Peg-Intron
INDICATIONS
Chronic Hepatitis C
Combination therapy
PegIntron (peginterferon alfa-2b) ® in combination with REBETOL® (ribavirin) is indicated for the treatment of chronic hepatitis C in patients 3 years of age and older with compensated liver disease.
The following points should be considered when initiating therapy with PegIntron (peginterferon alfa-2b) in combination with REBETOL:
- These indications are based on achieving undetectable HCV-RNA after treatment for 24 or 48weeks andmaintaining a Sustained Virologic Response (SVR) 24weeks after the last dose.
- Patients with the following characteristics are less likely to benefit from re-treatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection [see Clinical Studies].
- No safety and efficacy data are available for treatment of longer than 1 year.
Monotherapy (for patients who are intolerant to ribavirin)
PegIntron (Peginterferon alfa-2b) is indicated for use alone for the treatment of chronic hepatitis C in patients with compensated liver disease previously untreated with interferon alpha and who are at least 18 years of age.
The following point should be considered when initiating therapy with PegIntron (peginterferon alfa-2b) alone:
- Combination therapy with REBETOL is preferred over PegIntron (peginterferon alfa-2b) monotherapy unless there are contraindications to or significant intolerance of REBETOL. Combination therapy provides substantially better response rates than monotherapy [see Clinical Studies].
DOSAGE AND ADMINISTRATION
PegIntron (peginterferon alfa-2b) /REBETOL Combination Therapy
REBETOL should be taken with food. REBETOL should not be used in patients with creatinine clearance < 50 mL/min.
Adults
The recommended dose of PegIntron (peginterferon alfa-2b) is 1.5 mcg/kg/week subcutaneously in combination with 800 to 1400 mg of REBETOL orally based on patient body weight. The volume of PegIntron (peginterferon alfa-2b) to be injected depends on the strength of PegIntron (peginterferon alfa-2b) and patient's body weight (see Table 1).
Duration of Treatment – Interferon Alpha-naïve Patients
The treatment duration for patients with genotype 1 is 48 weeks. Discontinuation of therapy should be considered in patients who do not achieve at least a 2 log10 drop or loss of HCV-RNA at 12 weeks, or if HCV-RNA remains detectable after 24 weeks of therapy. Patients with genotype 2 and 3 should be treated for 24 weeks.
Duration of Treatment – Re-treatment with PegIntron (peginterferon alfa-2b) /REBETOL of Prior Treatment Failures
The treatment duration for patients who previously failed therapy is 48 weeks, regardless of HCV genotype.
Re-treated patients who fail to achieve undetectable HCV-RNA at Week 12 of therapy, or whose HCV-RNA remains detectable after 24 weeks of therapy, are highly unlikely to achieve SVR and discontinuation of therapy should be considered [see Clinical Studies].
