Soliris

Adults & childn w/ paroxysmal nocturnal haemoglobinuria (PNH); atypical haemolytic uremic syndrome (aHUS). Refractory generalized myasthenia gravis (gMG) in patients ≥6 yr who are anti-acetylcholine receptor (AChR) Ab +ve. Neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 Ab +ve.

IV Adult ≥18 yr & paed ≥40 kg PNH Initial phase: 600 mg via 25-45 min infusion every wk for 1st 4 wk. Maintenance phase: 900 mg via 25-45 min infusion for 5th wk followed by 900 mg via 25-45 min infusion every 14±2 days. aHUS & refractory gMG Initial phase: 900 mg via 25-45 min infusion every wk for 1st 4 wk. Maintenance phase: 1,200 mg via 25-45 min infusion for 5th wk followed by 1,200 mg via 25-45 min infusion every 14±2 days. Adult ≥18 yr NMOSD Initial phase: 900 mg via 25-45 min infusion every wk for 1st 4 wk. Maintenance phase: 1,200 mg via 25-45 min infusion for 5th wk followed by 1,200 mg via 25-45 min infusion every 14±2 days. PNH, aHUS, refractory gMG Paed 30 to <40 kg Initial phase: 600 mg wkly for 1st 2 wk. Maintenance phase: 900 mg at wk 3 then every 2 wk, 20 to <30 kg Initial phase: 600 mg wkly for 1st 2 wk. Maintenance phase: 600 mg at wk 3 then every 2 wk, 10 to <20 kg Initial phase: 600 mg wkly at wk 1. Maintenance phase: 300 mg at wk 2 then every 2 wk, 5 to <10 kg Initial phase: 300 mg wkly at wk 1. Maintenance phase: 300 mg at wk 2 then every 3 wk.

Hypersensitivity to eculizumab or murine proteins. Unresolved Neisseria meningitidis infection; patients currently unvaccinated against Neisseria meningitidis unless prophylactic treatment w/ appropriate antibiotics is received until 2 wk after vaccination.

Infusion reactions or immunogenicity. Not to be administered as IV push or bolus. Meningococcal, disseminated gonococcal & active systemic infections; patients w/ complement-mediated diseases. Vaccinate against meningococcal infections at least 2 wk prior treatment. Administer appropriate antibiotic prophylaxis until 2 wk after vaccination in patients who initiate treatment <2 wk after meningococcal vaccine. Vaccinate patients <18 yr against H. influenzae & pneumococcal infections. Monitor signs & symptoms of intravascular haemolysis including serum LDH levels in PNH patients; thrombotic microangiopathy (TMA) by measuring platelet counts, serum LDH & creatinine, for signs & symptoms of severe TMA complications after discontinuation in aHUS patients. Carefully monitor for signs & symptoms of disease exacerbation after discontinuation or when immunosuppressant & anticholinesterase therapies are decreased/discontinued in patients w/ refractory gMG; potential NMOSD relapse after discontinuation. Hepatic impairment. Women of childbearing potential should use effective contraception during & for at least 5 mth after last dose. Pregnancy & lactation. Childn <6 yr w/ refractory gMG; <18 yr w/ NMOSD.

Headache. Pneumonia, URTI, bronchitis, nasopharyngitis, UTI, oral herpes; leukopenia, anaemia; insomnia; dizziness; HTN; cough, oropharyngeal pain; diarrhoea, vomiting, nausea, abdominal pain; rash, pruritus, alopecia; arthralgia, myalgia, pain in extremity; pyrexia, fatigue, flu-like illness; infusion-related reaction.

Reduced expected pharmacodynamic effects of rituximab. Reduced serum levels w/ plasma exchange, plasmapheresis, fresh frozen plasma infusion, IVIg. Reduced effectiveness w/ IVIg; neonatal Fc receptor blockers. Lowered systemic exposure w/ neonatal Fc receptor blockers.

Immunosuppressants / Haemorrheologicals / Neuromuscular Disorder Drugs

L04AJ01 - eculizumab ; Belongs to the class of complement inhibitors. Used as immunosuppressants.

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