Symkevi

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

tezacaftor, ivacaftor

Διαθέσιμο από:

Vertex Pharmaceuticals (Ireland) Limited

Φαρμακολογική κατηγορία (ATC):

R07AX31

INN (Διεθνής Όνομα):

tezacaftor, ivacaftor

Θεραπευτική ομάδα:

Other respiratory system products

Θεραπευτική περιοχή:

Cystic Fibrosis

Θεραπευτικές ενδείξεις:

Symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (CF) aged 6 years and older who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G, and 3849+10kbC→T.

Περίληψη προϊόντος:

Revision: 12

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2018-10-31

Φύλλο οδηγιών χρήσης

38
B. PACKAGE LEAFLET
39
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SYMKEVI 50 MG/75 MG FILM-COATED TABLETS
SYMKEVI 100 MG/150 MG FILM-COATED TABLETS
tezacaftor/ivacaftor
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Symkevi is and what it is used for
2.
What you need to know before you take Symkevi
3.
How to take Symkevi
4.
Possible side effects
5.
How to store Symkevi
6.
Contents of the pack and other information
1.
WHAT SYMKEVI IS AND WHAT IT IS USED FOR
SYMKEVI CONTAINS TWO ACTIVE SUBSTANCES,
tezacaftor and ivacaftor. The medicine helps lung cells to
work better in some patients with cystic fibrosis (CF). CF is
an inherited condition in which the lungs
and the digestive system can become clogged with thick, sticky mucus.
Symkevi works on a protein called CFTR (
_cystic fibrosis transmembrane conductance regulator_
),
which is damaged in some people with CF (who have a mutation in the
_CFTR_
gene). Ivacaftor causes
the protein to work better while tezacaftor increases the amount of
protein at the cell surface. Symkevi
is normally taken with ivacaftor, another medicine.
Symkevi taken with ivacaftor is for long-term treatment of patients
aged 6 years and over who have
CF with certain genetic mutations
t
hat result in reduced amount and/or function of the CFTR protein.
Symkevi taken with ivacaftor helps your breathing by improving your
lung function. You may also
notice that you do not get ill as often and/or that it is easier to
gain weight.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
_ _
_ _
2
1.
NAME OF THE MEDICINAL PRODUCT
Symkevi 50 mg/75 mg film-coated tablets
Symkevi 100 mg/150 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Symkevi 50 mg/75 mg film-coated tablets
Each tablet contains 50 mg of tezacaftor and 75 mg of ivacaftor.
Symkevi 100 mg/150 mg film-coated tablets
Each tablet contains 100 mg of tezacaftor and 150 mg of ivacaftor.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Symkevi 50 mg/75 mg film-coated tablets
White, capsule-shaped tablet debossed with “V50” on one side and
plain on the other (dimensions
12.70 mm x 6.78 mm).
Symkevi 100 mg/150 mg film-coated tablets
Yellow, capsule-shaped tablet debossed with “V100” on one side and
plain on the other (dimensions
15.9 mm x 8.5 mm).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symkevi is indicated in a combination regimen with ivacaftor tablets
for the treatment of patients with
cystic fibrosis (CF) aged 6 years and older who are homozygous for the
_F508del_
mutation or who are
heterozygous for the
_F508del_
mutation and have one of the following mutations in the cystic
fibrosis
transmembrane conductance regulator (
_CFTR_
) gene:
_P67L, R117C, L206W, R352Q, A455E, D579G, _
_711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G,
_
and
_ 3849+10kbC→T_
.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Symkevi should only be prescribed by physicians with experience in the
treatment of CF. If the
patient’s genotype is unknown, an accurate and validated genotyping
method should be performed to
confirm the presence of an indicated mutation using a genotyping
assay.
Posology
_ _
Adults, adolescents and children aged 6 years and older should be
dosed according to Table 1.
_ _
3
TABLE 1: DOSING RECOMMENDATIONS FOR PATIENTS AGED 6 YEARS AND OLDER
AGE/WEIGHT
MORNING
(1 TABLET)
EVENING
(1 TABLET)
6 to < 12 years weighing < 30 kg
tezacaftor 50 mg/ivacaftor 75 mg
ivacaftor 75 mg
6 to < 12 years weigh