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تعداد آیتم قابل مشاهده باقیمانده : 2 مورد

Basiliximab: Pediatric drug information

Basiliximab: Pediatric drug information
2025© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Basiliximab: Drug information" and "Basiliximab: Patient drug information"

For abbreviations, symbols, and age group definitions show table
ALERT: US Boxed Warning
Experienced physician:

Only physicians experienced in immunosuppression therapy and management of organ transplantation patients should prescribe basiliximab. The physician responsible for basiliximab administration should have complete information requisite for the follow-up of the patient. Patients receiving the drug should be managed in facilities equipped with adequate laboratory and supportive medical resources.

Brand Names: US
  • Simulect
Brand Names: Canada
  • Simulect
Therapeutic Category
  • Monoclonal Antibody
Dosing: Pediatric

Note: Patients previously administered basiliximab should only be re-exposed to a subsequent course of therapy with extreme caution due to increased risk of hypersensitivity reactions. Hold second or subsequent dose(s) if severe hypersensitivity reactions or graft failure occurs.

Heart transplantation

Heart transplantation: Limited data available (Ref):

Infants, Children, and Adolescents:

Patient weight <35 kg:

Initial dose: IV: 10 mg administered immediately before cardiopulmonary bypass started is recommended, or may administer within 6 hours of organ perfusion (Ref); reported timing of doses is variable; however, superior outcomes have been reported with pretransplant basiliximab administration (Ref).

Second dose: IV: 10 mg administered 4 days after transplantation (Ref).

Patient weight ≥35 kg:

Initial dose: IV: 20 mg administered immediately before cardiopulmonary bypass started is recommended, or may administer within 6 hours of organ perfusion (Ref); reported timing of doses is variable; however, superior outcomes have been reported with pretransplant basiliximab administration (Ref).

Second dose: IV: 20 mg administered 4 days after transplantation (Ref).

Liver transplantation

Liver transplantation: Limited data available:

Infants, Children, and Adolescents:

Patient weight <35 kg:

Initial dose: IV: 10 mg administered within 6 hours of organ perfusion (Ref).

Second dose: IV: 10 mg administered 4 days after transplantation (Ref).

Third dose (optional): IV: 10 mg has been repeated on postoperative days 8 to 10 if ascites fluid loss exceeds 70 mL/kg (Ref).

Patient weight ≥35 kg:

Initial dose: IV: 20 mg administered within 6 hours of organ perfusion (Ref).

Second dose: IV: 20 mg administered 4 days after transplantation (Ref).

Third dose (optional): IV: 20 mg has been repeated on postoperative days 8 to 10 if ascites fluid loss exceeds 70 mL/kg or if total ascites volume ≥5 L (Ref).

Renal transplantation

Renal transplantation:

Children and Adolescents:

Patient weight <35 kg:

Initial dose: IV: 10 mg administered within 2 hours prior to renal transplant surgery.

Second dose: IV: 10 mg administered 4 days after transplantation.

Patient weight ≥35 kg:

Initial dose: IV: 20 mg administered within 2 hours prior to renal transplant surgery.

Second dose: IV: 20 mg administered 4 days after transplantation.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling.

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling.

Dosing: Adult

(For additional information see "Basiliximab: Drug information")

Note: Patients previously administered basiliximab should only be re-exposed to a subsequent course of therapy with extreme caution.

Renal transplantation

Renal transplantation (prophylaxis of acute rejection): IV: 20 mg within 2 hours prior to transplant surgery, followed by a second 20 mg dose 4 days after transplantation (in combination with other immunosuppressants). The second dose should be withheld if complications occur (including severe hypersensitivity reactions or graft loss). Timing of basiliximab dosing may vary based on clinical and institutional factors; refer to institutional protocol for specific information.

Graft-versus-host disease, acute, refractory

Graft-versus-host disease, acute (aGVHD), refractory (treatment) (off-label use): IV: 20 mg on days 1 and 4; may repeat for recurrent acute GVHD (Ref). Additional data may be necessary to further define the role of basiliximab in this condition.

