ROFERON-A SOLN-LIQ IM SC 9MILLION I.U./ML SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

INTERFERON ALPHA-2A

Available from:

HOFFMANN-LA ROCHE LIMITED

ATC code:

L03AB04

INN (International Name):

INTERFERON ALFA-2A

Dosage:

9M

Pharmaceutical form:

SOLUTION

Composition:

INTERFERON ALPHA-2A 9M

Administration route:

INTRAMUSCULAR

Units in package:

1ML

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0121068015; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2004-11-01

Summary of Product characteristics

PRODUCT MONOGRAPH
ROFERON®-A
(interferon alfa-2a)
Solution for Injection
Biological Response Modifier
Manufactured by:
Hoffmann-La Roche Inc.
Nutley, New Jersey 07110
U.S.A.
or
F. Hoffmann-La Roche Limited
CH-4002 Basle
Switzerland
Distributed by:
DATE OF APPROVAL:
HOFFMANN-LA ROCHE LIMITED
July 22, 2002
2455 MEADOWPINE BOULEVARD
MISSISSAUGA, ONTARIO
L5N 6L7
®
Registered Trademark
© Copyright 1998-2002, Hoffmann-La Roche Limited
CDS Version 1.0
Control #: 077714
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NAME OF DRUG
ROFERON
®
-A
(interferon alfa-2a)
Solution for Injection
THERAPEUTIC CLASSIFICATION
Biological Response Modifier
ACTIONS AND CLINICAL PHARMACOLOGY
The mechanisms by which ‘Roferon’-A (interferon alfa-2a), or any
other interferon, exerts
antitumor activity are not clearly understood. However, it is believed
that the direct
antiproliferative action against tumor cells and modulation of the
host immune response play
important roles in the antitumor activity.
‘Roferon’-A has been shown to exert antiproliferative activity
against a variety of human tumors in
vitro and to inhibit the growth of some human tumor xenografts in
immunocompromised (nude)
mice.
1
The serum concentrations of interferon alfa-2a exhibited a large
intersubject variation in both
healthy volunteers and patients with disseminated cancer.
The pharmacokinetics of ‘Roferon’-A in man are linear over a 3 to
198 million IU dose range. In
healthy people, recombinant interferon alfa-2a exhibited an
elimination half-life of 3.7 to 8.5 hours
(mean 5.1 hours)
2
, volume of distribution at steady-state of 0.223 to 0.748 L/kg (mean
0.400 L/kg)
and a total body clearance of 2.14 to 3.62 mL/min/kg (mean 2.79
mL/min/kg) after a 36 million IU
(2.2 x 10
8
pg) intravenous infusion. Renal catabolism is the major pathway for
‘Roferon’-A
elimination; biliary excretion and liver metabolism are minor
pathways. After intramuscular and
subcutaneous administrations of 36 million IU,