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a monoclonal antibody that is an interleukin-2 receptor antagonist; used in prophylaxis of acute organ rejection after renal transplantation.



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.

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


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.


/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.


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.


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.


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


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.
References in periodicals archive ?
Contract award notice: Pnsp 21/2017 dabrafenib, Nilotinib, Everolimus, Lapatinib, Pazopanib, Basiliximab, Mycophenolic acid, Verteporfin and octreotide.
Injection basiliximab 20 mg intravenously in 100 ml normal saline stat was given to all the recipients if the donor was unrelated.
All patients received either basiliximab or rabbit antithymocyte globulin (ATG) as an induction therapy.
Mostly thymoglobulin, alemtuzumab, basiliximab, and daclizumab are used for this induction.
This US FDA approval was based on the company's two randomised multicentre studies comparing Thymoglobulin to interleukin-2 receptor antagonists (IL2RA: basiliximab or daclizumab) in deceased donor kidney transplant recipients.
El riesgo de infeccion en el trasplante renal depende principalmente del estado serologico pretrasplante, profilaxis e inmunosupresion recibidas; con respecto a la terapia inmunosupresora, la induccion con timoglobulina, los esteroides a altas dosis, los anticuerpos monoclonales como alentuzumab y basiliximab y el OKT-3 se consideran factores de riesgo (1, 2).
After the transplant, the patient received basiliximab, methylprednisolone and byclosporine for induction immune suppression and then triple therapy with cyclosporine, prednisone and myclophenolate mofetil (MMF) for maintenance immune suppression.
Todos los pacientes recibieron terapia de induccion con timoglobulina o basiliximab mas metilprednisolona y posteriormente se inicio la terapia de mantenimiento con micofenolato, prednisolona e inhibidores de la calcineurina.
Zahid Nabi from KRL hospital was asked about the induction protocol to which he responded by saying that he used Basiliximab for induction in his entire patients and valgancyclovir for CMV.
Also, in a single case study of severe erosive OLP, the use of the anti IL-2 receptor agent basiliximab (Bolus intravenous infusion of 20 mg, 2 doses, 4 days apart) resulted in remission of oral lesions, which was only temporal as lesions reappeared soon after the agent was withdrawn.