Heart transplantation

Heart transplantation (prophylaxis of acute rejection) (off-label use): IV: 20 mg on the day of transplant, followed by a second 20 mg dose on day 4 post-transplantation (in combination with other immunosuppressants) (Ref). The first dose is usually administered immediately prior to transplant or within the first hours postoperatively.

Liver transplantation

Liver transplantation (prophylaxis of acute rejection) (off-label use): IV: 20 mg on the day of transplant (day 0), followed by a second 20 mg dose on day 4 post-transplantation (in combination with other immunosuppressants) (Ref). In clinical trials, the first dose was administered during the procedure once hemostasis was achieved or immediately post-transplant, or within 6 hours of organ reperfusion.

Lung transplantation

Lung transplantation (prophylaxis of acute rejection) (off-label use): IV: 20 mg prior to transplantation, followed by a second 20 mg dose 4 days after transplantation (in combination with other immunosuppressants) (Ref). Additional trials may be necessary to further define the role of basiliximab in this condition.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported with combination therapy.

>10%:

Cardiovascular: Hypertension (exacerbation of hypertension: 3% to 10%), peripheral edema (leg edema: 3% to 10%)

Dermatologic: Acne vulgaris

Endocrine & metabolic: Hypercholesterolemia, hyperglycemia, hyperkalemia, hyperuricemia, hypokalemia, hypophosphatemia

Gastrointestinal: Abdominal pain, constipation, diarrhea, dyspepsia, nausea, vomiting

Genitourinary: Urinary tract infection

Hematologic & oncologic: Anemia

Infection: Cytomegalovirus disease (11%), viral infection

Nervous system: Headache, insomnia, pain, tremor

Respiratory: Dyspnea, upper respiratory infection

Miscellaneous: Fever

1% to 10%:

Cardiovascular: Abnormal heart sounds (3% to 10%), angina pectoris (3% to 10%), atrial fibrillation (3% to 10%), cardiac arrhythmia (3% to 10%), chest pain (3% to 10%), dependent edema (3% to 10%), edema (3% to 10%), heart failure (3% to 10%), hypotension (3% to 10%), tachycardia (3% to 10%), thrombosis (3% to 10%), vascular disease (3% to 10%)

Dermatologic: Dermal ulcer (3% to 10%), hypertrichosis (3% to 10%), pruritus (3% to 10%), skin rash (3% to 10%)

Endocrine & metabolic: Acidosis (3% to 10%), albuminuria (3% to 10%), dehydration (3% to 10%), diabetes mellitus (3% to 10%), hypercalcemia (3% to 10%), hyperlipidemia (3% to 10%), hypertriglyceridemia (3% to 10%), hypervolemia (3% to 10%), hypocalcemia (3% to 10%), hypoglycemia (3% to 10%), hypomagnesemia (3% to 10%), increased nonprotein nitrogen (3% to 10%), increased serum glucocorticoids (3% to 10%), weight gain (3% to 10%)

Gastrointestinal: Aphthous stomatitis (3% to 10%), enlargement of abdomen (3% to 10%), esophagitis (3% to 10%), flatulence (3% to 10%), gastroenteritis (3% to 10%), gastrointestinal candidiasis (3% to 10%), gastrointestinal hemorrhage (3% to 10%), gingival hyperplasia (3% to 10%), hernia of abdominal cavity (3% to 10%), melena (3% to 10%)

Genitourinary: Bladder dysfunction (3% to 10%), dysuria (3% to 10%), erectile dysfunction (3% to 10%), genital edema (male) (3% to 10%), hematuria (3% to 10%), oliguria (3% to 10%), ureteral disease (3% to 10%), urinary frequency (3% to 10%), urinary retention (3% to 10%)

Hematologic & oncologic: Hematoma (3% to 10%), hemorrhage (3% to 10%), hypoproteinemia (3% to 10%), leukopenia (3% to 10%), polycythemia (3% to 10%), purpuric disease (3% to 10%), thrombocytopenia (3% to 10%)

