YERVOY SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

IPILIMUMAB

Tersedia dari:

BRISTOL-MYERS SQUIBB CANADA

Kode ATC:

L01FX04

INN (Nama Internasional):

IPILIMUMAB

Dosis:

5MG

Bentuk farmasi:

SOLUTION

Komposisi:

IPILIMUMAB 5MG

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

10ML/40ML

Jenis Resep:

Prescription

Area terapi:

ANTINEOPLASTIC AGENTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2012-02-01

Karakteristik produk

_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