Country: Canada
Language: English
Source: Health Canada
TRALOKINUMAB
LEO PHARMA INC
D11AH07
TRALOKINUMAB
150MG
SOLUTION
TRALOKINUMAB 150MG
SUBCUTANEOUS
15G/50G
Prescription
MISC. SKIN AND MUCOUS MEMBRANE AGENTS
Active ingredient group (AIG) number: 0163195001; AHFS:
APPROVED
2021-10-13
_Product Monograph _ _ _ _Pr_ _ADTRALZA_ _®_ _ (tralokinumab injection) _ _Page 1 of 48_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR ADTRALZA ® Tralokinumab injection Single-use pre-filled syringe (150 mg/1 mL) Single-use pre-filled pen (300 mg/2 mL) Solution for subcutaneous injection Immunomodulator, Interleukin inhibitor ATC Code: D11AH07 LEO Pharma Inc. Toronto, Ontario M2H 3S8 www.leo-pharma.ca Date of Initial Authorization: October 13, 2021 Date of Revision: August 4, 2023 Submission Control Number: 270639 ® Registered trademark of LEO Pharma A/S used under license by LEO Pharma Inc. Canada _ _ _Product Monograph _ _ _ _Pr_ _ADTRALZA_ _®_ _ (tralokinumab injection) _ _Page 2 of 48_ RECENT MAJOR LABEL CHANGES 1 Indications 02/2023 1 Indications, 1.1 Pediatrics 02/2023 4 Dosage and Administration, 4.1 Dosing Considerations 02/2023 4 Dosage and Administration, 4.2 Recommended Dose and Dosage Adjustment 07/2023 4 Dosage and Administration, 4.4 Administration 07/2023 7 Warnings and Precautions, 7.1.3 Pediatrics 02/2023 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 Read the complete document