Hypersensitivity: Facial edema (3% to 10%)

Immunologic: Antibody development (1%)

Infection: Infection (including herpes simplex infection, herpes zoster infection) (3% to 10%), sepsis (3% to 10%)

Nervous system: Agitation (3% to 10%), anxiety (3% to 10%), asthenia (3% to 10%), depression (3% to 10%), dizziness (3% to 10%), fatigue (3% to 10%), hypoesthesia (3% to 10%), malaise (3% to 10%), neuropathy (3% to 10%), paresthesia (3% to 10%), rigors (3% to 10%)

Neuromuscular & skeletal: Arthralgia (3% to 10%), arthropathy (3% to 10%), back pain (3% to 10%), bone fracture (3% to 10%), lower leg pain (3% to 10%), muscle cramps (3% to 10%), myalgia (3% to 10%)

Ophthalmic: Cataract (3% to 10%), conjunctivitis (3% to 10%), visual disturbance (3% to 10%)

Renal: Kidney impairment (including renal tubular necrosis) (3% to 10%)

Respiratory: Abnormal breath sounds (3% to 10%), bronchitis (3% to 10%), bronchospasm (3% to 10%), cough (3% to 10%), pharyngitis (3% to 10%), pneumonia (3% to 10%), pulmonary edema (3% to 10%), rhinitis (3% to 10%), sinusitis (3% to 10%)

Miscellaneous: Cyst (3% to 10%)

Postmarketing:

Cardiovascular: Capillary leak syndrome

Hypersensitivity: Cytokine release syndrome, hypersensitivity reaction (including anaphylaxis, severe hypersensitivity reaction)

Contraindications

Known hypersensitivity to basiliximab or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid/hypersensitivity reactions: Severe hypersensitivity reactions, occurring within 24 hours, have been reported. Reactions, including anaphylaxis, have occurred both with the initial exposure and/or following re-exposure after several months; use caution during re-exposure to a subsequent course of therapy in a patient who has previously received basiliximab. Patients in whom concomitant immunosuppression was prematurely discontinued due to abandoned transplantation or early graft loss are at increased risk for developing a severe hypersensitivity reaction upon re-exposure. Discontinue permanently if a severe reaction occurs. Medications for the treatment of hypersensitivity reactions should be available for immediate use.

• Diabetes: In renal transplant recipients receiving basiliximab plus prednisone, cyclosporine, and mycophenolate, new-onset diabetes, glucose intolerance, and impaired fasting glucose were observed at rates significantly higher than observed in patients receiving prednisone, cyclosporine, and mycophenolate without basiliximab (Aasebo 2010).

• Human antimurine antibodies (HAMA): Treatment may result in the development of HAMA; however, limited evidence suggests the use of murine anti-lymphocytic antibody products is not precluded.

• Lymphoproliferative disorders: The incidence of lymphoproliferative disorders may be increased by immunosuppressive therapy.

• Opportunistic infections: The incidence of opportunistic infections may be increased by immunosuppressive therapy.

Other warnings/precautions:

• Appropriate use: To be used as a component of an immunosuppressive regimen that may include a calcineurin inhibitor, adjunctive agent (eg, mycophenolate mofetil, everolimus), and corticosteroids.

• Experienced physician: [US Boxed Warning]: Should be administered under the supervision of a physician experienced in immunosuppression therapy and organ transplant management.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous [preservative free]:

Simulect: 10 mg (1 ea); 20 mg (1 ea)

Generic Equivalent Available: US

No

Pricing: US

Solution (reconstituted) (Simulect Intravenous)

10 mg (per each): $4,168.39

20 mg (per each): $5,471.00

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous:

Simulect: 20 mg (1 ea)

Administration: Pediatric

IV: For IV administration only through central or peripheral access. Administer only after confirmation that patient will receive graft and immunosuppression. Reconstituted basiliximab solution may be administered undiluted as a bolus injection or further diluted and infused over 20 to 30 minutes. Bolus injection is associated with nausea, vomiting, and local pain at the injection site.

