All the Therapeutic System Drugs
4-Hydroxyphenylpyruvate Dioxygenase Inhibitor. Nitsinone 2, 5, 10 mg. CAPS: 60. Recomm. inititial dose in
ped., adult populat: 1 mg/kg body wt
dly in 2 divid. doses.
Tmt. pts with confirmed diagnos.
hereditary tyrosinemia type 1 (HT-1) in
combinat. with dietary restrict. of tyrosine
C/I: Hypersens., lact.
Monoclonal Antibody. Alirocumab 75 mg/ml, 150 mg/ml. PEN/SYR.: 1,2×75,150 mg/ml
The usual init. dose is 75 mg admin. SC once every 2 wks.
Pts. requir. larger LDL-C reduction (>60%) may be started on 150 mg admin.
SC once every 2 wks.
The dose can be individual. based on pt. characteristics such as baseline
LDL-C level, goal of ther. &response. See lit.
Primary Hypercholesterolaemia (heterozygous familial &non-familial) or mixed dyslipidaemia in adults, as an adjunct to diet:
- in comb .with a statin or statin with other lipid lowering therapies in patients unable to
reach LDL-C goals with the max. tolerated dose of a statin or,
- alone or in comb. with other lipid-low. therapies in pts. who are statin-intoler.
The effect of the drug on cardiovasc. morbid. and mortal. has not yet been determin.
Human Monoclonal Antibody. Evolocumab 140 mg/ml. PRE-FILL.PEN.: 1, 2, 3, 6. Prim.
hypercholesterolaemia & mixed
dyslipidaemia in adults: 140 mg every
two wks. or 420 mg once mnthly.; both
doses are clinic.equival.
Homozyg. fam. hypercholesterolaemia
in adults & adolesc. aged 12 yrs. and
over: Initial. 420 mg once monthly.
After 12 wks. of tmt., dose frequen. can
be up titrated to 420 mg once every 2
wks. if a clinic. meaningful response is
not achieved. Pts. on apheresis may
init. tmt. with 420 mg every two wks. to
corresp.with their apheresis schedule.
Hypercholesterolaemia & mixed
famil. & non famil.) or mixed
dyslipidaemia in adult., as an adjunct to
diet: In comb. with a statin or statin with
other lipid low. therap. in pts. unable to
reach LDL C goals with the max.
tolerated dose of a statin or, Alone or in
comb.with other lipid-low. therap. in pts.
who are statin-intolerant/ for whom a
statin is contraind. Homozyg. famil.
hypercholesterolaemia in adults &
adolesc. aged 12 yrs. and over with
homozyg. famil. hypercholesterolaemia
in comb. with other lipid-low. therap.. The
effect of Evolocumab on cardiovasc.
morbidity & mortal. has not yet been