Basiliximab is an active pharmaceutical ingredient in the Interleukin Inhibitors group (L04AC). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised February 27, 2026[1]
2). It is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression, in patients with panel reactive antibodies less than 80%, or in a triple maintenance immunosuppressive regimen containing ciclosporin for microemulsion, corticosteroids and either azathioprine or mycophenolate mofetil.
How to take
EUEuropean Union· EMA
1 product
Uses
EUOfficial regulatory label· revised December 19, 2025[2]
2). It is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression, in patients with panel reactive antibodies less than 80%, or in a triple maintenance immunosuppressive regimen containing ciclosporin for microemulsion, corticosteroids and either azathioprine or mycophenolate mofetil.
How to take
CACanada· Health Canada
1 product
Uses
CAOfficial regulatory label· revised March 22, 2025[3]
AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS ................................................................................................... 3 WARNINGS AND PRECAUTIONS .................................................................................
4 ADVERSE REACTIONS ................................................................................................... 6 DRUG INTERACTIONS ..................................................................................................
10 OVERDOSAGE ................................................................................................................ 11 ACTION AND CLINICAL PHARMACOLOGY ............................................................ 11 STORAGE AND STABILITY .........................................................................................
13 SPECIAL HANDLING INSTRUCTIONS ....................................................................... 13 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................. 14 PART II: SCIENTIFIC INFORMATION ...............................................................................
Drug interactions
Known interactions involving Basiliximab. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]MHRA (UK) · PLGB001011144 · revised February 27, 2026
[2]European Medicines Agency · EMEA/H/C/000207 · revised December 19, 2025
[3]Health Canada (DPD) · 02242815 · revised March 22, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
Simulect should be prescribed only by physicians who are experienced in the use of immunosuppressive therapy following organ transplantation. Simulect should be administered under qualified medical supervision. Simulect must not be administered unless it is absolutely certain that the patient will receive the graft and concomitant immunosuppression.
Simulect is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression. It can be used in a ciclosporin for microemulsion- and corticosteroid-based triple immunosuppressive regimen including azathioprine or mycophenolate mofetil.
Posology Adults The standard total dose is 40 mg, given in two doses of 20 mg each. The first 20 mg dose should be given within 2 hours prior to transplantation surgery. The second 20 mg dose should be given 4 days after transplantation.
4). Children and adolescents (1–17 years) In paediatric patients weighing less than 35 kg, the recommended total dose is 20 mg, given in two doses of 10 mg each. e. a total dose of 40 mg, given in two doses of 20 mg each. The first dose should be given within 2 hours prior to transplantation surgery.
The second dose should be given 4 days after transplantation. 4). Elderly ( ≥ 65 years) There are limited data available on the use of Simulect in the elderly, but there is no evidence that elderly patients require a different dosage from younger adult patients.
Method of administration Reconstituted Simulect can be administered as an intravenous bolus injection or as an intravenous infusion over 20–30 minutes. 6.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised February 27, 2026[1]
Basiliximab has been tested in four randomised, double-blind, placebo-controlled studies in renal transplant recipients as an induction agent in combination with the following immunosuppressive regimens: ciclosporin for microemulsion and corticosteroids in two studies (346 and 380 patients), ciclosporin for microemulsion, azathioprine and corticosteroids in one study (340 patients), and ciclosporin for microemulsion, mycophenolate mofetil and corticosteroids in another study (123 patients).
Safety data in paediatric patients have been obtained from one open- label pharmacokinetic and pharmacodynamic study in renal transplant recipients (41 patients).
Incidence of adverse events:
In the above four placebo-controlled trials, the pattern of adverse events in 590 patients treated with the recommended dose of basiliximab was comparable to that observed in 595 patients treated with placebo. 6% - 39%) treatment groups.
Adult patients The most commonly reported (> 20%) events following dual or triple therapy in both treatment groups (basiliximab vs. placebo) were constipation, urinary tract infection, pain, nausea, peripheral oedema, hypertension, anaemia, headache, hyperkalaemia, hypercholesterolaemia, postoperative wound complication, weight increase, increase in blood creatinine, hypophosphataemia, diarrhoea and upper respiratory tract infection.
