Simulect

1 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 



 

2 

1. NAME OF THE MEDICINAL PRODUCT 

 

Simulect 20 mg powder and solvent for solution for injection or infusion 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

Each vial contains 20 mg basiliximab*. 

 

One ml of the reconstituted solution contains 4 mg basiliximab. 

 

* recombinant murine/human chimeric monoclonal antibody directed against the interleukin-2 

receptor -chain (CD25 antigen) produced in a mouse myeloma cell line by recombinant DNA 

technology. 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 

 

Powder and solvent for solution for injection or infusion 

 

White powder 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

Simulect is indicated for the prophylaxis of acute organ rejection in de novo allogeneic renal 

transplantation in adult and paediatric patients (1-17 years) (see section 4.2). 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. 

 

4.2 Posology and method of administration 

 

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. The second dose should be withheld in the 

event of a severe hypersensitivity reaction to Simulect or post-operative complications such as graft 

loss (see section 4.4). 

 

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. In paediatric patients weighing 35 kg or more, the recommended dose is the 

adult dose, i.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. The second dose should be withheld in the event of a severe 

hypersensitivity reaction to Simulect or post-operative complications such as graft loss (see 

section 4.4). 

 

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. 

 

For instructions on reconstitution of the medicinal product before administration, see section 6.6. 

 

4.3 Contraindications 

 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 

 

Pregnancy and lactation (see section 4.6). 

 

4.4 Special warnings and precautions for use 

 

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). 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 combination of basiliximab (see section 4.8). 

 

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. In several small clinical trials in heart 

transplant recipients, serious cardiac adverse events such as cardiac arrest (2.2%), atrial flutter (1.9%) 

and palpitations (1.4%) 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’. 

 

This medicinal product contains potassium, less than 1 mmol (39 mg) per vial, i.e. essentially 

‘potassium-free’. 

 

  



 

5 

4.5 Interaction with other medicinal products and other forms of interaction 

 

Because basiliximab is an immunoglobulin, no metabolic drug-drug interactions are to be expected. 

 

In addition to ciclosporin for microemulsion, steroids, azathioprine and mycophenolate mofetil, other 

concomitant medications routinely administered in organ transplantation have been administered in 

clinical trials without any incremental adverse reactions. These concomitant medications include 

systemic antiviral, antibacterial and antimycotic medications, analgesics, antihypertensive medications 

such as beta-blocking agents or calcium channel blockers, and diuretics. 

 

Human antimurine antibody (HAMA) responses were reported in a clinical trial of 172 patients treated 

with basiliximab, without predictive value for clinical tolerability. The incidence was 2/138 in patients 

not exposed to muromonab-CD3 (OKT3) and 4/34 in patients who received muromonab-CD3 

concomitantly. The use of basiliximab does not preclude subsequent treatment with murine 

antilymphocyte antibody preparations. 

 

In the original phase III studies during the first 3 months post-transplantation, 14% of patients in the 

basiliximab group and 27% of patients in the placebo group had an acute rejection episode treated with 

antibody therapy (OKT 3 or antithymocyte globulin/antilymphocyte globulin [ATG/ALG]), with no 

increase in adverse events or infections in the basiliximab group as compared to placebo. 

 

Three clinical trials have investigated basiliximab use in combination with a triple therapy regimen 

which included either azathioprine or mycophenolate mofetil. The total body clearance of basiliximab 

was reduced by an average 22% when azathioprine was added to a regimen consisting of ciclosporin 

for microemulsion and corticosteroids. The total body clearance of basiliximab was reduced by an 

average 51% when mycophenolate mofetil was added to a regimen consisting of ciclosporin for 

microemulsion and corticosteroids. The use of basiliximab in a triple therapy regimen including 

azathioprine or mycophenolate mofetil did not increase adverse events or infections in the basiliximab 

group as compared to placebo (see section 4.8). 

 

4.6 Fertility, pregnancy and lactation 

 

Simulect is contraindicated in pregnancy and lactation (see section 4.3). Basiliximab has potentially 

hazardous immunosuppressive effects with respect to the course of gestation and the suckling neonate 

exposed to basiliximab in breast milk. Women of childbearing potential must use effective 

contraception during and up to 16 weeks after treatment. 

 

There is no animal or human data available concerning excretion of basiliximab into breast milk. 

However, based on the IgG1 nature of basiliximab, excretion into milk should be expected. Breast-

feeding must therefore be avoided. 

 

4.7 Effects on ability to drive and use machines 

 

Simulect has no influence on the ability to drive and use machines. 

 

4.8 Undesirable effects 

 

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). 

 



 

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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. The overall incidence of treatment-related adverse events among all 

patients in the individual studies was not significantly different between the basiliximab (7.1% - 40%) 

and the placebo (7.6% - 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. Overall, 

lymphoma/lymphoproliferative disease occurred in 0.1% (1/701) of patients in the basiliximab group 

compared with 0.3% (2/595) of patients receiving placebo, both in combination with dual and triple 

immunosuppressive therapy. Other malignancies were reported among 1.0% (7/701) of patients in the 

basiliximab group compared with 1.2% (7/595) of placebo patients. In a pooled analysis of two five-

year extension studies, the incidence of LPDs and cancer was found to be equal with basiliximab 7% 

(21/295) and placebo 7% (21/291) (see section 4.4). 

 

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. The overall incidence of infections 

was 75.9% in the basiliximab group and 75.6% in the placebo group and the incidence of serious 

infections was 26.1% and 24.8%, respectively. The incidence of CMV infections was similar in both 

groups (14.6% vs. 17.3%), following either dual or triple therapy regimen (see section 4.4). 

 

The incidence and causes of deaths following dual or triple therapy were similar in basiliximab (2.9%) 

and placebo groups (2.6%), with the most common cause of deaths in both treatment groups being 

infections (basiliximab = 1.3%, placebo = 1.4%). 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. 

 

Immune system disorders 

Hypersensitivity/anaphylactoid reactions such as rash, urticaria, pruritus, sneezing, wheezing, 

bronchospasm, dyspnoea, pulmonary oedema, cardiac failure, hypotension, tachycardia, respiratory 

failure, capillary leak syndrome (see section 4.4). Cytokine release syndrome. 

 



 

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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. 

 

4.9 Overdose 

 

In clinical studies basiliximab has been administered to humans in single doses of up to 60 mg and 

multiple doses of up to 150 mg over 24 days with no acute undesirable effects. 

 

For information on preclinical toxicology see section 5.3. 

 

 

5. PHARMACOLOGICAL PROPERTIES 

 

5.1 Pharmacodynamic properties 

 

Pharmacotherapeutic group: Interleukin inhibitors, ATC code: L04AC02. 

 

Mechanism of action 

 

Basiliximab is a murine/human chimeric monoclonal antibody (IgG1) that is directed against the 

interleukin-2 receptor -chain (CD25 antigen), which is expressed on the surface of T-lymphocytes in 

response to antigenic challenge. Basiliximab specifically binds with high affinity (KD-value 0.1 nM) to 

the CD25 antigen on activated T-lymphocytes expressing the high affinity interleukin-2 receptor (IL-

2R) and thereby prevents binding of interleukin-2, a critical signal for T-cell proliferation in the 

cellular immune response involved in allograft rejection. Complete and consistent blocking of the 

interleukin-2 receptor is maintained as long as serum basiliximab levels exceed 0.2 g/ml (usually up 

to 4–6 weeks after administration). As concentrations fall below this level, expression of the CD25 

antigen returns to pretherapy values within 1–2 weeks. Basiliximab does not cause myelosuppression. 

 

Clinical efficacy and safety 

 

The efficacy of basiliximab in prophylaxis of organ rejection in de novo renal transplantation has been 

demonstrated in double-blind placebo-controlled studies. Results from two pivotal 12-month 

multicentre studies (722 patients in total) comparing basiliximab with placebo show that basiliximab, 

used concomitantly with ciclosporin for microemulsion and corticosteroids, significantly reduces the 

incidence of acute rejection episodes both within 6 (31% vs. 45%, p<0.001) and 12 (33% vs. 48%, 

p<0.001) months after transplantation. There was no significant difference between basiliximab and 

placebo-treated patients in graft survival after 6 and 12 months (at 12 months 32 graft losses on 

basiliximab (9%) and 37 graft losses on placebo (10%)). The incidence of acute rejection episode was 

substantially lower in patients receiving basiliximab and a triple drug immunosuppressive regimen. 

