Soliris is a chronic therapy for a chronic disease1,2
|Soliris PNH dosing schedule1|
|Pretreatment||Induction phase||Maintenance phase|
|≥ 2 weeks before induction||Week||1||2||3||4||5||6||7||8||9||
|Neisseria meningitidis vaccination||Soliris dose||600 mg||600 mg||600 mg||600 mg||900 mg||X||900 mg||X||900 mg|
Dose within ±2 days.
Please click here for aHUS dosing and administration.
A meningococcal vaccination must be administered to all patients at least 2 weeks prior to the first dose of Soliris1
No dosing adjustments recommended based on age, gender, race, renal insufficiency, or hepatic disease1
Infusions are administered over 35 minutes in adults; premedications are not routinely required1
Patients who discontinue Soliris should be monitored for at least 8 weeks to detect hemolysis1
Only administer as an intravenous infusion
Soliris is supplied as a 300-mg, single-use vial
Soliris should be administered as an IV infusion and must be diluted to a final concentration of 5 mg/mL prior to administration.
The final admixed Soliris 5 mg/mL infusion volume is 120 mL for 600-mg doses or 180 mL for 900-mg doses
The Soliris admixture should be inspected visually for particulate matter and discoloration prior to administration
DO NOT ADMINISTER AS AN IV PUSH OR BOLUS INJECTION.
Prior to administration, the admixture should be allowed to adjust to room temperature (18°C-25°C [64°F-77°F])
Administer as an IV infusion during 35 minutes via gravity feed, a syringe-type pump, or an infusion pump
As with all proteins, administration of Soliris may result in infusion reaction, including anaphylaxis or other hypersensitivty reactions
In clinical trials, no patients experienced an infusion reaction which required discontinuation
Interrupt Soliris infusion and institute appropriate supportive measures if signs of cardiovasular instability or respiratory compromise occur
Monitor patients after discontinuing Soliris for at least 8 weeks to detect hemolysis1
How Supplied, Storage, and Distribution1
Vial–30 mL, liquid
Product strength–10 mg/mL
Product count–300 mg/30 mL (vial)
Product physical specs–1 vial per carton
Shipped just in time for infusion
Weight: <1 lb
Dimensions: 1.625" x 1.625" x 3.125"
Must be stored in the original carton until time of use under conditions at 2°C-8°C (36°F-46°F)
Protect from light
DO NOT FREEZE; DO NOT SHAKE
Do not infuse beyond the expiration date stamped on the carton
NDC 25682-001-01 : Each single-unit carton contains one 30-mL vial of Soliris (10 mg/mL)