Paediatric population The most commonly reported (> 20%) events following dual therapy in both (< 35 kg vs. ≥ 35 kg weight) cohorts were urinary tract infection, hypertrichosis, rhinitis, pyrexia, hypertension, upper respiratory tract infection, viral infection, sepsis and constipation.
Incidence of malignant neoplasms:
The overall incidence of malignancies among all patients in the individual studies was similar between the basiliximab and the comparator treatment groups. 3% (2/595) of patients receiving placebo, both in combination with dual and triple immunosuppressive therapy.
2% (7/595) of placebo patients. 4).
Incidence of infectious episodes:
The overall incidence and profile of viral, bacterial and fungal infections among patients treated with basiliximab or placebo in combination with dual and triple immunosuppressive therapy was comparable between the groups. 8%, respectively.
6% vs. 4). 4%). In a pooled analysis of two five-year extension studies the incidence and cause of death remained similar in both treatment groups, (basiliximab 15%, placebo 11%), the primary cause of death being cardiac-related disorders such as cardiac failure and myocardial infarction (basiliximab 5%, placebo 4%).
Listing of adverse reactions from post-marketing spontaneous reports The following adverse reactions have been identified based on post-marketing spontaneous reports and are organised by system organ class. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.
4). Cytokine release syndrome. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised February 27, 2026[1]
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Patients receiving Simulect must be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources, including medications for the treatment of severe hypersensitivity reactions.
Immunosuppressive regimens involving combinations of medications increase the susceptibility to infection, including opportunistic infections, fatal infections and sepsis; the risk increased with total immunosuppressive load. Simulect must not be administered unless it is absolutely certain that the patient will receive the graft and concomitant immunosuppression.
Hypersensitivity reactions Severe acute (less than 24 hours) hypersensitivity reactions have been observed both on initial exposure to Simulect and on re-exposure to a subsequent course of therapy. These included anaphylactoid-type reactions such as rash, urticaria, pruritus, sneezing, wheezing, hypotension, tachycardia, dyspnoea, bronchospasm, pulmonary oedema, cardiac failure, respiratory failure and capillary leak syndrome.
If a severe hypersensitivity reaction occurs, therapy with Simulect must be permanently discontinued and no further dose be administered. Caution should be exercised when patients previously given Simulect are re-exposed to a subsequent course of therapy with this medicinal product.
There is accumulating evidence that a subgroup of patients is at an increased risk of developing hypersensitivity reactions. These are patients in whom, following the initial administration of Simulect, the concomitant immunosuppression was discontinued prematurely due, for example, to abandoned transplantation or early loss of the graft.
Acute hypersensitivity reactions were observed on re-administration of Simulect for a subsequent transplantation in some of these patients. Neoplasms and infections Transplant patients receiving immunosuppressive regimens involving combinations with or without basiliximab are at increased risk of developing lymphoproliferative disorders (LPDs) (such as lymphoma) and opportunistic infections (such as cytomegalovirus [CMV], BK virus).
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised February 27, 2026[1]
1. 6).
This is not medical advice. Consult a qualified healthcare professional.
Simulect should be prescribed only by physicians who are experienced in the use of immunosuppressive therapy following organ transplantation. Simulect should be administered under qualified medical supervision. Simulect must not be administered unless it is absolutely certain that the patient will receive the graft and concomitant immunosuppression.
Simulect is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression. It can be used in a ciclosporin for microemulsion- and corticosteroid-based triple immunosuppressive regimen including azathioprine or mycophenolate mofetil.
3 Posology Adults The standard total dose is 40 mg, given in two doses of 20 mg each. The first 20 mg dose should be given within 2 hours prior to transplantation surgery. The second 20 mg dose should be given 4 days after transplantation.
4). Children and adolescents (1–17 years) In paediatric patients weighing less than 35 kg, the recommended total dose is 20 mg, given in two doses of 10 mg each. e. a total dose of 40 mg, given in two doses of 20 mg each. The first dose should be given within 2 hours prior to transplantation surgery.
The second dose should be given 4 days after transplantation. 4). Elderly ( 65 years) There are limited data available on the use of Simulect in the elderly, but there is no evidence that elderly patients require a different dosage from younger adult patients.