 

Results from two multicentre double-blind studies comparing basiliximab with placebo (463 patients 

in total) show that basiliximab significantly reduces the incidence of acute rejection episodes within 

6 months after transplantation when used concomitantly with ciclosporin for microemulsion, 

corticosteroids, and either azathioprine (21% vs. 35%) or mycophenolate mofetil (15% vs. 27%). Graft 

loss occurred in 6% of basiliximab-treated and 10% of placebo-treated patients by 6 months. The 

adverse event profile remained comparable between treatment groups. 

 

In a pooled analysis of two five-year open-label extension studies (586 patients total) the combined 

graft and patient survival rates were not statistically different for the basiliximab and placebo groups. 

Extension studies also showed that patients who experienced an acute rejection episode during the first 

year after transplantation experienced more graft losses and deaths over the five-year follow-up period 

than patients who had no rejection. These events were not influenced by basiliximab. 



 

8 

 

Paediatric population 

The efficacy and safety of basiliximab were evaluated in two paediatric studies. 

 

Basiliximab was used concomitantly with ciclosporin for microemulsion and steroids in an 

uncontrolled study in 41 paediatric de novo renal transplant recipients. Acute rejection occurred in 

14.6% of patients by 6 months post-transplantation, and in 24.3% by 12 months. Overall the adverse 

event profile was consistent with general clinical experience in the paediatric renal transplantation 

population and with the profile in the controlled adult transplantation studies. 

 

A 12-month, randomised, placebo-controlled, double-blind, multicentre study investigated basiliximab 

in combination with ciclosporin for microemulsion, mycophenolate mofetil and steroids in paediatric 

renal allograft recipients. The primary objective of the study was to demonstrate superiority of this 

combination versus treatment with ciclosporin for microemulsion, mycophenolate mofetil and steroids 

in the prevention of acute rejections. Of the 202 patients, 104 were randomised to basiliximab and 98 

to placebo. The primary efficacy endpoint, time to first biopsy-proven acute rejection (BPAR) episode 

or treatment failure defined as graft loss, death or presumptive rejection within the first 6 months post 

transplantation, occurred in 16.7% of basiliximab-treated patients and 21.7% of placebo-treated 

patients. When borderline rejections were included in the primary efficacy endpoint, the rates were 

26.0% and 23.9% respectively, with no statistically significant difference between the basiliximab- 

and placebo-treated groups (HR: 1.04, 90% CI: [0.64; 1.68]). The rates of BPAR were 9.4% in the 

basiliximab group and 17.4% in the placebo group (HR: 0.50, 90% CI: [0.25; 0.99]). When borderline 

rejections were included, the rates were 20.8% and 19.6% respectively (HR: 1.01, 90% CI: [0.59; 

1.72]). The overall safety profiles were similar in both groups. The incidence rates of adverse events 

and the pattern of adverse events were comparable between the two treatment groups and to be 

expected for the treatment regimens and the underlying diseases. 

 

Immunogenicity 

Of 339 renal transplant patients treated with basiliximab and tested for anti-idiotype antibodies, 4 

(1.2%) developed an anti-idiotype antibody response. In a clinical trial with 172 patients receiving 

basiliximab, the incidence of human antimurine antibody (HAMA) in renal transplantation patients 

treated with basiliximab was 2/138 in patients not exposed to muromonab-CD3 and 4/34 in patients 

who received muromonab-CD3 concomitantly. The available clinical data on the use of muromonab-

CD3 in patients previously treated with basiliximab suggest that subsequent use of muromonab-CD3 

or other murine anti-lymphocytic antibody preparations is not precluded. 

 

5.2 Pharmacokinetic properties 

 

Adults 

 

Single-dose and multiple-dose pharmacokinetic studies have been conducted in adult patients 

undergoing kidney transplantation. Cumulative doses ranged from 20 mg up to 60 mg. Peak serum 

concentration following intravenous infusion of 20 mg over 30 minutes is 7.15.1 mg/l. There is a 

proportional increase in Cmax and AUC from 20 mg to 60 mg, the range of single-dose administrations 

tested. The volume of distribution at steady state was 8.64.1 l. The extent and degree of distribution 

to various body compartments have not been fully studied. In vitro studies using human tissues 

indicate that basiliximab binds only to activated lymphocytes and macrophages/monocytes. The 

terminal half-life was 7.23.2 days. Total body clearance was 4119 ml/h. 

 

No clinically relevant influence of body weight or gender on distribution volume or clearance has been 

observed in adult patients. Elimination half-life was not influenced by age, gender, or race. 

 



 

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Paediatric population 

 

The pharmacokinetics of basiliximab were assessed in 39 paediatric de novo renal transplantation 

patients. In infants and children (age 1–11 years, n=25), the steady-state distribution volume was 

4.82.1 l, half-life was 9.54.5 days and clearance was 176 ml/h. Distribution volume and clearance 

are reduced by about 50% compared to adult renal transplantation patients. Disposition parameters 

were not influenced to a clinically relevant extent by age (1–11 years), body weight (9–37 kg) or body 

surface area (0.44–1.20 m) in this age group. In adolescents (age 12–16 years, n=14), the steady-state 

distribution volume was 7.85.1 l, half-life was 9.13.9 days and clearance was 3119 ml/h. 

Disposition in adolescents was similar to that in adult renal transplantation patients. The relationship 

between serum concentration and receptor saturation was assessed in 13 patients and was similar to 

that characterised in adult renal transplantation patients. 

 

5.3 Preclinical safety data 

 

No toxicity was observed when rhesus monkeys received intravenous doses of either up to 5 mg/kg 

basiliximab twice weekly for 4 weeks followed by an 8-week withdrawal period or 24 mg/kg 

basiliximab weekly for 39 weeks followed by a 13-week withdrawal period. In the 39-week study, the 

highest dose resulted in approximately 1,000 times the systemic exposure (AUC) observed in patients 

given the recommended clinical dose together with concomitant immunosuppressive therapy. 

 

No maternal toxicity, embryotoxicity, or teratogenicity was observed in cynomolgous monkeys 

following injections of up to 5 mg/kg basiliximab administered twice weekly during the organogenesis 

period. 

 

No mutagenic potential was observed in vitro. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 

 

Powder 

 

Potassium dihydrogen phosphate 

Disodium phosphate, anhydrous 

Sodium chloride 

Sucrose 

Mannitol (E421) 

Glycine 

 

Solvent 

 

Water for injections 

 

6.2 Incompatibilities 

 

This medicinal product must not be mixed with other medicinal products except those mentioned in 

section 6.6. 

 

6.3 Shelf life 

 

Powder: 3 years 

 

Chemical and physical stability of the reconstituted solution is demonstrated for 24 hours at 2°C - 8°C 

or for 4 hours at room temperature (see section 6.6). 

 



 

10 

6.4 Special precautions for storage 

 

Store and transport refrigerated (2°C - 8°C). 

 

6.5 Nature and contents of container 

 

Simulect powder 

 

Colourless type I glass vial, grey fluor-resin coated butyl rubber stopper, held in place by a flanged 

aluminium band, blue polypropylene flip-off cap, containing 20 mg basiliximab as powder for solution 

for injection or infusion. 

 

Solvent 

 

Colourless glass ampoule, type I glass, containing 5 ml water for injections. 

 

Simulect is also available in vials with 10 mg basiliximab. 

