Alexion Pharmaceuticals Inc.
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Alexion Pharmaceuticals Inc. Drugs
Healthcare professionals who prescribe Soliris must enroll in the Soliris REMS. [see Warnings and Precautions (5.2)].
Vaccinate patients according to current ACIP guidelines to reduce the risk of serious infection. [see Warnings and Precautions (5.1) and (5.2)].
Only administer as an intravenous infusion.
2.1 Recommended Dosage Regimen - PNH
Soliris therapy consists of:600 mg weekly for the first 4 weeks, followed by 900 mg for the fifth dose 1 week later, then 900 mg every 2 weeks thereafter.
Soliris should be administered at the recommended dosage regimen time points, or within two days of these time points [see Warnings and Precautions (5.6)].
2.2 Recommended Dosage Regimen - aHUS
For patients 18 years of age and older, Soliris therapy consists of:900 mg weekly for the first 4 weeks, followed by 1200 mg for the fifth dose 1 week later, then 1200 mg every 2 weeks thereafter.
For patients less than 18 years of age, administer Soliris based upon body weight, according to the following schedule (Table 1):Table 1: Dosing recommendations in patients less than 18 years of age Patient Body Weight Induction Maintenance 40 kg and over 900 mg weekly x 4 doses 1200 mg at week 5;then 1200 mg every 2 weeks 30 kg to less than 40 kg 600 mg weekly x 2 doses 900 mg at week 3;then 900 mg every 2 weeks 20 kg to less than 30 kg 600 mg weekly x 2 doses 600 mg at week 3;then 600 mg every 2 weeks 10 kg to less than 20 kg 600 mg weekly x 1 dose 300 mg at week 2;then 300 mg every 2 weeks 5 kg to less than 10 kg 300 mg weekly x 1 dose 300 mg at week 2;then 300 mg every 3 weeks
Soliris should be administered at the recommended dosage regimen time points, or within two days of these time points.
Supplemental dosing of Soliris is required in the setting of concomitant support with PE/PI (plasmapheresis or plasma exchange; or fresh frozen plasma infusion) (Table 2).Table 2: Supplemental dose of Soliris after PE/PI Type of Intervention Most Recent Soliris Dose Supplemental Soliris Dose With Each PE/PI Intervention Timing of Supplemental Soliris Dose Plasmapheresis or plasma exchange 300 mg 300 mg per each plasmapheresis or plasma exchange session Within 60 minutes after each plasmapheresis or plasma exchange 600 mg or more 600 mg per each plasmapheresis or plasma exchange session Fresh frozen plasma infusion 300 mg or more 300 mg per infusion of fresh frozen plasma 60 minutes prior to each infusion of fresh frozen plasma
2.3 Preparation and 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 60 mL for 300 mg doses, 120 mL for 600 mg doses, 180 mL for 900 mg doses or 240 mL for 1200 mg doses (Table 3).Table 3: Preparation and Reconstitution of Soliris Soliris Dose Diluent Volume Final Volume 300 mg 30 mL 60 mL 600 mg 60 mL 120 mL 900 mg 90 mL 180 mL 1200 mg 120 mL 240 mL
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.
Do Not Administer As An Intravenous Push or Bolus Injection
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