Country: Canada
Language: English
Source: Health Canada
IVACAFTOR
VERTEX PHARMACEUTICALS (CANADA) INCORPORATED
R07AX02
IVACAFTOR
150MG
TABLET
IVACAFTOR 150MG
ORAL
56/60
Prescription
Cystic Fibrosis Transmembrane Conductance Regulator Potentiators
Active ingredient group (AIG) number: 0153450001; AHFS:
APPROVED
2012-11-26
_ _ _Pr_ _KALYDECO_ _®_ _ (ivacaftor) Tablets and Granules _ _Page 1 of 43_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR KALYDECO ® Ivacaftor Tablets Tablets: 150 mg, Oral Ivacaftor Granules Granules: 13.4 mg per packet, 25 mg per packet, 50 mg per packet, and 75 mg per packet, Oral Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Potentiator ATC R07AX02 Vertex Pharmaceuticals (Canada) Incorporated 20 Bay Street, Suite 1520 Toronto, Ontario M5J 2N8 Date of Initial Authorization: Nov 26, 2012 Date of Revision: Nov 27, 2023 Submission Control Number: 273575 _ _ _KALYDECO (ivacaftor) Tablets and Granules _ _Page 2 of 43_ RECENT MAJOR LABEL CHANGES 1 Indications 11/2023 1 Indications, 1.1 Pediatrics 11/2023 4 Dosage and Administration 11/2023 7 Warnings and Precautions 11/2023 7 Warnings and Precautions, 7.1.3 Pediatrics 11/2023 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. 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................................................................................ 4 4.2 Recommended Dose and Dosage Adjustment ......................................... Read the complete document