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.

Simulect^® is used as part of an immunosuppressive regimen that includes cyclosporine, USP (MODIFIED) and corticosteroids. Simulect^® is for central or peripheral intravenous administration only. Reconstituted Simulect^® should 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.

Simulect^® should only be administered once it has been determined that the patient will receive the graft and concomitant immunosuppression. Patients previously administered Simulect^®should only be re-exposed to a subsequent course of therapy with extreme caution.

Parenteral drug products should be inspected visually for particulate matter and discoloration before administration. After reconstitution, Simulect^® should 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 Simulect^® and polyvinyl chloride bags or infusion sets has been observed. No data are available on the compatibility of Simulect^® with other intravenous substances. Other drug substances should not be added or infused simultaneously through the same intravenous line.

In adult patients, the recommended regimen is two doses of 20 mg each. The first 20-mg dose should be given within 2 hours prior to transplantation surgery. The recommended second 20-mg dose should be given 4 days after transplantation. The second dose should be withheld if complications such as severe hypersensitivity reactions to Simulect^®or graft loss occur.

In pediatric patients weighing less than 35 kg, the recommended regimen is two doses of 10 mg each. In pediatric patients weighing 35 kg or more, the recommended regimen is two doses of 20 mg each. The first dose should be given within 2 hours prior to transplantation surgery. The recommended second dose should be given 4 days after transplantation. The second dose should be withheld if complications such as severe hypersensitivity reactions to Simulect^®or graft loss occur.

Reconstitution of 10 mg Simulect^® Vial

To prepare the reconstituted solution, add 2.5 mL of Sterile Water for Injection, USP, using aseptic technique, to the vial containing the Simulect^® powder. Shake the vial gently to dissolve the powder.

The reconstituted solution is isotonic and may be given either as a bolus injection or diluted to a volume of 25 mL with normal saline or dextrose 5% for infusion. When mixing the solution, gently invert the bag in order to avoid foaming; DO NOT SHAKE.

Reconstitution of 20 mg Simulect^® Vial

To prepare the reconstituted solution, add 5 mL of Sterile Water for Injection, USP, using aseptic technique, to the vial containing the Simulect^® powder. Shake the vial gently to dissolve the powder.

The reconstituted solution is isotonic and may be given either as a bolus injection or diluted to a volume of 50 mL with normal saline or dextrose 5% for infusion. When mixing the solution, gently invert the bag in order to avoid foaming; DO NOT SHAKE.

Simulect^® (basiliximab) is supplied in a single-use glass vial.

Each carton contains one of the following

1 Simulect^® 10 mg vial.......................................................................NDC 0078-0393-61

1 Simulect^® 20 mg vial..........................................................................NDC 0078-0331-84

Store lyophilized Simulect^® under refrigerated conditions (2ºC to 8ºC; 36ºF to 46ºF).

Do not use beyond the expiration date stamped on the vial.

Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, ©Novartis

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