ORKAMBI GRANULES

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LUMACAFTOR; IVACAFTOR

Available from:

VERTEX PHARMACEUTICALS (CANADA) INCORPORATED

ATC code:

R07AX30

INN (International Name):

IVACAFTOR AND LUMACAFTOR

Dosage:

100MG; 125MG

Pharmaceutical form:

GRANULES

Composition:

LUMACAFTOR 100MG; IVACAFTOR 125MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

Cystic Fibrosis Transmembrane Conductance Regulator Correctors

Product summary:

Active ingredient group (AIG) number: 0257771002; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-12-11

Summary of Product characteristics

_Pr_
_ORKAMBI_
®
_ (Lumacaftor/Ivacaftor Tablets and Granules)_
_ _
_Page 1 of 47_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ORKAMBI
®
Lumacaftor / Ivacaftor Tablets 100 mg / 125 mg, Oral
Lumacaftor / Ivacaftor Tablets 200 mg / 125 mg, Oral
Lumacaftor / Ivacaftor Granules 75 mg / 94 mg, Oral
Lumacaftor / Ivacaftor Granules 100 mg / 125 mg, Oral
Lumacaftor / Ivacaftor Granules 150 mg / 188 mg, Oral
Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Corrector
and Potentiator
ATC R07AX30
Vertex Pharmaceuticals (Canada) Incorporated
20 Bay Street, Suite 1520
Toronto, Ontario
M5J 2N8
Date of Initial Authorization:
January 25, 2016
Date of Revision:
April 6, 2023
Submission Control Number: 264825
_Pr_
_ORKAMBI_
®
_ (Lumacaftor/Ivacaftor Tablets and Granules)_
_ _
_Page 2 of 47_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS 1.1 Pediatrics
04/2023
2 DOSAGE AND ADMINISTRATION 4.1 Dosing Considerations
04/2023
2 DOSAGE AND ADMINISTRATION 4.2 Recommended Dose and
Dosage Adjustment
04/2023
2 DOSAGE AND ADMINISTRATION 4.4 Administration
04/2023
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES ...............................................................................
2
TABLE OF CONTENTS ......................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION ...................................................... 4
1
INDICATIONS ...........................................................................................................
4
1.1
Pediatrics
................................................................................................................
4
1.2
Geriatrics
................................................................................................................
4
2
CONTRAINDICATIONS ...........................................................................................
4
4
DOSAGE AND ADMINISTRATION ........................................................................
4
4.1
Dosing Considerations