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Simulect (Basiliximab) - Summary

 
 



WARNING

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

 

SIMULECT SUMMARY

Simulect® (basiliximab) is a chimeric (murine/human) monoclonal antibody (IgG1[kgr ]), produced by recombinant DNA technology, that functions as an immunosuppressive agent, specifically binding to and blocking the interleukin-2 receptor (alpha)-chain (IL-2R(alpha), also known as CD25 antigen) on the surface of activated T-lymphocytes.

Simulect® is indicated for the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine, USP (MODIFIED) and corticosteroids.

The efficacy of Simulect® for the prophylaxis of acute rejection in recipients of other solid organ allografts has not been demonstrated.


See all Simulect indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Simulect (Basiliximab)

Progress Made on Robot-assisted Kidney Transplantation
Source: Medscape Allergy & Clinical Immunology Headlines [2017.09.29]
When performed in selected patients by surgeons with specialized experience, robot-assisted kidney transplantation (RAKT) can result in “low complication rates, rapid recovery, and excellent graft function,” researchers in Europe conclude.
Reuters Health Information

Selena Gomez's Kidney Transplant Puts Lupus Center Stage
Source: MedicineNet Rash Specialty [2017.09.18]
Title: Selena Gomez's Kidney Transplant Puts Lupus Center Stage
Category: Health News
Created: 9/15/2017 12:00:00 AM
Last Editorial Review: 9/18/2017 12:00:00 AM

Selena Gomez Had a Kidney Transplant Earlier This Year
Source: MedicineNet Kidney Failure Specialty [2017.09.15]
Title: Selena Gomez Had a Kidney Transplant Earlier This Year
Category: Health News
Created: 9/15/2017 12:00:00 AM
Last Editorial Review: 9/15/2017 12:00:00 AM

Novel Procedure Improves Kidney Transplant Success
Source: MedicineNet Blood Transfusion Specialty [2017.08.03]
Title: Novel Procedure Improves Kidney Transplant Success
Category: Health News
Created: 8/2/2017 12:00:00 AM
Last Editorial Review: 8/3/2017 12:00:00 AM

more news >>

Published Studies Related to Simulect (Basiliximab)

Basiliximab versus daclizumab combined with triple immunosuppression in deceased donor renal transplantation: a prospective, randomized study. [2010.04.27]
BACKGROUND: In this prospective, randomized, open-label, single-center study, we compared the efficacy and safety of two anti-interleukin-2 receptor monoclonal antibodies combined with triple immunosuppression... CONCLUSION: Basiliximab or daclizumab combined with triple therapy was an efficient and a safe immunosuppression strategy, demonstrated with low incidence of acute rejections, excellent graft function, high survival rates, and acceptable adverse event profile in adult recipients within the 1st year after deceased donor renal transplantation.

A randomized trial of basiliximab with three different patterns of cyclosporin A initiation in renal transplant from expanded criteria donors and at high risk of delayed graft function. [2009.01]
This study assays therapy with basiliximab and different patterns of cyclosporin A (CsA) initiation in renal transplant (RT) recipients from expanded criteria donors (ECD) and at high risk of delayed graft function (DGF). A multicentre six-month open-label randomized trial with three parallel groups treated with basiliximab plus steroids, mycophenolate mofetil and different patterns of CsA initiation: early within 24 h post-RT at 3 mg/kg/d (Group 1; n = 38), and at 5 mg/kg/d (Group 2; n = 40), or delayed after 7-10 d at 5 mg/kg/d (Group 3; n = 36).

Efficacy and safety of basiliximab in pediatric renal transplant patients receiving cyclosporine, mycophenolate mofetil, and steroids. [2008.11.15]
BACKGROUND: Basiliximab, a monoclonal CD25 antibody has proofed effective in reducing acute rejection episodes in adults in various immunosuppressive regimens. The effect of basiliximab in the pediatric population is controversial... CONCLUSIONS: Addition of basiliximab induction to a regimen of cyclosporine microemulsion, mycophenolate mofetil, and steroids resulted in a numerically lower but not significant incidence of biopsy-proven acute rejection versus placebo and excellent graft and patient survival at 1 year in pediatric renal transplant recipients. Whether this numerical difference is a true therapeutic benefit in view of the higher rate and severity of subclinical rejections in the basiliximab group in the protocol biopsy will be investigated in a long-term follow-up study.

Pharmacokinetics and immunodynamics of basiliximab in pediatric renal transplant recipients on mycophenolate mofetil comedication. [2008.11.15]
BACKGROUND: The aim of this substudy within a prospective, multicenter, placebo-controlled trial was to assess the pharmacokinetics and immunodynamics of basiliximab in pediatric renal transplant recipients on comedication with mycophenolate mofetil (MMF)... CONCLUSIONS: The currently recommended basiliximab dose for pediatric patients, when used with cyclosporine microemulsion and corticosteroids, yielded adequate drug exposure in children and adolescents also under MMF comedication. The observation that about a quarter of BPARs occurred despite adequate IL2-R blockade suggests that another T-cell activation pathway independent of the IL-2/IL-2R pathway is operative, for example, the IL-15 signaling pathway.

