Soliris® Is a Chronic Therapy for a Chronic Disease1-3
Patients receiving Soliris must be vaccinated against Neisseria meningitidis1
- A meningococcal vaccination must be administered to all patients at least 2 weeks
prior to the first dose of Soliris1
- Fixed dose on time is critical to control chronic hemolysis; for breakthrough hemolysis,
dosing may be adjusted to every 12 days instead of 14 1,2
- In clinical trials, Soliris protected PNH RBCs from chronic hemolysis for as long
as therapy was continued2,3
- Soliris is intended to be a chronic therapy3
- Soliris should be administered every 7 days during the induction phase1
- Soliris should be administered every 14 days (or within ±2 days) during the maintenance
phase1
- No dosing adjustments recommended based on age, gender, race, renal insufficiency,
or hepatic disease1
- Infusions are typically completed within 35 minutes1
- Patients who discontinue Soliris should be monitored for at least 8 weeks1
- In clinical studies of 196 patients, 16 patients discontinued treatment with Soliris
and serious hemolysis was not observed4
Administration via 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 diluted solution is a clear, colorless liquid and should be practically free
of any particles
DO NOT ADMINISTER AS AN IV PUSH OR BOLUS INJECTION.
- If diluted solution is refrigerated, warm to room temperature (18°C-25°C [64°F-77°F])
only by exposure to ambient air. The admixture must not be heated in a microwave
or with any heat source
- Administer as an IV infusion over 35 minutes via gravity feed, a syringe-type pump,
or an infusion pump
- It is not necessary to protect diluted solution from light during administration
No infusion-related reactions
- No difference was observed between Soliris- and placebo-treated patients in immune
system disorders within 48 hours of administration 2
- No discontinuations due to infusion reactions occurred 2
Antibodies rarely develop
- Low titers of antibodies against Soliris rarely developed during 6 months of treatment
1,2
- No correlation of antibody development to clinical response was observed 1