Symdeko 100/150

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Ivacaftor 150mg;  ;  ; Tezacaftor 100mg;  ;  ; Ivacaftor 150mg

Tilgjengelig fra:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

Legemiddelform:

Film coated tablet

Sammensetning:

Active: Ivacaftor 150mg     Tezacaftor 100mg     Excipient: Croscarmellose sodium Hypromellose Hypromellose acetate succinate Magnesium stearate Microcrystalline cellulose Opadry yellow 20A120010 Sodium laurilsulfate Active: Ivacaftor 150mg Excipient: Carnauba wax Colloidal silicon dioxide Croscarmellose sodium Hypromellose acetate succinate Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opacode black S-1-17823 Opadry blue 85F90614 Sodium laurilsulfate

Resept typen:

Prescription

Indikasjoner:

Symdeko is indicated for the treatment of patients with cystic fibrosis (CF) aged 12 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence.

Produkt oppsummering:

Package - Contents - Shelf Life: Blister pack, PCTFE (Aclar)/PVC/Al co-pack 4 x 14 tablets (7 tezacaftor/ivacaftor and 7 ivacaftor) - 56 tablets - 36 months from date of manufacture stored at or below 30°C

Autorisasjon dato:

2021-04-22

Informasjon til brukeren

220120_FINAL_SYMDEKO_CMI
1
SYMDEKO
®
Tezacaftor and Ivacaftor
Ivacaftor
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SYMDEKO tablets.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking SYMDEKO
against the benefits he/she expects it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT SYMDEKO IS
USED FOR
SYMDEKO is used for the treatment
of cystic fibrosis (CF) in patients
aged 12 years and older who are
homozygous for the F508del
mutation or who have at least one
mutation in the cystic fibrosis
transmembrane conductance
regulator
(CFTR) gene that is listed in the
approved indication.
WHAT IS CYSTIC FIBROSIS?
Cystic fibrosis is caused by genetic
defects that limit the flow of chloride
and water through cell membranes.
As a result, the mucus in the lungs
(and other organs) becomes thick and
sticky, clogging the lungs and
making it easier for germs to grow.
SYMDEKO is a medicine that works
by improving the flow of chloride
and water in patients with cystic
fibrosis who have a certain genetic
defect.
HOW SYMDEKO WORKS
SYMDEKO belongs to a group of
medicines called “cystic fibrosis
transmembrane conductance
regulator (CFTR) modulators”.
SYMDEKO includes two types of
tablets, one contains tezacaftor and
ivacaftor (morning dose) and the
other contains ivacaftor (evening
dose).
Tezacaftor is a “CFTR corrector” and
works to increase the amount of
protein at the cell surface.
Ivacaftor is a “CFTR potentiator”
that makes the protein work better
once it reaches the cell surface.
SYMDEKO is not addictive.
BEFORE YOU TAKE
SYMDEKO
WHEN YOU MUST NOT TAKE IT
DO NOT TAKE SYMDEKO IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
tezacaftor or ivacaftor (the active
ingredients in SYMD

Preparatomtale

220120 Symdeko Data Sheet
Page 1 of 19
NEW ZEALAND DATA SHEET
SYMDEKO (TEZACAFTOR/IVACAFTOR, IVACAFTOR)
FILM–COATED TABLETS
1
SYMDEKO FILM-COATED TABLETS
SYMDEKO tezacaftor 100 mg/ivacaftor 150 mg film-coated tablet and
ivacaftor 150 mg film-
coated tablet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
MORNING DOSE
Each film-coated tablet contains 100 mg of tezacaftor and 150 mg of
ivacaftor as a fixed-dose
combination tablet.
EVENING DOSE
Each film-coated tablet contains 150 mg of ivacaftor.
Excipients with known effect:
Lactose monohydrate
For the full list of excipients, see Section 6.1LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
COMPOSITE PACK
MORNING DOSE
_Film-coated tablet _
Yellow, capsule-shaped tablet debossed with “V100” on one side and
plain on the other
(15.9 mm x 8.5 mm).
EVENING DOSE
_Film-coated tablet _
Light blue, capsule-shaped tablet, printed with “V150” in black
ink on one side and plain on the
other (16.5 mm x 8.4 mm).
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symdeko is indicated for the treatment of patients with cystic
fibrosis (CF) aged 12 years and
older who are homozygous for the _F508del _mutation or who have at
least one mutation in the
cystic fibrosis transmembrane conductance regulator (_CFTR_) gene that
is responsive to
tezacaftor/ivacaftor based on _in vitro _data and/or clinical
evidence.
Refer to Table 1 for a list of responsive mutations.
220120 Symdeko Data Sheet
Page 2 of 19
4.2
DOSE AND METHOD OF ADMINISTRATION
SYMDEKO SHOULD ONLY BE PRESCRIBED BY PHYSICIANS WITH EXPERIENCE IN THE
TREATMENT OF
CYSTIC FIBROSIS. If the patient's genotype is unknown, an accurate and
validated genotyping
method should be performed to confirm the presence of an indicated
mutation (see Table 1).
Table 1 below lists mutations that are responsive to
tezacaftor/ivacaftor based on positive
clinical response and/or _in vitro_ data obtained from FRT cells (see
Section 5.1
PHARMACODYNAMIC PROPERTIES).
TABLE 1: LIST OF _CFTR _GENE MUTATIONS THAT PRODUCE CFTR PROTEIN
RESPONSIVE TO SYMDEKO
_E56