Simulect (Novartis Pharmaceuticals)

Simulect (Novartis Pharmaceuticals) - General Information

A recombinant chimeric (murine/human) monoclonal antibody (IgG1k) that functions as an immunosuppressive agent, specifically binding to and blocking the interleukin-2 receptor a-chain (IL-2R alpha, also known as CD25 antigen) on the surface of activated T-lymphocytes. It is a 144 kDa glycoprotein obtained from fermentation of an established mouse myeloma cell line genetically engineered to express plasmids containing the human heavy and light chain constant region genes and mouse heavy and light chain variable region genes encoding the RFT5 antibody that binds selectively to the IL-2R alpha.

Pharmacology of Simulect (Novartis Pharmaceuticals)

Simulect functions as an IL-2 receptor antagonist. Specifically it inhibits IL-2-mediated activation of lymphocytes, a critical pathway in the cellular immune response involved in allograft rejection.

Simulect (Novartis Pharmaceuticals) for patients

Simulect (Novartis Pharmaceuticals) Interactions

No dose adjustment is necessary when Simulect^® is added to triple-immunosuppression regimens including cyclosporine, corticosteroids, and either azathioprine or mycophenolate mofetil. Three clinical trials have investigated Simulect^® use in combination with triple-therapy regimens. Pharmacokinetics were assessed in two of these trials. Total body clearance of Simulect^® was reduced by an average 22% and 51% when azathioprine and mycophenolate mofetil, respectively, were added to a regimen consisting of cyclosporine, USP (MODIFIED) and corticosteroids. Nonetheless, the range of individual Simulect^® clearance values in the presence of azathioprine (12-57 mL/h) or mycophenolate mofetil (7-54 mL/h) did not extend outside the range observed with dual therapy (10-78 mL/h). The following medications have been administered in clinical trials with Simulect^® with no increase in adverse reactions: ATG/ALG, azathioprine, corticosteroids, cyclosporine, mycophenolate mofetil, and muromonab-CD3.

Simulect (Novartis Pharmaceuticals) Contraindications

Simulect^® is contraindicated in patients with known hypersensitivity to basiliximab or any other component of the formulation. See composition of Simulect^® under DESCRIPTION.

Additional information about Simulect (Novartis Pharmaceuticals)

Simulect (Novartis Pharmaceuticals) Indication: For prophylactic treatment of kidney transplant rejection
Mechanism Of Action: Simulect binds with high-affinity to the Tac subunit of the high-affinity IL-2 receptor complex and inhibits IL-2 binding. The IL-2 receptor (Tac) subunit is expressed on activated but not resting lymphocytes.
Drug Interactions: Not Available
Food Interactions: Not Available
Generic Name: Basiliximab
Synonyms: Ig gamma-1 chain C region; chimeric mouse-human antiCD25
Drug Category: Immunomodulatory Agents; Immunosuppressive Agents
Drug Type: Biotech; Approved; Investigational

Other Brand Names containing Basiliximab: Simulect (Novartis Pharmaceuticals);
Absorption: Not Available
Toxicity (Overdose): Not Available
Protein Binding: Not Available
Biotransformation: Most likely removed by opsonization via the reticuloendothelial system when bound to lymphocytes, or by human antimurine antibody production
Half Life: 7.2 +/- 3.2 days (adults)
Dosage Forms of Simulect (Novartis Pharmaceuticals): Powder, for solution Intravenous
Chemical IUPAC Name: Chimeric murine/human anti-CD25 antibody
Chemical Formula: C6378H9844N1698O1997S48
Basiliximab on Wikipedia: https://en.wikipedia.org/wiki/Basiliximab
Organisms Affected: Humans and other mammals