Method of administration Reconstituted Simulect can be administered as an intravenous bolus injection or as an intravenous infusion over 20–30 minutes. 6.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised December 19, 2025[2]
Basiliximab has been tested in four randomised, double-blind, placebo-controlled studies in renal transplant recipients as an induction agent in combination with the following immunosuppressive regimens: ciclosporin for microemulsion and corticosteroids in two studies (346 and 380 patients), ciclosporin for microemulsion, azathioprine and corticosteroids in one study (340 patients), and ciclosporin for microemulsion, mycophenolate mofetil and corticosteroids in another study (123 patients).
Safety data in paediatric patients have been obtained from one open-label pharmacokinetic and pharmacodynamic study in renal transplant recipients (41 patients).
Incidence of adverse events:
In the above four placebo-controlled trials, the pattern of adverse events in 590 patients treated with the recommended dose of basiliximab was comparable to that observed in 595 patients treated with placebo. 6% - 39%) treatment groups.
6 Adult patients The most commonly reported (> 20%) events following dual or triple therapy in both treatment groups (basiliximab vs. placebo) were constipation, urinary tract infection, pain, nausea, peripheral oedema, hypertension, anaemia, headache, hyperkalaemia, hypercholesterolaemia, postoperative wound complication, weight increase, increase in blood creatinine, hypophosphataemia, diarrhoea and upper respiratory tract infection.
Paediatric population The most commonly reported (> 20%) events following dual therapy in both (< 35 kg vs. 35 kg weight) cohorts were urinary tract infection, hypertrichosis, rhinitis, pyrexia, hypertension, upper respiratory tract infection, viral infection, sepsis and constipation.
Incidence of malignant neoplasms:
The overall incidence of malignancies among all patients in the individual studies was similar between the basiliximab and the comparator treatment groups. 3% (2/595) of patients receiving placebo, both in combination with dual and triple immunosuppressive therapy.
2% (7/595) of placebo patients. 4).
Incidence of infectious episodes:
The overall incidence and profile of viral, bacterial and fungal infections among patients treated with basiliximab or placebo in combination with dual and triple immunosuppressive therapy was comparable between the groups. 8%, respectively.
6% vs. 4). 4%). In a pooled analysis of two five-year extension studies the incidence and cause of death remained similar in both treatment groups, (basiliximab 15%, placebo 11%), the primary cause of death being cardiac-related disorders such as cardiac failure and myocardial infarction (basiliximab 5%, placebo 4%).
Listing of adverse reactions from post-marketing spontaneous reports The following adverse reactions have been identified based on post-marketing spontaneous reports and are organised by system organ class. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.
4). Cytokine release syndrome. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 7
EUOfficial regulatory label· Warnings and precautions· revised December 19, 2025[2]
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Patients receiving Simulect must be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources, including medications for the treatment of severe hypersensitivity reactions.
Immunosuppressive regimens involving combinations of medications increase the susceptibility to infection, including opportunistic infections, fatal infections and sepsis; the risk increased with total immunosuppressive load. Simulect must not be administered unless it is absolutely certain that the patient will receive the graft and concomitant immunosuppression.
4 Hypersensitivity reactions Severe acute (less than 24 hours) hypersensitivity reactions have been observed both on initial exposure to Simulect and on re-exposure to a subsequent course of therapy. These included anaphylactoid-type reactions such as rash, urticaria, pruritus, sneezing, wheezing, hypotension, tachycardia, dyspnoea, bronchospasm, pulmonary oedema, cardiac failure, respiratory failure and capillary leak syndrome.
If a severe hypersensitivity reaction occurs, therapy with Simulect must be permanently discontinued and no further dose be administered. Caution should be exercised when patients previously given Simulect are re-exposed to a subsequent course of therapy with this medicinal product.
There is accumulating evidence that a subgroup of patients is at an increased risk of developing hypersensitivity reactions. These are patients in whom, following the initial administration of Simulect, the concomitant immunosuppression was discontinued prematurely due, for example, to abandoned transplantation or early loss of the graft.
Acute hypersensitivity reactions were observed on re-administration of Simulect for a subsequent transplantation in some of these patients. Neoplasms and infections Transplant patients receiving immunosuppressive regimens involving combinations with or without basiliximab are at increased risk of developing lymphoproliferative disorders (LPDs) (such as lymphoma) and opportunistic infections (such as cytomegalovirus [CMV], BK virus).
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised December 19, 2025[2]
1. 6).