 

6.6 Special precautions for disposal and other handling 

 

Reconstitution 

 

To prepare the solution for infusion or injection, add 5 ml of water for injections from the 

accompanying ampoule aseptically to the vial containing the Simulect powder. Shake the vial gently 

to dissolve the powder, avoiding foaming. It is recommended that after reconstitution the colourless, 

clear to opalescent solution should be used immediately. Reconstituted products should be inspected 

visually for particulate matter prior to administration. Do not use if foreign particles are present. After 

reconstitution, chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8C 

or for 4 hours at room temperature. From a microbiological point of view, the product should be used 

immediately. If not used immediately, in-use storage times and conditions prior to use are the 

responsibility of the user. 

 

Discard the reconstituted solution if not used within 24 hours. 

 

The reconstituted solution is isotonic and may be given as a bolus injection or diluted to a volume of 

50 ml or greater with normal saline or dextrose 50 mg/ml (5%) for infusion. 

 

Since no data are available on the compatibility of Simulect with other medicinal products intended 

for intravenous administration, Simulect should not be mixed with other medicinal products and 

should always be given through a separate infusion line. 

 

Compatibility with a number of infusion sets has been verified. 

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements. 

 

 

7. MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 



 

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8. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/98/084/001 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 09 October 1998 

Date of latest renewal: 09 October 2008 

 

 

10. DATE OF REVISION OF THE TEXT 

 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency http://www.ema.europa.eu 

 



 

12 

1. NAME OF THE MEDICINAL PRODUCT 

 

Simulect 10 mg powder and solvent for solution for injection or infusion 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

Each vial contains 10 mg basiliximab*. 

 

One ml of the reconstituted solution contains 4 mg basiliximab. 

 

* recombinant murine/human chimeric monoclonal antibody directed against the interleukin-2 

receptor -chain (CD25 antigen) produced in a mouse myeloma cell line by recombinant DNA 

technology. 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 

 

Powder and solvent for solution for injection or infusion 

 

White powder 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

Simulect is indicated for the prophylaxis of acute organ rejection in de novo allogeneic renal 

transplantation in adult and paediatric patients (1-17 years) (see section 4.2). 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. 

 

4.2 Posology and method of administration 

 

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. 

 

  



 

13 

Posology 

 

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. In paediatric patients weighing 35 kg or more, the recommended dose is the 

adult dose, i.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. The second dose should be withheld in the event of a severe 

hypersensitivity reaction to Simulect or post-operative complications such as graft loss (see 

section 4.4). 

 

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. The second dose should be withheld in the 

event of a severe hypersensitivity reaction to Simulect or post-operative complications such as graft 

loss (see section 4.4). 

 

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. 

 

For instructions on reconstitution of the medicinal product before administration, see section 6.6. 

 

4.3 Contraindications 

 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 

 

Pregnancy and lactation (see section 4.6). 

 

4.4 Special warnings and precautions for use 

 

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. 

 



 

14 

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). 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 combination of basiliximab (see section 4.8). 

 

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. In several small clinical trials in heart 

transplant recipients, serious cardiac adverse events such as cardiac arrest (2.2%), atrial flutter (1.9%) 

and palpitations (1.4%) 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’. 

 

This medicinal product contains potassium, less than 1 mmol (39 mg) per vial, i.e. essentially 

‘potassium-free’. 

 

  



 

15 

4.5 Interaction with other medicinal products and other forms of interaction 

 

Because basiliximab is an immunoglobulin, no metabolic drug-drug interactions are to be expected. 

 

In addition to ciclosporin for microemulsion, steroids, azathioprine and mycophenolate mofetil, other 

concomitant medications routinely administered in organ transplantation have been administered in 

clinical trials without any incremental adverse reactions. These concomitant medications include 

systemic antiviral, antibacterial and antimycotic medications, analgesics, antihypertensive medications 

such as beta-blocking agents or calcium channel blockers, and diuretics. 

 

Human antimurine antibody (HAMA) responses were reported in a clinical trial of 172 patients treated 

with basiliximab, without predictive value for clinical tolerability. The incidence was 2/138 in patients 

not exposed to muromonab-CD3 (OKT3) and 4/34 in patients who received muromonab-CD3 

concomitantly. The use of basiliximab does not preclude subsequent treatment with murine 

antilymphocyte antibody preparations. 

 

In the original phase III studies during the first 3 months post-transplantation, 14% of patients in the 

basiliximab group and 27% of patients in the placebo group had an acute rejection episode treated with 

antibody therapy (OKT 3 or antithymocyte globulin/antilymphocyte globulin [ATG/ALG]), with no 

increase in adverse events or infections in the basiliximab group as compared to placebo. 

 

Three clinical trials have investigated basiliximab use in combination with a triple therapy regimen 

which included either azathioprine or mycophenolate mofetil. The total body clearance of basiliximab 

was reduced by an average 22% when azathioprine was added to a regimen consisting of ciclosporin 

for microemulsion and corticosteroids. The total body clearance of basiliximab was reduced by an 

average 51% when mycophenolate mofetil was added to a regimen consisting of ciclosporin for 

microemulsion and corticosteroids. The use of basiliximab in a triple therapy regimen including 

azathioprine or mycophenolate mofetil did not increase adverse events or infections in the basiliximab 

group as compared to placebo (see section 4.8). 

 

4.6 Fertility, pregnancy and lactation 

 

Simulect is contraindicated in pregnancy and lactation (see section 4.3). Basiliximab has potentially 

hazardous immunosuppressive effects with respect to the course of gestation and the suckling neonate 

exposed to basiliximab in breast milk. Women of childbearing potential must use effective 

contraception during and up to 16 weeks after treatment. 

 

There is no animal or human data available concerning excretion of basiliximab into breast milk. 

However, based on the IgG1 nature of basiliximab, excretion into milk should be expected. Breast-

feeding must therefore be avoided. 

 

4.7 Effects on ability to drive and use machines 

 

Simulect has no influence on the ability to drive and use machines. 

 

4.8 Undesirable effects 

 

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). 

 



 

16 

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. The overall incidence of treatment-related adverse events among all 

patients in the individual studies was not significantly different between the basiliximab (7.1% - 40%) 

and the placebo (7.6% - 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. Overall, 

lymphoma/lymphoproliferative disease occurred in 0.1% (1/701) of patients in the basiliximab group 

compared with 0.3% (2/595) of patients receiving placebo, both in combination with dual and triple 

immunosuppressive therapy. Other malignancies were reported among 1.0% (7/701) of patients in the 

basiliximab group compared with 1.2% (7/595) of placebo patients. In a pooled analysis of two five-

year extension studies, the incidence of LPDs and cancer was found to be equal with basiliximab 7% 

(21/295) and placebo 7% (21/291) (see section 4.4). 

 

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. The overall incidence of infections 

was 75.9% in the basiliximab group and 75.6% in the placebo group and the incidence of serious 

infections was 26.1% and 24.8%, respectively. The incidence of CMV infections was similar in both 

groups (14.6% vs. 17.3%), following either dual or triple therapy regimen (see section 4.4). 

 

The incidence and causes of deaths following dual or triple therapy were similar in basiliximab (2.9%) 

and placebo groups (2.6%), with the most common cause of deaths in both treatment groups being 

infections (basiliximab = 1.3%, placebo = 1.4%). 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. 

 

Immune system disorders 

Hypersensitivity/anaphylactoid reactions such as rash, urticaria, pruritus, sneezing, wheezing, 

bronchospasm, dyspnoea, pulmonary oedema, cardiac failure, hypotension, tachycardia, respiratory 

failure, capillary leak syndrome (see section 4.4). Cytokine release syndrome. 

 



 

17 

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. 

 

4.9 Overdose 

 

In clinical studies basiliximab has been administered to humans in single doses of up to 60 mg and 

multiple doses of up to 150 mg over 24 days with no acute undesirable effects. 

 

For information on preclinical toxicology see section 5.3. 

 

 

5. PHARMACOLOGICAL PROPERTIES 

 

5.1 Pharmacodynamic properties 

 

Pharmacotherapeutic group: Interleukin inhibitors, ATC code: L04AC02. 

