Antineoplastic interferons
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Pegintron Dosage

Drug Detail:Pegintron (Peginterferon alfa-2b [ peg-in-ter-feer-on-al-fa-too-bee ])

Generic Name: Peginterferon alfa-2b 50ug in 0.5mL

Dosage Form: injection, powder, lyophilized, for solution

Drug Class: Antineoplastic interferons Antiviral interferons

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

PEGINTRON Combination Therapy

Adults

The recommended dose of PEGINTRON is 1.5 mcg/kg/week. The volume of PEGINTRON to be injected depends on the strength of PEGINTRON and patient's body weight (see Table 1).

PEGINTRON is used in combination with other products including ribavirin and HCV direct acting antivirals. For further information on dosing and administration, refer to the respective prescribing information.

Duration of Treatment – Treatment with PEGINTRON/Ribavirin in 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/Ribavirin of Prior Treatment Failures

For patients with genotype 1 infection, PEGINTRON and ribavirin without an HCV NS3/4A protease inhibitor should only be used if there are contraindications, significant intolerance or other clinical factors that would not warrant use of an HCV NS3/4A protease inhibitor. 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 (14.1)].

Table 1: Recommended PEGINTRON Dosing (Adults)
Body Weight
kg (lbs)		 PEGINTRON REDIPEN Pre-filled pen or Vial Strength to Use Amount of PEGINTRON to Administer
(mcg)		 Volume* of PEGINTRON to Administer
(mL)
*
When reconstituted as directed.
†
For patients weighing greater than 105 kg (greater than 231 pounds), the PEGINTRON dose of 1.5 mcg/kg/week should be calculated based on the individual patient weight. This may require combinations of various PEGINTRON dose strengths and volumes.
<40
(<88)		 50 mcg per 0.5 mL 50 0.5
40-50
(88-111)		 80 mcg per 0.5 mL 64 0.4
51-60
(112-133)		 80 0.5
61-65
(134-144)		 120 mcg per 0.5 mL 96 0.4
66-75
(145-166)
76-80
(167-177)		 120 0.5
81-85
(178-187)
86-105
(188-231)		 150 mcg per 0.5 mL 150 0.5
>105
(>231)		 † † †

Pediatric Patients

Dosing for pediatric patients is determined by body surface area for PEGINTRON and by body weight for ribavirin. For information on ribavirin dosing, refer to the ribavirin prescribing information. The recommended dose of PEGINTRON is 60 mcg/m2/week subcutaneously for pediatric patients aged 3 to 17 years. Patients who reach their 18th birthday while receiving PEGINTRON/ribavirin should remain on the pediatric dosing regimen. The treatment duration for patients with genotype 1 is 48 weeks. Patients with genotype 2 and 3 should be treated for 24 weeks.

PEGINTRON Monotherapy

The recommended dose of PEGINTRON 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 to be injected depends on patient weight (see Table 2).

Table 2: Recommended PEGINTRON Monotherapy Dosing
Body Weight
kg (lbs)		 PEGINTRON REDIPEN Pre-filled pen or Vial Strength to Use Amount of PEGINTRON to Administer
(mcg)		 Volume of PEGINTRON to Administer
(mL)*
*
When reconstituted as directed.
≤45
(≤100)		 50 mcg per 0.5 mL 40 0.4
46-56
(101-124)		 50 0.5
57-72
(125-159)		 80 mcg per 0.5 mL 64 0.4
73-88
(160-195)		 80 0.5
89-106
(196-234)		 120 mcg per 0.5 mL 96 0.4
107-136
(235-300)		 120 0.5
137-160
(301-353)		 150 mcg per 0.5 mL 150 0.5

Dosage Modifications

If a serious adverse reaction develops during the course of treatment, discontinue or modify the dosage of PEGINTRON and ribavirin until the adverse event abates or decreases in severity [see Warnings and Precautions (5)]. 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 3 and 4. Dose reduction of PEGINTRON in adult patients on PEGINTRON/ribavirin 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 monotherapy is accomplished by reducing the original starting dose of 1 mcg/kg/week to 0.5 mcg/kg/week. Instructions for dose reductions in adults are outlined in Tables 5 (Monotherapy: REDIPEN/Vial) and 6 (Combination therapy: REDIPEN/Vial).

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 20 mcg/m2/week, if needed (see Tables 3 and 4).

