Ravulizumab (NON-FORMULARY)

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Alternate Name(s):

ULTOMIRIS

Classification:

Complement C5 Inhibitor

Original Date:

August 2025

Indications:

Atypical Hemolytic Uremic Syndrome (aHUS)
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Generalized Myasthenia Gravis (gMG)
Neuromyelitis Optica Spectrum Disorder (NMOSD)

Reconstitution and Stability:

Available as 10 mg/mL (30 mL) and 100 mg/mL (3 mL, 11 mL) single use vials. Store vials in original cartons at 2 – 8°C.
Do not shake. Protect from light.
Ravulizumab 100 mg/mL must be diluted to a final concentration of 50 mg/mL.
Ravulizumab 10 mg/mL must be diluted to a final concentration of 5 mg/mL.
DO NOT MIX CONCENTRATIONS OF RAVULIZUMAB TOGETHER.
All products are preservative-free and therefore are single-use vials.
Once diluted in 0.9% sodium chloride, the dose should be administered immediately. If not used immediately, may be stored under refrigeration (2 - 8°C) for 24 hours (including expected infusion time. Prior to administration, the admixture should be allowed to adjust to room temperature (18 - 25°C) and administered with 4 – 6 hours.
Do not use if solution has discoloration, opaque particles or any foreign material observed.

Compatibility:

Solutions compatible: 0.9% Sodium Chloride
Additives/Above Cassette Compatible: Unknown
Y-Site compatibility: Unknown
Incompatible: DO NOT infuse with any other medication or solution

Administration:

(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)

SC	NO
IM	NO
IV Direct	NO
IV Intermittent Infusion	YES Administer using 0.2-micron low protein being in-line filter. Flush line with 0.9% NaCl after infusion complete. For rates, see dosing charts. Note, rate is based on final concentration AND dose.
IV Continuous Infusion	NO

Dosage:

(For neonatal dosages, refer to Neonatal IV Drug Manual.)

Every 8 weeks Atypical Hemolytic Uremic Syndrome (aHUS)

For 5 mg/mL final concentration infusion:

Body Weight (kg)	Dose Type	Total dose/volume	Maximum Infusion Rate	Minimum Infusion Time	Dosing Interval
≥ 5 to < 10	Loading	600 mg/120 mL	32 mL/hr	3.8 hours
≥ 5 to < 10	Maintenance	300 mg/60 mL	32 mL/hr	1.9 hours	Every 4 weeks
10 to < 20	Loading	600 mg/120 mL	64 mL/hr	1.9 hours
10 to < 20	Maintenance	600 mg/120 mL	64 mL/hr	1.9 hours	Every 4 weeks
20 to < 30	Loading	900 mg/180 mL	120 mL/hr	1.9 hours
20 to < 30	Maintenance	2100 mg/420 mL	128 mL/hr	3.3 hours	Every 8 weeks
30 to < 40	Loading	1200 mg/240 mL	185 mL/hr	1.3 hours
30 to < 40	Maintenance	2700 mg/540 mL	193 mL/hr	2.8 hours	Every 8 weeks
40 to < 60	Loading	2400 mg/480 mL	253 mL/hr	1.9 hours
40 to < 60	Maintenance	3000 mg/600 mL	261 mL/hr	2.3 hours	Every 8 weeks
60 to < 100	Loading	2700 mg/540 mL	318 mL/hr	1.7 hours
60 to < 100	Maintenance	3300 mg/660 mL	330 mL/hr	2 hours	Every 8 weeks
≥ 100	Loading	3000 mg/600 mL	334 mL/hr	1.8 hours
≥ 100	Maintenance	3600 mg/720 mL	328 mL/hr	2.2 hours	Every 8 weeks

For 50 mg/mL final concentration infusion:

Body Weight (kg)	Dose Type	Total dose/volume	Maximum Infusion Rate	Minimum Infusion Time	Dosing Interval
≥ 5 to < 10	Loading	600 mg/12 mL	9 mL/hr	1.4 hours
≥ 5 to < 10	Maintenance	300 mg/6 mL	8 mL/hr	0.8 hours	Every 4 weeks
10 to < 20	Loading	600 mg/12 mL	15 mL/hr	0.8 hours
10 to < 20	Maintenance	600 mg/12 mL	15 mL/hr	0.8 hours	Every 4 weeks
20 to < 30	Loading	900 mg/18 mL	30 mL/hr	0.6 hours
20 to < 30	Maintenance	2100 mg/42 mL	33 mL/hr	1.3 hours	Every 8 weeks
30 to < 40	Loading	1200 mg/24 mL	48 mL/hr	0.5 hours
30 to < 40	Maintenance	2700 mg/54 mL	50 mL/hr	1.1 hours	Every 8 weeks
40 to < 60	Loading	2400 mg/48 mL	60 mL/hr	0.8 hours
40 to < 60	Maintenance	3000 mg/60 mL	67 mL/hr	0.9 hours	Every 8 weeks
60 to < 100	Loading	2700 mg/54 mL	90 mL/hr	0.6 hours
60 to < 100	Maintenance	3300 mg/66 mL	95 mL/hr	0.7 hours	Every 8 weeks
≥ 100	Loading	3000 mg/60 mL	150 mL/hr	0.4 hours
≥ 100	Maintenance	3600 mg/72 mL	144 mL/hr	0.5 hours	Every 8 weeks

*For supplemental doses following plasma exchange (PLEX), plasmapheresis or intravenous immunoglobulin (IVIg) administration, please refer to ULTOMIRIS monograph

Potential hazards of parenteral administration:

Monitor for hypersensitivity reactions, including infusion-related and anaphylactic reactions (hypotension, tachycardia, bradycardia, dyspnea, wheezing, angioedema, rash, nausea, vomiting, diaphoresis).
Ravulizumab increases the risk of meningococcal infections from Neisseria meningitidis. Patients must be vaccinated against meningococcal infections (serotypes A, C, Y, W135, B) prior to starting therapy. If ravulizumab treatment must start less than 2 weeks after receiving a meningococcal vaccine, the patient must also receive treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination date. All patients should be monitored for early signs of meningococcal infection and if infection is suspected they should be treated appropriately immediately.
Ravulizumab should be administered with caution to patients with active system infections.

Notes:

Immunization with live vaccines is not recommended while receiving ravulizumab.
Ravulizumab 10 mg/mL diluted with 0.9% NaCl contains 2.65 g sodium per 720 mL (maximum dose). Ravulizumab 100 mg/mL when diluted with 0.9% NaCl contains 0.18g of sodium per 72 mL (maximum dose).

References:

ULTOMIRIS™ Product Monograph, Alexion Pharma GmbH, October 2023
LexiComp, Ravulizumab

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Ravulizumab (NON-FORMULARY)