 

Mechanism of action 

 

Basiliximab is a murine/human chimeric monoclonal antibody (IgG1) that is directed against the 

interleukin-2 receptor -chain (CD25 antigen), which is expressed on the surface of T-lymphocytes in 

response to antigenic challenge. Basiliximab specifically binds with high affinity (KD-value 0.1 nM) to 

the CD25 antigen on activated T-lymphocytes expressing the high affinity interleukin-2 receptor (IL-

2R) and thereby prevents binding of interleukin-2, a critical signal for T-cell proliferation in the 

cellular immune response involved in allograft rejection. Complete and consistent blocking of the 

interleukin-2 receptor is maintained as long as serum basiliximab levels exceed 0.2 g/ml (usually up 

to 4–6 weeks after administration). As concentrations fall below this level, expression of the CD25 

antigen returns to pretherapy values within 1–2 weeks. Basiliximab does not cause myelosuppression. 

 

Clinical efficacy and safety 

 

The efficacy of basiliximab in prophylaxis of organ rejection in de novo renal transplantation has been 

demonstrated in double-blind placebo-controlled studies. Results from two pivotal 12-month 

multicentre studies (722 patients in total) comparing basiliximab with placebo show that basiliximab, 

used concomitantly with ciclosporin for microemulsion and corticosteroids, significantly reduces the 

incidence of acute rejection episodes both within 6 (31% vs. 45%, p<0.001) and 12 (33% vs. 48%, 

p<0.001) months after transplantation. There was no significant difference between basiliximab and 

placebo-treated patients in graft survival after 6 and 12 months (at 12 months 32 graft losses on 

basiliximab (9%) and 37 graft losses on placebo (10%)). The incidence of acute rejection episode was 

substantially lower in patients receiving basiliximab and a triple drug immunosuppressive regimen. 

 

Results from two multicentre double-blind studies comparing basiliximab with placebo (463 patients 

in total) show that basiliximab significantly reduces the incidence of acute rejection episodes within 

6 months after transplantation when used concomitantly with ciclosporin for microemulsion, 

corticosteroids, and either azathioprine (21% vs. 35%) or mycophenolate mofetil (15% vs. 27%). Graft 

loss occurred in 6% of basiliximab-treated and 10% of placebo-treated patients by 6 months. The 

adverse event profile remained comparable between treatment groups. 

 

In a pooled analysis of two five-year open-label extension studies (586 patients total) the combined 

graft and patient survival rates were not statistically different for the basiliximab and placebo groups. 

Extension studies also showed that patients who experienced an acute rejection episode during the first 

year after transplantation experienced more graft losses and deaths over the five-year follow-up period 

than patients who had no rejection. These events were not influenced by basiliximab. 



 

18 

 

Paediatric population 

The efficacy and safety of basiliximab were evaluated in two paediatric studies. 

 

Basiliximab was used concomitantly with ciclosporin for microemulsion and steroids in an 

uncontrolled study in 41 paediatric de novo renal transplant recipients. Acute rejection occurred in 

14.6% of patients by 6 months post-transplantation, and in 24.3% by 12 months. Overall the adverse 

event profile was consistent with general clinical experience in the paediatric renal transplantation 

population and with the profile in the controlled adult transplantation studies. 

 

A 12-month, randomised, placebo-controlled, double-blind, multicentre study investigated basiliximab 

in combination with ciclosporin for microemulsion, mycophenolate mofetil and steroids in paediatric 

renal allograft recipients. The primary objective of the study was to demonstrate superiority of this 

combination versus treatment with ciclosporin for microemulsion, mycophenolate mofetil and steroids 

in the prevention of acute rejections. Of the 202 patients, 104 were randomised to basiliximab and 98 

to placebo. The primary efficacy endpoint, time to first biopsy-proven acute rejection (BPAR) episode 

or treatment failure defined as graft loss, death or presumptive rejection within the first 6 months post 

transplantation, occurred in 16.7% of basiliximab-treated patients and 21.7% of placebo-treated 

patients. When borderline rejections were included in the primary efficacy endpoint, the rates were 

26.0% and 23.9% respectively, with no statistically significant difference between the basiliximab- 

and placebo-treated groups (HR: 1.04, 90% CI: [0.64; 1.68]). The rates of BPAR were 9.4% in the 

basiliximab group and 17.4% in the placebo group (HR: 0.50, 90% CI: [0.25; 0.99]). When borderline 

rejections were included, the rates were 20.8% and 19.6%, respectively (HR: 1.01, 90% CI: [0.59; 

1.72]). The overall safety profiles were similar in both groups. The incidence rates of adverse events 

and the pattern of adverse events were comparable between the two treatment groups and to be 

expected for the treatment regimens and the underlying diseases. 

 

Immunogenicity 

Of 339 renal transplant patients treated with basiliximab and tested for anti-idiotype antibodies, 4 

(1.2%) developed an anti-idiotype antibody response. In a clinical trial with 172 patients receiving 

basiliximab, the incidence of human antimurine antibody (HAMA) in renal transplantation patients 

treated with basiliximab was 2/138 in patients not exposed to muromonab-CD3 and 4/34 in patients 

who received muromonab-CD3 concomitantly. The available clinical data on the use of muromonab-

CD3 in patients previously treated with basiliximab suggest that subsequent use of muromonab-CD3 

or other murine anti-lymphocytic antibody preparations is not precluded. 

 

5.2 Pharmacokinetic properties 

 

Adults 

 

Single-dose and multiple-dose pharmacokinetic studies have been conducted in adult patients 

undergoing kidney transplantation. Cumulative doses ranged from 20 mg up to 60 mg. Peak serum 

concentration following intravenous infusion of 20 mg over 30 minutes is 7.15.1 mg/l. There is a 

proportional increase in Cmax and AUC from 20 mg to 60 mg, the range of single-dose administrations 

tested. The volume of distribution at steady state was 8.64.1 l. The extent and degree of distribution 

to various body compartments have not been fully studied. In vitro studies using human tissues 

indicate that basiliximab binds only to activated lymphocytes and macrophages/monocytes. The 

terminal half-life was 7.23.2 days. Total body clearance was 4119 ml/h. 

 

No clinically relevant influence of body weight or gender on distribution volume or clearance has been 

observed in adult patients. Elimination half-life was not influenced by age, gender, or race. 

 



 

19 

Paediatric population 

 

The pharmacokinetics of basiliximab were assessed in 39 paediatric de novo renal transplantation 

patients. In infants and children (age 1–11 years, n=25), the steady-state distribution volume was 

4.82.1 l, half-life was 9.54.5 days and clearance was 176 ml/h. Distribution volume and clearance 

are reduced by about 50% compared to adult renal transplantation patients. Disposition parameters 

were not influenced to a clinically relevant extent by age (1–11 years), body weight (9–37 kg) or body 

surface area (0.44–1.20 m) in this age group. In adolescents (age 12–16 years, n=14), the steady-state 

distribution volume was 7.85.1 l, half-life was 9.13.9 days and clearance was 3119 ml/h. 

Disposition in adolescents was similar to that in adult renal transplantation patients. The relationship 

between serum concentration and receptor saturation was assessed in 13 patients and was similar to 

that characterised in adult renal transplantation patients. 

 

5.3 Preclinical safety data 

 

No toxicity was observed when rhesus monkeys received intravenous doses of either up to 5 mg/kg 

basiliximab twice weekly for 4 weeks followed by an 8-week withdrawal period or 24 mg/kg 

basiliximab weekly for 39 weeks followed by a 13-week withdrawal period. In the 39-week study, the 

highest dose resulted in approximately 1,000 times the systemic exposure (AUC) observed in patients 

given the recommended clinical dose together with concomitant immunosuppressive therapy. 

 

No maternal toxicity, embryotoxicity, or teratogenicity was observed in cynomolgous monkeys 

following injections of up to 5 mg/kg basiliximab administered twice weekly during the organogenesis 

period. 

