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    7 Drugs classified under this therapeutic system


    All the Therapeutic System Drugs

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    Kuvan
    Medison
    RX
    partial basket chart
    Kuvan

    Enzyme Cofactor. Sapropterin (dihydrochloride) 100 mg.
    SOL. TABS: 30, 120 x 100 mg. 5-20 mg/
    kg/dly. See lit.
    Tmt. HPA in adults, child over 4 yrs with
    PKU, shown respons. to such tmt. Tmt.
    HPA in adults, child over 4 yrs with BH4
    defic., shown respons. to such tmt.
    C/I: Hypersens.

    Orfadin 2 mg, 5 mg, 10 mg
    Megapharm
    RX
    partial basket chart
    Orfadin 2 mg, 5 mg, 10 mg

    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
    and phenylalaline.
    C/I: Hypersens., lact.

    Praluent 75, 150 mg
    Sanofi
    RX
    partial basket chart
    Praluent 75, 150 mg

    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.
    C/I: Hypersens.

    Repatha
    Amgen
    RX
    partial basket chart
    Repatha

    Human Monoclonal Antibody. Evolocumab 140 mg/ml.
    PRE-FILL.SYR.: 1, 2, 3, 6. Prim. hypercholesterolem & mixed dyslipidem. in adult.: either 140 mg every two wks. or 420 mg once month.; both doses are clinic. equiv.
    Homozyg. famil. hypercholesterolem. in adult. and adolesc. ≥ 12 yrs.: The init. recomm. dose is 420 mg once month. After 12 wks. of tmt., dose frequency can be up-titrated to 420 mg once every 2 wks. if a clinic. meaningful response is not achieved. Pts. on apheresis may initiate tmt. with 420 mg every two wks. to corresp. with their apheresis schedule.
    Establish. atherosclerotic cardiovasc. dis. in adult.: 140 mg every two wks. or 420 mg once month.; both dosesare clinic. equiv.
    Pts. with ren.impair.- pts with mild- moder. ren. impair.,- No dose adjust. is necessary in pts. with severe ren. impair. (eGFR<30 mL/min/1.73 m²).
    Pts. with hep. impair.- No dose adjust. is necessary in pts. with mild hep. impair. See lit.
    Hypercholesterolem. & and mixed dyslipidem., in adults with primary hypercholesterolem. (heterozygous famil. and non-famil.) or mixed dyslipidem., as an adjunct to diet: In comb. with a statin or statin with other lipid-lowering 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-lower. therap. in pts. who are statin-intoler., or for whom a statin is contraindic.
    Homozygous famil. hypercholesterolem.–adult. & adolesc. ≥12 yrs. and over with homozyg. famil. hypercholesterolem. in comb. with other lipid-lower. therap.
    Establish. atherosclerotic cardiovasc. dis.-adults with established atherosclerotic cardiovasc. dis. (MI, stroke or peripher. arterial dis.) to reduce cardiovasc. risk by lower. LDL-C levels, as an adjunct to correct. of other risk factors: In comb. with the maxim. tolerated dose of a statin with/without other lipid-lower. therap.
    Alone or in comb. with other lipid-lower. therap. in pts. who are statin-intoler., or for whom a statin is contraindic.
    C/I: Hypersens.

    Strensiq
    Alexion
    RX
    partial basket chart
    Strensiq

    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.

    Translarna
    Medison
    RX
    not in the basket chart
    Translarna

    Drug for musculo-skeletal system. Ataluren 125, 250, 1000 mg.
    SACHET: 30×125,250,1000 mg. Admin. oral. every day in 3 doses. The 1ST dose should be taken in the morn., the 2ND at midday, and the 3RD in the eve. Recommend. dosing intervals are 6 hrs. betwn. morn. and midday doses, 6 hours betwn. midday and eve. doses, and 12 hrs. betwn. the eve. dose and the first dose on the next day.
    The recomm. dose is 10 mg/kg bdy. wt. in the morn. 10 mg/kg bdy. wt. at midday, and 20 mg/kg bdy. wt. in the eve. (for a total dly. dose of 40 mg/kg bdy. wt.). See Lit.
    Tmt. of Duchenne muscul. dystrophy result. from a nonsense mutation in the dystrophin gene, in ambulatory pts. aged 2 yrs. & older. Efficacy has not been demonstrated in non-ambulat. pts.
    The presence of a nonsense mutation in the dystrophin gene should be determined by genetic testing.
    C/I: Hypersens. Concom. use of IV aminoglycosides.


    Other therapeutic systems under Affecting Nutrition and Metabolism

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