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Basiliximab: Drug information

Basiliximab: Drug information
(For additional information see "Basiliximab: Patient drug information" and see "Basiliximab: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (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
Pharmacologic Category
  • Immunosuppressant Agent;
  • Interleukin-2 Inhibitor;
  • Monoclonal Antibody
Dosing: Adult

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 (Schmidt-Hieber 2005). 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) (Mehra 2005). 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) (Neuhaus 2002; Trunecka 2015). 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) (Clinckart 2009; Swarup 2011). 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: Hepatic Impairment: Adult

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

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Basiliximab: Pediatric drug information")

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 (ISHLT [Velleca 2023]):

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 (Ford 2005); reported timing of doses is variable; however, superior outcomes have been reported with pretransplant basiliximab administration (Grundy 2009).

Second dose: IV: 10 mg administered 4 days after transplantation (Ford 2005).

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 (Ford 2005); reported timing of doses is variable; however, superior outcomes have been reported with pretransplant basiliximab administration (Grundy 2009).

Second dose: IV: 20 mg administered 4 days after transplantation (Ford 2005).

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 (Cintorino 2006; Newland 2019; Spada 2006).

Second dose: IV: 10 mg administered 4 days after transplantation (Cintorino 2006; Newland 2019; Spada 2006).

Third dose (optional): IV: 10 mg has been repeated on postoperative days 8 to 10 if ascites fluid loss exceeds 70 mL/kg (Cintorino 2006; Spada 2006).

Patient weight ≥35 kg:

Initial dose: IV: 20 mg administered within 6 hours of organ perfusion (Cintorino 2006; Newland 2019; Spada 2006).

Second dose: IV: 20 mg administered 4 days after transplantation (Cintorino 2006; Newland 2019; Spada 2006).

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 (Cintorino 2006; Spada 2006).

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: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in 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): $4,006.52

20 mg (per each): $5,258.56

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: 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 (Schmidt-Hieber 2005).

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.

Use: Labeled Indications

Renal transplant (prophylaxis of acute rejection): Prophylaxis of acute organ rejection in renal transplantation in combination with cyclosporine (modified) and corticosteroids.

Use: Off-Label: Adult

Acute graft-versus-host disease, refractory (treatment); Heart transplant (prophylaxis of acute rejection); Liver transplant (prophylaxis of acute rejection); Lung transplant (prophylaxis of acute rejection)

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

Basiliximab may be confused with bezlotoxumab.

High alert medication:

This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes that have a heightened risk of causing significant patient harm when used in error.

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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

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

Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination

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

Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy

Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

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

Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination

Coccidioides immitis Skin Test: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. 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 (Adenovirus Vector): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy

COVID-19 Vaccine (mRNA): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect 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 diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy

COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy

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

Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect 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 enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy

Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect 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 enhance the immunosuppressive effect 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 enhance the adverse/toxic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination

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

Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination

Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy

Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy

Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy

Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Pimecrolimus. Risk X: Avoid combination

Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy

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

Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the potential for allergic or hypersensitivity reactions to 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 diminish the therapeutic effect 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 enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination

Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination

Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect 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 Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor therapy

Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination

Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect 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 combination

Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination

Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect 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 combination

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

Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy

Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination

Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider therapy modification

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

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

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.

Breastfeeding Considerations

It is not known if basiliximab is present in human milk. Because many immunoglobulins are secreted in milk and the potential for serious adverse reactions exists, a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Monitoring Parameters

Monitor for signs and symptoms of acute rejection; hypersensitivity, 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;
  • (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. Simulect (basiliximab) [product monograph]. Dorval, Quebec, Canada: Novartis Pharmaceuticals Canada Inc; July 2019.
  27. 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.
  28. 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]
  29. 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]
  30. 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]
  31. 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]
  32. 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]
Topic 8803 Version 235.0

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