This is not medical advice. Consult a qualified healthcare professional.
17 PART III: CONSUMER INFORMATION ............................................................................. 21 Page 3 of 24 PrSIMULECT® (basiliximab) PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength Clinically Relevant Nonmedicinal Ingredients injection 20 mg sterile lyophilized powder none INDICATIONS AND CLINICAL USE SIMULECT® (basiliximab) is indicated for the prophylaxis of acute organ rejection in de novo renal transplantation and is to be used concomitantly with NEORAL® (cyclosporine for microemulsion) and corticosteroid-based immunosuppression.
CONTRAINDICATIONS SIMULECT® (basiliximab) is contraindicated in patients with known hypersensitivity to basiliximab, mouse cell proteins or any other component of the formulation. See PHARMACEUTICAL INFORMATION – Composition. SIMULECT® IS A POTENT DRUG.
THIS DRUG SHOULD ONLY BE USED BY PHYSICIANS EXPERIENCED IN IMMUNOSUPPRESSION THERAPY AND MANAGEMENT OF ORGAN TRANSPLANTATION PATIENTS IN A SETTING WHERE FULL RESUSCITATION FACILITIES ARE IMMEDIATELY AVAILABLE. > Page 4 of 24 WARNINGS AND PRECAUTIONS General SIMULECT® (basiliximab) should be prescribed only by physicians who are experienced in the use of immunosuppressive therapy following organ transplantation.
Patients receiving SIMULECT® should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources including medications for the treatment of severe hypersensitivity reactions. The addition of agents other than NEORAL® (cyclosporine for microemulsion) and corticosteroids to SIMULECT® therapy may increase the risk of overimmunosuppression.
Please note that following initiation of treatment with NEORAL®, due to the different bioavailabilities of the different oral cyclosporine formulations, patients should not be converted to any other oral formulation of cyclosporine without appropriate monitoring of cyclosporine blood concentrations, serum creatinine levels and blood pressure.
This does not apply to the conversion between NEORAL® soft gelatine capsule and NEORAL® oral solution as these two dosage forms are bioequivalent. It is therefore important that prescribers, pharmacists and patients be aware that substitution of NEORAL® with any other oral formulation of cyclosporine is not recommended as this may lead to alterations in cyclosporine blood concentrations.
For this reason, it might be appropriate to prescribe by brand. Carcinogenesis and Mutagenesis Transplant patients receiving immunosuppressive regimens involving combinations with or without SIMULECT® are at increased risk of developing lymphoproliferative disorders (LPDs) (such as lymphoma) and opportunistic infections (such as cytomegalovirus, CMV).
In clinical trials, the incidence of opportunistic infections was similar in patients using immunosuppressive regimens with or without SIMULECT®. In a pooled analysis of two five-year extension studies, no differences were found in the incidence of malignancies and LPDs between immunosuppressive regimens with or without SIMULECT®.
Immune Severe acute (less than 24 hours) hypersensitivity reactions have been observed both on initial exposure to SIMULECT® and on reexposure to a subsequent course of therapy. These included anaphylactoid type reactions such as rash, urticaria, pruritis, sneezing, wheezing, hypotension, tachycardia, dyspnea, bronchospasm, pulmonary edema, cardiac failure, respiratory failure and capillary leak syndrome.
If severe hypersensitivity occurs, therapy with SIMULECT® should be permanently discontinued and no further dose should be administered. Therefore, physicians prescribing SIMULECT® for a second course of therapy should be fully aware of the risks of anaphylactic reaction and should exercise caution.
There is accumulating evidence that a subgroup of patients is at increased risk of developing hypersensitivity reactions. These are patients Page 5 of 24 in whom, following the initial administration of SIMULECT®, the concomitant immunosuppression was discontinued prematurely, for example, due to abandoned transplantation or due to early loss of the graft.
Acute hypersensitivity reactions were observed on re-administration of SIMULECT® for a subsequent transplantation in some of these patients. Individual cases of suspected cytokine release syndrome (CRS) have been reported during post- marketing experience with […]
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[3]
Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. SIMULECT® (basiliximab) does not appear to add to the background of adverse events seen in organ transplant patients as a consequence of their underlying disease and the concurrent administration of immunosuppressants and other medications.
