ODEFSEY TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

EMTRICITABINE; RILPIVIRINE (RILPIVIRINE HYDROCHLORIDE); TENOFOVIR ALAFENAMIDE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)

Available from:

GILEAD SCIENCES CANADA INC

ATC code:

J05AR19

INN (International Name):

EMTRICITABINE, TENOFOVIR ALAFENAMIDE AND RILPIVIRINE

Dosage:

200MG; 25MG; 25MG

Pharmaceutical form:

TABLET

Composition:

EMTRICITABINE 200MG; RILPIVIRINE (RILPIVIRINE HYDROCHLORIDE) 25MG; TENOFOVIR ALAFENAMIDE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE) 25MG

Administration route:

ORAL

Units in package:

30

Prescription type:

Prescription

Therapeutic area:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0358830001; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-02-10

Summary of Product characteristics

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ODEFSEY
®
(EMTRICITABINE/RILPIVIRINE/TENOFOVIR ALAFENAMIDE) TABLETS
200 mg emtricitabine
25 mg rilpivirine (as rilpivirine hydrochloride)
25 mg tenofovir alafenamide (as tenofovir alafenamide hemifumarate)
ANTIRETROVIRAL AGENT
Gilead Sciences Canada, Inc.
Mississauga, ON L5N 2W3
www.gilead.ca
Submission Control No: 229507
Date of Initial Approval:
February 10, 2017
Date of Revision:
November 13, 2019
ODEFSEY (emtricitabine/rilpivirine*/tenofovir alafenamide**) tablets
*as rilpivirine hydrochloride **as tenofovir alafenamide hemifumarate
Product Monograph
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_Page 2 of 97_
RECENT MAJOR LABEL CHANGES
Serious Warnings and Precautions Box (3)
06/2018
Dosage and Administration, Dosing Considerations (4.1)
10/2019
Dosage and Administration, Recommended Dose and Dose Adjustment (4.2)
12/2018
Warnings and Precautions, General (7)
10/2019
Warnings and Precautions, Cardiovascular (7)
10/2019
Warnings and Precautions, Serum Lipids and Blood Glucose (7)
06/2018
Warnings and Precautions, Gastrointestinal (7)
01/2018
Warnings and Precautions, Lactic Acidosis/Severe Hepatomegaly with
Steatosis
(7)
06/2018
Warnings and Precautions, Musculoskeletal (7)
06/2018
Warnings and Precautions, Renal (7)
10/2019
Warnings and Precautions, Risk of Adverse Reactions or Loss of
Virologic
Response Due to Drug Interactions (7)
10/2019
Warnings and Precautions, Special Populations, Pregnant Women (7.1.2)
12/2018
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
...........................................................................................................
2
TABLE OF CONTENTS
................................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................................................
4
1.
INDICATIONS
....................................................................................................................................