Administration: Adult

IV: For intravenous administration only. Infuse as a bolus or IV infusion over 20 to 30 minutes (bolus dosing is associated with nausea, vomiting, and local pain at the injection site); may be administered through either a peripheral or central line. For the treatment of acute GVHD (off-label use), the dose was administered over 30 minutes (Ref).

Storage/Stability

Store intact vials refrigerated at 2°C to 8°C (36°F to 46°F). Should be used immediately after reconstitution; however, if not used immediately, reconstituted solution may be stored at 2°C to 8°C for up to 24 hours or at room temperature for up to 4 hours. Discard the reconstituted solution if not used within 24 hours.

Use

Induction therapy for the prophylaxis of acute organ rejection in patients receiving renal transplant in combination with an immunosuppressive regimen (cyclosporine and corticosteroids) (FDA approved in pediatric patients [age not specified] and adults); basiliximab has also been used for prophylaxis of acute organ rejection in liver, heart, and lung transplant.

Medication Safety Issues
Sound-alike/look-alike issues:

Basiliximab may be confused with bezlotoxumab.

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (immunosuppressant agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Community/Ambulatory Care and Long-Term Care Settings).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program

Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Antidiabetic Agents: Hyperglycemia-Associated Agents may decrease therapeutic effects of Antidiabetic Agents. Risk C: Monitor

Antithymocyte Globulin (Equine): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor

Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid

BCG Products: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor

Brivudine: May increase adverse/toxic effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Chikungunya Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid

Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid

Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Therapeutic Immunosuppressant Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor

COVID-19 Vaccine (mRNA): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider Therapy Modification

Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Efgartigimod Alfa: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor

Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate 2 to 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification

Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid

Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid

Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor

Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor

Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor

Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Pimecrolimus. Risk X: Avoid

Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification

Rabies Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification

Ritlecitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid

Rozanolixizumab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid

Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification

Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor

Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid

Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid

Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid

Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid

Typhoid Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor

Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid

Vaccines (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider Therapy Modification

Yellow Fever Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Zoster Vaccine (Live/Attenuated): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid

Reproductive Considerations

Females of childbearing potential should use effective contraceptive measures before beginning treatment, during, and for 4 months after completion of basiliximab treatment.

Pregnancy Considerations

Basiliximab is a monoclonal IgG antibody which targets IL-2 receptors. IgG is known to cross the placenta; IL-2 receptors play an important role in the development of the immune system.

The Transplant Pregnancy Registry International (TPR) is a registry that follows pregnancies that occur in maternal transplant recipients or those fathered by male transplant recipients. The TPR encourages reporting of pregnancies following solid organ transplant by contacting them at 1-877-955-6877 or https://www.transplantpregnancyregistry.org.

Monitoring Parameters

CBC with differential, vital signs, immunologic monitoring of T cells, renal function, serum glucose, signs or symptoms of hypersensitivity (more common with subsequent doses), infection.

Mechanism of Action

Basiliximab is a chimeric (murine/human) immunosuppressant monoclonal antibody which blocks the alpha-chain of the interleukin-2 (IL-2) receptor complex; this receptor is expressed on activated T lymphocytes and is a critical pathway for activating cell-mediated allograft rejection

Pharmacokinetics (Adult Data Unless Noted)

Duration: Mean: 36 days ± 14 days (determined by IL-2R alpha saturation in patients also on cyclosporine and corticosteroids).

Distribution: Mean: Vd: Children 1 to 11 years: 4.8 ± 2.1 L; Adolescents 12 to 16 years: 7.8 ± 5.1 L; Adults: 8.6 ± 4.1 L.

Half-life elimination: Children 1 to 11 years: 9.5 ± 4.5 days; Adolescents 12 to 16 years: 9.1 ± 3.9 days; Adults: Mean: 7.2 ± 3.2 days.

Excretion: Clearance:

Children 1 to 11 years: 17 ± 6 mL/hour; in pediatric liver transplant recipients, significant basiliximab loss through ascites fluid can increase total body clearance and reduce IL-2R (CD25) saturation duration; dosage adjustments may be necessary (Cintorino 2006; Kovarik 2002; Spada 2006).

