VAN-LETROZOLE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LETROZOLE

Available from:

VANC PHARMACEUTICALS INC

ATC code:

L02BG04

INN (International Name):

LETROZOLE

Dosage:

2.5MG

Pharmaceutical form:

TABLET

Composition:

LETROZOLE 2.5MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0132937001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2019-08-07

Summary of Product characteristics

Page 1 of 59
PRODUCT MONOGRAPH
PR
VAN-LETROZOLE
Letrozole Tablets, USP
2.5 mg Tablets
Non-steroidal aromatase inhibitor; inhibitor of estrogen biosynthesis;
anti-tumour agent
MANUFACTURER AND DISTRIBUTOR:
Vanc Pharmaceuticals Inc.
Date of Preparation:
Building 152, 11782 River Road
September 23, 2014
Richmond, BC V6X 1Z7
www.vancpharm.com
CONTROL NUMBER: 177338
Page 2 of 59
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
3
SUMMARY PRODUCT INFORMATION
3
INDICATIONS AND CLINICAL USE
3
CONTRAINDICATIONS
4
WARNINGS AND PRECAUTIONS
4
ADVERSE REACTIONS
9
DRUG INTERACTIONS
24
DOSAGE AND ADMINISTRATION
26
OVERDOSAGE
27
ACTION AND CLINICAL PHARMACOLOGY
27
STORAGE AND STABILITY
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
29
PART II: SCIENTIFIC INFORMATION
30
PHARMACEUTICAL INFORMATION
30
CLINICAL TRIALS
31
DETAILED PHARMACOLOGY
45
TOXICOLOGY
50
REFERENCES
54
PART III: CONSUMER INFORMATION
56
Page 3 of 59
PR
VAN-LETROZOLE
Letrozole Tablets, USP
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
ROUTE OF ADMINISTRATION
PHARMACEUTICAL
FORM/STRENGTH
CLINICALLY RELEVANT NONMEDICINAL INGREDIENTS
Oral
Tablets, 2.5 mg
Lactose
For a complete listing see _DOSAGE FORMS, _
_COMPOSITION AND PACKAGING_ section
INDICATIONS AND CLINICAL USE
VAN-Letrozole (Letrozole) is indicated for:
•
The adjuvant treatment of postmenopausal women with hormone
receptor-positive invasive
early breast cancer.
Approval was based on superior Disease-Free Survival (DFS) compared to
tamoxifen at a
median follow-up of 26 months. However, overall survival was not
significantly different
between the two treatments (see CLINICAL TRIALS section).
•
The extended adjuvant treatment of hormone receptor-positive invasive
early breast cancer
in postmenopausal women who have received approximately 5 years of
prior standard
adjuvant tamoxifen therapy.
Approval was based on superior Disease-Free Survival (DFS) compared to
placebo in the
overall study population, at a median follow-up of 28 months. However,
overall survival
was not signific