REDDY-LENALIDOMIDE CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LENALIDOMIDE

Available from:

DR REDDY'S LABORATORIES LTD

ATC code:

L04AX04

INN (International Name):

LENALIDOMIDE

Dosage:

2.5MG

Pharmaceutical form:

CAPSULE

Composition:

LENALIDOMIDE 2.5MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0152422006; AHFS:

Authorization status:

APPROVED

Authorization date:

2021-09-01

Summary of Product characteristics

Page 1 of 105
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATIO N
Pr
REDDY-LENALIDOMIDE
Lenalidomide Capsules
Capsules, 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg, oral
Antineoplastic Agent
Immunomodulatory Agent
Manufactured by:
DR. REDDY’S LABORATORIES LTD.
Bachupally – 500 090 India
Imported and Distributed by:
DR. REDDY’S LABORATORIES CANADA INC.
Mississauga, ON, L4W 4Y1, Canada
Date of Initial Authorization:
Sep 01, 2021
Date of Revision:
Apr 25, 2023
Submission Control Number: 269874
Page 2 of 105
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Immune
04/2023
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 INFORM ATION
....................................................
4
1
INDICATIONS
......................................................................................................
4
1.1
Pediatrics
...............................................................................................
4
1.2
Geriatrics
................................................................................................
4
2
CONTRAINDICATIONS
.......................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................
5
4
DOSAGE AND
ADMINISTRATION .......................................................................
5
4.1
Dosing
Considerations
.............................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................
6
4.4
Administration
......................................................................................
11
4.5
Missed Dose
...............................................................