Adolescents 12 to 16 years: 31 ±19 mL/hour.

Adults: 41 ± 19 mL/hour.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Simulect;
  • (AR) Argentina: Simulect;
  • (AT) Austria: Simulect;
  • (AU) Australia: Simulect;
  • (BE) Belgium: Simulect;
  • (BG) Bulgaria: Simulect;
  • (BR) Brazil: Simulect;
  • (CH) Switzerland: Simulect;
  • (CI) Côte d'Ivoire: Simulect;
  • (CL) Chile: Simulect;
  • (CN) China: Simulect;
  • (CO) Colombia: Simulect;
  • (CZ) Czech Republic: Simulect;
  • (DO) Dominican Republic: Simulect;
  • (EC) Ecuador: Simulect;
  • (EE) Estonia: Simulect;
  • (EG) Egypt: Simulect;
  • (ES) Spain: Simulect;
  • (ET) Ethiopia: Simulect;
  • (FI) Finland: Simulect;
  • (FR) France: Simulect;
  • (GB) United Kingdom: Simulect;
  • (GR) Greece: Simulect;
  • (HK) Hong Kong: Simulect;
  • (HR) Croatia: Simulect;
  • (HU) Hungary: Simulect;
  • (ID) Indonesia: Simulect;
  • (IE) Ireland: Simulect;
  • (IN) India: Simulect;
  • (IT) Italy: Simulect;
  • (JO) Jordan: Simulect;
  • (JP) Japan: Simulect;
  • (KE) Kenya: Simulect;
  • (KR) Korea, Republic of: Simulect;
  • (KW) Kuwait: Simulect;
  • (LB) Lebanon: Simulect;
  • (LT) Lithuania: Simulect;
  • (LV) Latvia: Simulect;
  • (MX) Mexico: Simulect;
  • (MY) Malaysia: Simulect;
  • (NL) Netherlands: Simulect;
  • (NO) Norway: Simulect;
  • (NZ) New Zealand: Simulect;
  • (PE) Peru: Simulect;
  • (PH) Philippines: Simulect;
  • (PK) Pakistan: Simulect;
  • (PL) Poland: Simulect;
  • (PR) Puerto Rico: Simulect;
  • (PT) Portugal: Simulect;
  • (PY) Paraguay: Simulect;
  • (QA) Qatar: Simulect;
  • (RU) Russian Federation: Simulect;
  • (SA) Saudi Arabia: Simulect;
  • (SE) Sweden: Simulect;
  • (SG) Singapore: Simulect;
  • (SI) Slovenia: Simulect;
  • (SK) Slovakia: Simulect;
  • (TH) Thailand: Simulect;
  • (TN) Tunisia: Simulect;
  • (TR) Turkey: Simulect;
  • (TW) Taiwan: Simulect;
  • (UA) Ukraine: Simulect;
  • (VE) Venezuela, Bolivarian Republic of: Simulect;
  • (ZA) South Africa: Simulect
  1. Aasebø W, Midtvedt K, Valderhaug TG, et al. Impaired Glucose Homeostasis in Renal Transplant Recipients Receiving Basiliximab. Nephrol Dial Transplant. 2010;25(4):1289-1293. [PubMed 19934089]
  2. Best LM, Leung J, Freeman SC, et al. Induction immunosuppression in adults undergoing liver transplantation: a network meta-analysis. Cochrane Database Syst Rev. 2020;1(1):CD013203. doi:10.1002/14651858.CD013203.pub2 [PubMed 31978255]
  3. Brennen DC, Daller JA, Lake KD, et al. Rabbit Antithymocyte Globulin Versus Basiliximab in Renal Transplantation. N Engl J Med. 2006;355(19):1967-177. [PubMed 17093248]
  4. Cintorino D, Riva S, Spada M, et al. Corticosteroid-Free Immunosuppression in Pediatric Liver Transplantation: Safety and Efficacy After a Short-Term Follow-Up. Transplant Proc. 2006;38(4):1099-1100. [PubMed 16757276]
  5. Clinckart F, Bulpa P, Jamart J, et al. Basiliximab as an alternative to antithymocyte globulin for early immunosuppression in lung transplantation. Transplant Proc. 2009;41(2):607-609. [PubMed 19328937]
  6. Diaz-Castrillon CE, Seese L, Mathier MA, et al. Nationwide variability in the use of induction immunosuppression for adult heart transplantation. J Card Surg. 2020;35(11):3053-3061. doi:10.1111/jocs.15075 [PubMed 33016378]
