Orkambi 200mg125mg tablets

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Ivacaftor; Lumacaftor

Saatavilla:

Vertex Pharmaceuticals (UK

ATC-koodi:

R07AX30

INN (Kansainvälinen yleisnimi):

Ivacaftor; Lumacaftor

Annos:

125mg ; 200mg

Lääkemuoto:

Tablet

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 03070000

Pakkausseloste

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ORKAMBI 100
MG/125
MG FILM-COATED TABLETS
ORKAMBI 200
MG/125
MG FILM-COATED TABLETS
lumacaftor/ivacaftor
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 Orkambi is and what it is used for
2.
What you need to know before you take Orkambi
3.
How to take Orkambi
4.
Possible side effects
5.
How to store Orkambi
6.
Contents of the pack and other information
1.
WHAT ORKAMBI IS AND WHAT IT IS USED FOR
Orkambi (lumacaftor and ivacaftor) is a medicine used for long-term
treatment of cystic fibrosis (CF)
in patients aged 6 years and older who have a specific change (called
_F508del _
mutation) affecting the
gene for a protein called cystic fibrosis transmembrane conductance
regulator (CFTR), which plays an
important role in regulating the flow of mucus in the lungs. People
with the mutation will produce an
abnormal CFTR protein. Cells contain two copies of the
_CFTR_
gene; Orkambi is used in patients in
whom both copies are affected by the
_F508del_
mutation.
Orkambi is a single tablet that contains two active substances,
lumacaftor and ivacaftor. These two
work together to improve the function of the abnormal CFTR protein.
Lumacaftor increases the
amount of CFTR available and ivacaftor helps the abnormal protein to
work more normally.

Valmisteyhteenveto

OBJECT 1
ORKAMBI 200 MG/125 MG FILM COATED TABLETS
Summary of Product Characteristics Updated 01-Mar-2018 | Vertex
Pharmaceuticals (Europe) Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Orkambi 100 mg/125 mg film-coated tablets
Orkambi 200 mg/125 mg film-coated tablets
2. Qualitative and quantitative composition
Orkambi 100 mg/125 mg film-coated tablets
Each film-coated tablet contains 100 mg of lumacaftor and 125 mg of
ivacaftor.
Orkambi 200 mg/125 mg film-coated tablets
Each film-coated tablet contains 200 mg of lumacaftor and 125 mg of
ivacaftor.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet)
Orkambi 100 mg/125 mg film-coated tablets
Pink, oval-shaped tablets (dimensions 14 × 7.6 × 4.9 mm) printed
with “1V125” in black ink on one side.
Orkambi 200 mg/125 mg film-coated tablets
Pink, oval-shaped tablets (dimensions 14 × 8.4 × 6.8 mm) printed
with “2V125” in black ink on one side.
4. Clinical particulars
4.1 Therapeutic indications
Orkambi is indicated for the treatment of cystic fibrosis (CF) in
patients aged 6 years and older who are
homozygous for the _F508del_ mutation in the _CFTR_ gene (see sections
4.2, 4.4 and 5.1).
4.2 Posology and method of administration
Orkambi 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 the _F508del_ mutation on both alleles of the _CFTR_ gene.
Posology
For standard dosing recommendations see Table 1.
TABLE 1: RECOMMENDED DOSE OF ORKAMBI IN PATIENTS AGED 6 YEARS AND
OLDER
AGE
ORKAMBI DOSE
TOTAL DAILY DOSE
6 to 11 years
Two lumacaftor 100 mg/ivacaftor 125 mg
tablets every 12 hours
lumacaftor 400 mg/ ivacaftor 50