 

No mutagenic potential was observed in vitro. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 

 

Powder 

 

Potassium dihydrogen phosphate 

Disodium phosphate, anhydrous 

Sodium chloride 

Sucrose 

Mannitol (E421) 

Glycine 

 

Solvent 

 

Water for injections 

 

6.2 Incompatibilities 

 

This medicinal product must not be mixed with other medicinal products except those mentioned in 

section 6.6. 

 

6.3 Shelf life 

 

Powder: 3 years 

 

Chemical and physical stability of the reconstituted solution is demonstrated for 24 hours at 2°C - 8°C 

or for 4 hours at room temperature (see section 6.6). 

 



 

20 

6.4 Special precautions for storage 

 

Store and transport refrigerated (2°C - 8°C). 

 

6.5 Nature and contents of container 

 

Simulect powder 

 

Colourless type I glass vial, grey fluor-resin coated butyl rubber stopper, held in place by a flanged 

aluminium band, blue polypropylene flip-off cap, containing 10 mg basiliximab as powder for solution 

for injection or infusion. 

 

Solvent 

 

Colourless glass ampoule, type I glass, containing 5 ml water for injections. 

 

Simulect is also available in vials with 20 mg basiliximab. 

 

6.6 Special precautions for disposal and other handling 

 

Reconstitution 

 

To prepare the solution for infusion or injection, take 2.5 ml water for injections out of the 

accompanying 5 ml ampoule aseptically and add this 2.5 ml of water for injections aseptically to the 

vial containing the Simulect powder. Shake the vial gently to dissolve the powder, avoiding foaming. 

It is recommended that after reconstitution the colourless, clear to opalescent solution should be used 

immediately. Reconstituted products should be inspected visually for particulate matter prior to 

administration. Do not use if foreign particles are present. After reconstitution, chemical and physical 

in-use stability has been demonstrated for 24 hours at 2°C - 8C or for 4 hours at room temperature. 

From a microbiological point of view, the product should be used immediately. If not used 

immediately, in-use storage times and conditions prior to use are the responsibility of the user. 

 

Discard the reconstituted solution if not used within 24 hours. 

 

The reconstituted solution is isotonic and may be given as a bolus injection or diluted to a volume of 

25 ml or greater with normal saline or dextrose 50 mg/ml (5%) for infusion. 

 

Since no data are available on the compatibility of Simulect with other medicinal products intended 

for intravenous administration, Simulect should not be mixed with other medicinal products and 

should always be given through a separate infusion line. 

 

Compatibility with a number of infusion sets has been verified. 

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements. 

 

 

7. MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 



 

21 

8. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/98/084/002 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 09 October 1998 

Date of latest renewal: 09 October 2008 

 

 

10. DATE OF REVISION OF THE TEXT 

 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency http://www.ema.europa.eu 

 

  



 

22 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX II 
 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE 

SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR 

BATCH RELEASE 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPLY 

AND USE 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 

PRODUCT 

 



 

23 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 

MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 

Name and address of the manufacturer of the biological active substance 

 

Novartis Pharma S.A.S. 

Centre de Biotechnologie 

8 rue de l’Industrie 

68330 Huningue 

France 

 

Name and address of the manufacturer responsible for batch release 

 

Novartis Pharma GmbH 

Roonstrasse 25 

90429 Nuremberg 

Germany 

 

Novartis Farmacéutica S.A. 

Ronda de Santa Maria, 158 

08210 Barberà del Vallès, Barcelona 

Spain 

 

The printed package leaflet of the medicinal product must state the name and address of the 

manufacturer responsible for the release of the concerned batch. 

 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPLY AND USE 
 

Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product 

Characteristics, section 4.2). 

 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 

 Periodic Safety Update Reports (PSURs) 

 

The requirements for submission of PSURs for this medicinal product are set out in the list of Union 

reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any 

subsequent updates published on the European medicines web-portal. 

 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 

 Risk Management Plan (RMP) 

 

Not applicable. 

 

  



 

24 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 

  



 

25 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 

  



 

26 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

FOLDING BOX FOR 1 VIAL AND 1 AMPOULE AS UNIT PACK 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Simulect 20 mg powder and solvent for solution for injection or infusion 

basiliximab 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One vial contains 20 mg of basiliximab. 

 

 

3. LIST OF EXCIPIENTS 

 

It also contains potassium dihydrogen phosphate; disodium phosphate, anhydrous; sodium chloride; 

sucrose; mannitol (E421); glycine. 

The solvent ampoule contains 5 ml water for injections. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Powder and solvent for solution for injection or infusion 

 

1 vial with 20 mg powder 

1 ampoule with 5 ml solvent 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Intravenous use 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

Use immediately after reconstitution (chemically and physically stable at 2°C - 8°C for 24 hours or at 

room temperature for 4 hours). 

 

 



 

27 

9. SPECIAL STORAGE CONDITIONS 

 

Store in a refrigerator. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/98/084/001 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

Please open here. 

 

 

16. INFORMATION IN BRAILLE 

 

Justification for not including Braille accepted. 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC 

SN 

NN 

 

  



 

28 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

VIAL LABEL 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Simulect 20 mg powder for solution for injection/infusion 

basiliximab 

Intravenous use 

 

 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

 

6. OTHER 

 

Store in a refrigerator. 

 

  



 

29 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

AMPOULE LABEL 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Solvent for Simulect 

Water for injections 

 

 

2. METHOD OF ADMINISTRATION 

 

See package leaflet 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

5 ml 

 

 

6. OTHER 

 

 

  



 

30 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

FOLDING BOX FOR 1 VIAL AND 1 AMPOULE AS UNIT PACK 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Simulect 10 mg powder and solvent for solution for injection or infusion 

basiliximab 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One vial contains 10 mg of basiliximab. 

 

 

3. LIST OF EXCIPIENTS 

 

It also contains potassium dihydrogen phosphate; disodium phosphate, anhydrous; sodium chloride; 

sucrose; mannitol (E421); glycine. 

The solvent ampoule contains 5 ml water for injections. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Powder and solvent for solution for injection or infusion 

 

1 vial with 10 mg powder 

1 ampoule with 5 ml solvent 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Intravenous use 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

Use immediately after reconstitution (chemically and physically stable at 2°C - 8°C for 24 hours or at 

room temperature for 4 hours). 

 

 



 

31 

9. SPECIAL STORAGE CONDITIONS 

 

Store in a refrigerator. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/98/084/002 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

Please open here. 

 

 

16. INFORMATION IN BRAILLE 

 

Justification for not including Braille accepted. 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC 

SN 

NN 

  



 

32 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

VIAL LABEL 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Simulect 10 mg powder for solution for injection/infusion 

basiliximab 

Intravenous use 

 

 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

 

6. OTHER 

 

Store in a refrigerator. 

 

  



 

33 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

AMPOULE LABEL 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Solvent for Simulect 

Water for injections 

 

 

2. METHOD OF ADMINISTRATION 

 

See package leaflet 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

5 ml 

 

 

6. OTHER 

 

 

  



 

34 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 



 

35 

Package leaflet: Information for the user 

 

Simulect 20 mg powder and solvent for solution for injection or infusion 

 

basiliximab 

 

Read all of this leaflet carefully before you are given this medicine because it contains important 

information for you. 

- Keep this leaflet. You may need to read it again. 

- If you have any further questions, ask your doctor, nurse or pharmacist. 

- If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible 

side effects not listed in this leaflet. See section 4. 

 

 

What is in this leaflet 
 

1. What Simulect is and what it is used for 

2. What you need to know before you are given Simulect 

3. How Simulect is given 

4. Possible side effects 

5. How to store Simulect 

6. Contents of the pack and other information 

 

 

1. What Simulect is and what it is used for 

 

Simulect belongs to a group of medicines called immunosuppressants. It is given in hospital to adults, 

adolescents and children who are having a kidney transplant. Immunosuppressants reduce the body’s 

response to anything that it sees as “foreign” – which includes transplanted organs. The body’s 

immune system thinks a transplanted organ is a foreign body and will try to reject it. Simulect works 

by stopping the immune cells that attack transplanted organs. 