  7. Ford KA, Cale CM, Rees PG, et al. Initial Data on Basiliximab in Critically Ill Children Undergoing Heart Transplantation. J Heart Lung Transplant. 2005;24(9):1284-1288. [PubMed 16143246]
  8. Furuya Y, Jayarajian SN, Taghavi S, et al. The impact of alemtuzumab and basiliximab induction on patient survival and time to bronchiolitis obliterans syndrome in double lung transplantation recipients. Am J Transplant. 2016;16(8):2334-2341. [PubMed 26833657]
  9. Grundy N, Simmonds J, Dawkins H, et al. Pre-Implantation Basiliximab Reduces Incidence of Early Acute Rejection in Pediatric Heart Transplantation. J Heart Lung Transplant. 2009;28(12):1279-1284. [PubMed 19864164]
  10. Ji SQ, Chen HR, Yan HM, et al. Anti-CD25 Monoclonal Antibody (Basiliximab) for Prevention of Graft-Versus-Host Disease After Haploidentical Bone Marrow Transplantation for Hematological Malignancies. Bone Marrow Transplant. 2005;36(4):349-354. [PubMed 15968293]
  11. Kahan BD, Rajagopalan PR, Hall M. Reduction of the Occurrence of Acute Cellular Rejection Among Renal Allograft Recipients Treated With Basiliximab, a Chimeric Anti-Interleukin-2-Receptor Monoclonal Antibody. United States Simulect Renal Study Group. Transplantation. 1999;67(2):276-284. [PubMed 10075594]
  12. Kovarik JM, Gridelli BG, Martin S, et al. Basiliximab in Pediatric Liver Transplantation: A Pharmacokinetic-Derived Dosing Algorithm. Pediatr Transplant. 2002;6(3):224-230. [PubMed 12100507]
  13. Lange NW, Salerno DM, Sammons CM, Jesudian AB, Verna EC, Brown RS Jr. Delayed calcineurin inhibitor introduction and renal outcomes in liver transplant recipients receiving basiliximab induction. Clin Transplant. 2018;32(12):e13415. doi:10.1111/ctr.13415 [PubMed 30276862]
  14. Lladó L, González-Castillo A, Fabregat J, et al. Efficacy and safety of delayed prolonged-release tacrolimus initiation in de novo hepatitis C virus-negative orthotopic liver transplant recipients: a single-center, single-arm, prospective study. Ann Transplant. 2019;24:36-44. doi:10.12659/AOT.912444 [PubMed 30655498]
  15. Mehra MR, Zucker MJ, Wagoner L, et al. A multicenter, prospective, randomized, double-blind trial of basiliximab in heart transplantation. J Heart Lung Transplant. 2005;24(9):1297-1304. [PubMed 16143248]
  16. Nanni AN, Harris M, Watson M, et al. Association of tacrolimus time-to-therapeutic range on renal dysfunction and acute cellular rejection after orthotopic heart transplantation in a high use basiliximab population. Clin Transplant. 2022;36(3):e14542. doi:10.1111/ctr.14542 [PubMed 34797576]
  17. Nashan B, Moore R, Amlot P, et al. Randomised Trial of Basiliximab Versus Placebo for Control of Acute Cellular Rejection in Renal Allograft Recipients. Lancet. 1997;350(9086):1193-1198. [PubMed 9652559]
  18. Neuberger JM, Mamelok RD, Neuhaus P, et al; ReSpECT Study Group. Delayed introduction of reduced-dose tacrolimus, and renal function in liver transplantation: the 'ReSpECT' study. Am J Transplant. 2009;9(2):327-336. doi:10.1111/j.1600-6143.2008.02493.x [PubMed 19120077]
