Section 07 · Monograph

Ravulizumab

Reviewed Nov 2026FDA label

UltomirisComplement C5 inhibitor

Black Box Warning

Life-threatening and fatal meningococcal (Neisseria meningitidis) infections have occurred, including in vaccinated patients
Complement inhibition increases susceptibility to invasive meningococcal disease of any serogroup, including non-groupable strains
Patients must receive meningococcal vaccination(s) against serogroups A, C, W, Y and B at least 2 weeks prior to first dose unless the risk of delaying therapy outweighs the risk of infection, in which case antibiotic prophylaxis and vaccination should be given as soon as possible
Vaccination reduces but does not eliminate risk; monitor patients for early signs of meningococcal infection
Available only through the ULTOMIRIS and SOLIRIS REMS restricted program

Generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positiveFDA-labeled
Paroxysmal nocturnal hemoglobinuria (PNH) in adults and children ≥1 month oldFDA-labeled
Atypical hemolytic uremic syndrome (aHUS) in adults and children ≥1 month oldFDA-labeled
Neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positiveFDA-labeled

Humanized IgG2/4 kappa monoclonal antibody that binds with high affinity to complement protein C5
Inhibits cleavage of C5 into C5a (anaphylatoxin) and C5b, preventing generation of the terminal complement complex C5b-9 (membrane attack complex)
In gMG, reduction of complement-mediated C5b-9 deposition at the postsynaptic neuromuscular junction is believed to decrease AChR degradation and preserve neuromuscular transmission
Engineered with modified Fc and C5-binding domains for pH-dependent recycling via the neonatal Fc receptor, extending serum half-life and enabling every-8-week dosing
Does not affect proximal complement components (C3, C3b), preserving opsonization function

Weight-based two-step regimen: IV loading dose on day 1, followed by first maintenance dose 2 weeks later, then maintenance dosing every 8 weeks thereafter
Loading dose ranges from 2,400 mg (40–<60 kg) up to 3,000 mg (≥100 kg); maintenance dose ranges from 3,000 mg up to 3,600 mg
Administered as an IV infusion through a 0.2 or 0.22 micron in-line filter
If a scheduled dose is missed, administer as soon as possible without waiting until the next scheduled dose
Supplemental dosing required after plasma exchange, plasmapheresis, or IVIG given concurrently
Long-acting formulation allows 8-week maintenance dosing interval versus every-2-weeks for eculizumab

Patients with unresolved serious Neisseria meningitidis infection
Patients not currently vaccinated against meningococcus unless treated with prophylactic antibiotics until 2 weeks post-vaccination

Concomitant plasma exchange, plasmapheresis, or fresh frozen plasma infusion transiently lowers serum levels — requires supplemental dosing
Concomitant IVIG may interfere with Fc-receptor-mediated recycling, reducing exposure — requires supplemental dosing
FcRn antagonists (efgartigimod, rozanolixizumab) may reduce ravulizumab serum concentrations and effectiveness through accelerated IgG clearance
Live or live-attenuated vaccines should be administered prior to ravulizumab when possible

Confirm up-to-date meningococcal vaccination (serogroups A, C, W, Y, B) at least 2 weeks before initiation
REMS enrollment for prescriber and pharmacy; patient carries Patient Safety Card for 8 months after discontinuation
Monitor closely for early signs/symptoms of meningococcal infection at every visit
Assess for other encapsulated bacterial infections and immunize against S. pneumoniae and H. influenzae per ACIP guidance
Clinical response monitoring: MG-ADL and QMG scores
Monitor for infusion reactions during and after administration

No adequate human data on use in pregnancy; ravulizumab crosses the placenta (IgG)
Animal reproduction studies with similar C5 inhibitors showed embryofetal toxicity at exposures relevant to clinical use
Meningococcal infection risk in a pregnant patient could have serious consequences for both mother and fetus — vaccination status should be optimized before conception if possible
No data on presence in human milk; a pregnancy exposure registry is available
Breastfeeding infants should be monitored for infection given potential immunoglobulin transfer