In two controlled, double-blind, multicenter trials, the pattern of adverse events in 363 SIMULECT®-treated patients was indistinguishable from that of 359 placebo-treated patients. The cumulative incidence of adverse events which occurred in ≥ 6% in either treatment group during the first 12 months post-transplantation for the pooled studies is summarized in Table 1.
Serious adverse events occurred with similar incidence and profile in both the SIMULECT® and placebo treatment groups (SIMULECT® 59%, placebo 63% overall). The rates of malignancies, reported infections, serious infections and infectious organisms were similar in the SIMULECT® and placebo treatment groups.
No specific SIMULECT®-related risk was identified.
Incidence of death:
In a pooled analysis of two five-year extension studies, the incidence and cause of death remained similar in both treatment groups (SIMULECT® 15%, placebo 11%). The primary cause of death being cardiac-related disorders (SIMULECT® 5%, placebo 4%) such as cardiac failure and myocardial infarction.
Incidence of Malignant Neoplasms:
The incidence of malignancies among the 722 patients in the two 12-month controlled trials was not significantly different between the SIMULECT® and placebo- treatment groups, and compared to the incidence reported in the literature for renal allograft recipients.
6%) in the placebo group. 9%) in patients treated with placebo. No differences were found in the incidence of malignancies and lymphoproliferative disease between SIMULECT® 7% (21/295) and placebo 7% (21/291) in a pooled analysis of two five-year extension studies.
Because these reactions are reported voluntary from a population of uncertain size, it is not always possible to reliably estimate their frequency. Immune system disorders Cytokine release syndrome has been reported. Hypersensitivity/anaphylactoid reaction such as rash, urticaria, pruritus, sneezing, wheezing, bronchospasm, dyspnoea, pulmonary oedema, cardiac failure, hypotension, tachycardia, respiratory failure, capillary leak syndrome have also been reported (see WARNINGS AND PRECAUTIONS).
Some reports of anaphylaxis and other infusion-related adverse events suggest that patients receiving subsequent courses of therapy with SIMULECT® […]
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[3]
General SIMULECT® (basiliximab) should be prescribed only by physicians who are experienced in the use of immunosuppressive therapy following organ transplantation. Patients receiving SIMULECT® should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources including medications for the treatment of severe hypersensitivity reactions.
The addition of agents other than NEORAL® (cyclosporine for microemulsion) and corticosteroids to SIMULECT® therapy may increase the risk of overimmunosuppression. Please note that following initiation of treatment with NEORAL®, due to the different bioavailabilities of the different oral cyclosporine formulations, patients should not be converted to any other oral formulation of cyclosporine without appropriate monitoring of cyclosporine blood concentrations, serum creatinine levels and blood pressure.
This does not apply to the conversion between NEORAL® soft gelatine capsule and NEORAL® oral solution as these two dosage forms are bioequivalent. It is therefore important that prescribers, pharmacists and patients be aware that substitution of NEORAL® with any other oral formulation of cyclosporine is not recommended as this may lead to alterations in cyclosporine blood concentrations.
For this reason, it might be appropriate to prescribe by brand. Carcinogenesis and Mutagenesis Transplant patients receiving immunosuppressive regimens involving combinations with or without SIMULECT® are at increased risk of developing lymphoproliferative disorders (LPDs) (such as lymphoma) and opportunistic infections (such as cytomegalovirus, CMV).
In clinical trials, the incidence of opportunistic infections was similar in patients using immunosuppressive regimens with or without SIMULECT®. In a pooled analysis of two five-year extension studies, no differences were found in the incidence of malignancies and LPDs between immunosuppressive regimens with or without SIMULECT®.
Immune Severe acute (less than 24 hours) hypersensitivity reactions have been observed both on initial exposure to SIMULECT® and on reexposure to a subsequent course of therapy. These included anaphylactoid type reactions such as rash, urticaria, pruritis, sneezing, wheezing, hypotension, tachycardia, dyspnea, bronchospasm, pulmonary edema, cardiac failure, respiratory failure and capillary leak syndrome.
This is not medical advice. Consult a qualified healthcare professional.
In clinical trials, the incidence of opportunistic infections was similar in patients using immunosuppressive regimens with or without Simulect. 8). Vaccination No data are available on either the effects of live and inactive vaccination or the transmission of infection by live vaccines in patients receiving Simulect.