  19. Neuhaus P, Clavien PA, Kittur D, et al. Improved Treatment Response With Basiliximab Immunoprophylaxis After Transplantation: Results From a Double-Blind Randomized Placebo-Controlled Trial. Liver Transpl. 2002;8(2):132-142. [PubMed 11862589]
  20. Newland DM, Royston MJ, McDonald DR, et al. Analysis of rabbit anti-thymocyte globulin vs basiliximab induction in pediatric liver transplant recipients. Pediatr Transplant. 2019;23(8):e13573. doi:10.1111/petr.13573 [PubMed 31512802]
  21. Penninga L, Møller CH, Penninga EI, Iversen M, Gluud C, Steinbrüchel DA. Antibody induction therapy for lung transplant recipients. Cochrane Database Syst Rev. 2013;2013(11):CD008927. doi:10.1002/14651858.CD008927.pub2 [PubMed 24282128]
  22. Rosenberg PB, Vriesendorp AE, Drazner MH, et al. Induction therapy with basiliximab allows delayed initiation of cyclosporine and preserves renal function after cardiac transplantation. J Heart Lung Transplant. 2005;24(9):1327-1331. doi: 10.1016/j.healun.2004.08.003 [PubMed 16143252]
  23. Schmidt-Hieber M, Feitz T, Knauf W, et al. Efficacy if the Interleukin-2 Receptor Antagonist Basiliximab in Steroid-Refractory Acute Graft-Versus-Host Disease. Br J Haematol. 2005;130(4):568-574. [PubMed 16098072]
  24. Segovia J, Rodríguez-Lambert JL, Crespo-Leiro MG, et al. A randomized multicenter comparison of basiliximab and muromonab (OKT3) in heart transplantation: SIMCOR study. Transplantation. 2006;81(11):1542-1548. doi:10.1097/01.tp.0000209924.00229.e5 [PubMed 16770243]
  25. Simulect (basiliximab) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; August 2020.
  26. Spada M, Petz W, Bertani A, et al. Randomized Trial of Basiliximab Induction Versus Steroid Therapy in Pediatric Liver Allograft Recipients Under Tacrolimus Immunosuppression. Am J Transplant. 2006;6(8):1913-1921. [PubMed 16771811]
  27. Swarup R, Allenspach LL, Nemeh HW, et al. Timing of basiliximab induction and development of acute rejection in lung transplant patients. J Heart Lung Transplant. 2011;30(11):1228-1235. [PubMed 21764603]
  28. Trunecka P, Klempnauer J, Bechstein WO, et al. Renal function in de novo liver transplant recipients receiving different prolonged-release tacrolimus regimens – the DIAMOND study. Am J Transplant. 2015;15(7):1843-1854. [PubMed 25707487]
  29. Velleca A, Shullo MA, Dhital K, et al. The International Society for Heart and Lung Transplantation (ISHLT) guidelines for the care of heart transplant recipients. J Heart Lung Transplant. 2023;42(5):e1-e141. doi:10.1016/j.healun.2022.10.015 [PubMed 37080658]
  30. Watanabe T, Yanase M, Seguchi O, et al. Influence of induction therapy using basiliximab with delayed tacrolimus administration in heart transplant recipients - comparison with standard tacrolimus-based triple immunosuppression. Circ J. 2020;84(12):2212-2223. doi:10.1253/circj.CJ-20-0164 [PubMed 33148937]
  31. Webster AC, Playford EG, Higgins G, Chapman JR, Craig JC. Interleukin 2 receptor antagonists for renal transplant recipients: a meta-analysis of randomized trials. Transplantation. 2004;77(2):166-176. [PubMed 14742976]
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