País: Canadá
Língua: inglês
Origem: Health Canada
TEZACAFTOR; IVACAFTOR; IVACAFTOR; ELEXACAFTOR
VERTEX PHARMACEUTICALS (CANADA) INCORPORATED
R07AX32
IVACAFTOR, TEZACAFTOR AND ELEXACAFTOR
25MG; 37.5MG; 75MG; 50MG
TABLET
TEZACAFTOR 25MG; IVACAFTOR 37.5MG; IVACAFTOR 75MG; ELEXACAFTOR 50MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0462989002; AHFS:
APPROVED
2022-04-20
_ _ _ _ _Pr_ _TRIKAFTA_ _®_ _ (elexacaftor/tezacaftor/ivacaftor and ivacaftor) tablets and granules _ _Page 1 of 43_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR TRIKAFTA ® Elexacaftor 100 mg / Tezacaftor 50 mg / Ivacaftor 75 mg Tablets and Ivacaftor 150 mg Tablets Elexacaftor 50 mg / Tezacaftor 25 mg / Ivacaftor 37.5 mg Tablets and Ivacaftor 75 mg Tablets Oral Elexacaftor 100 mg / Tezacaftor 50 mg / Ivacaftor 75 mg Granules and Ivacaftor 75 mg Granules Elexacaftor 80 mg / Tezacaftor 40 mg / Ivacaftor 60 mg Granules and Ivacaftor 59.5 mg Granules Oral Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Corrector and Potentiator ATC R07AX32 Vertex Pharmaceuticals (Canada) Incorporated 20 Bay Street, Suite 1520 Toronto, Ontario M5J 2N8 Date of Initial Authorization: June 17, 2021 Date of Revision: October 13, 2023 Submission Control Number: 271750 _ _ _TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) tablets and granules _ _Page 2 of 43_ RECENT MAJOR LABEL CHANGES 1 Indications 10/2023 1 Indications, 1.1 Pediatrics 10/2023 4 Dosage and administration, 4.2 Recommended Dose and Dosage Adjustment 10/2023 4 Dosage and administration, 4.4 Administration 10/2023 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 ....... Leia o documento completo