YERVOY SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IPILIMUMAB

Available from:

BRISTOL-MYERS SQUIBB CANADA

ATC code:

L01FX04

INN (International Name):

IPILIMUMAB

Dosage:

5MG

Pharmaceutical form:

SOLUTION

Composition:

IPILIMUMAB 5MG

Administration route:

INTRAVENOUS

Units in package:

10ML/40ML

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0153088001; AHFS:

Authorization status:

APPROVED

Authorization date:

2012-02-01

Summary of Product characteristics

_Product Monograph Master Template _
_Template Date: September 2020 _
YERVOY
®
(ipilimumab for injection)
Page 1 of 74
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
YERVOY®
Ipilimumab for injection
Intravenous Infusion, 5 mg ipilimumab / mL
10 mL and 40 mL vials
Antineoplastic
Pr
YERVOY®, indicated for:
•
in combination with nivolumab, for the treatment of adult patients
with microsatellite
instability-high (MSI-H) or mismatch repair deficient (dMMR)
metastatic colorectal cancer after
prior fluoropyrimidine-based therapy in combination with oxaliplatin
or irinotecan.
An improvement in survival has not yet been established.
has been issued market 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
Pr
YERVOY® 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”
Pr
YERVOY®, indicated for:
•
the treatment of unresectable or metastatic melanoma, as a single
agent.
•
the treatment of unresectable or metastatic melanoma in adults who
have not received prior
systemic therapy for unresectable or metastatic melanoma, when used in
combination with
nivolumab.
•
the treatment of adult patients with intermediate/poor-risk advanced
or metastatic renal cell
carcinoma (RCC), when used in combination with nivolumab.
•
the treatment of adult patients with metastatic non-small cell lung
cancer (NSCLC), expressing
_Product Monograph Master Template _
_Template Date: September 2020 _
YERVOY
®
(ipilimumab for injection)
Page 2 of 74
PD-L1 ≥ 1% as determined by a validated test, with no EGFR or ALK
genomic tumour aberrations,
and no prior systemic therapy for metastatic NSCLC, when used in
combination with nivolumab.
•
the treatment of adult patients with metastatic NSCLC with no EGFR or
ALK genomic tumour
ab