Abbreviated Prescribing Information
Soliris (Eculizumab)

Presentation: 300mg/30mL concentrate for solution for infusion. Indications: Treatment of paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS). Dosage: (Adult PNH) initial phase: 600 mg/wk for 4 wks, followed by maintenance phase: 900 mg in wk 5, then every 14 +/- 2 days thereafter; (Adult aHUS) initial phase: 900 mg/wk for 4 wks, followed by maintenance phase: 1200 mg in wk 5, then every 14 days +/- 2 days thereafter; (Paediatric PNH/aHUS; < 18 yrs of age) initial phase: 600 mg/wk for 2 wks (20 to < 40 kg), 600 mg in wk 1 (10 to < 20 kg), 300 mg in wk 1 (5 to < 10 kg), then followed by maintenance phase: 900 mg in wk 3 and every 2 wks after (30 to < 40 kg), 600 mg in wk 3 and every 2 wks after (20 to < 30 kg), 300 mg in wk 2 and every 2 wks thereafter (10 to < 20 kg), 300 mg in wk 2 and every 3 wks after (5 to < 10 kg), paediatric patients with body weight ≥ 40 kg follow adult dosage. No dosage adjustment required for patients with renal impairment. For aHUS, supplemental dosing of SOLIRIS is required in the setting of concomitant PE/PI (see PI). Administration: reconstitute to 5 mg/mL with 0.9%, 0.45% Sodium Chloride Solution for Injection or 5% Dextrose in Water; administer SOLIRIS by IV infusion over 25-45 min (35 ± 10 min) in adults; administer SOLIRIS over 1-4 hours in pediatric patients via gravity feed, a syringe-type pump, or an infusion pump. Monitor for 1 hour following infusion. Contraindications: hypersensitivity to eculizumab, murine protein or to any excipients; unresolved Neisseria meningitidis infection; unvaccinated against Neisseria meningitidis unless receiving prophylactic treatment with appropriate antibiotics until 2 wks after vaccination. Precautions: Meningococcal Infection/Immunisation- vaccinate all patients at least 2 wks prior to treatment with SOLIRIS; if patient is treated < 2 wks, admin prophylactic antibiotics for 2 wks after tetravalent meningococcal vaccination; maintain immunisation currency (esp < 18 yrs of age against Haemophilus influenza, pneumococcal infection); admin with caution with active systemic infections; monitor for early signs of meningococcal infection, including fever, headache with fever +/- stiff neck, light sensitivity. Laboratory Monitoring: (PNH) monitor for intravascular haemolysis; (aHUS) monitor for thrombotic microangiopathy. Discontinuation: (PNH) closely monitor patients for at least 8 wks to detect serious haemolysis and other reactions. (aHUS) closely monitor patients for severe TMA complications. Use in Pregnancy/Lactation: Women should use effective contraception during treatment with SOLIRIS, and for at least 5 months after the last dose of treatment; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for eculizumab and any potential adverse effects on the breastfed child from eculizumab or from the underlying maternal condition. Adverse Reactions: Very common (≥10%): headache; Common (≥1% to <10%): pneumonia, nasopharyngitis, leukopenia, anaemia, insomnia, dizziness, dysgeusia, cough, diarrhoea, rash, myalgia, fatigue, etc. Full local prescribing information is available upon request. API.HK.SOL.0321 ​

HK-11564  03/2025