TABLE 1: Recommended PegIntron (peginterferon alfa-2b) Combination Therapy Dosing
(Adults)
| Body weight kg (lbs) | PegIn tron REDIPEN® or Vial Strength to Use |
Amount of PegIntron (mcg) to Administer |
Volume (mL)* of PegIntron (peginterferon alfa-2b) to Administer |
REBETOL Daily Dose |
REBETOL Number of Capsules |
| < 40 | 50 mcg per 0.5 mL | 50 | 0.5 | 800 mg/day | 2 x 200 mg capsules a.m. |
| ( < 88) | 2 x 200 mg capsules p.m. | ||||
| 40-50 | 80 mcg per 0.5 mL | 64 | 0.4 | 800 mg/day | 2 x 200 mg capsules a.m. |
| 8 (8-111) | 2 x 200 mg capsules p.m. | ||||
| 51-60 | 80 | 0.5 | 800 mg/day | 2 x 200 mg capsules a.m. | |
| (112-133) | 2 x 200 mg capsules p.m. | ||||
| 61-65 | 120 mcg per 0.5 mL | 96 | 0.4 | 800 mg/day | 2 x 200 mg capsules a.m. |
| (134-144) | 2 x 200 mg capsules p.m. | ||||
| 66-75 | 96 | 0.4 | 1000 mg/day | 2 x 200 mg capsules a.m. | |
| (145-166) | 3 x 200 mg capsules p.m. | ||||
| 76-80 | 120 | 0.5 | 1000 mg/d ay | 2 x 200 mg capsules a.m. | |
| (167-177) | 3 x 200 mg capsules p.m. | ||||
| 81-85 | 150 mcg per 0.5 mL | 120 | 0.5 | 1200 mg/d ay | 3 x 200 mg capsules a.m. |
| (178-187) | 3 x 200 mg capsules p.m. | ||||
| 86-1 05 | 150 | 0.5 | 1200 mg/d ay | 3 x 200 mg capsules a.m. | |
| (188-231) | 3 x 200 mg capsules p.m. | ||||
| > 105 | † | † | † | 1400 mg/day | 3 x 200 mg capsules a.m. |
| ( > 231) | 4 x 200 mg capsules p.m. | ||||
| * When reconstituted as directed. † For patients weighing > 105 kg ( > 231 pounds), the PegIntron dose of 1.5mcg/kg/week should be calculated based on the individual patientweight. Two vials ofPegIntronmay be necessary to provide the dose. |
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Pediatric Patients
Dosing for pediatric patients is determined by body surface area for PegIntron (peginterferon alfa-2b) and by body weight for REBETOL. The recommended dose of PegIntron (peginterferon alfa-2b) is 60 mcg/m²/week subcutaneously in combination with 15 mg/kg/day of REBETOL orally in 2 divided doses (see Table 2) for pediatric patients ages 3 to 17 years. Patients who reach their 18th birthday while receiving PegIntron (peginterferon alfa-2b) /REBETOL should remain on the pediatric dosing regimen. The treatment duration for patients with genotype 1 is 48 weeks. Patients with genotypes 2 and 3 should be treated for 24 weeks.
TABLE 2: Recommended REBETOL* Dosing in Combination Therapy
(Pediatrics)
| Body weight kg (lbs) | REBETOL DailyDose | REBETOL Number of Capsules |
| < 47 | 15 mg/kg/day | Use REBETOL Oral Solution† |
| ( < 103) | ||
| 47-5 9 | 800 mg/day | 2 x 200 mg capsules a.m. |
| 1 ( 03-1 31) | 2 x 200 mg capsule s p.m . | |
| 60-7 3 | 1000 mg/day | 2 x 200 mg capsules a.m. |
| 1 ( 32-1 62) | 3 x 200 mg capsule s p.m . | |
| > 73 | 1200 mg/day | 3 x 200 mg capsules a.m. |
| ( > 162) | 3 x 200 mg capsule s p.m . | |
| * REBETOL to be used in combination with PegIntron (peginterferon alfa-2b) 60 mcg/m²
weekly. † REBETOL Oral Solution may be used for any patient regardless of body weight. |
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PegIntron (peginterferon alfa-2b) Monotherapy
The recommended dose of PegIntron (peginterferon alfa-2b) regimen is 1 mcg/kg/week subcutaneously for 1 year administered on the same day of the week. Discontinuation of therapy should be considered in patients who do not achieve at least a 2 log10 drop or loss of HCV-RNA at 12 weeks of therapy, or whose HCV-RNA levels remain detectable after 24 weeks of therapy. The volume of PegIntron (peginterferon alfa-2b) to be injected depends on patient weight (see Table 3).