 

You will only be given two doses of Simulect. These will be given in hospital, around the time of your 

transplant operation. Simulect is given to stop your body from rejecting the new organ during the first 

4 to 6 weeks after the transplant operation, when rejection is most likely. You will be given other 

medicines to help protect your new kidney during this time, such as ciclosporin and corticosteroids 

and after you leave hospital. 

 

 

2. What you need to know before you are given Simulect 

 

Follow your doctor’s instructions carefully. If you are unsure about anything, ask your doctor, nurse or 

pharmacist. 

 

You must not be given Simulect 

- if you are allergic (hypersensitive) to basiliximab or any of the other ingredients of Simulect 

listed in section 6 under “What Simulect contains”. Tell your doctor if you suspect you may 

have had an allergic reaction to any of these ingredients in the past. 

- if you are pregnant or breast-feeding. 

 

  



 

36 

Warnings and precautions 

Talk to your doctor, nurse or pharmacist before you are given Simulect: 

- if you have previously received a transplant that failed after only a short time or, 

- if you have previously been in the operating theatre for a transplantation that in the end was not 

performed. 

In this situation, you may have received Simulect. Your doctor will check this for you and discuss 

with you the possibility of repeated treatment with Simulect. 

 

If you need to have a vaccination, seek your doctor’s advice first. 

 

Other medicines and Simulect 

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other 

medicines. 

 

Older patients (aged 65 years and over) 

Simulect can be given to older patients, but the information available is limited. Your doctor may 

discuss this with you before you are given Simulect. 

 

Children and adolescents (aged 1 to 17 years) 

Simulect can be given to children and adolescents. The dose for children who weigh less than 35 kg will 

be smaller than the dose usually given to adults. 

 

Pregnancy and breast-feeding 

It is very important to tell your doctor before your transplant if you are pregnant or you think that you 

may be pregnant. You must not be given Simulect if you are pregnant. You must use adequate 

contraception to prevent pregnancy during treatment and up to 4 months after receiving the last dose 

of Simulect. If you become pregnant during this time, despite the use of contraceptive measures, you 

should tell your doctor immediately. 

 

You should also tell your doctor if you are breast-feeding. Simulect may harm your baby. You must 

not breast-feed after being given Simulect or up to 4 months after the second dose. 

 

Ask your doctor, nurse or pharmacist for advice before taking any medicine while you are pregnant or 

breast-feeding. 

 

Driving and using machines 

There is no evidence to indicate that Simulect has an effect on your ability to drive a car or use 

machines. 

 

Simulect contains sodium and potassium 

This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-

free’. 

 

This medicine contains potassium, less than 1 mmol (39 mg) per vial, i.e. essentially ‘potassium-free’. 

 

 

3. How Simulect is given 

 

You will only be given Simulect if you are receiving a new kidney. Simulect is given twice, in 

hospital, either slowly through a needle in your vein as an infusion lasting 20–30 minutes or as an 

intravenous injection using a syringe. 

 

If you have experienced a severe allergic reaction to Simulect or if you had complications after your 

surgery such as graft loss, the second dose of Simulect should not be given to you. 

 

The first dose is given just before the transplant operation, and the second dose 4 days after the 

operation. 



 

37 

 

Usual dose for adults 

The usual dose for adults is 20 mg in each infusion or injection. 

 

Usual dose for children and adolescents (aged 1 to 17 years) 

- For children and adolescents who weigh 35 kg or more, the dose of Simulect given in each 

infusion or injection is 20 mg. 

- For children and adolescents who weigh less than 35 kg, the dose of Simulect given in each 

infusion or injection is 10 mg. 

 

If you are given too much Simulect 

An overdose of Simulect is not likely to cause side effects straight away, but it may weaken your 

immune system for longer. Your doctor will watch out for any effects on your immune system and 

treat them if necessary. 

 

 

4. Possible side effects 

 

Like all medicines, this medicine can cause side effects, although not everybody gets them. 

 

Tell your doctor or nurse as soon as possible if you get any unexpected symptoms while you are 

being given Simulect, or during the 8 weeks afterwards, even if you do not think that they are related 

to the medicine. 

 

Sudden severe allergic reactions have been reported in patients treated with Simulect. If you notice 

sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or 

other parts of the body, fast heart beat, dizziness, light headedness, shortness of breath, sneezing, 

wheezing or trouble breathing, severely decreased urine output, or fever and flu-like symptoms, tell 

your doctor or nurse immediately. 

 

In adults, the most commonly reported side effects were constipation, nausea, diarrhoea, weight 

increase, headache, pain, swelling of hands, ankles or feet, high blood pressure, anaemia, changes in 

blood chemistry (e.g. potassium, cholesterol, phosphate, creatinine), surgical wound complications, 

and various kinds of infections. 

 

In children, the most commonly reported side effects were constipation, excessive growth of normal 

hair, runny or blocked nose, fever, high blood pressure, and various kinds of infections. 

 
Reporting of side effects 

If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side 

effects not listed in this leaflet. You can also report side effects directly via the national reporting 

system listed in Appendix V. By reporting side effects you can help provide more information on the 

safety of this medicine. 

 

 

5. How to store Simulect 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The 

expiry date refers to the last day of that month. 

 

Store in a refrigerator (2°C - 8°C). 

 

 



 

38 

6. Contents of the pack and other information 

 

What Simulect contains 

- The active substance is basiliximab. Each vial contains 20 mg of basiliximab. 

- The other ingredients are potassium dihydrogen phosphate; disodium phosphate, anhydrous; 

sodium chloride; sucrose; mannitol (E421); glycine. 

 

What Simulect looks like and contents of the pack 

Simulect comes as a white powder in a colourless glass vial containing 20 mg of basiliximab. It is 

supplied in a pack with a colourless glass ampoule containing 5 ml sterile water for injections. This 

solvent is used to dissolve the powder before it is given to you. 

 

Simulect is also available in vials with 10 mg basiliximab. 

 

Marketing Authorisation Holder 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

Manufacturer 

Novartis Pharma GmbH 

Roonstrasse 25 

90429 Nuremberg 

Germany 

 

Novartis Farmacéutica S.A. 

Ronda de Santa Maria, 158 

08210 Barberà del Vallès, Barcelona 

Spain 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

 

België/Belgique/Belgien 

Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Lietuva 

SIA Novartis Baltics Lietuvos filialas 

Tel: +370 5 269 16 50 

 

България 

Novartis Bulgaria EOOD 

Тел.: +359 2 489 98 28 

 

Luxembourg/Luxemburg 

Novartis Pharma N.V. 

Tel: +32 2 246 16 11 

 

Česká republika 

Novartis s.r.o. 

Tel: +420 225 775 111 

 

Magyarország 

Novartis Hungária Kft. 

Tel.: +36 1 457 65 00 

Danmark 

Novartis Healthcare A/S 

Tlf: +45 39 16 84 00 

 

Malta 

Novartis Pharma Services Inc. 

Tel: +356 2122 2872 

Deutschland 

Novartis Pharma GmbH 

Tel: +49 911 273 0 

 

Nederland 

Novartis Pharma B.V. 

Tel: +31 88 04 52 111 



 

39 

Eesti 

SIA Novartis Baltics Eesti filiaal 

Tel: +372 66 30 810 

 

Norge 

Novartis Norge AS 

Tlf: +47 23 05 20 00 

Ελλάδα 

Novartis (Hellas) A.E.B.E. 

Τηλ: +30 210 281 17 12 

 

Österreich 

Novartis Pharma GmbH 

Tel: +43 1 86 6570 

España 

Novartis Farmacéutica, S.A. 

Tel: +34 93 306 42 00 

 

Polska 

Novartis Poland Sp. z o.o. 

Tel.: +48 22 375 4888 

France 

Novartis Pharma S.A.S. 

Tél: +33 1 55 47 66 00 

 

Portugal 

Novartis Farma - Produtos Farmacêuticos, S.A. 

Tel: +351 21 000 8600 

Hrvatska 

Novartis Hrvatska d.o.o. 

