Cber, basiliximab, renal, transplantation, labeling. Renflexis infliximababda for injection, for intravenous use. Dailymed simulect basiliximab injection, powder, for. Basiliximab functions as an il2 receptor antagonist by binding with high affinity k a 1 x 1010 m1 to the alpha chain of the high affinity il2 receptor complex and inhibiting il2 binding. Progressive multifocal leukoencephalopathy pml is an opportunistic viral infection of the brain caused by the john cunningham jc virus that typically only occurs in. Based on the amino acid sequence, the calculated molecular. You should not use basiliximab if you are allergic to it. These highlights do not include all the information needed to use renflexis safely and effectively. Infliximab and basiliximab for treatment of steroid. Dosing and administration guide please see important safety information, including boxed warnings, on pages 1012. Basiliximab maintenance in ulcerative colitis the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Promacta eltrombopag tablets, for oral use promacta eltrombopag for oral suspension initial u. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for remicade infliximab. To prepare the solution for infusion or injection, take 2.
This medication comes in an injectable form to be given directly into a vein iv by a healthcare professional. Basiliximab injection is used with other medications to prevent immediate transplant rejection attack of the transplanted organ by the immune system of the person receiving the organ in people who are receiving kidney transplants. Highlights of prescribing information initiate promacta at. You will receive this injection just before your transplant and again 4 days afterward. Request pdf basiliximab, mechanism of action and pharmacological properties basiliximab is a chimeric antiintcrleukin2 receptor monoclonal antibody.
Robert eisenberg, in stiehms immune deficiencies, 2014. Listing a study does not mean it has been evaluated by the u. Simulect 10 mg powder and solvent for solution for injection or infusion. Add 5 ml sterile water for injection to a 20 mg vial, rock vial gently to dissolve then further dilute in an infusion bag to a volume of 50 ml of ns or d5w. It is used to prevent rejection in organ transplantation, especially in kidney transplants. Simulect basiliximab side effects, images, uses, dosage. Simulect basiliximab is a chimeric murinehuman monoclonal antibody igg 1k, produced by recombinant dna technology, that functions as an immunosuppressive agent, specifically binding to and blocking the interleukin2 receptor achain il2ra, also known as cd25 antigen on the surface of activated tlymphocytes. Each vial of simulect contains either 10 mg or 20 mg basiliximab as a sterile freezedried powder for reconstitution with water for injections. Basiliximab is a chimeric mab directed at cd25, which is the. Basiliximab is a drug used to prevent transplant rejection in people who recently had a kidney transplant. Precautions and warnings with basiliximab if you have a history of transplant rejection, talk to your healthcare provider about whether basiliximab is an appropriate medicine for your situation.
The antibody is given intravenously two hours before transplant surgery and 4 days afterwards. Only physicians experienced in immunosuppression therapy and management of organ. Pdf the role of basiliximab induction therapy in organ. Optimizing use of basiliximab in liver transplantation trrm. Highlights of prescribing information who initially. Some of the symptoms of an allergic reaction may include rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, fast heart beat, dizziness or light. Basiliximab belongs to a group of drugs called immunosuppressants. The chimaeric monoclonal antibody basiliximab specifically binds the a subunit of the interleukin2 il2 receptor on activated t lymphocytes. Discard if diluted solution is colored or has particulate matter. The authors report a 42yearold woman who received a dose of basiliximab without adverse reaction before an anticipated renal transplant that was canceled.
It is therefore important that prescribers, pharmacists and patients be aware that substitution of. Product monograph simulect basiliximab ask novartis. 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. Emapalumab, marketed under the trade name gamifant, is an anti interferongamma ifn. An african view jacob olugbenga awobusuyi 1,2, julie m bridson 2, ajay sharma 2,3 and ahmed halawa 2,4 1 department of medicine, lagos state university college. Infliximab and basiliximab for treatment of steroid refractory acute graft versus host disease the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Basiliximab, when used as part of an immunosuppressive regimen that includes a calcineurin inhibitor, is recommended as an initial option to prevent organ rejection in adults having a kidney transplant. It works by slowing down your bodys defense system immune system to prevent your body from rejecting the new kidney after surgery acute rejection. Cimzia should be brought to room temperature before reconstituting. However, in recent years there has been an upward trend in the use of antibody. It is used to prevent rejection in organ transplantation.
The role of induction therapy in renal transplantation. Basiliximab, novartis pharmaceutical corp package insert. Basiliximab, mechanism of action and pharmacological properties. Optimizing use of basiliximab in liver transplantation carlo b ramirez, adam bozdin, adam frank, warren maley, cataldo doriadepartment of surgery, thomas jefferson university, philadelphia, pa, usaabstract. Use of simulect from novartis pharma, pregnancy, lactation in childrens and special precautions for simulect from novartis pharma, prices of simulect from novartis pharma.