TABLE 3: Recommended PegIntron (peginterferon alfa-2b) Monotherapy Dosing
| Body weight kg (lbs) |
PegIn tron REDIPEN or Vial Strength to Use | Amount of PegIntron (mcg) to Administer |
Volume(mL)* of PegIntron to Administer |
| ≤ 45 | 50 mcg per 0.5 mL | 40 | 0.4 |
| ( ≤ 100) | |||
| 46-56 | 50 | 0.5 | |
| (101-124) | |||
| 57-72 | 80 mcg per 0.5 mL | 64 | 0.4 |
| (125-159) | |||
| 73-88 | 80 | 0.5 | |
| (160-195) | |||
| 89-106 | 120 mcg per 0.5 mL | 96 | 0.4 |
| (196-234) | |||
| 107-136 | 120 | 0.5 | |
| (235-300) | |||
| 137-160 | 150 mcg per 0.5 mL | 150 | 0.5 |
| (301-353) | |||
| * When reconstituted as directed. | |||
Dose Reduction
If a serious adverse reaction develops during the course of treatment [see WARNINGS AND PRECAUTIONS] discontinue or modify the dosage of PegIntron (peginterferon alfa-2b) and REBETOL until the adverse event abates or decreases in severity. If persistent or recurrent serious adverse events develop despite adequate dosage adjustment, discontinue treatment. For guidelines for dose modifications and discontinuation based on depression or laboratory parameters, see Tables 4 and 5. Dose reduction of PegIntron (peginterferon alfa-2b) in adult patients on PegIntron (peginterferon alfa-2b) /REBETOL combination therapy is accomplished in a two-step process from the original starting dose of 1.5 mcg/kg/week, to 1 mcg/kg/week, then to 0.5 mcg/kg/week, if needed. Dose reduction in patients on PegIntron (peginterferon alfa-2b) monotherapy is accomplished by reducing the original starting dose of 1mcg/kg/week to 0.5mcg/kg/week.Dose reduction of PegIntron (peginterferon alfa-2b) in adultsmay be accomplished by utilizing a lower dose strength or administering a lesser volume as shown in Table6 or 7.
In the adult combination therapy Study 2, dose reductions occurred in 42% of subjects receiving PegIntron (peginterferon alfa-2b) 1.5 mcg/kg plus REBETOL 800 mg daily, including 57% of those subjects weighing 60 kg or less. In Study 4, 16%of subjects had a dose reduction of PegIntron (peginterferon alfa-2b) to 1 mcg/kg in combination with REBETOL, with an additional 4%requiring the second dose reduction of PegIntron (peginterferon alfa-2b) to 0.5mcg/kg due to adverse events [see ADVERSE REACTIONS].
Dose reduction in pediatric patients is accomplished by modifying the recommended dose in a 2-step process from the original starting dose of 60 mcg/m²/week, to 40 mcg/m²/week, then to 20mcg/m²/ week, if needed (see Tables 4 and 5). In the pediatric combination therapy trial, dose reductions occurred in 25%of subjects receiving PegIntron (peginterferon alfa-2b) 60mcg/m²weekly plusREBETOL 15mg/kg daily.
TABLE 4: Guidelines for Modification or Discontinuation of
PegIntron (peginterferon alfa-2b) or PegIntron (peginterferon alfa-2b) /REBETOL and for Scheduling Visits for PatientsWith Depression
| Depression Severity* |
Initial Management (4-8 weeks) | Depression Status | |||
| Dose Modification | Visit Schedule | Remains Stable | Improves | Worsens | |
| Mild | No change | Evaluate once weekly by visit or phone. | Continue weekly visit schedule. | Resume normal visit schedule. | See moderate or severe depression |
| Moderate | Adults: Adjust Dose Pediatrics: Decrease dose to 40 mcg/m²/week, then to 20 mcg/m²/week, if neededq | Evaluate once weekly (office visit at least every other week). | Consider psychiatric consultation. Continue reduced dosing. | If symptoms improve and are stable for 4 weeks, may resume normal visit schedule. Continue reduced dosing or return to normal dose. | See severe depression |
