Anemias:

Indications for ULTOMIRIS:

Treatment of paroxysmal nocturnal hemoglobinuria (PNH).

Adult:

Give by IV infusion; monitor for ≥1hr after completion. Dosing regimen: give initial loading dose (LD), followed by maintenance doses (MD) 2 weeks later at a once every 8-week interval. ≥18yrs (≥40–<60kg): LD: 2400mg; MD: 3000mg; (≥60–<100kg): LD: 2700mg; MD: 3300mg; (≥100kg): LD: 3000mg; MD: 3600mg. Switching from eculizumab: see full labeling.

Children:

<18yrs: not established.

Contraindications:

Unresolved Neisseria meningitidis infections.

Boxed Warning:

Serious meningococcal infections.

Warnings/Precautions:

Increased risk of serious meningococcal infections (septicemia and/or meningitis). Vaccinate or revaccinate for meningococcal disease according to ACIP guidelines. Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to treatment. Monitor closely for signs of meningococcal infection; evaluate immediately if infection is suspected. Discontinue ravulizumab if undergoing treatment for meningococcal infection. Risk of other infections (eg, due to N. species [including gonococcal infections], S. pneumoniae, H. influenza); monitor closely for signs of worsening infection. Risk of hemolysis and other reactions (eg, thrombosis) after treatment discontinuation; monitor closely for at least 16 weeks. Pregnancy. Nursing mothers: not recommended (during and for 8 months after last dose).

Pharmacologic Class:

Complement inhibitor.

Adverse Reactions:

Upper RTI, headache, diarrhea, nausea, pyrexia, abdominal pain, pain in extremity, arthralgia, dizziness; meningococcal infection (may be fatal), infusion reactions.

REMS:

YES

Generic Availability:

NO

How Supplied:

Single-dose vial (30mL)—1