basiliximab

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basiliximab

 [bas″ĭ-lik´sĭ-mab]
a monoclonal antibody that is an interleukin-2 receptor antagonist; used in prophylaxis of acute organ rejection after renal transplantation.

basiliximab

Simulect

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.

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: 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.

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.

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. 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

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.

basiliximab

A high-affinity, mouse–human chimeric monoclonal antibody raised against the alpha chain (CD25) of the IL-2 receptor on T cells. It is used to prevent or minimise the rejection of transplanted solid organs, and meant to complement other drugs.

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.

basiliximab

A chimeric monoclonal antibody to the alpha chain (CD 25), one of the three transmembrane protein chain receptors of INTERLEUKIN 2R. This interleukin plays an important role in T lymphocyte proliferation. On resting T cells the level of expression of CD 25 is low but allogenic stimulation after organ grafting causes it to rise. This provides specificity for a means of control of graft rejection. Trials have suggested that basiliximab can reduce graft rejection by one third. A brand name is Simulect.