| Severe | Discontinue PegIntron/ REBETOL permanently. | Obtain immediate psychiatric consultation. | Psychiatric therapy as necessary | ||
| * See DSM-IV for definitions. For patients on PegIntron/REBETOL combination therapy: 1st dose reduction of PegIntron is to 1 mcg/kg/week, 2nd dose reduction (if needed) of PegIntron is to 0.5 mcg/kg/week. For patients on PegIntron monotherapy: decrease PegIntron dose to 0.5 mcg/kg/week. | |||||
TABLE 5: Guidelines for Dose Modification and Discontinuation
of PegIntron (peginterferon alfa-2b) or PegIntron (peginterferon alfa-2b) /REBETOL Based on Laboratory Parameters in Adults and
Pediatrics
| PegIntron | REBETOL | |||
| Labora tory Values | Adults | Pediatrics | Adults | Pediatrics |
| Hgb < 10 g/dL | For patients with cardiac disease, reduce by 50%* | See footnote* | Adjust Dose† | 1st reduction to 12 mg/kg/day 2nd reduction to 8 mg/kg/day |
| WBC < 1.5 x 109/L |
Adjust Dose‡ | 1st reduction to 40 mcg/m²/week 2nd reducti on to 20 mcg/m²/week | No dose change | No dose change |
| Neutrophils < 0.7 5 x 109/L |
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| Pla telets < 50 x 109/L (Adults) <70 x 109/L (Pediatrics) |
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| Hgb < 8.5 g/dL |
Permanently discontinue | Permanently discontinue | Permanently discontinue | Permanently discontinue |
| WBC < 1 x 109/L |
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| Neutrophils < 0.5 x 109/ L |
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| Pla telets <25 x 109/L (Adults) < 50 x 109/L(Pediartics) |
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| Creatinine > 2 mg/dL (Pediatrics) |
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| * For adult patients with a history of stable cardiac disease
receiving PegIntron (peginterferon alfa-2b) in combination with ribavirin, the PegIntron (peginterferon alfa-2b) dose
should be reduced by half and the ribavirin dose by 200 mg/day if a > 2
g/dL decrease in hemoglobin is observed during any 4-week period. Both
PegIntron (peginterferon alfa-2b) and ribavirin should be permanently discontinued if patients
have hemoglobin levels < 12 g/dL after this ribavirin dose reduction.
Pediatric patients who have pre-existing cardiac conditions and experience
a hemoglobin decrease ≥ 2 g/dL during any 4-week period during treatment
should have weekly evaluations and hematology testing. † 1st dose reduction of REBETOL is by 200 mg/day, except in patients receiving the 1400 mg dose it is by 400 mg/day; 2nd dose reduction of REBETOL (if needed) is by an additional 200 mg/day. ‡ For patients on PegIntron (peginterferon alfa-2b) /REBETOL combination therapy: 1st dose reduction of PegIntron (peginterferon alfa-2b) is to 1 mcg/kg/week, 2nd dose reduction (if needed) of PegIntron (peginterferon alfa-2b) is to 0.5 mcg/kg/week. For patients on PegIntron (peginterferon alfa-2b) monotherapy: decrease PegIntron (peginterferon alfa-2b) dose to 0.5 mcg/kg/week. |
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TABLE 6: Reduced PegIntron (peginterferon alfa-2b) Dose (0.5 mcg/kg) for (1 mcg/kg)
Monotherapy in Adults
| Body weight kg (lbs) |
PegIntron REDIPEN/Vial Strength to Use | Amount of PegIntron (mcg) to Administer | Volume(mL)† of PegIntron toAdminister |
| ≤ 5 | 50 mcg per 0.5 mL* | 20 | 0.2 |
| ( ≤ 100) | |||
| 46-56 | 50 mcg per 0.5 mL | 25 | 0.2 5 |
| (101-124) | |||
| 57-72 | 30 | 0.3 | |
| (125-159) | |||
| 73-88 | 40 | 0.4 | |
| (160-195) | |||
| 89-1 06 | 50 mcg per 0.5 mL | 50 | 0.5 |
