Anemias:
Indications for: ULTOMIRIS
Paroxysmal nocturnal hemoglobinuria (PNH). Atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).
Limitations of Use:
Not for treating Shiga toxin E. coli-related HUS.
Adults and Children:
<1month: not established. IV infusion may be given for loading dose (LD) and maintenance dose (MD) in adult and pediatric patients; monitor for ≥1hr after completion. Give initial IV LD, followed by IV MD 2 weeks later. For IV regimen: ≥1month (5–<10kg): LD: 600mg; MD: 300mg every 4wks; (10–<20kg): LD: 600mg; MD: 600mg every 4wks; (20–<30kg): LD: 900mg; MD: 2100mg every 8wks; (30–<40kg): LD: 1200mg; MD: 2700mg every 8wks; (40–<60kg): LD: 2400mg; MD: 3000mg every 8wks; (60–<100kg): LD: 2700mg; MD: 3300mg every 8wks; (≥100kg): LD: 3000mg; MD: 3600mg every 8wks. SC inj (via on-body injector) may be given for MD only in adults. Inject SC into the abdomen, thigh, or upper arm; rotate inj sites and avoid areas with scars or stretch marks. For SC MD: adults (≥40kg): 490mg once weekly. Treatment initiation instructions, other dosing considerations: see full labeling.
ULTOMIRIS Contraindications:
Unresolved Neisseria meningitidis infections. Individuals not vaccinated against Neisseria meningitidis, unless the risks of delaying ravulizumab therapy outweigh the risks of developing a meningococcal infection.
Boxed Warning:
Serious meningococcal infections.
ULTOMIRIS 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. Give 2 weeks of antibacterial prophylaxis if ravulizumab must be initiated immediately and vaccines administered <2 weeks before starting therapy. 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. PNH: risk of hemolysis and other reactions (eg, thrombosis) after treatment discontinuation; monitor closely for at least 16 weeks; if hemolysis (eg, elevated LDH) occurs, consider restarting ravulizumab. aHUS: risk of TMA complications after treatment discontinuation; monitor for at least 12 months; if TMA occurs, consider reinitiating ravulizumab or organ-specific supportive measures. On-body injector (uses acrylic adhesive); consider premedication in those with known allergy. Pregnancy. Nursing mothers: not recommended (during and for 8 months after last dose).
ULTOMIRIS Classification:
Complement inhibitor.
ULTOMIRIS Interactions:
Administration of PE/PI (plasmapheresis or plasma exchange, or fresh frozen plasma) may reduce ravulizumab serum levels.
Adverse Reactions:
Upper RTI, headache, diarrhea, nausea, vomiting, headache, hypertension, pyrexia; meningococcal infection (may be fatal), infusion-related reactions (interrupt infusion if cardiovascular instability or respiratory compromise occur; manage appropriately).
Note:
Available only through a restricted Ultomiris REMS program. To enroll or for more information call (888) 765-4747.
REMS:
Generic Drug Availability:
NO
How Supplied:
Single-dose vial (300mg/3mL, 1100mg/11mL, 300mg/30mL)—1; Single-dose cartridge (245mg/3.5mL)—1 (with on-body injector)
Myasthenia gravis:
Indications for: ULTOMIRIS
Generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive.
Adult Dosage:
Give by IV infusion only; monitor for ≥1hr after completion. Give initial loading dose (LD), followed by maintenance doses (MD) 2 weeks later. 40–<60kg: LD: 2400mg; MD: 3000mg every 8wks; 60–<100kg: LD: 2700mg; MD: 3300mg every 8wks; ≥100kg: LD: 3000mg; MD: 3600mg every 8wks. Treatment initiation instructions, other dosing considerations: see full labeling.
Children Dosage:
Not established.
ULTOMIRIS Contraindications:
Unresolved Neisseria meningitidis infections. Individuals not vaccinated against Neisseria meningitidis, unless the risks of delaying ravulizumab therapy outweigh the risks of developing a meningococcal infection.
Boxed Warning:
Serious meningococcal infections.
ULTOMIRIS 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. Give 2 weeks of antibacterial prophylaxis if ravulizumab must be initiated immediately and vaccines administered <2 weeks before starting therapy. 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. PNH: risk of hemolysis and other reactions (eg, thrombosis) after treatment discontinuation; monitor closely for at least 16 weeks; if hemolysis (eg, elevated LDH) occurs, consider restarting ravulizumab. aHUS: risk of TMA complications after treatment discontinuation; monitor for at least 12 months; if TMA occurs, consider reinitiating ravulizumab or organ-specific supportive measures. On-body injector (uses acrylic adhesive); consider premedication in those with known allergy. Pregnancy. Nursing mothers: not recommended (during and for 8 months after last dose).
ULTOMIRIS Classification:
Complement inhibitor.
ULTOMIRIS Interactions:
Administration of PE/PI (plasmapheresis or plasma exchange, or fresh frozen plasma) may reduce ravulizumab serum levels.
Adverse Reactions:
Upper RTI, diarrhea; meningococcal infection (may be fatal), infusion-related reactions (interrupt infusion if cardiovascular instability or respiratory compromise occur; manage appropriately).
Note:
Available only through a restricted Ultomiris REMS program. To enroll or for more information call (888) 765-4747.
REMS:
Generic Drug Availability:
NO
How Supplied:
Single-dose vial (300mg/3mL, 1100mg/11mL, 300mg/30mL)—1; Single-dose cartridge (245mg/3.5mL)—1 (with on-body injector)
