Abbreviated Prescribing Information
Ultomiris (Ravulizumab)

Presentation: 300mg/3mL and 1,100mg/11mL concentrate for solution for infusion. Indications: 1) Adult and pediatric patients with a body weight of 10 kg or above with paroxysmal nocturnal haemoglobinuria (PNH). 2) Adult and pediatric patients with a body weight of 10kg or above with atypical haemolytic uremic syndrome (aHUS). 3) Adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody- positive. 4) Adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin 4 (AQP4) antibody-positive Dosage: (Adult PNH, aHUS, gMG & NMOSD, Pediatric PNH & aHUS with body weight ≥40kg) loading dose (IV infusion): 2,400mg (≥40 to <60kg) / 2,700mg (≥60 to <100kg) / 3,000mg (≥100kg), followed by maintenance dose (IV infusion): 3,000mg (≥40 to <60kg) / 3,300mg (≥60 to <100kg) / 3,600mg (≥100kg) starting 2 wks after loading dose administration and then every 8 wks. (Paediatric PNH & aHUS with body weight <40kg) loading dose (IV infusion): 600mg (≥10 to <20kg) / 900mg (≥20 to <30kg) / 1,200mg (≥30 to <40kg), followed by maintenance dose (IV infusion): 600mg (≥10 to <20kg) / 2,100mg (≥20 to <30kg) / 2,700mg (≥30 to <40kg) starting 2 wks after loading dose administration and then every 4 (≥10 to <20kg) / 8 (≥20 to <40kg) wks. Switching from eculizumab to ravulizumab: Loading dose of ravulizumab administered at the time of next scheduled eculizumab dose, and then maintenance doses administered per regimen above, starting 2 wks after loading dose administration. Administration: Diluted to a final concentration of 50 mg/mL prior to administration by IV infusion using a syringe-type pump or an infusion pump over a minimal period of 25 to 75 minutes depending on body weight. Contraindications: hypersensitivity to ravulizumab or any excipients; unresolved Neisseria meningitidis infection; unvaccinated against Neisseria meningitidis unless receiving prophylactic antibiotics until 2 wks after vaccination. Precautions: Meningococcal Infection/Immunisation - Vaccinate all patients at least 2 wks prior to initiating ravulizumab. If initiate <2 wks, administer prophylactic antibiotics until 2 wks after vaccination. Patients <18 yrs of age must be vaccinated against Haemophilus influenza and pneumococcal infection. Discontinuation: (PNH) Closely monitor patients for at least 16 wks to detect haemolysis and other reactions. (aHUS) Closely monitor patients for severe TMA complications. (gMG) Monitor symptoms of gMG. (NMOSD) Monitor symptoms of NMOSD relapse. Use in Pregnancy/Lactation: Women of childbearing potential should use effective contraception during treatment with ravulizumab, and for up to 8 months after treatment; breastfeeding should be discontinued during treatment, and up to 8 months after treatment. Adverse Reactions: Very common (≥10%): upper respiratory tract infection, nasopharyngitis, headache, diarrhea, nausea, abdominal pain, arthralgia, back pain, pyrexia, fatigue. Common (≥1% to <10%): urinary tract infection, hypersensitivity, dizziness, vomiting, dyspepsia, urticaria, rash, pruritus, myalgia, muscle spasms, influenza-like illness, chills, asthenia, infusion related reaction. Full local prescribing information is available upon request. API.HK.ULT.0325

HK-11525  03/2025