| (196-234) | |||
| 107-136 | 64 | 0.4 | |
| (235-300) | |||
| ≥ 137 | 80 mcg per 0.5 mL | 80 | 0.5 |
| ( ≥ 301) | |||
| * Must use vial. Minimum delivery for REDIPEN 0.3 mL. † When reconstituted as directed. |
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TABLE 7: Two-Step Dose Reduction of PegIntron (peginterferon alfa-2b) in Combination
Therapy in Adults
| First DoseReduction to PegIntron 1 mcg/kg | Second Dose Reduction to PegIntron 0.5 mcg/kg | ||||||
| Body weight kg (lbs) |
PegIntron (peginterferon alfa-2b) REDIPEN/ Vial Strength to Use |
Amount of PegIntron (peginterferon alfa-2b) (mcg) to Administer |
Volume (mL)† of PegIntron (peginterferon alfa-2b) to Administer |
Body weight kg (lbs) |
PegIntron (peginterferon alfa-2b) REDIPEN/ Vial Strength to Use |
Amount of PegIntron (peginterferon alfa-2b) (mcg) to Administer |
Volume (mL)† of PegIntron (peginterferon alfa-2b) to Administer |
| > 40 | 50 mcg per 0.5 mL | 35 | 0.35 | < 40 | 50 mcg per 0.5 mL* | 20 | 0.2 |
| ( < 88) | ( < 88) | ||||||
| 40 – 50 | 45 | 0.45 | 40 – 50 | 25 | 0.2 5 | ||
| (88 – 111) | 8 (8 – 111) | ||||||
| 51 – 60 | 50 | 0.5 | 51 – 60 | 30 | 0.3 | ||
| (112–133) | 1 (12–133) | ||||||
| 61 – 75 | 80 mcg per0.5 mL | 64 | 0.4 | 61 – 75 | 50 mcg per 0.5 mL | 35 | 0.3 5 |
| (134–166) | (134-166) | ||||||
| 76 – 85 | 80 | 0.5 | 76 – 85(167-187) | 45 | 0.4 5 | ||
| (167-1 87) | |||||||
| 86-104 | 120 mcg per 0.5 mL | 96 | 0.4 | 86-104 | 50 mcg per 0.5 mL | 50 | 0.5 |
| (188 -230) | (188-230) | ||||||
| 105 – 125 | 108 | 0.45 | 105 – 125 | 80 mcg per 0.5 mL | 64 | 0.4 | |
| (231-275) | (231-275) | ||||||
| > 125 | 150 mcg per | 135 | 0.45 | > 125 | 72 | 0.45 | |
| ( > 275) | 0.5 mL | ( > 275) | |||||
| * Must use vial. Minimum delivery for REDIPEN 0.3 mL. † When reconstituted as directed. |
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Discontinuation of Dosing
Adults
It is recommended that HCV genotype 1 interferon-alfa-naïve patients receiving PegIntron (peginterferon alfa-2b) , alone or in combination with ribavirin, be discontinued from therapy if there is not at least a 2 log10 drop or loss of HCV-RNA at 12 weeks of therapy, or whose HCV-RNA levels remain detectable after 24 weeks of therapy. Regardless of genotype, previously treated patients who have detectable HCV-RNA at Week 12 or 24, are highly unlikely to achieve SVR and discontinuation of therapy should be considered.
Pediatrics (3-17 years of age)
It is recommended that patients receiving PegIntron (peginterferon alfa-2b) /REBETOL combination (excluding those with HCV Genotype 2 and 3) be discontinued from therapy at 12 weeks if their treatment Week 12 HCV RNA dropped < 2 log10 compared to pretreatment or at 24 weeks if they have detectable HCV RNA at treatment Week 24.
Renal Function
In patients with moderate renal dysfunction (creatinine clearance 30-50mL/min), the PegIntron (peginterferon alfa-2b) dose should be reduced by 25%. Patients with severe renal dysfunction (creatinine clearance 10-29 mL/min), including those on hemodialysis, should have the PegIntron (peginterferon alfa-2b) dose reduced by 50%. If renal function decreases during treatment, PegIntron (peginterferon alfa-2b) therapy should be discontinued. When PegIntron (peginterferon alfa-2b) is administered in combination with REBETOL, subjects with impaired renal function or those over the age of 50 should be more carefully monitored with respect to the development of anemia. PegIntron (peginterferon alfa-2b) /REBETOL should not be used in patients with creatinine clearance < 50 mL/min.
