Alexion Pharma Israel Ltd

Monoclonal Antibody. Eculizumab 10 mg/ml.
VIAL (concentrate for sol. for infus.): 1×300mg. Adult. (≥18 years of age): (PNH)-consists of a 4-week initial phase follow. by a mainten. phase: Initial phase: 600 mg admin. via a 25–45 min. IV infus. every wk. for the first 4 wks.
Mainten. phase: 900 mg admin. via a 25-45 min. IV infus. for the 5^TH week, follow. by 900 mg admin. via a 25–45 min. IV infus. every 14±2 d.
In atyp. Haemolytic Uremic Synd. (aHUS) and refract. general. Myasthenia Gravis (gMG): The aHUS and refract. gMG dosing regimen for adult pts. (≥18 yrs. of age) consists of a 4 wk. init. phase follow. by a mainten. phase: Init. phase: 900 mg admin. via a 25–45 min. IV infus. every wk. for the first 4 wks.
Mainten. phase: 1,200 mg admin. via a 25–45 min. IV infus. for the fifth wk., follow. by 1,200 mg admin. via a 25–45 min. IV infus. every 14±2 d.
Paed. pts. in PNH and aHUS: Paed. pts PNH, above 11 yrs. old, and aHUS pts. with bdy. wt.≥40 kg are treated with the adult dosing recommend. respectively.
Pts. bdy. wt. 30 to<40 kg init. phase 600 mg wkly.×2, mainten. phase 900 mg at wk. 3; then 900 mg every 2 wks.
Pts. bdy. wt. 20 to<30 kg, init. phase 600 mg wkly.×2, mainten. phase 600 mg at wk. 3; then 600 mg every 2 wks.
Pts. bdy. wt. 10 to<20 kg, init. phase 600 mg wkly.×1, mainten. phase 300 mg at wk. 2; then 300 mg every 2 wks.
Pts. bdy. wt. 5 to<10 kg, init. phase 300 mg wkly.×1 mainten. phase 300 mg at wk. 2; then 300 mg every 3 wks. See lit.
Paroxysmal nocturnal haemoglobinuria (PNH).
Evidence of clinical benefit is demonstrat. in pts. with haemolysis with clinical sympt. indicative of high dis. activity, regardless of transfus. history.
Eculizumab has not been studied in clinic. trials in pts. with PNH below 11 yrs. of age.
Atypical haemolytic uremic syndr. (aHUS).
Soliris is indicated in adult. for the tmt. of: Refract. generalized myasthenia gravis (gMG) in pts. who are anti-acetylcholine receptor (AChR) antibody-positive.
C/I: Hypersens. Therapy must not be init. in pts.: with unresolved Neisseria meningitidis infect, pts. that are not current. vaccine. against Neisseria meningitidis unless they receive prophylact. tmt. with appropr. antibiot. until 2 wks. after vaccinat.

Alimentary Tract, Metabolism Enzymes. Asfotase Alfa 40 mg/ml, 100 mg/ml.
VIAL: 1, 12×100mg, 1×40mg.
2 mg/kg of bdy. wt. admin. S.C. three times per week, or a dosage regimen of 1 mg/kg of bdy. wt. admin. S.C. six times per week. See lit.
Indicated for long-term enzyme replacement ther. in pts. with paediatric-onset hypophosphatasia to treat the bone manifestations of the dis.
C/I: Severe or life-threaten. hypersens. to the active subst. or to any of the excipients if hypersens. is not controllable.