owing preparation. Refer to theadministration reference tables below for minimum infusion duration. Infusion must
be administered through a 0.22 micron filter.
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.
Administration of ULTOMIRIS
Only administer as an intravenous infusion.
Dilute ULTOMIRIS to a final concentration of 5 mg/mL.
Administer ULTOMIRIS only through a 0.22 micron filter.
Table 2: Loading Dose Administration Reference Table
Body
Weight
Range (kg)a
Loading
Dose (mg)
ULTOMIRIS
Volume (mL)
Volume of
NaCl
Diluentb
(mL)
Total
Volume
(mL)
Maximum
Infusion
Rate
(mL/hr)
greater than
or equal to
40 to less
than 60
2,400 240 240 480 252
greater than
or equal to
60 to less
than 100
2,700 270 270 540 317
greater than
or equal to
100
3,000 300 300 600 333
a Body weight at time of treatment
b Dilute ULTOMIRIS only using 0.9% Sodium Chloride Injection, USP.
Table 3: Maintenance Dose Administration Reference Table
Body
Weight
Range (kg)a
Maintenance
Dose
(mg)
ULTOMIRIS
Volume (mL)
Volume of
NaCl
Diluentb
(mL)
Total
Volume
(mL)
Maximum
Infusion
Rate
(mL/hr)
greater than
or equal to
40 to less
than 60
3,000 300 300 600 257
greater than
or equal to
60 to less
than 100
3,300 330 330 660 330
greater than
or equal to
100
3,600 360 360 720 327
a Body weight at time of treatment b Dilute ULTOMIRIS only using 0.9% Sodium Chloride Injection, USP.
Prior to administration, allow the admixture to adjust to room temperature (18°-25°C,64°-77°F). Do not heat the admixture in a microwave or with any heat source other thanambient air temperature.
Parenteral drug products should be inspected visually for particulate matter anddiscoloration prior to administration, whenever solution and container permit.
If an adverse reaction occurs during the administration of ULTOMIRIS, the infusion maybe slowed or stopped at the discretion of the physician. Monitor the patient for at leastone hour following completion of the infusion for signs or symptoms of an infusionreaction.
3 DOSAGE FORMS AND STRENGTHS
Injection: 300 mg/30 mL (10 mg/mL) as a clear to translucent, slight whitish colorsolution in a single-dose vial.
4 CONTRAINDICATIONS
ULTOMIRIS is contraindicated in patients with unresolved Neisseria meningitidisinfection [see Warnings and Precautions (5.1)].
5 WARNINGS AND PRECAUTIONS
5.1 Serious Meningococcal Infections
Risk and Prevention
Life-threatening meningococcal infections have occurred in patients treated withULTOMIRIS.
The use of ULTOMIRIS increases a patient’s susceptibility to seriousmeningococcal infections (septicemia and/or meningitis). Meningococcal disease due to
any serogroup may occur.
Vaccinate for meningococcal disease according to the most current Advisory Committeeon Immunization Practices (ACIP) recommendations for patients with complement
deficiencies. Revaccinate patients in accordance with ACIP recommendationsconsid
