VITRAKVI CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LAROTRECTINIB (LAROTRECTINIB SULFATE)

Available from:

BAYER INC

ATC code:

L01EX12

INN (International Name):

LAROTRECTINIB

Dosage:

100MG

Pharmaceutical form:

CAPSULE

Composition:

LAROTRECTINIB (LAROTRECTINIB SULFATE) 100MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0161630002; AHFS:

Authorization status:

APPROVED

Authorization date:

2019-07-10

Summary of Product characteristics

_VITRAKVI_ _(larotrectinib) Product Monograph_
Page 1 of 37
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
VITRAKVI
®
larotrectinib capsules
25 mg and 100 mg larotrectinib (as larotrectinib sulfate)
larotrectinib oral solution
20 mg/mL larotrectinib (as larotrectinib sulfate)
Antineoplastic Agent
(ATC: L01XE53)
_VITRAKVI, indicated for:_ _ _
_ - the treatment of adult and pediatric patients with solid tumours
that: _
•
_have a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion
without a known _
_acquired resistance mutation, _
•
_are metastatic or where surgical resection is likely to result in
severe morbidity, and _
•
_have no satisfactory treatment options _
_has been issued marketing authorization with conditions, pending the
results of trials to verify _
_its clinical benefit. Patients should be advised of the nature of the
authorization. For further _
_information for VITRAKVI please refer to Health Canada’s Notice of
Compliance with _
_conditions - drug products web site:
https://www.canada.ca/en/health-canada/services/drugs-_
_health-products/drug-products/notice-compliance/conditions.html. _
Bayer Inc.
2920 Matheson Blvd East,
Mississauga, Ontario
L4W 5R6
www.bayer.ca
Date of Initial Authorization:
July 4, 2019
Date of Revision:
August 17, 2023
Submission Control No: 274854
©
2023, Bayer Inc.
® TM see www.bayer.ca/tm-mc
_VITRAKVI_ _(larotrectinib) Product Monograph_
Page 2 of 37
WHAT IS A NOTICE OF COMPLIANCE WITH CONDITIONS (NOC/C)?
_An NOC/c is a form of market approval granted to a product on the
basis of PROMISING _
_evidence of clinical effectiveness following review of the submission
by Health Canada. _
_Products authorized under Health Canada’s NOC/c policy are intended
for the treatment, _
_prevention or diagnosis of a serious, life-threatening or severely
debilitating illness. They _
_have demonstrated promising benefit, are of high quality and possess
an acceptable _
_safety profile based on a benefit/risk assessment. In addition, they
either respond to a _
_se