Preparation and Administration
PegIntron (peginterferon alfa-2b) REDIPEN
PegIntron (peginterferon alfa-2b) REDIPEN consists of a dual-chamber glass cartridge with sterile, lyophilized peginterferon alfa-2b in the active chamber and Sterile Water for Injection USP in the diluent chamber. The PegIntron (peginterferon alfa-2b) in the glass cartridge should appear as a white to off-white tabletshaped solid that is whole or in pieces, or powder.
To reconstitute the lyophilized peginterferon alfa-2b in the REDIPEN:
- Hold the REDIPEN upright (dose button down) and press the 2 halves of the pen together until there is an audible click.
- Gently invert the pen to mix the solution. DO NOT SHAKE. The reconstituted solution has a concentration of either 50 mcg per 0.5 mL, 80 mcg per 0.5 mL, 120 mcg per 0.5 mL, or 150 mcg per 0.5 mL for a single subcutaneous injection.
- Visually inspect the solution for particulate matter and discoloration prior to administration. The reconstituted solution should be clear and colorless. Do not use the solution if it is discolored or not clear, or if particulates are present.
Keeping the pen upright, attach the supplied needle and select the appropriate PegIntron (peginterferon alfa-2b) dose by pulling back on the dosing button until the dark bands are visible and turning the button until the dark band is aligned with the correct dose. The prepared PegIntron (peginterferon alfa-2b) solution is to be injected subcutaneously.
The PegIntron (peginterferon alfa-2b) REDIPEN is a single-use pen and does not contain a preservative. The reconstituted solution should be used immediately and cannot be stored for more than 24 hours at 2°-8°C [see HOW SUPPLIED/Storage and Handling]. DO NOT REUSE THE REDIPEN. The sterility of any remaining product can no longer be guaranteed. DISCARD THE UNUSED PORTION. Pooling of unused portions of some medications has been linked to bacterial contamination and morbidity.
PegIntron (peginterferon alfa-2b) Vials
Two BD® 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. Instructions for the preparation and administration of PegIntron (peginterferon alfa-2b) Powder for Injection are provided below.
- Reconstitute the PegIntron (peginterferon alfa-2b) lyophilized product with only 0.7 mL of the 1.25 mL of supplied diluent (Sterile Water for Injection USP). The diluent vial is for single use only. The remaining diluent should bediscarded. No other medications should be added to solutions containing PegIntron (peginterferon alfa-2b) , and PegIntron (peginterferon alfa-2b) 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.
- The appropriate PegIntron (peginterferon alfa-2b) dose should be withdrawn and injected subcutaneously. PegIntron (peginterferon alfa-2b) vials are for single use only and do not contain a preservative.
The reconstituted solution should be used immediately and cannot be stored for more than 24 hours at 2°-8°C [see HOW SUPPLIED/Storage and Handling]. DO NOT REUSE THE VIAL. The sterility of any remaining product can no longer be guaranteed. DISCARD THE UNUSED PORTION. Pooling of unused portions of somemedications has been linked to bacterial contamination andmorbidity.
HOW SUPPLIED
Dosage Forms And Strengths
- Single-use vial: 1.25 mL diluent vial: 50 mcg per 0.5 mL, 80 mcg per 0.5 mL, 120 mcg per 0.5 mL, 150 mcg per 0.5 mL.
- Single-use REDIPEN: 50 mcg per 0.5 mL, 80 mcg per 0.5 mL, 120 mcg per 0.5 mL, 150 mcg per 0.5 mL.
