Soliris

Eculizumab

Adult & childn w/ paroxysmal nocturnal haemoglobinuria (PNH); atypical haemolytic uremic syndrome (aHUS).

IV Adult ≥18 yr & paed weighing ≥40 kg PNH Initial phase: Administer 600 mg via 25-45 min infusion every wk for the 1st 4 wk. Maintenance phase: Administer 900 mg via 25-45 min infusion for the 5th wk followed by 900 mg via 25-45 min infusion every 14 ± 2 days. aHUS Initial phase: Administer 900 mg via 25-45 min infusion every wk for the 1st 4 wk. Maintenance phase: Administer 1,200 mg via 25-45 min infusion for the 5th wk followed by 1,200 mg via 25-45 min infusion every 14 ± 2 days. Concomitant use w/ plasmapheresis or plasma exchange: Most recent dose: 300 or ≥600 mg. Supplemental dose: 300 mg or 600 mg respectively, w/in 60 min after each plasmapheresis or plasma exchange. Concomitant use w/ fresh frozen plasma infusion: Most recent dose: ≥300 mg. Supplemental dose: 300 mg 60 min prior to each fresh frozen plasma infusion. PNH & aHUS Paed weighing 30 to <40 kg Initial phase: 600 mg wkly x 2. Maintenance phase: 900 mg at wk 3 then every 2 wk, 20 to <30 kg Initial phase: 600 mg wkly x 2. Maintenance phase: 600 mg at wk 3 then every 2 wk, 10 to <20 kg Initial phase: 600 mg wkly x 1. Maintenance phase: 300 mg at wk 2 then every 2 wk, 5 to <10 kg Initial phase: 300 mg wkly x 1. Maintenance phase: 300 mg at wk 2 then every 3 wk.

Hypersensitivity to eculizumab or murine proteins. Not to be initiated in patients w/ unresolved Neisseria meningitidis infection; who are not currently vaccinated against Neisseria meningitidis unless they receive prophylactic treatment w/ appropriate antibiotics until 2 wk after vaccination.

Not for IV push or bolus inj administration. Allergic or hypersensitivity reactions (including anaphylaxis). Interrupt administration in all patients experiencing severe infusion reactions & administer appropriate medical therapy. Not expected to affect the aplastic component of anaemia in patients w/ PNH. Increased susceptibility to meningococcal infection (Neisseria meningitidis). Vaccinate against meningococcal infections at least 2 wk prior to treatment. Administer appropriate antibiotic prophylaxis until 2 wk after vaccination in patients who initiate treatment <2 wk after meningococcal vaccine. Closely monitor for disease symptoms [(eg, haemolysis (PNH) or thrombotic microangiopathy (TMA) (aHUS)] after recommended vaccination. Possible serious or fatal meningococcal infections; monitor for early signs & immediately evaluate if infection is suspected & treat w/ antibiotics if necessary. Patients w/ active systemic infections; advise patients about gonorrhoea prevention. Possible infrequent Ab responses. Vaccinate patients <18 yr against H. influenzae & pneumococcal infections. Treatment should not alter anticoagulant management. Monitor signs & symptoms of intravascular haemolysis including serum LDH levels in PNH patients receiving treatment; at least 8 wk to detect serious haemolysis & other reactions after treatment discontinuation in PNH patients. Monitor for TMA by measuring platelet counts, serum LDH levels & creatinine in aHUS patients; for signs & symptoms of severe TMA complications after treatment discontinuation in aHUS patients. Instruct patients to immediately seek medical care if fever, headache accompanied w/ fever &/or stiff neck or light sensitivity develops. Contains Na 5 mmol/vial. Hepatic impairment. Consider use of adequate contraception to prevent pregnancy & for at least 5 mth after last dose of treatment in women of childbearing potential. Pregnancy & lactation.

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

Serum conc may be decreased w/ chronic IVIg.

Haemorrheologicals

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

POM