Simulect (Basiliximab) - Summary

SIMULECT SUMMARY

Simulect^®

Simulect® (basiliximab) is a chimeric (murine/human) monoclonal antibody (IgG_{1[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.

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NEWS HIGHLIGHTS

Media Articles Related to Simulect (Basiliximab)

Robotic Kidney Transplants May Be Best Option For Obese Patients
Source: Health News from Medical News Today [2013.05.17]
Obese patients who received robotic kidney transplants had fewer wound complications than patients who received traditional "open" transplant surgery, according to surgeons at the University of Illinois Hospital & Health Sciences System. The findings should allow more obese patients to receive kidney transplants. Patients with a body mass index (BMI) greater than 35 who have end-stage kidney disease are often denied transplantation, and patients with a BMI over 40 often die on dialysis without an opportunity for transplant...

Disparities In Kidney Transplants For African-Americans
Source: Transplants / Organ Donations News From Medical News Today [2013.05.10]
While the percentage of kidney transplants involving live donors has remained stable for other minority populations, African Americans have seen a decline in live donors even as more of them receive kidney transplants, according to a study by Henry Ford Hospital in Detroit. Those findings were presented at the annual meeting of the American Urological Association in San Diego...

Combined Liver-Kidney Transplantation May Benefit Some Patients With Complicated Childhood Polycystic Kidney Disease
Source: Liver Disease / Hepatitis News From Medical News Today [2013.04.30]
A collaborative team of physician-scientists at the Medical College of Wisconsin (MCW) and Children's Hospital of Wisconsin Research Institute has developed a new evidence-based, clinical algorithm to help physicians treat complex patients with autosomal recessive polycystic kidney disease (ARPKD). Their invited manuscript, written by Grzegorz Telega, M.D...

Lab-Grown Kidney Transplanted Into Rats Produces Urine
Source: Transplants / Organ Donations News From Medical News Today [2013.04.15]
US scientists have grown kidneys that produce rudimentary urine in the lab and also after being transplanted into rats. They hope to refine the approach so one day it is possible to grow human kidneys in the lab that work as well as donor kidneys in transplant patients but without the need for them to take drugs to suppress their immune system...

Tool Created To Help Patients Decide Whether To Take A Kidney Transplant Immediately Or Wait For A Better One
Source: IT / Internet / E-mail News From Medical News Today [2013.04.12]
Johns Hopkins scientists have created a free, Web-based tool to help patients decide whether it's best to accept an immediately available, but less-than-ideal deceased donor kidney for transplant, or wait for a healthier one in the future...

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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.

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Clinical Trials Related to Simulect (Basiliximab)

Pharmacodynamics, Efficacy, Safety of Basiliximab 40 or 80 mg Combined With CsA or Everolimus, in Low Risk de Novo Renal Transplant Recipients [Not yet recruiting]
TPharmacodynamics, efficacy, safety of basiliximab 40 or 80 mg combined with CsA or everolimus, in de novo renal transplant recipients.

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

Prospective, Randomized Trial of Basiliximab (Simulect) in the Prophylaxis of High-Risk Keratoplasty Patients [Completed]
Most high risk keratoplasties are currently performed under systemic immunosuppression. Immunosuppressants are currently either Cyclosporine A or mycophenolate mofetile, administered for around 6 months. Due to potentially severe adverse effects, new immunosuppressive exerting less side effects would be desirable. Basiliximab is a monoclonal, chimeric antibody, targeted specifically against the Interleukin-2-Rezeptor from activated T-cells. This agent is known to specifically inhibit T-cell proliferation upon intravenous application only twice following transplantation. Basiliximab has already been demonstrated effective in kidney transplantation.

This investigation is a prospective, randomized clinical trial on orthotopic, high-risk penetrating keratoplasty. Basiliximab is evaluated against systemic Cyclosporine A. Primary endpoint is graft rejection. Secondary endpoint is clear graft survival.

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.

Radiolabeled Monoclonal Antibody Therapy and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With Primary Refractory or Relapsed Hodgkin Lymphoma [Recruiting]
This phase I/II clinical trial studies the side effects and best dose of radiolabeled monoclonal antibody therapy when given together with combination chemotherapy before stem cell transplant and to see how well it works in treating patients with primary refractory or relapsed Hodgkin lymphoma. Radiolabeled monoclonal antibodies can find cancer cells and carry cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carmustine, etoposide, cytarabine, and melphalan (BEAM), work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving radiolabeled monoclonal antibody therapy together with combination chemotherapy may kill more cancer cells

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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 >>