UNITUXIN SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DINUTUXIMAB

Available from:

UNITED THERAPEUTICS CORPORATION

ATC code:

L01FX06

INN (International Name):

DINUTUXIMAB BETA

Dosage:

3.5MG

Pharmaceutical form:

SOLUTION

Composition:

DINUTUXIMAB 3.5MG

Administration route:

INTRAVENOUS

Units in package:

5ML

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0160890001; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-11-28

Summary of Product characteristics

_Unituxin Product Monograph _
_Page 1 of 32_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
UNITUXIN
®
Dinutuximab for injection
3.5 mg/mL Injection for Intravenous Use
Antineoplastic
United Therapeutics Corp.
Research Triangle Park, NC
27709, USA
Imported By:
Unither Biotech Inc.
Magog, QC, J1X 2B4
Date of Initial Approval:
November 28, 2018
Submission Control No: 212066
_Unituxin Product Monograph _
_Page 2 of 32_
TABLE OF CONTENTS
TABLE OF CONTENTS
...............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................. 4
1.
INDICATIONS
...................................................................................................................
4
2
CONTRAINDICATIONS
...................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................ 4
4
DOSAGE AND ADMINISTRATION
..................................................................................
4
4.1
DOSING CONSIDERATIONS
......................................................................................
4
4.2
RECOMMENDED DOSE AND DOSAGE ADJUSTMENT
............................................... 5
4.2.1
RECOMMENDED DOSE
.........................................................................................
5
4.2.2
REQUIRED PRE-TREATMENT AND GUIDELINES FOR PAIN MANAGEMENT AND
INFUSION REACTIONS
.............................................................................................
5
4.2.2.1
REQUIRED PRE-TREATMENT AND GUIDELINES FOR PAIN MANAGEMENT AND
INFUSION REACTIONS DURING ALL UNITUXIN-ADMINISTERED COURSES
................. 5
4.2.2.2
REQUIRED PRETREATMENT AND GUIDELINES FOR PAIN MANAGEMENT AND
INFUSION REACTION WHEN IL-2 IS ADMINISTERED ALONE (COURSE 2 AND 4,
COURSE DAYS 0-3)
..............................................................................