Soliris Dosage

Generic name: ECULIZUMAB 300mg in 30mL
Dosage form: injection, solution, concentrate
Drug class: Selective immunosuppressants

Medically reviewed by Drugs.com. Last updated on Mar 28, 2024.

Recommended Vaccination and Prophylaxis for Meningococcal Infection

Vaccinate patients against meningococcal infection (serogroups A, C, W, Y and B) according to current ACIP recommendations at least 2 weeks prior to initiation of SOLIRIS [see Warnings and Precautions (5.1)].

If urgent SOLIRIS therapy is indicated in a patient who is not up to date with meningococcal vaccines according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible.

Healthcare providers who prescribe SOLIRIS must enroll in the ULTOMIRIS and SOLIRIS REMS [see Warnings and Precautions (5.2)].

Recommended Dosage Regimen – PNH

For patients 18 years of age and older, 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.

Administer SOLIRIS at the recommended dosage regimen time points, or within two days of these time points [see Warnings and Precautions (5.4)].

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 aHUS Patients Less Than 18 Years of Age
Patient Body Weight	Induction	Maintenance
40 kg and over	900 mg weekly × 4 doses	1200 mg at week 5; then 1200 mg every 2 weeks
30 kg to less than 40 kg	600 mg weekly × 2 doses	900 mg at week 3; then 900 mg every 2 weeks
20 kg to less than 30 kg	600 mg weekly × 2 doses	600 mg at week 3; then 600 mg every 2 weeks
10 kg to less than 20 kg	600 mg weekly × 1 dose	300 mg at week 2; then 300 mg every 2 weeks
5 kg to less than 10 kg	300 mg weekly × 1 dose	300 mg at week 2; then 300 mg every 3 weeks

Administer SOLIRIS at the recommended dosage regimen time points, or within two days of these time points.

Recommended Dosage Regimen – gMG and NMOSD

For adult patients with generalized myasthenia gravis or neuromyelitis optica spectrum disorder, 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.

Administer SOLIRIS at the recommended dosage regimen time points, or within two days of these time points.

Dose Adjustment in Case of Plasmapheresis, Plasma Exchange, or Fresh Frozen Plasma Infusion

For adult and pediatric patients with aHUS, and adult patients with gMG or NMOSD, supplemental dosing of SOLIRIS is required in the setting of concomitant plasmapheresis or plasma exchange, or fresh frozen plasma infusion (PE/PI) (Table 2).

Table 2: Supplemental Dose of SOLIRIS after PE/PI
Type of Plasma Intervention	Most Recent SOLIRIS Dose	Supplemental SOLIRIS Dose with Each Plasma 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
Plasmapheresis or plasma exchange	≥600 mg	600 mg per each plasmapheresis or plasma exchange session
Fresh frozen plasma infusion	≥300 mg	300 mg per infusion of fresh frozen plasma	60 minutes prior to each infusion of fresh frozen plasma

Preparation

Dilute SOLIRIS 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.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Administration

Only administer as an intravenous infusion.

Do not administer as an intravenous push or bolus injection.

Administer the SOLIRIS admixture 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 h 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-related reaction.