Alexion Pharmaceuticals Inc.

Alexion Pharmaceuticals Inc. Drugs

• Soliris
  

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  Soliris

  

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  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.

  2.4 Administration

  Do Not Administer As An Intravenous Push or Bolus Injection

  The Soliris admixture should be administered by intravenous infusion over 35 minutes in adults and 1 to 4 hours in pediatric patients 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 in adults.  Monitor the patient for at least one hour following completion of the infusion for signs or symptoms of an infusion reaction.

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