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Simulect

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Overview

What is Simulect?

Simulect (basiliximab) is a chimeric (murine/human) monoclonal antibody (IgG ), produced by recombinant DNA technology, that functions as an immunosuppressive agent, specifically binding to and blocking the interleukin-2 receptor α-chain (IL-2Rα, also known as CD25 antigen) on the surface of activated T-lymphocytes. Based on the amino acid sequence, the calculated molecular weight of the protein is 144 kilodaltons. It is a 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-2Rα.

      The active ingredient, basiliximab, is water soluble. The drug product, Simulect, is a sterile lyophilisate which is available in 6 mL colorless glass vials and is available in 10 mg and 20 mg strengths.

      Each 10-mg vial contains 10 mg basiliximab, 3.61 mg monobasic potassium phosphate, 0.50 mg disodium hydrogen phosphate (anhydrous), 0.80 mg sodium chloride, 10 mg sucrose, 40 mg mannitol and 20 mg glycine, to be reconstituted in 2.5 mL of Sterile Water for Injection, USP. No preservatives are added.

      Each 20-mg vial contains 20 mg basiliximab, 7.21 mg monobasic potassium phosphate, 0.99 mg disodium hydrogen phosphate (anhydrous), 1.61 mg sodium chloride, 20 mg sucrose, 80 mg mannitol and 40 mg glycine, to be reconstituted in 5 mL of Sterile Water for Injection, USP. No preservatives are added.



What does Simulect look like?



What are the available doses of Simulect?

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What should I talk to my health care provider before I take Simulect?

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How should I use Simulect?

Simulect (basiliximab) 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 Simulectfor the prophylaxis of acute rejection in recipients of other solid organ allografts has not been demonstrated.

Simulect (basiliximab) is used as part of an immunosuppressive regimen that includes cyclosporine, USP (MODIFIED) and corticosteroids. Simulectis for central or peripheral intravenous administration only. Reconstituted Simulectshould be given either as a bolus injection or diluted to a volume of 25 mL (10-mg vial) or 50 mL (20-mg vial) with normal saline or dextrose 5% and administered as an intravenous infusion over 20 to 30 minutes. Bolus administration may be associated with nausea, vomiting and local reactions, including pain.

      Simulectshould only be administered once it has been determined that the patient will receive the graft and concomitant immunosuppression. Patients previously administered Simulectshould only be re-exposed to a subsequent course of therapy with extreme caution due to the potential risk of hypersensitivity (see WARNINGS).

      Parenteral drug products should be inspected visually for particulate matter and discoloration before administration. After reconstitution, Simulectshould be a clear-to-opalescent, colorless solution. If particulate matter is present or the solution is colored, do not use.      

      Care must be taken to assure sterility of the prepared solution because the drug product does not contain any antimicrobial preservatives or bacteriostatic agents.

      It is recommended that after reconstitution, the solution should be used immediately. If not used immediately, it can be stored at 2ºC to 8ºC for 24 hours or at room temperature for 4 hours. Discard the reconstituted solution if not used within 24 hours.

      No incompatibility between Simulectand polyvinyl chloride bags or infusion sets has been observed. No data are available on the compatibility of Simulectwith other intravenous substances. Other drug substances should not be added or infused simultaneously through the same intravenous line.


What interacts with Simulect?

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What are the warnings of Simulect?

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What are the precautions of Simulect?

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What are the side effects of Simulect?

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What should I look out for while using Simulect?

Simulect (basiliximab)is contraindicated in patients with known hypersensitivity to basiliximab or any other component of the formulation. See composition of Simulectunder DESCRIPTION.

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.


What might happen if I take too much Simulect?

A maximum tolerated dose of Simulect (basiliximab) has not been determined in patients. During the course of clinical studies, Simulecthas been administered to adult renal transplantation patients in single doses of up to 60 mg, or in divided doses over 3-5 days of up to 120 mg, without any associated serious adverse events. There has been one spontaneous report of a pediatric renal transplantation patient who received a single 20-mg dose (2.3 mg/kg) without adverse events.


How should I store and handle Simulect?

