 receptor antagonist; used in the prophylaxis of acute organ rejection after renal transplantation.

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basiliximab,

a monoclonal antibody used for immunosuppression.

indications This drug is used in combination with cyclosporine and corticosteroids to treat acute allograft rejection in renal transplant patients.

contraindications Known hypersensitivity to this drug contraindicates its use.

adverse effects Life-threatening effects of this drug include pulmonary edema and cardiac failure. Other adverse effects include hypotension, headache, constipation, abdominal pain, infection, and moniliasis. Common side effects include pyrexia, chills, tremors, dyspnea, wheezing, chest pain, vomiting, nausea, and diarrhea.

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basiliximab

Simulect

Pharmacologic class: Monoclonal antibody

Therapeutic class: Immunosuppressant

Pregnancy risk category B

FDA Boxed Warning

• Give under supervision of physician experienced in immunosuppressive therapy and management of organ transplant recipients, in facility with adequate diagnostic and treatment resources.

Action

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.

Availability

Powder for injection: 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, hypersensitivity 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.

Contraindications

• Hypersensitivity to drug
• Pregnancy or breastfeeding

Precautions

Use cautiously in:
• elderly patients
• females of childbearing age.

Administration

☞ 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.

Route	Onset	Peak	Duration
I.V.	2 hr	Unknown	36 days

Adverse reactions

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

Interactions

Drug-drug. Immunosuppressants: additive immunosuppression

Drug-diagnostic tests. Alanine aminotransferase, aspartate aminotransferase, magnesium, calcium, white blood cells: increased levels

Glucose, potassium: increased or decreased levels

Hemoglobin, neutrophils, platelets: decreased values

Drug-herbs. Astragalus, echinacea, melatonin: interference with immunosuppressant action

Patient monitoring

☞ 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.

Patient teaching

• 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.

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basiliximab

Simulect^® Nephrology A high-affinity, monoclonal antibody used to minimize acute rejection post renal transplant, which complements antirejection drugs–eg, Neoral^®. See Kidney transplant.