Nevertheless, live vaccines are not recommended for immunosuppressed patients. The use of live attenuated vaccines should therefore be avoided in patients treated with Simulect. Inactivated vaccines may be administered to immunosuppressed patients; however, response to the vaccine may depend on the degree of the immunosuppression, therefore vaccination during treatment with Simulect may be less effective.
Use in heart transplantation The efficacy and safety of Simulect for the prophylaxis of acute rejection in recipients of solid organ allografts other than renal have not been demonstrated. 4%) have been reported more frequently with Simulect than with other induction agents.
Excipients with known effect This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’. e. essentially ‘potassium-free’.
In clinical trials, the incidence of opportunistic infections was similar in patients using immunosuppressive regimens with or without Simulect. 8). Vaccination No data are available on either the effects of live and inactive vaccination or the transmission of infection by live vaccines in patients receiving Simulect.
Nevertheless, live vaccines are not recommended for immunosuppressed patients. The use of live attenuated vaccines should therefore be avoided in patients treated with Simulect. Inactivated vaccines may be administered to immunosuppressed patients; however, response to the vaccine may depend on the degree of the immunosuppression, therefore vaccination during treatment with Simulect may be less effective.
Use in heart transplantation The efficacy and safety of Simulect for the prophylaxis of acute rejection in recipients of solid organ allografts other than renal have not been demonstrated. 4%) have been reported more frequently with Simulect than with other induction agents.
Excipients with known effect This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’. e. essentially ‘potassium-free’.
If severe hypersensitivity occurs, therapy with SIMULECT® should be permanently discontinued and no further dose should be administered. Therefore, physicians prescribing SIMULECT® for a second course of therapy should be fully aware of the risks of anaphylactic reaction and should exercise caution.
There is accumulating evidence that a subgroup of patients is at increased risk of developing hypersensitivity reactions. These are patients Page 5 of 24 in whom, following the initial administration of SIMULECT®, the concomitant immunosuppression was discontinued prematurely, for example, due to abandoned transplantation or due to early loss of the graft.
Acute hypersensitivity reactions were observed on re-administration of SIMULECT® for a subsequent transplantation in some of these patients. Individual cases of suspected cytokine release syndrome (CRS) have been reported during post- marketing experience with SIMULECT® (see Post-Market Adverse Drug Reactions).
Review of the clinical symptoms for each of the cases does not support the diagnosis of CRS. However, the contribution of SIMULECT® could not be excluded. Vaccination No data are available on either the effects of live and inactive vaccination or the transmission of infection by live vaccines in patients receiving SIMULECT®.
Nevertheless, live vaccines are not recommended for immunosuppressed patients. Inactivated vaccines may be administered to immunosuppressed patients; however, response to the vaccine may depend on the degree of the immunosuppression.
Special Populations Pregnant Women:
There is no adequate information for use in pregnant women. SIMULECT® (basiliximab) should not be given to pregnant women except in cases where the potential benefit for the mother outweighs the potential risk for the fetus.
Nursing Women:
There are no data in lactating women. Since basiliximab is an immunoglobulin G (IgG1k) antibody, it may cross the human placenta and may be excreted in human milk. Women receiving SIMULECT® should not breast feed for 4 months following the last dose.
Pediatrics:
No adequate and well-controlled studies have been completed in pediatric patients. Safety and efficacy in pediatric patients have not been established and pharmacokinetic data is very limited (See ACTION AND CLINICAL PHARMACOLOGY - Pharmacokinetics).
No studies have been performed in neonates or children aged less than two years.
Geriatrics:
Controlled clinical trials of SIMULECT® have included a small number of patients 65 years and older (SIMULECT® 15; placebo 19). From the available data comparing SIMULECT® and placebo-treated patients, the adverse event profile in patients ≥65 years of age is not different from patients < 65 years of age and no initial age-related dosing adjustment is required.
Caution must be used in giving immunosuppressive drugs to elderly patients.
Use in Women of Childbearing Potential:
Women of childbearing potential should use effective contraception before beginning SIMULECT® therapy, during therapy and for 4 months after completion of SIMULECT® therapy.
Fertility:
No human data on the effect of basiliximab on fertility are available. Formal studies of the potential effect of SIMULECT® on animal fertility have not been conducted (see TOXICOLOGY). Page 6 of