Simulect (basiliximab) is supplied in a single-use glass vial. Each carton contains one of the following1 Simulect 10 mg vial…………………………………………………….NDC 0078-0393-61 1 Simulect 20 mg vial…………………………………………………….NDC 0078-0331-84 Store lyophilized Simulectunder refrigerated conditions (2ºC to 8ºC; 36ºF to 46ºF). Do not use beyond the expiration date stamped on the vial.Simulect (basiliximab) is supplied in a single-use glass vial. Each carton contains one of the following1 Simulect 10 mg vial…………………………………………………….NDC 0078-0393-61 1 Simulect 20 mg vial…………………………………………………….NDC 0078-0331-84 Store lyophilized Simulectunder refrigerated conditions (2ºC to 8ºC; 36ºF to 46ºF). Do not use beyond the expiration date stamped on the vial.Simulect (basiliximab) is supplied in a single-use glass vial. Each carton contains one of the following1 Simulect 10 mg vial…………………………………………………….NDC 0078-0393-61 1 Simulect 20 mg vial…………………………………………………….NDC 0078-0331-84 Store lyophilized Simulectunder refrigerated conditions (2ºC to 8ºC; 36ºF to 46ºF). Do not use beyond the expiration date stamped on the vial.Simulect (basiliximab) is supplied in a single-use glass vial. Each carton contains one of the following1 Simulect 10 mg vial…………………………………………………….NDC 0078-0393-61 1 Simulect 20 mg vial…………………………………………………….NDC 0078-0331-84 Store lyophilized Simulectunder refrigerated conditions (2ºC to 8ºC; 36ºF to 46ºF). Do not use beyond the expiration date stamped on the vial.Simulect (basiliximab) is supplied in a single-use glass vial. Each carton contains one of the following1 Simulect 10 mg vial…………………………………………………….NDC 0078-0393-61 1 Simulect 20 mg vial…………………………………………………….NDC 0078-0331-84 Store lyophilized Simulectunder refrigerated conditions (2ºC to 8ºC; 36ºF to 46ºF). Do not use beyond the expiration date stamped on the vial.Simulect (basiliximab) is supplied in a single-use glass vial. Each carton contains one of the following1 Simulect 10 mg vial…………………………………………………….NDC 0078-0393-61 1 Simulect 20 mg vial…………………………………………………….NDC 0078-0331-84 Store lyophilized Simulectunder refrigerated conditions (2ºC to 8ºC; 36ºF to 46ºF). Do not use beyond the expiration date stamped on the vial.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Mechanism of Action

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      While in the circulation, Simulectimpairs the response of the immune system to antigenic challenges. Whether the ability to respond to repeated or ongoing challenges with those antigens returns to normal after Simulectis cleared is unknown (see PRECAUTIONS).

Non-Clinical Toxicology
Simulect (basiliximab)is contraindicated in patients with known hypersensitivity to basiliximab or any other component of the formulation. See composition of Simulectunder DESCRIPTION.

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.

No dose adjustment is necessary when Simulectis added to triple-immunosuppression regimens including cyclosporine, corticosteroids, and either azathioprine or mycophenolate mofetil. Three clinical trials have investigated Simulectuse in combination with triple-therapy regimens. Pharmacokinetics were assessed in two of these trials. Total body clearance of Simulectwas 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 Simulectclearance 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 Simulectwith no increase in adverse reactions: ATG/ALG, azathioprine, corticosteroids, cyclosporine, mycophenolate mofetil, and muromonab-CD3.

It is not known whether Simulect (basiliximab) use will have a long-term effect on the ability of the immune system to respond to antigens first encountered during Simulect-induced immunosuppression.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

      The incidence of adverse events for Simulect (basiliximab) was determined in four randomized, double-blind, placebo-controlled clinical trials for the prevention of renal allograft rejection. Two of the studies (Study 1 and Study 2), used a dual maintenance immunosuppressive regimen comprised of cyclosporine, USP (MODIFIED) and corticosteroids, whereas the other two studies (Study 3 and Study 4) used a triple-immunosuppressive regimen comprised of cyclosporine, USP (MODIFIED), corticosteroids, and either azathioprine or mycophenolate mofetil.

      Simulectdid not appear to add to the background of adverse events seen in organ transplantation patients as a consequence of their underlying disease and the concurrent administration of immunosuppressants and other medications. Adverse events were reported by 96% of the patients in the placebo-treated group and 96% of the patients in the Simulect-treated group. In the four placebo-controlled studies, the pattern of adverse events in 590 patients treated with the recommended dose of Simulectwas similar to that in 594 patients treated with placebo. Simulectdid not increase the incidence of serious adverse events observed compared with placebo.

      The most frequently reported adverse events were gastrointestinal disorders, reported in 69% of Simulect-treated patients and 67% of placebo-treated patients.

      The incidence and types of adverse events were similar in Simulect-treated and placebo-treated patients. The following adverse events occurred in ≥10% of Simulect-treated patients: constipation, nausea, abdominal pain, vomiting, diarrhea, dyspepsia; pain, peripheral edema, fever, viral infection; hyperkalemia, hypokalemia, hyperglycemia, hypercholesterolemia, hypophosphatemia, hyperuricemia; urinary tract infection; dyspnea, upper respiratory tract infection; surgical wound complications, acne; hypertension; headache, tremor; insomnia; anemia.

      The following adverse events, not mentioned above, were reported with an incidence of ≥3% and
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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Tips

Tips

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Interactions

Interactions

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