Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.

Patients must be administered a meningococcal vaccine at least two weeks prior to initiation of Soliris therapy and revaccinated according to current medical guidelines for vaccine use. [see WARNINGS and PRECAUTIONS].

Recommended Dosage Regimen

Soliris therapy consists of:

• 600 mg every 7 days for the first 4 weeks, followed by
• 900 mg for the fifth dose 7 days later, then
• 900 mg every 14 days thereafter.

Soliris should be administered at the recommended dosage regimen time points, or within two days of these time points. [see WARNINGS and PRECAUTIONS ]

Preparation for Administration

Soliris must be diluted to a final admixture concentration of 5 mg/mL using the following steps:

• Withdraw the required amount of Soliris from the vial into a sterile syringe.
• Transfer the recommended dose to an infusion bag.
• Dilute Soliris to a final concentration of 5 mg/mL by adding the appropriate amount (equal volume of diluent to drug volume) of 0.9% Sodium Chloride Injection, USP; 0.45% Sodium Chloride Injection, USP; 5% Dextrose in Water Injection, USP; or Ringer's Injection, USP to the infusion bag.

The final admixed Soliris 5 mg/mL infusion volume is 120 mL for 600 mg doses or 180 mL for 900 mg doses. Gently invert the infusion bag containing the diluted Soliris solution to ensure thorough mixing of the product and diluent. Discard any unused portion left in a vial, as the product contains no preservatives.

Prior to administration, the admixture should be allowed to adjust to room temperature [18°-25° C, 64-77° F]. The admixture must not be heated in a microwave or with any heat source other than ambient air temperature. The Soliris admixture should be inspected visually for particulate matter and discoloration prior to administration.

Administration

Do Not Administer As An Intravenous Push Or Bolus Injection

The Soliris admixture should be administered by intravenous infusion over 35 minutes via gravity feed, a syringe-type pump, or an infusion pump. Admixed solutions of Soliris are stable for 24 hours at 2-8° C (36-46° F) and at room temperature.

If an adverse reaction occurs during the administration of Soliris, the infusion may be slowed or stopped at the discretion of the physician. If the infusion is slowed, the total infusion time should not exceed two hours. Monitor the patient for at least one hour following completion of the infusion for signs or symptoms of an infusion reaction.

Dosage Forms and Strength

Soliris is supplied as 300 mg single-use vials each containing 30 mL of 10 mg/mL sterile, preservative-free eculizumab solution.

Storage and Handling

Soliris (eculizumab) is supplied as 300 mg single-use vials containing 30 mL of 10 mg/mL sterile, preservative-free Soliris solution per vial.

Soliris vials must be stored in the original carton until time of use under refrigerated conditions at 2-8º C (36-46º F) and protected from light. Do not use beyond the expiration date stamped on the carton. Refer to Dosage and Administration for information on the stability and storage of diluted solutions of Soliris.

DO NOT FREEZE. DO NOT SHAKE.

NDC 25682-001-01 Single unit 300 mg carton: Contains one (1) 30 mL vial of Soliris (10 mg/mL).

Manufactured by:
Alexion Pharmaceuticals, Inc.
352 Knotter Drive
Cheshire, CT 06410 USA
US License Number 1743
FDA rev date: 3/16/2007

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