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
Roferon-A Indications, Dosage, Storage, Stability - Peginterferon alfa-2b
Roferon-A Indications, Dosage, Storage, Stability - Peginterferon alfa-2b
INDICATIONS
AND USES
PEG-Intron, peginterferon alfa-2b, monotherapy is indicated for the treatment
of chronic hepatitis C in patients not previously treated with interferon alpha
who have compensated liver disease and are at least 18 years of age. The safety
and efficacy of peginterferon alfa-2b (PEG-Intron) in combination with ribavirin
(REBETOL) for the treatment of chronic hepatitis C have not been established.
DOSAGE AND ADMINISTRATION
A patient should self-inject only if the physician determines that it is appropriate
and the patient agrees to medical follow-up as necessary and training in proper
injection technique has been given to him/her. (See illustrated MEDICATION
GUIDE for instructions.)
PEG-Intron is administered subcutaneously once weekly for one year. The dose
should be administered on the same day of each week. Initial dosing should be
based on weight as described in Table 3.
TABLE 3. Recommended Dosing
Vial Strength*
to Use
(µg/mL) |
Weight
(kg) |
Amount of
PEG-Intron
to Administer (µg) |
Volume of
PEG-Intron *
to Administer (mL) |
| 100 |
37-45
46-56 |
40
50 |
0.4
0.5 |
| 160 |
57-72
73-88 |
64
80 |
0.4
0.5 |
| 240 |
89-106
107-136 |
96
120 |
0.4
0.5 |
| 300 |
137-160 |
150 |
0.5 |
| * When reconstituted as directed |
Serum HCV RNA levels should be assessed after 24 weeks of treatment. Discontinuation
of treatment should be considered in any patient who has not achieved an HCV
RNA below the limit of detection of the assay after 24 weeks of therapy with
PEG-Intron. (See CLINICAL STUDIES .)
There are no safety and efficacy data for treatment longer than 48 weeks or
for re-treatment of patients who relapse following PEG-Intron therapy.
Dose Reduction
If a serious adverse reaction develops during the course of treatment (see
WARNINGS) discontinue or modify the dosage of PEG-Intron to one-half
the starting dosage until the adverse event abates or decreases in severity.
If persistent or recurrent intolerance develops despite adequate dosage adjustment,
discontinue treatment with PEG-Intron. For dose modification in the event of
neutropenia and thrombocytopenia see Table 4.
TABLE 4. Guidelines for Dose Modifications
for Neutropenia and Thrombocytopenia
| |
Dose Reduction |
Permanent Discontinuation |
|
Neutrophil Count
|
<0.75 × 10 9 /L |
<0.50 × 10 9 /L |
|
Platelet Count
|
<80 × 10 9 /L |
<50 × 10 9 /L |
Preparation and Administration
Two B-D Safety Lok™ syringes are provided in the package; one syringe is for
the reconstitution steps and one for the patient injection. There is a plastic
safety sleeve to be pulled over the needle after use. The syringe locks with
an audible click when the green stripe on the safety sleeve covers the red stripe
on the needle. Brief instructions for the preparation and administration of
PEG-Intron Powder for Injection are provided below. Please refer to the MEDICATION
GUIDE for detailed, step by step instructions.
Reconstitute the PEG-Intron lyophilized product with only 0.7 mL of supplied
diluent (Sterile Water for Injection, USP). The diluent vial is for single
use only. The remaining diluent should be discarded. No other medications
should be added to solutions containing PEG-Intron, and PEG-Intron should not
be reconstituted with other diluents. Swirl gently to hasten complete dissolution
of the powder. The reconstituted solution should be clear and colorless. Visually
inspect the solution for particulate matter and discoloration prior to administration.
The solution should not be used if discolored or cloudy, or if particulates
are present. (See MEDICATION GUIDE for detailed instructions).
The reconstituted solution should be used immediately and cannot be stored
for more than 24 hours at 2°-8°C (see Storage ). The appropriate PEG-Intron
dose should be withdrawn and injected subcutaneously. (See MEDICATION GUIDE
for detailed instructions.) The PEG-Intron vial is a single use vial and
does not contain a preservative. DO NOT REENTER VIAL. DISCARD UNUSED PORTION.
Once the dose from a single dose vial has been withdrawn, the sterility
of any remaining product can no longer be guaranteed. Pooling of unused portions
of some medications has been linked to bacterial contamination and morbidity.
After preparation and administration of the PEG-Intron injection, it is essential
to follow the procedure for proper disposal of syringes and needles. A puncture-resistant
container should be used for disposal of syringes. Patients should be instructed
in the technique and importance of proper syringe disposal and be cautioned
against reuse of these items (see MEDICATION GUIDE for detailed instructions.)
Storage
PEG-Intron, should be stored at 25°C (77°F): excursions permitted to 15-30°C
(59-86°F)[see USP Controlled Room Temperature]. After reconstitution with supplied
Diluent the solution should be used immediately, but may be stored up to 24
hours at 2° to 8°C (36° to 46°F). The reconstituted solution contains no preservative,
is clear and colorless. Do not freeze.
HOW SUPPLIED
PEG-Intron is a white to off-white lyophilized powder supplied in 2-mL vials.
The PEG-Intron Powder for Injection should be reconstituted with 0.7 mL of the
supplied Diluent (Sterile Water for Injection, USP) prior to use.
| |
Each PEG-Intron Package Contains:
|
|
For Patients
37-56 kg |
A box containing one 100 µg/mL vial of PEG-Intron Powder
for Injection and one 5 mL vial of Diluent (Sterile Water for Injection,
USP), 2 B-D Safety Lok™ syringes with a safety sleeve and 2 alcohol
swabs.
|
(NDC 0085-1368-01) |
For Patients
57-88 kg |
A box containing one 160 µg/mL vial of PEG-Intron Powder
for Injection and one 5 mL vial of Diluent (Sterile Water for Injection,
USP), 2 B-D Safety Lok™ syringes with a safety sleeve and 2 alcohol
swabs.
|
(NDC 0085-1291-01) |
For Patients
89-136 kg |
A box containing one 240 µg/mL vial of PEG-Intron Powder
for Injection and one 5 mL vial of Diluent (Sterile Water for Injection,
USP), 2 B-D Safety Lok™ syringes with a safety sleeve and 2 alcohol
swabs.
|
(NDC 0085-1304-01) |
For Patients
137-160 kg |
A box containing one 300 µg/mL vial of PEG-Intron Powder
for Injection and one 5 mL vial of Diluent (Sterile Water for Injection,
USP), 2 B-D Safety Lok™ syringes with a safety sleeve and 2 alcohol
swabs.
|
(NDC 0085-1279-01) |
Schering Corporation
Kenilworth, NJ 07033 USA
Copyright © 2001, Schering Corporation. All rights reserved.
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