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 4).

Preparation of ULTOMIRIS Vials for Intravenous Administration

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

​ULTOMIRIS vials are for intravenous administration by a healthcare provider and are intended for intravenous administration only.

​Dilute before use.

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 IV preparation and minimum infusion duration:

• ​ULTOMIRIS 100 mg/mL (3 mL and 11 mL vials): see Table 5 (loading doses), Table 6 (maintenance doses), and Table 7 (supplemental doses)
• ​ULTOMIRIS 10 mg/mL (30 mL vial): see Table 8 (loading doses), Table 9 (maintenance doses), and Table 10 (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.

Intravenous Administration of ULTOMIRIS (Healthcare Providers)

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 intravenous administration of ULTOMIRIS, the infusion may be slowed or stopped at the discretion of the physician. Monitor the patient for at least 1 hour following completion of the infusion for signs or symptoms of an infusion-related reaction.

Preparation of ULTOMIRIS On-Body Delivery System for Subcutaneous Administration

​ULTOMIRIS on-body delivery system is intended for administration by patients/caregivers. Patients/caregivers may administer after training from a healthcare provider. Refer to the Instructions for Use for detailed instructions on how to use and administer subcutaneous ULTOMIRIS.

1. ​Remove 2 cartons of ULTOMIRIS on-body delivery system for subcutaneous administration from the refrigerator. Two on-body injectors and 2 prefilled cartridges are required for a full dose (490 mg).
2. ​Inspect the packaging. The on-body injectors or cartridges should not be used if they have been dropped or appear to be broken or damaged.
3. ​Wait at least 45 minutes for the on-body injectors and prefilled cartridges in the cartons to naturally reach room temperature prior to administration. Do not return to the refrigerator. Discard after 3 days if unused.
4. ​Before administration, visually inspect the solution. The solution should not be injected if it contains flakes or particles, or is cloudy or discolored.

Subcutaneous Administration of ULTOMIRIS On-Body Delivery System

​ULTOMIRIS on-body delivery system is for subcutaneous administration into the abdomen, thigh, or upper arm region. A patient may self-administer, or the patient caregiver may administer ULTOMIRIS on-body delivery system after the healthcare provider determines it is appropriate. Injection sites should be rotated, and injections should not be given into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks. The 2 on-body delivery systems can be administered concurrently or sequentially. Each injection is delivered over approximately 10 minutes.

1. ​Load the first clean cartridge into the first on-body injector and secure in place before closing the cartridge door on the injector. Do not insert the cartridge more than 5 minutes before the injection to avoid drying out the solution.
2. ​Peel away the adhesive backing of the first on-body injector and apply onto the clean, dry, chosen injection site (thigh, abdomen, or upper arm).
3. ​Start the injection by firmly pressing and releasing the blue start button.
4. ​Do not remove until the injection is complete (signaled by the solid green status light, 3 beeping sounds, and the white plunger filling the medicine window).
5. ​Repeat steps 1-4 for the second on-body injector.

​If an allergic reaction occurs during the subcutaneous administration of ULTOMIRIS, treatment should be stopped, the on-body injector(s) should be removed, and the patient should seek medical attention prior to further administration.

​The patient should monitor for signs or symptoms of infusion-related reaction for at least 1 hour following completion of the injection.

​Any unused medicinal product and waste material should be disposed of in accordance with local requirements.