Storage And Handling
PegIntron (peginterferon alfa-2b) REDIPEN
| Each PegIntron REDIPEN Package Contains: | |
| A box containing one 50 mcg per 0.5 mL PegIntron REDIPEN and 1 BD needle and 2 alcohol swabs. | NDC 0085-1323-01) |
| A box containing one 80 mcg per 0.5 mL PegIntron REDIPEN and 1 BD needle and 2 alcohol swabs. | NDC 0085-1316-01) |
| A box containing one 120 mcg per 0.5 mL PegIntron REDIPEN and 1 BD needle and 2 alcohol swabs. | NDC 0085-1297-01) |
| A box containing one 150 mcg per 0.5 mL PegIntron REDIPEN and 1 BD needle and 2 alcohol swabs. | NDC 0085-1370-01) |
| Each PegIntron REDIPEN PAK 4 Contains: | |
| A box containing four 50 mcg per 0.5 mL PegIntron REDIPEN Units, each containing 1 BD needle and 2 alcohol swabs. | NDC 0085-1323-02) |
| A box containing four 80 mcg per 0.5 mL PegIntron REDIPEN Units, each containing 1 BD needle and 2 alcohol swabs. | NDC 0085-1316-02) |
| A box containing four 120 mcg per 0.5 mL PegIntron REDIPEN Units, each containing 1 BD needle and 2 alcohol swabs. | NDC 0085-1297-02) |
| A box containing four 150 mcg per 0.5 mL PegIntron REDIPEN Units, each containing 1 BD needle and 2 alcohol swabs. | NDC 0085-1370-02) |
PegIntron (peginterferon alfa-2b) Vials
| Each PegIntron Package Contains: | |
| A box containing one 50 mcg per 0.5 mL vial of PegIntron Powder for Injection and one 1.25 mL vial of Diluent (SterileWater for Injection USP), 2 BD Safety-Lok syringes with a safety sleeve and 2 alcohol swabs. | (NDC 0085-1368-01) |
| A box containing one 80 mcg per 0.5 mL vial of PegIntron Powder for Injection and one 1.25 mL vial of Diluent (SterileWater for Injection USP), 2 BD Safety-Lok syringes with a safety sleeve and 2 alcohol swabs. | (NDC 0085-1291-01) |
| A box containing one 120 mcg per 0.5 mL vial of PegIntron Powder for Injection and one 1.25 mL vial of Diluent (SterileWater for Injection USP), 2 BD Safety-Lok syringes with a safety sleeve and 2 alcohol swabs. | (NDC 0085-1304-01) |
| A box containing one 150 mcg per 0.5 mL vial of PegIntron Powder for Injection and one 1.25 mL vial of Diluent (SterileWater for Injection USP), 2 BD Safety-Lok syringes with a safety sleeve and 2 alcohol swabs. | (NDC 0085-1279-01) |
Storage
PegIntron (peginterferon alfa-2b) REDIPEN: PegIntron (peginterferon alfa-2b) REDIPEN should be stored at 2°-8°C (36°-46°F).
After reconstitution, the solution should be used immediately, butmay be stored up to 24 hours at 2°-8°C (36°-46°F). The reconstituted solution contains no preservative, and is clear and colorless.
DO NOT FREEZE.
PegIntron (peginterferon alfa-2b) Vials: PegIntron (peginterferon alfa-2b) 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°-8°C (36°-46°F). The reconstituted solution contains no preservative, and is clear and colorless. DO NOT FREEZE.
Disposal Instructions: Patients should be thoroughly instructed in the importance of proper disposal. After preparation and administration of PegIntron (peginterferon alfa-2b) for Injection, patients should be advised to use a puncture-resistant container for the disposal of used syringes, needles, and the REDIPEN. The full container should be disposed of in accordance with state and local laws. Patients should also be cautioned against reusing or sharing needles, syringes, or the REDIPEN.
Manufactured by Schering Corporation, a subsidiary of Schering-Plough Corporation, Kenilworth, NJ 07033 USA. Rev. 5/09.
Last reviewed on RxList: 7/10/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Peg-Intron Information
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