Orkambi

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ivacaftor 188mg;  ; Lumacaftor 150mg;  

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

Pharmaceutical form:

Oral granules

Composition:

Active: Ivacaftor 188mg   Lumacaftor 150mg   Excipient: Croscarmellose sodium Hypromellose acetate succinate Microcrystalline cellulose Povidone Sodium laurilsulfate

Prescription type:

Prescription

Therapeutic indications:

Orkambi is indicated for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who are homozygous for the F508del mutation in the CFTR gene.

Product summary:

Package - Contents - Shelf Life: Sachet, laminate, Biaxially-oriented polyethylene terephthalate BOPET/ PE/Foil/PE, in outer carton - 56 dose units - 36 months from date of manufacture stored at or below 30°C

Authorization date:

2021-04-30

Patient Information leaflet

20230302 ORKAMBI
®
CONSUMER MEDICINES INFORMATION
1
ORKAMBI
®
_ _
_Lumacaftor and Ivacaftor _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
more common questions about
ORKAMBI.
It does not contain all of 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 ORKAMBI
against the benefits he/she expects it
will have for you.
IF YOU HAVE ANY CONCERNS OR
QUESTIONS ABOUT TAKING THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT ORKAMBI IS
USED FOR
ORKAMBI is for the treatment of
cystic fibrosis (CF) in patients age 2
years and older who have two copies
of the F508del mutation in the CFTR
gene.
_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.
ORKAMBI 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 ORKAMBI WORKS _
ORKAMBI belongs to a group of
medicines called "cystic fibrosis
transmembrane conductance
regulator (CFTR) modulators."
The CFTR protein is a chloride ion
channel that is normally present at
the cell surface of epithelial cells
where it transports chloride ions out
of the cell in multiple organs. In
people who have two copies of the
F508del mutation in the CFTR gene,
the amount of CFTR protein at the
cell surface is much lower than
normal. The small amount of CFTR
protein that reaches the cell surface
does not function properly, as the
chloride ion channel remains closed
more often than normal.
ORKAMBI is a combination product
that contains:
•
a CFTR corrector (lumacaftor),
which increases the amount of
working CFTR at the cell surface
•
and a CFTR poten

Summary of Product characteristics

Page 1
20230302_ORKAMBI
®
Data Sheet
ORKAMBI®Product Information
v6
NEW ZEALAND DATA SHEET
ORKAMBI

(LUMACAFTOR AND IVACAFTOR)
TABLETS AND GRANULES
1
ORKAMBI
FILM-COATED TABLETS AND GRANULES
ORKAMBI (lumacaftor 200 mg and ivacaftor 125 mg) film-coated tablets
ORKAMBI (lumacaftor 100 mg and ivacaftor 125 mg) film-coated tablets
ORKAMBI (lumacaftor 150 mg and ivacaftor 188 mg) granules
ORKAMBI (lumacaftor 100 mg and ivacaftor 125 mg) granules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Tablets _
Each film-coated tablet contains 200 mg of lumacaftor and 125 mg of
ivacaftor as a fixed dose
combination.
Or
Each film-coated tablet contains 100 mg of lumacaftor and 125 mg of
ivacaftor as a fixed dose
combination.
_Granules _
Each granule sachet contains 150 mg lumacaftor and 188 mg ivacaftor.
Or
Each granule sachet contains 100 mg lumacaftor and 125 mg ivacaftor.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ORKAMBI 200 mg/125 mg (lumacaftor/ivacaftor) film-coated tablets are
supplied as pink,
oval-shaped tablets (14 x 8.4 x 6.8 mm). Each tablet is printed with
“2V125” in black ink on one side
and plain on the other.
ORKAMBI 100 mg/125 mg (lumacaftor/ivacaftor) film-coated tablets are
supplied as pink,
oval-shaped tablets (14 x 7.6 x 4.9 mm). Each tablet is printed with
“1V125” in black ink on one side
and plain on the other.
ORKAMBI 150 mg/188 mg and ORKAMBI 100 mg /125 mg
(lumacaftor/ivacaftor) granules are supplied as
white to off-white granules enclosed in unit dose sachets.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ORKAMBI is indicated for the treatment of cystic fibrosis (CF) in
patients aged 2 years and older
who are homozygous for the
_F508del _
mutation in the
_CFTR _
gene.
4.2
D
OSE 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 _
muta