Tel. +385 1 6274 220 

 

România 

Novartis Pharma Services Romania SRL 

Tel: +40 21 31299 01 

Ireland 

Novartis Ireland Limited 

Tel: +353 1 260 12 55 

 

Slovenija 

Novartis Pharma Services Inc. 

Tel: +386 1 300 75 50 

Ísland 

Vistor hf. 

Sími: +354 535 7000 

 

Slovenská republika 

Novartis Slovakia s.r.o. 

Tel: +421 2 5542 5439 

 

Italia 

Novartis Farma S.p.A. 

Tel: +39 02 96 54 1 

Suomi/Finland 

Novartis Finland Oy 

Puh/Tel: +358 (0)10 6133 200 

 

Κύπρος 

Novartis Pharma Services Inc. 

Τηλ: +357 22 690 690 

 

Sverige 

Novartis Sverige AB 

Tel: +46 8 732 32 00 

 

Latvija 

SIA Novartis Baltics 

Tel: +371 67 887 070 

 

United Kingdom 

Novartis Pharmaceuticals UK Ltd. 

Tel: +44 1276 698370 

 

 

This leaflet was last revised in 

 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu 

 



 

40 

INSTRUCTIONS FOR RECONSTITUTION AND ADMINISTRATION 

 

The following information is intended for healthcare professionals only: 

 

Simulect must not be administered unless it is absolutely certain that the patient will receive the 

graft and concomitant immunosuppression. 

 

To prepare the solution for infusion or injection, add 5 ml water for injections from the accompanying 

ampoule to the vial containing the Simulect powder, using aseptic technique. Shake the vial gently to 

dissolve the powder, avoiding foaming. It is recommended that after reconstitution the colourless, 

clear to opalescent solution should be used immediately. Reconstituted products should be inspected 

visually for particulate matter prior to administration. Do not use if foreign particles are present. After 

reconstitution, chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C 

or for 4 hours at room temperature. Discard the reconstituted solution if not used within that time. 

From a microbiological point of view, the product should be used immediately. If not used 

immediately, in-use storage times and conditions prior to use are the responsibility of the user. 

 

Reconstituted Simulect is administered as an intravenous infusion over 20 to 30 minutes or as a bolus 

injection. The reconstituted solution is isotonic. For infusion, the reconstituted solution should be 

diluted to a volume of 50 ml or greater with normal saline or dextrose 50 mg/ml (5%). The first dose 

should be given within 2 hours before transplantation surgery, and the second dose 4 days after 

transplantation. The second dose should not be given if severe hypersensitivity reactions to 

Simulect or graft loss occur. 

 

Since no data are available on the compatibility of Simulect with other intravenous substances, 

Simulect should not be mixed with other medications/substances and should always be given through 

a separate infusion line. 

 

Compatibility with the following infusion sets has been verified: 

 

Infusion bag 

- Baxter minibag NaCl 0.9% 

 

Infusion sets 

- Luer Lock, H. Noolens 

- Sterile vented i.v. set, Abbott 

- Infusion set, Codan 

- Infusomat, Braun 

- Infusionsgerät R 87 plus, Ohmeda 

- Lifecare 5000Plumset Microdrip, Abbott 

- Vented basic set, Baxter 

- Flashball device, Baxter 

- Vented primary administration set, Imed 

 

Do not use after the expiry date stated on the pack. 

 

Store in a refrigerator (2°C - 8°C). 

 

Any unused product or waste material should be disposed of in accordance with local requirements. 



 

41 

Package leaflet: Information for the user 

 

Simulect 10 mg powder and solvent for solution for injection or infusion 

 

basiliximab 

 

Read all of this leaflet carefully before you are given this medicine because it contains important 

information for you. 

- Keep this leaflet. You may need to read it again. 

- If you have any further questions, ask your doctor, nurse or pharmacist. 

- If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible 

side effects not listed in this leaflet. See section 4. 

 

 

What is in this leaflet 

 

1. What Simulect is and what it is used for 

2. What you need to know before you are given Simulect 

3. How Simulect is given 

4. Possible side effects 

5. How to store Simulect 

6. Contents of the pack and other information 

 

 

1. What Simulect is and what it is used for 

 

Simulect belongs to a group of medicines called immunosuppressants. It is given in hospital to adults, 

adolescents and children who are having a kidney transplant. Immunosuppressants reduce the body’s 

response to anything that it sees as “foreign” – which includes transplanted organs. The body’s 

immune system thinks a transplanted organ is a foreign body and will try to reject it. Simulect works 

by stopping the immune cells that attack transplanted organs. 

 

You will only be given two doses of Simulect. These will be given in hospital, around the time of your 

transplant operation. Simulect is given to stop your body from rejecting the new organ during the first 

4 to 6 weeks after the transplant operation, when rejection is most likely. You will be given other 

medicines to help protect your new kidney during this time, such as ciclosporin and corticosteroids 

and after you leave hospital. 

 

 

2. What you need to know before you are given Simulect 

 

Follow your doctor’s instructions carefully. If you are unsure about anything, ask your doctor, nurse or 

pharmacist. 

 

You must not be given Simulect 

- if you are allergic (hypersensitive) to basiliximab or any of the other ingredients of Simulect 

listed in section 6 under “What Simulect contains”. Tell your doctor if you suspect you may 

have had an allergic reaction to any of these ingredients in the past. 

- if you are pregnant or breast-feeding. 

 

  



 

42 

Warnings and precautions 

Talk to your doctor, nurse or pharmacist before you are given Simulect: 

- if you have previously received a transplant that failed after only a short time or, 

- if you have previously been in the operating theatre for a transplantation that in the end was not 

performed. 

In this situation, you may have received Simulect. Your doctor will check this for you and discuss 

with you the possibility of repeated treatment with Simulect. 

 

If you need to have a vaccination, seek your doctor’s advice first. 

 

Other medicines and Simulect 

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other 

medicines. 

 

Older patients (aged 65 years and over) 

Simulect can be given to older patients, but the information available is limited. Your doctor may 

discuss this with you before you are given Simulect. 

 

Children and adolescents (aged 1 to 17 years) 

Simulect can be given to children and adolescents. The dose for children who weigh less than 35 kg will 

be smaller than the dose usually given to adults. 

 

Pregnancy and breast-feeding 

It is very important to tell your doctor before your transplant if you are pregnant or you think that you 

may be pregnant. You must not be given Simulect if you are pregnant. You must use adequate 

contraception to prevent pregnancy during treatment and up to 4 months after receiving the last dose 

of Simulect. If you become pregnant during this time, despite the use of contraceptive measures, you 

should tell your doctor immediately. 

 

You should also tell your doctor if you are breast-feeding. Simulect may harm your baby. You must 

not breast-feed after being given Simulect or up to 4 months after the second dose. 

 

Ask your doctor, nurse or pharmacist for advice before taking any medicine while you are pregnant or 

breast-feeding. 

 

Driving and using machines 

There is no evidence to indicate that Simulect has an effect on your ability to drive a car or use 

machines. 

 

Simulect contains sodium and potassium 

This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-

free’. 

 

This medicine contains potassium, less than 1 mmol (39 mg) per vial, i.e. essentially ‘potassium-free’. 

 

 

3. How Simulect is given 

 

You will only be given Simulect if you are receiving a new kidney. Simulect is given twice, in 

hospital, either slowly through a needle in your vein as an infusion lasting 20–30 minutes or as an 

intravenous injection using a syringe. 

 

If you have experienced a severe allergic reaction to Simulect or if you had complications after your 

surgery such as graft loss, the second dose of Simulect should not be given to you. 

 

The first dose is given just before the transplant operation, and the second dose 4 days after the 

operation. 



 

43 

 

Usual dose for children and adolescents (aged 1 to 17 years) 

- For children and adolescents who weigh less than 35 kg, the dose of Simulect given in each 

infusion or injection is 10 mg. 

- For children and adolescents who weigh 35 kg or more, the dose of Simulect given in each 

infusion or injection is 20 mg. 

 

Usual dose for adults 

The usual dose for adults is 20 mg in each infusion or injection. 

