ORKAMBI 200/125 lumacaftor/ivacaftor 200mg/125mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ivacaftor, Quantity: 125 mg; lumacaftor, Quantity: 200 mg

Available from:

Vertex Pharmaceuticals Australia Pty Ltd

INN (International Name):

Ivacaftor,lumacaftor

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: hypromellose acetate succinate; sodium lauryl sulfate; microcrystalline cellulose; povidone; magnesium stearate; croscarmellose sodium; titanium dioxide; purified water; purified talc; brilliant blue FCF aluminium lake; polyvinyl alcohol; macrogol 3350; cochineal; indigo carmine aluminium lake; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid

Administration route:

Oral

Units in package:

112 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ORKAMBI is indicated for the treatment of cystic fibrosis (CF) in patients aged 1 year and older who are homozygous for the F508del mutation in the CFTR gene.

Product summary:

Visual Identification: Orkambi is a pink, oval-shaped, film-coated tablet, printed in black ink with 2V125 on one face.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 30 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2016-03-08

Patient Information leaflet

ORKAMBI
®
O
R
K
A
M
B
I
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ORKAMBI?
ORKAMBI contains the active ingredients lumacaftor and ivacaftor.
ORKAMBI is used for the treatment of cystic fibrosis (CF) in
patients aged 2 years or older who are homozygous for the F508del
mutation in the cystic fibrosis transmembrane conductance
regulator (CFTR) gene. For more information, see Section 1. Why am I
using ORKAMBI? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ORKAMBI?
Do not use if you have ever had an allergic reaction to ORKAMBI or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
ORKAMBI? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ORKAMBI and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE ORKAMBI?
•
Your doctor will tell you how much ORKAMBI you need to take each day.
This may depend on your condition and whether or
not you are taking any other medicines. ORKAMBI is for oral use.
More instructions can be found in Section 4. How do I use ORKAMBI? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ORKAMBI?
THINGS YOU
SHOULD DO
•
REMIND ANY DOCTOR, DENTIST OR PHARMACIST YOU VISIT THAT YOU ARE USING
ORKAMBI.
•
USE ORKAMBI EXACTLY AS YOUR DOCTOR HAS PRESCRIBED
•
TAKE ORKAMBI WITH FAT CONTAINING FOOD
•
TELL YOUR DOCTOR IF YOU BECOME PREGNANT OR PLAN TO BECOME PREGNANT
WHILE USING ORKAMBI.
THINGS YOU
SHOULD NOT DO
•
Do not stop using ORKAMBI or change the dose without first checking
with your doctor
•
Do not take any other medicines whether they require a prescription or
not without first telling your

Summary of Product characteristics

Page 1
220207_ORKAMBI
®
Product Information
ORKAMBI®Product Information
v6
AUSTRALIAN PI – ORKAMBI
 (LUMACAFTOR AND IVACAFTOR) TABLETS AND GRANULES
1
NAME OF THE MEDICINE
lumacaftor and ivacaftor
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Tablets _
ORKAMBI 200/125 film-coated tablets contain 200 mg of lumacaftor and
125 mg of ivacaftor.
ORKAMBI 100/125 film-coated tablets contain 100 mg of lumacaftor and
125 mg of ivacaftor.
_Granules _
ORKAMBI 150/188 granules contain 150 mg lumacaftor and 188 mg
ivacaftor per sachet.
ORKAMBI 100/125 granules contain 100 mg lumacaftor and 125 mg
ivacaftor per sachet.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ORKAMBI 200/125 (lumacaftor/ivacaftor) film-coated tablets are
supplied as pink,
oval-shaped tablets. Each tablet is printed with “2V125” in black
ink on one side and plain on the
other.
ORKAMBI 100/125 (lumacaftor/ivacaftor) film-coated tablets are
supplied as pink,
oval-shaped tablets. Each tablet is printed with “1V125” in black
ink on one side and plain on the
other.
ORKAMBI (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 age 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 _
mutation on both alleles of the
_CFTR _
gene.
Page 2
220207_ORKAMBI
®
Product Information
ORKAMBI®Product Information
v6
For standard dosing recommendations see Table 1.
TABLE 1: RECOMMENDED DOSE OF ORKAMBI IN PATIENTS AGED 2 YEARS AND
OLDER
AGE
ORKAMBI DOSE
TOTAL DAILY DOSE
2 through 5 years and
weighing less than 14 kg
One lumacaftor 100 mg/ivacafto