A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Rebif Indications, Dosage, Storage, Stability - Interferon beta-1a
Rebif Indications, Dosage, Storage, Stability - Interferon beta-1a
INDICATIONS AND USAGE
Rebif® (interferon beta-1a) is indicated for
the treatment of patients with relapsing forms of multiple sclerosis to decrease
the frequency of clinical exacerbations and delay the accumulation of physical
disability. Efficacy of Rebif® in chronic progressive multiple
sclerosis has not been established.
DOSAGE AND ADMINISTRATION
Dosages of Rebif® shown to be safe and effective
are 22 mcg and 44 mcg injected subcutaneously three times per week. Rebif®
should be administered, if possible, at the same time (preferably in the
late afternoon or evening) on the same three days (e.g. Monday, Wednesday, and
Friday) at least 48 hours apart each week (see CLINICAL
STUDIES). Generally, patients should be started
at 20% of the prescribed dose tiw and increased over a 4-week period to the
targeted dose, either 22 mcg or 44 mcg tiw (see Table 4). Following the administration
of each dose, any residual product remaining in the syringe should be discarded
in a safe and proper manner.
|
Table 4: Schedule for Patient Titration
|
|
| |
Recommended
titration
% of final
|
Titration dose
for Rebif®
22 mcg
|
Titration dose
for Rebif®
44 mcg
|
Injection
Volume
|
|
Weeks 1–2
|
20%
|
4.4 mcg
|
8.8 mcg
|
0.1 mL
|
|
Weeks 3–4
|
50%
|
11 mcg
|
22 mcg
|
0.25 mL
|
|
Weeks 5+
|
100%
|
22 mcg
|
44 mcg
|
0.5 mL
|
Leukopenia or elevated liver function tests may necessitate
dose reductions of 20 – 50% until toxicity is resolved (see WARNINGS:
Hepatic Injury and PRECAUTIONS: General).
Rebif® is intended for use under the guidance
and supervision of a physician. It is recommended that physicians or qualified
medical personnel train patients in the proper technique for self-administering
subcutaneous injections using the prefilled syringe. Patients should be advised
to rotate sites for sc injections (see PRECAUTIONS:
Information for Patients). Concurrent use of analgesics and/or antipyretics
may help ameliorate flu-like symptoms on treatment days. Rebif® should
be inspected visually for particulate matter and discoloration prior to administration.
Stability and Storage
Rebif® should be stored refrigerated between
2-8°C (36-46°F). DO NOT FREEZE. If a refrigerator is not available, Rebif®
may be stored at or below 25°C/77°F for up to 30 days and away from heat
and light.
Do not use beyond the expiration date printed on packages.
Rebif® contains no preservatives. Each syringe is intended for
single use. Unused portions should be discarded.
HOW SUPPLIED
Rebif® is supplied as a sterile, preservative-free
solution packaged in graduated, ready to use 0.5 mL prefilled syringes with
29- gauge, 0.5 inch needle for subcutaneous injection. The following package
presentations are available.
Rebif® (interferon beta -1a) 22 mcg Prefilled
syringe
- One Rebif® 22 mcg prefilled syringes, NDC 44087-0022-1
- Twelve Rebif® 22 mcg prefilled syringes, NDC 44087-0022-3
Rebif® (interferon beta -1a) 44 mcg Prefilled
syringe
- One Rebif® 44 mcg prefilled syringe, NDC 44087-0044-1
- Twelve Rebif® 44 mcg prefilled syringes, NDC 44087-0044-3
Manufacturer: Serono, Inc. Rockland,
MA 02370 U.S. Licence # 1574, Co-Marketed by: Serono, Inc., Rockland, MA
02370 Pfizer Inc, New York, NY 10017 Revised: March 2004, *Avonex® is
a registered trademark of Biogen Idec Inc., N6700101B 11/04
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