Although basiliximab is clearly immunosuppressive, the population in which it is used also. Basiliximab must be given slowly, and the iv infusion can take up to 30 minutes to complete. Simulect basiliximab dosing, indications, interactions. Basiliximab can lower blood cells that help your body fight infections and help your blood clot. Basiliximab is a chimeric antiintcrleukin2 receptor monoclonal antibody. Cimzia is provided in a package that contains everything required to reconstitute and inject the drug see how suppliedstorage and handling 16. Basiliximab definition of basiliximab by medical dictionary. Simulect 10mg and 20mg powder and solvent for solution for. Immunosuppressant pregnancy risk category b fda box warning give under supervision of. This antirejection drug can cause potentially dangerous complications for some people, including those with certain allergies or people taking certain. Insert the syringe needle into the vial through the dosage in adult kidney transplant recipients nulojix should be administered in combination with basiliximab induction, mycophenolate mofetil mmf, and corticosteroids. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Highlights of prescribing information these highlights do not include all the information needed to use promacta safely and effectively. Antibody induction therapy has not been part of standard immunosuppressive regimens in liver transplantation.
Supplement renal transplantation labeling keywords. Renflexis infliximababda is biosimilar to remicade. Simulect from novartis pharma, basiliximab to basiliximab is a chimeric mousehuman monoclonal antibody to the. Use nulojix only in patients who are epsteinbarr virus ebv seropositive. Pdf basiliximab is a chimeric monoclonal antibody that selectively. Indication r nulojix in combination with basiliximab induction, mycophenolate mofetil mmf, and corticosteroids is indicated for prophylaxis of organ rejection in adults. These work by decreasing the activity of the bodys immune system to prevent it from attacking the new kidney. Supplement letter pdf label is not available on this site. Basiliximab is an immunosuppressant drug known as a monoclonal antibody. It is usually given as 2 doses, one before and one after. Use of nulojix for prophylaxis of organ rejection in transplanted organs other than kidney has not been established.
Each vial of simulect contains either 10 mg or 20 mg basiliximab. J0480 is a valid 2020 hcpcs code for injection, basiliximab, 20 mg or just basiliximab for short, used in medical care. Through competitive antagonism of il2, basiliximab supplements standard immunosuppressive therapy after renal transplantation. Basiliximab injection simulect side effects, medical. Basiliximab trade name simulect is a chimeric mousehuman monoclonal antibody to the. This medication is given by injection into a vein by a health care professional. What is the most important information i should know about basiliximab simulect. Prior to tasigna administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies. Basiliximab, mechanism of action and pharmacological. O basiliximab bloqueia a atividade da il2, comportandose como um antagonista da mesma, reduzindo a velocidade e. The dosage of basiliximab is 20 mg iv daily on day 1 and day 4 after transplant. Stepbystep preparation and administration instructions are provided below.
Zortress is indicated for the prophylaxis of organ rejection in adult patients at lowmoderate immunologic risk receiving a kidney transplant see clinical studies 14. Before you receive this medicine, tell your doctor if you have cancer, diabetes, high cholesterol, or high or low levels of potassium in your blood. Safe administration of a humanized murine antibody after. This emedtv segment takes a detailed look at this antirejection drug, with information on how it is given, how it works, safety issues, and more. Basiliximab injection is in a class of medications called immunosuppressants.
Simulect basiliximab is a monoclonal antibody that functions as an immunosuppressive agent. Highlights of prescribing information for intravenous. The actual drug to drug cost of basiliximab is higher compared to atg. Federal usa law restricts this drug to use by or on the order of a licensed veterinarian. J0480 has been in effect since 01012006 hcpcs code details j0480. Basiliximab is a chimeric mousehuman monoclonal antibody which acts as an immunosuppressant by blocking the interleukin2 receptor. The use of basiliximab with tacrolimus is outside the terms of the marketing authorisation. J0480 hcpcs code for injection, basiliximab, 20 mg. As per the package insert, sofosbuvirvelpatasvir was given at least four hours prior to administering a proton pump inhibitor, or simultaneously with or 12 hours apart from an h2receptor. Two weeks later, she received a second dose of basiliximab. The halflife of basiliximab is approximately one week.
This medication guide does not take the place of talking with your doctor about your medical condition. See full prescribing information for complete boxed warning. Simulect, innbasiliximab european medicines agency. Basiliximab maintenance in ulcerative colitis full text. Simulect 10 mg powder and solvent for solution for injection or infusion basiliximab. Zortress is to be administered in combination with basiliximab induction and concurrently with reduced doses of cyclosporine and with corticosteroids.