 

If you are given too much Simulect 

An overdose of Simulect is not likely to cause side effects straight away, but it may weaken your 

immune system for longer. Your doctor will watch out for any effects on your immune system and 

treat them if necessary. 

 

 

4. Possible side effects 

 

Like all medicines, this medicine can cause side effects, although not everybody gets them. 

 

Tell your doctor or nurse as soon as possible if you get any unexpected symptoms while you are 

being given Simulect, or during the 8 weeks afterwards, even if you do not think that they are related 

to the medicine. 

 

Sudden severe allergic reactions have been reported in patients treated with Simulect. If you notice 

sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or 

other parts of the body, fast heart beat, dizziness, light headedness, shortness of breath, sneezing, 

wheezing or trouble breathing, severely decreased urine output, or fever and flu-like symptoms, tell 

your doctor or nurse immediately. 

 

In children, the most commonly reported side effects were constipation, excessive growth of normal 

hair, runny or blocked nose, fever, high blood pressure, and various kinds of infections. 

 

In adults, the most commonly reported side effects were constipation, nausea, diarrhoea, weight 

increase, headache, pain, swelling of hands, ankles or feet, high blood pressure, anaemia, changes in 

blood chemistry (e.g. potassium, cholesterol, phosphate, creatinine), surgical wound complications, 

and various kinds of infections. 

 

Reporting of side effects 

If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side 

effects not listed in this leaflet. You can also report side effects directly via the national reporting 

system listed in Appendix V. By reporting side effects you can help provide more information on the 

safety of this medicine. 

 

 

5. How to store Simulect 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The 

expiry date refers to the last day of that month. 

 

Store in a refrigerator (2°C - 8°C). 

 

 



 

44 

6. Contents of the pack and other information 

 

What Simulect contains 

- The active substance is basiliximab. Each vial contains 10 mg of basiliximab. 

- The other ingredients are potassium dihydrogen phosphate; disodium phosphate, anhydrous; 

sodium chloride; sucrose; mannitol (E421); glycine. 

 

What Simulect looks like and contents of the pack 

Simulect comes as a white powder in a colourless glass vial containing 10 mg of basiliximab. It is 

supplied in a pack with a colourless glass ampoule containing 5 ml sterile water for injections. 2.5 ml 

of the sterile water is used to dissolve the powder before it is given to you. 

 

Simulect is also available in vials with 20 mg basiliximab. 

 

Marketing Authorisation Holder 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

Manufacturer 

Novartis Pharma GmbH 

Roonstrasse 25 

90429 Nuremberg 

Germany 

 

Novartis Farmacéutica S.A. 

Ronda de Santa Maria, 158 

08210 Barberà del Vallès, Barcelona 

Spain 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

 

België/Belgique/Belgien 

Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Lietuva 

SIA Novartis Baltics Lietuvos filialas 

Tel: +370 5 269 16 50 

 

България 

Novartis Bulgaria EOOD 

Тел.: +359 2 489 98 28 

 

Luxembourg/Luxemburg 

Novartis Pharma N.V. 

Tel: +32 2 246 16 11 

 

Česká republika 

Novartis s.r.o. 

Tel: +420 225 775 111 

 

Magyarország 

Novartis Hungária Kft. 

Tel.: +36 1 457 65 00 

Danmark 

Novartis Healthcare A/S 

Tlf: +45 39 16 84 00 

 

Malta 

Novartis Pharma Services Inc. 

Tel: +356 2122 2872 

Deutschland 

Novartis Pharma GmbH 

Tel: +49 911 273 0 

 

Nederland 

Novartis Pharma B.V. 

Tel: +31 88 04 52 111 



 

45 

Eesti 

SIA Novartis Baltics Eesti filiaal 

Tel: +372 66 30 810 

 

Norge 

Novartis Norge AS 

Tlf: +47 23 05 20 00 

Ελλάδα 

Novartis (Hellas) A.E.B.E. 

Τηλ: +30 210 281 17 12 

 

Österreich 

Novartis Pharma GmbH 

Tel: +43 1 86 6570 

España 

Novartis Farmacéutica, S.A. 

Tel: +34 93 306 42 00 

 

Polska 

Novartis Poland Sp. z o.o. 

Tel.: +48 22 375 4888 

France 

Novartis Pharma S.A.S. 

Tél: +33 1 55 47 66 00 

 

Portugal 

Novartis Farma - Produtos Farmacêuticos, S.A. 

Tel: +351 21 000 8600 

Hrvatska 

Novartis Hrvatska d.o.o. 

Tel. +385 1 6274 220 

 

România 

Novartis Pharma Services Romania SRL 

Tel: +40 21 31299 01 

Ireland 

Novartis Ireland Limited 

Tel: +353 1 260 12 55 

 

Slovenija 

Novartis Pharma Services Inc. 

Tel: +386 1 300 75 50 

Ísland 

Vistor hf. 

Sími: +354 535 7000 

 

Slovenská republika 

Novartis Slovakia s.r.o. 

Tel: +421 2 5542 5439 

 

Italia 

Novartis Farma S.p.A. 

Tel: +39 02 96 54 1 

Suomi/Finland 

Novartis Finland Oy 

Puh/Tel: +358 (0)10 6133 200 

 

Κύπρος 

Novartis Pharma Services Inc. 

Τηλ: +357 22 690 690 

 

Sverige 

Novartis Sverige AB 

Tel: +46 8 732 32 00 

 

Latvija 

SIA Novartis Baltics 

Tel: +371 67 887 070 

 

United Kingdom 

Novartis Pharmaceuticals UK Ltd. 

Tel: +44 1276 698370 

 

 

This leaflet was last revised in 

 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu 

 



 

46 

INSTRUCTIONS FOR RECONSTITUTION AND ADMINISTRATION 

 

The following information is intended for healthcare professionals only: 

 

Simulect 10 mg must not be administered unless it is absolutely certain that the patient will 

receive the graft and concomitant immunosuppression. 

 

To prepare the solution for infusion or injection, take 2.5 ml water for injections out of the 

accompanying 5 ml ampoule aseptically and add this 2.5 ml water for injections to the vial containing 

the Simulect powder, using aseptic technique. Shake the vial gently to dissolve the powder, avoiding 

foaming. It is recommended that after reconstitution the colourless, clear to opalescent solution should 

be used immediately. Reconstituted products should be inspected visually for particulate matter prior 

to administration. Do not use if foreign particles are present. After reconstitution, chemical and 

physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C or for 4 hours at room 

temperature. Discard the reconstituted solution if not used within that time. From a microbiological 

point of view, the product should be used immediately. If not used immediately, in-use storage times 

and conditions prior to use are the responsibility of the user. 

 

Reconstituted Simulect is administered as an intravenous infusion over 20 to 30 minutes or as a bolus 

injection. The reconstituted solution is isotonic. For infusion, the reconstituted solution should be 

diluted to a volume of 25 ml or greater with normal saline or dextrose 50 mg/ml (5%). The first dose 

should be given within 2 hours before transplantation surgery, and the second dose 4 days after 

transplantation. The second dose should not be given if severe hypersensitivity reactions to 

Simulect or graft loss occur. 

 

Since no data are available on the compatibility of Simulect with other intravenous substances, 

Simulect should not be mixed with other medications/substances and should always be given through 

a separate infusion line. 

 

Compatibility with the following infusion sets has been verified: 

 

Infusion bag 

- Baxter minibag NaCl 0.9% 

 

Infusion sets 

- Luer Lock, H. Noolens 

- Sterile vented i.v. set, Abbott 

- Infusion set, Codan 

- Infusomat, Braun 

- Infusionsgerät R 87 plus, Ohmeda 

- Lifecare 5000Plumset Microdrip, Abbott 

- Vented basic set, Baxter 

- Flashball device, Baxter 

- Vented primary administration set, Imed 

 

Do not use after the expiry date stated on the pack. 

 

Store in a refrigerator (2°C - 8°C). 

 

Any unused product or waste material should be disposed of in accordance with local requirements. 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET