ORKAMBI 100 MG125 MG FILM COATED TABLETS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

IVACAFTOR; LUMACAFTOR

Available from:

VERTEX PHARMACEUTICALS (U.K) LIMITED, ISRAEL

ATC code:

R07AX30

Pharmaceutical form:

FILM COATED TABLETS

Composition:

IVACAFTOR 125 MG; LUMACAFTOR 100 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

VERTEX PHARMACEUTICALS (EUROPE) LIMITED, UK

Therapeutic area:

IVACAFTOR AND LUMACAFTOR

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 Limitations of Use The efficacy and safety of ORKAMBI have not been established in patients with CF other than those homozygous for the F508del mutation

Authorization date:

2019-03-20

Patient Information leaflet

ORKA_100_125-200_125-PIL-0121-V1 Page 1 of 6
PATIENT
LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS)
- 1986
This medicine is dispensed with a doctor’s prescription only
ORKAMBI 100 MG/125 MG FILM COATED TABLETS
ORKAMBI 200 MG/125 MG FILM COATED TABLETS
ACTIVE INGREDIENTS AND THEIR QUANTITIES
Orkambi 100mg/125mg film coated tablets
Each film coated tablet contains:
100 mg lumacaftor
125 mg ivacaftor
Orkambi 200mg/125mg film coated tablets
Each film coated tablet contains:
200 mg lumacaftor
125 mg ivacaftor
Inactive ingredients - See section 6 “ADDITIONAL INFORMATION”.
See also "IMPORTANT INFORMATION ABOUT
SOME OF THIS MEDICINE’S INGREDIENTS" in section 2.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains concise
information about this medicine. If you have further questions,
consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them,
even if it seems to you that their illness is similar to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Orkambi (lumacaftor and ivacaftor) is 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 has an important role in
regulating the flow of mucus in the lungs. People with the mutation
will produce an abnormal CFTR
protein. Orkambi is used in patients in whom both copies of the CFTR
gene in the cell 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
properly.
THERAPEUTIC GROUP: Lumacaftor – CFTR corrector
Ivacaftor – Potentiator of the CFTR protein
2.
BEFORE USING THIS MEDICINE
DO

Summary of Product characteristics

ORKA_100_125-200_125-SPC-0121-V1 Page 1 of 31
PHYSICIAN PRESCRIBING INFORMATION
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 tablets
Orkambi 100 mg/125 mg film coated tablets
Pink oval-shaped tablets with “1V125” printed in black on one face
and plain on the other.
Orkambi
200 mg/125 mg film coated tablets
Pink oval-shaped tablets with “2V125” printed in black on one face
and plain on the other.
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).
If the patient's genotype is unknown, CF mutation test should be used
to detect the presence of the
_F508del_
mutation on both alleles of the
_CFTR_
gene.
Limitations of Use
The efficacy and safety of ORKAMBI have not been established in
patients with CF other than those
homozygous for the F508del mutation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Orkambi should only be prescribed by physicians with experience in the
treatment of CF.
Posology
ORKA_100_125-200_125-SPC-0121-V1 Page 2 of 31
TABLE 1: DOSING RECOMMENDATIONS IN PATIENTS AGED 6 YEARS AND OLDER
AGE
DOSE
TOTAL DAILY DOSE
6 to 11 years
2 tablets of lumacaftor
100 mg/ivacaftor 125 mg every
12 hours
lumacaftor 400 mg/
ivacaftor 500 mg
12 years and older
2 tablets of lumacaftor
200 mg/ivacaftor 125 mg every
12 hours
lumacaftor 800 mg/
ivacaftor 500 mg
Patients may start treatment on any day of the week.
This medicinal product should be taken with fat-containing food. A
fat-containi