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Soliris

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Soliris

INDICATIONS

Paroxysmal Nocturnal Hemoglobinuria (PNH)

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

Atypical Hemolytic Uremic Syndrome (aHUS)

Soliris is indicated for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

Limitation of Use

Soliris is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

DOSAGE AND ADMINISTRATION

Healthcare professionals who prescribe Soliris must enroll in the Soliris REMS [see WARNINGS AND PRECAUTIONS].

Vaccinate patients according to current ACIP guidelines to reduce the risk of serious infection [see WARNINGS AND PRECAUTIONS].

Only administer as an intravenous infusion.

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].

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

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 diluents 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.

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.

HOW SUPPLIED

Dosage Forms And Strengths

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 300mg single – use vials containing 30mL 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 2-8°C (36-46°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 300mg carton: Contains one (1) 30 mL vial of Soliris (10 mg/mL)

Manufactured by Alexion Pharmaceuticals, Inc., 352 Knotter Drive, Cheshire. Revised 04/2014

Last reviewed on RxList: 5/20/2014
This monograph has been modified to include the generic and brand name in many instances.

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