Overdose : מינון יתר

11    OVERDOSAGE
No specific antidote is available for overdose with SYMDEKO. Treatment of overdosage consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.

12 DESCRIPTION
SYMDEKO is co-packaged as a tezacaftor/ivacaftor fixed-dose combination tablet and an ivacaftor tablet. Both tablets are for oral administration.

Tezacaftor 50 mg/ivacaftor 75 mg fixed-dose combination tablets and ivacaftor 75 mg tablets: The tezacaftor/ivacaftor fixed-dose combination tablet is available as a white film-coated tablet containing 50 mg of tezacaftor, 75 mg of ivacaftor, and the following inactive ingredients: microcrystalline cellulose, hypromellose acetate succinate (HPMCAS), croscarmellose sodium, hypromellose (HPMC), magnesium stearate and sodium lauryl sulfate. The tablet film coat contains opadry white 20A180008 (HPMC 2910/hypromellose, hydroxypropyl cellulose, talc and titanium dioxide).

The ivacaftor tablet is available as a light blue, capsule-shaped, film-coated tablet containing 75 mg of ivacaftor and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, hypromellose acetate succinate, croscarmellose sodium, magnesium stearate, colloidal silicon dioxide and sodium lauryl sulfate. The tablet film coat contains opadry II (blue) 85F105098 (polyvinyl alcohol, titanium dioxide, PEG 3350, talc, FD&C Blue #2/Indigo Carmine Aluminum Lake) and carnauba wax. The printing ink contains opacode black s-1-17823 (shellac, iron oxide black, propylene glycol and ammonium hydroxide).

Tezacaftor 100 mg/ivacaftor 150 mg fixed-dose combination tablets and ivacaftor 150 mg tablets: The tezacaftor/ivacaftor fixed-dose combination tablet is available as a yellow film-coated tablet containing 100 mg of tezacaftor, 150 mg of ivacaftor, and the following inactive ingredients: microcrystalline cellulose, hypromellose acetate succinate (HPMCAS), croscarmellose sodium, hypromellose (HPMC), magnesium stearate and sodium lauryl sulfate. The tablet film coat contains opadry yellow (HPMC/hypromellose 2910, hydroxypropyl cellulose, titanium dioxide, talc, iron oxide yellow).

The ivacaftor tablet is available as a light blue, capsule-shaped, film-coated tablet containing 150 mg of ivacaftor and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, hypromellose acetate succinate, croscarmellose sodium, magnesium stearate, colloidal silicon dioxide and sodium lauryl sulfate. The tablet film coat contains opadry II (blue) 85F90614 (polyvinyl alcohol, titanium dioxide, PEG 3350, talc, FD&C Blue #2/indigo carmine aluminum lake) and carnauba wax. The printing ink contains opacode black s-1-17823 (shellac, isopropyl alcohol, iron oxide black, propylene glycol, ammonium hydroxide).


SYMD-SPC-0923-V1                                                              Page 6 of 15 The active ingredients of SYMDEKO are described below.

Tezacaftor
Tezacaftor is a white to off-white solid that is practically insoluble in water (<5 microgram/mL). Its chemical name of tezacaftor is 1-(2,2-difluoro-2H-1,3-benzodioxol- 5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1Hindol-5-yl}cyclopropane-1-carboxamide. Its molecular formula is C26H27N2F3O6 and its molecular weight is 520.50. Tezacaftor has the following structural formula: 


Ivacaftor
Ivacaftor is a white to off-white crystalline solid that is practically insoluble in water (<0.05 microgram/mL). Pharmacologically it is a CFTR potentiator. Its chemical name is N-(2,4-di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxamide. Its molecular formula is C24H28N2O3 and its molecular weight is 392.49.
Ivacaftor has the following structural formula:



O   HN            OH

O
N
H