Ultomiris Dosage

​Switch from Eculizumab to ULTOMIRIS

​For patients switching from eculizumab to ULTOMIRIS, administer the loading dose of ULTOMIRIS 2 weeks after the last eculizumab maintenance infusion (or 1 week after the last eculizumab induction infusion), and then administer ULTOMIRIS maintenance doses once every 4 weeks or every 8 weeks depending on body weight, as shown in Table 1), starting 2 weeks after loading dose administration.

​Supplemental Dose of ULTOMIRIS

​Plasma exchange (PE), plasmapheresis (PP), and intravenous immunoglobulin (IVIg) have been shown to reduce ULTOMIRIS serum levels. A supplemental dose of ULTOMIRIS is required in the setting of PE, PP, or IVIg (Table 2).

Preparation of ULTOMIRIS

​Dilute before use.

Each vial of ULTOMIRIS is intended for single-dose only.

Do not mix ULTOMIRIS 100 mg/mL (3 mL and 11 mL vials) and 10 mg/mL (30 mL vial) concentrations together.

Use aseptic technique to prepare ULTOMIRIS as follows:

1.

The number of vials to be diluted is determined based on the individual patient's weight and the prescribed dose [see Dosage and Administration (2.2)].

2.

Prior to dilution, visually inspect the solution in the vials; the solution should be free of any particulate matter or precipitation. Do not use if there is evidence of particulate matter or precipitation.

3.

Withdraw the calculated volume of ULTOMIRIS from the appropriate number of vials and dilute in an infusion bag using 0.9% Sodium Chloride Injection, USP to a final concentration of:

• 50 mg/mL for the 3 mL and 11 mL vial sizes or
• 5 mg/mL for the 30 mL vial size.

The product should be mixed gently. Do not shake. Protect from light. Do not freeze.

​Refer to the following reference tables for preparation and minimum infusion duration:

• ​ULTOMIRIS 100 mg/mL (3 mL and 11 mL vials): see Table 3 (loading doses), Table 4 (maintenance doses), and Table 5 (supplemental doses)
• ​ULTOMIRIS 10 mg/mL (30 mL vial): see Table 6 (loading doses),Table 7 (maintenance doses), and Table 8 (supplemental doses)

4.

​Administer the prepared solution immediately following preparation.

5.

​If the diluted ULTOMIRIS infusion solution is not used immediately, storage under refrigeration at 2°C - 8°C (36°F - 46°F) must not exceed 24 hours taking into account the expected infusion time. Once removed from refrigeration, administer the diluted ULTOMIRIS infusion solution within 6 hours if prepared with ULTOMIRIS 30 mL vials or within 4 hours if prepared with ULTOMIRIS 3 mL or 11 mL vials.

​Administration of ULTOMIRIS

​Only administer as an intravenous infusion through a 0.2 or 0.22 micron filter.

Dilute ULTOMIRIS to a final concentration of:

• 50 mg/mL for the 3 mL and 11 mL vial sizes or
• 5 mg/mL for the 30 mL vial size.

Prior to administration, allow the admixture to adjust to room temperature (18°C - 25°C, 64°F - 77°F). Do not heat the admixture 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.

If an adverse reaction occurs during the administration of ULTOMIRIS, the infusion may be slowed or stopped at the discretion of the physician. Monitor the patient for at least one hour following completion of the infusion for signs or symptoms of an infusion-related reaction.