[Basiliximab following penetrating risk-keratoplasty--a prospective randomized pilot study] [2008.01]
BACKGROUND: Until now cyclosporin A (CSA) and mycophenolate mofetil (MMF) are the only available systemic immunosuppressants for patients undergoing risk keratoplasty. Basiliximab is a chimeric monoclonal interleukin 2-receptor antibody, which inhibits T-cell proliferation. Basiliximab is approved for the treatment in patients after kidney transplantation. The aim of this study was to prove the efficacy and safety of Basiliximab after penetrating risk keratoplasty... CONCLUSIONS: Basiliximab has a lower efficacy in preventing immune reactions after risk keratoplasty than CSA. However, the side effect profile of basiliximab is more favourable than that of CSA.

more studies >>

Clinical Trials Related to Simulect (Basiliximab)

Study to Evaluate the Safety of Chronic Administration of Simulect to Subjects Receiving a First Kidney Transplant [Terminated]

Pharmacodynamics, Efficacy and Safety of Basiliximab 40 or 80 mg in Combination With Ciclosporine Microemulsion or Everolimus, in Adult Low Risk de Novo Renal Transplant Recipients (IDEALE Study) [Completed]
The aims of this study are to extensively study the levels of CD25-Receptors saturation and expression obtained with 2 different doses of Simulect® in combination with Neoral® (i. e to demonstrate that saturation and expression vary according to the dose of Simulect® given), and to study the levels of CD25-Receptors saturation without Neoral® and compare them to the data with Neoral®. It will be conducted in low risk de novo adult renal transplant recipients until 12 weeks post-transplant, receiving either a cumulative dose of 40 or 80 mg of Simulect® in combination with Neoral®, or a cumulative dose of 80 mg of Simulect® in a calcineurin inhibitor free immunosuppressant therapy.

Simulect Versus ATG in Sensitized Renal Transplant Patient [Recruiting]
Induction therapy by either T-cell depleting polyclonal antibodies such as anti-thymocyte globulins (ATG) or non-depleting anti-interleukine 2 receptor monoclonal antibodies (anti-CD25 moAb: basiliximab or daclizumab) are used to prevent acute rejection, especially in highly sensitized patients. Both induction therapy regimens have a different tolerance profile. Infections and haematological side-effects are more frequently reported in patients receiving ATG. The aim of the pilot study is to evaluate ATG and basiliximab induction therapy in de novo sensitized kidney-transplant patients (incompatible grafts rate ≥ 50%) without donor specific antibodies (DSAs) detected by Luminex.

Infliximab and Basiliximab for Treatment of Steroid Refractory Acute Graft Versus Host Disease [Recruiting]
Acute Graft Versus Host Disease (GVHD) is a serious medical condition that is a common development after Bone Marrow Transplant (BMT). Acute GVHD happens when the donor cells attack and damage your tissues and organs after transplant. Acute GVHD often causes: Skin rashes, nausea, vomiting, abdominal pain, diarrhea (may have blood), liver damage that can cause inflammation in the liver or jaundice (yellowing of the skin or eyes), damage to other organs Steroids are the first line of treatment for acute GVHD. About a quarter of the patients that develop acute GVHD may not respond to steroid and have steroid refractory GVHD (SR-aGVHD). Patients with SR-aGVHD may need other medications. SR-aGVHD, is a potentially life threatening condition. There is no standard treatment and it may not respond to treatment. The goals of this study are to find out if Infliximab and basiliximab can treat SR-aGVHD. Participants in this study will receive combination therapy (2 drugs: infliximab and basiliximab) once a week for four weeks.

Safety and Efficacy of Basiliximab in Calcineurin Inhibitor Intolerant Long-term Kidney Transplant Recipients Treated With Mycophenolic Acid and Steroids [Completed]
The long-term use of calcineurin inhibitors (CNI) in patients who have received a kidney transplantation is associated with renal dysfunction and hypertension. The study will evaluate the safety and efficacy of replacing the calcineurin inhibitors by using basiliximab at monthly doses.

more trials >>

Reports of Suspected Simulect (Basiliximab) Side Effects

Kidney Transplant Rejection (22)Blood Creatinine Increased (14)Cytomegalovirus Infection (13)Diarrhoea (12)Pyrexia (11)Pneumonia (10)Complications of Transplanted Kidney (9)Abdominal Pain (8)Thrombotic Microangiopathy (8)Hypotension (8)more >>


Page last updated: 2017-09-29

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