TRIKAFTA 100MG50MG75MG&150MG

Ország: Izrael

Nyelv: angol

Forrás: Ministry of Health

Aktív összetevők:

ELEXACAFTOR; IVACAFTOR; IVACAFTOR; TEZACAFTOR

Beszerezhető a:

VERTEX PHARMACEUTICALS (U.K) LIMITED, ISRAEL

ATC-kód:

R07AX32

Gyógyszerészeti forma:

FILM COATED TABLETS

Összetétel:

IVACAFTOR 75 MG; TEZACAFTOR 50 MG; ELEXACAFTOR 100 MG; IVACAFTOR 150 MG

Az alkalmazás módja:

PER OS

Recept típusa:

Required

Gyártó:

VERTEX PHARMACEUTICALS (IRELAND) LIMITED, IRELAND

Terápiás terület:

IVACAFTOR, TEZACAFTOR AND ELEXACAFTOR

Terápiás javallatok:

Trikafta is indicated for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one F508del mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data.

Engedély dátuma:

2021-04-04

Betegtájékoztató

TRIK-PIL-0923-V1
Page 1 of 6
PATIENT
LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS)
- 1986
This medicine is dispensed with
a doctor’s prescription only
TRIKAFTA
100MG/50MG/75MG & 150MG
FILM-COATED TABLETS
ACTIVE INGREDIENTS AND THEIR QUANTITIES
Orange film-coated tablets
Each film coated tablet contains elexacaftor 100 mg, tezacaftor 50 mg,
and ivacaftor 75 mg.
Light blue film-coated tablets
Each film coated tablet contains ivacaftor 150 mg.
Inactive ingredients and allergens - see section 6
“
ADDITIONAL INFORMATION
”
.
See also
“IMPORTANT INFORMATION ABOUT SOME OF THIS MEDICINE’S
INGREDIENTS”
in section 2.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains
concise information about this medicine. If you have further
questions, consult your doctor or
pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm
them, even if it seems to you that their illness is similar to yours.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Trikafta is indicated for the treatment of cystic fibrosis (CF) in
patients aged 12 years and older
who have at least one _F508del_ mutation in the CFTR gene or another
mutation that is
responsive to treatment with Trikafta.
THERAPEUTIC GROUP:
Elexacaftor
–
CFTR Corrector
Tezacaftor
–
CFTR Corrector
Ivacaftor
–
Potentiator of the CFTR protein
Tezacaftor and elexacaftor increase the amount of CFTR protein at the
cell surface and
ivacaftor causes the protein to work better.
2.
BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredients (elexacaftor,
tezacaftor, or
ivacaftor) or to any of the other ingredients in this medicine (see
section 6
“ADDITIONAL
INFORMATION”
).
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
BEFORE TAKING TRIKAFTA, TELL YOUR DOCTOR ABOUT ALL OF YOUR MEDICAL
CONDITIONS, INCLUDING IF
YOU:
•
have kidney problems
•
have or have had liver problems
•
are pregnant or plan to become pregnant
TRIK-P

Termékjellemzők

TRIK-SPC-0923-V1
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Trikafta 100mg/50mg/75mg & 150mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ELEXACAFTOR/TEZACAFTOR/IVACAFTOR TABLET:
Each film-coated tablet contains 100 mg elexacaftor, 50 mg tezacaftor
and 75 mg ivacaftor
IVACAFTOR TABLET:
Each film-coated tablet contains 150 mg ivacaftor.
EXCIPIENTS WITH KNOWN EFFECT:
Each Ivacaftor tablet contains 167.2 mg of lactose.
For the full list of excipients, _see Description (12)_.
3 PHARMACEUTICAL FORM
FILM-COATED TABLETS
ELEXACAFTOR/TEZACAFTOR/IVACAFTOR TABLET:
Orange film-
coated tablet, debossed with “T100” on one face and plain on the
other face.
IVACAFTOR TABLET:
Light blue film-
coated tablet, printed in black ink with “V 150” on one face.
4 THERAPEUTIC INDICATION
Trikafta is indicated for the treatment of cystic fibrosis (CF) in
patients aged 12 years and older who have at least one _F508del_
mutation in the _CFTR_ gene or a
mutation in the _CFTR_ gene that is responsive based on _in vitro_
data [_see Clinical Pharmacology (13.1)_].
5 DOSAGE AND ADMINISTRATION
5.1
GENERAL DOSING INFORMATION
Swallow the tablets whole.
Trikafta should be taken with fat-containing food. Examples of meals
or snacks that contain fat are those prepared with butter or oils or
those containing eggs, peanut
butter, cheeses, nuts, whole milk, or meats _[see Clinical
Pharmacology (13.3)]_.
5.2 RECOMMENDED DOSAGE IN ADULTS AND PEDIATRIC PATIENTS AGED 12 YEARS
AND OLDER
The recommended dosage is two tablets (each containing elexacaftor 100
mg, tezacaftor 50 mg and ivacaftor 75 mg) taken in the morning and one
ivacaftor tablet
(containing ivacaftor 150 mg) taken in the evening, administered
orally, approximately 12 hours apart.
Information for Missed Doses:
If 6 hours or less have passed since the missed morning or evening
dose, the patient should take the missed dose as soon as possible and
continue on the original
schedule.
If more than 6 hours have passed since:
•
the missed MORNING dose, the patie