Table 3: Guidelines for Modification or Discontinuation of PEGINTRON or PEGINTRON/ribavirin and for Scheduling Visits for Patients with Depression
Depression Severity* Initial Management (4-8 weeks) Depression Status
Dose Modification Visit Schedule Remains Stable Improves Worsens
*
See DSM-IV for definitions. For patients on PEGINTRON/ribavirin 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.
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 needed		 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/ribavirin permanently Obtain immediate psychiatric consultation Psychiatric therapy as necessary
Table 4: Guidelines for Dose Modification and Discontinuation of PEGINTRON or PEGINTRON/ribavirin Based on Laboratory Parameters in Adults and Pediatrics
Laboratory Parameters Reduce PEGINTRON Dose (see note 1) if: Reduce ribavirin Daily Dose (see note 2) if: Discontinue Therapy if:
Note 1: Adult patients on combination therapy: 1st dose reduction of PEGINTRON is to 1 mcg/kg/week. If needed, 2nd dose reduction of PEGINTRON is to 0.5 mcg/kg/week.
Adult patients on PEGINTRON monotherapy: decrease PEGINTRON dose to 0.5 mcg/kg/week.
Pediatric patients: 1st dose reduction of PEGINTRON is to 40 mcg/m2/week, 2nd dose reduction of PEGINTRON is to 20 mcg/m2/week.
Note 2: Adult patients: 1st dose reduction of ribavirin is by 200 mg/day (except in patients receiving the 1400 mg, dose reduction should be by 400 mg/day). If needed, 2nd dose reduction of ribavirin is by an additional 200 mg/day. Patients whose dose of ribavirin is reduced to 600 mg daily receive one 200 mg capsule in the morning and two 200 mg capsules in the evening.
Pediatric patients: 1st dose reduction of ribavirin is to 12 mg/kg/day, 2nd dose reduction of ribavirin is to 8 mg/kg/day.
*
Pediatric patients who have pre-existing cardiac conditions and experience a hemoglobin decrease greater than or equal to 2 g/dL during any 4-week period during treatment should have weekly evaluations and hematology testing.
†
These guidelines are for patients with stable cardiac disease. Patients with a history of significant or unstable cardiac disease should not be treated with PEGINTRON /ribavirin combination therapy [see Warnings and Precautions (5.3)].
WBC 1.0 to <1.5 × 109/L N/A <1.0 × 109/L
Neutrophils 0.5 to <0.75 × 109/L N/A <0.5 × 109/L
Platelets 25 to <50 × 109/L (adults) N/A <25 × 109/L (adults)
50 to <70 × 109/L (pediatrics) N/A <50 × 109/L (pediatrics)
Creatinine N/A N/A >2 mg/dL (pediatrics)
Hemoglobin in patients without history of cardiac disease N/A 8.5 to <10 g/dL <8.5 g/dL
Reduce PEGINTRON Dose by Half and the Ribavirin Dose by 200 mg/day if:
Hemoglobin in patients with history of cardiac disease*† ≥2 g/dL decrease in hemoglobin during any four-week period during treatment <8.5 g/dL or <12 g/dL after four weeks of dose reduction
Table 5: Reduced PEGINTRON Dose (0.5 mcg/kg) for (1 mcg/kg) Monotherapy in Adults
Body Weight
kg (lbs)		 PEGINTRON
REDIPEN/Vial
Strength to Use Amount to Administer
(mcg)		 Volume* to Administer
(mL)
*
When reconstituted as directed.
†
Must use vial. Minimum delivery for REDIPEN 0.3 mL.
≤45
(≤100)		 50 mcg per 0.5 mL† 20 0.2
46-56
(101-124)		 50 mcg per 0.5 mL† 25 0.25
57-72
(125-159)		 50 mcg per 0.5 mL 30 0.3
73-88
(160-195)		 50 mcg per 0.5 mL 40 0.4
89-106
(196-234)		 50 mcg per 0.5 mL 50 0.5
107-136
(235-300)		 80 mcg per 0.5 mL 64 0.4
≥137
(≥301)		 80 mcg per 0.5 mL 80 0.5
Table 6: Two-Step Dose Reduction of PEGINTRON REDIPEN/Vial in Combination Therapy in Adults
First Dose Reduction to PEGINTRON 1 mcg/kg Second Dose Reduction to PEGINTRON 0.5 mcg/kg
Body weight
kg (lbs)		 PEGINTRON REDIPEN/Vial Strength to Use Amount of PEGINTRON (mcg) to Administer Volume (mL) * of PEGINTRON to Administer Body weight
kg (lbs)		 PEGINTRON REDIPEN/Vial Strength to Use Amount of PEGINTRON (mcg) to Administer Volume (mL) * of PEGINTRON to Administer
*
When reconstituted as directed.
†
Must use vial. Minimum delivery for REDIPEN 0.3 mL.
<40
(<88)		 50 mcg per 0.5 mL 35 0.35 <40
(<88)		 50 mcg per 0.5 mL† 20 0.2
40-50
(88-111)		 45 0.45 40-50
(88-111)		 25 0.25
51-60
(112-133)		 50 0.5 51-60
(112-133)		 50 mcg per 0.5 mL 30 0.3
61-75
(134-166)		 80 mcg per 0.5 mL 64 0.4 61-75
(134-166)		 35 0.35
76-85
(167-187)		 80 0.5 76-85
(167-187)		 45 0.45
86-104
(188-230)		 120 mcg per 0.5 mL 96 0.4 86-104
(188-230)		 50 0.5
105-125
(231-275)		 108 0.45 105-125
(231-275)		 80 mcg per 0.5 mL 64 0.4
>125
(>275)		 150 mcg per 0.5 mL 135 0.45 >125
(>275)		 72 0.45

Discontinuation of Dosing

Adults

See labeling of the specific HCV NS3/4A protease inhibitor for information regarding discontinuation of dosing based on treatment futility.

In HCV genotype 1, interferon-alfa-naïve patients receiving PEGINTRON, alone or in combination with ribavirin, discontinuation of therapy is recommended if there is not at least a 2 log10 drop or loss of HCV-RNA at 12 weeks of therapy, or if 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 is recommended.

Pediatrics (3-17 years of age)

Discontinue PEGINTRON/ribavirin combination treatment in pediatric patients (excluding those with HCV genotype 2 and 3) at 12 weeks if their treatment Week 12 HCV-RNA has dropped less than 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 30-50 mL/min), the PEGINTRON 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 dose reduced by 50%. If renal function decreases during treatment, PEGINTRON therapy should be discontinued. When PEGINTRON is administered in combination with ribavirin, 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/ribavirin should not be used in patients with creatinine clearance less than 50 mL/min.

Preparation and Administration

A patient should self-inject PEGINTRON only if a healthcare provider determines that it is appropriate and the patient agrees to medical follow-up as necessary and has been trained in proper injection technique [see illustrated FDA-approved Medication Guide and Instructions for Use for directions on injection site preparation and injection instructions].

Reconstitute PEGINTRON Powder for Solution with 0.7 mL of Sterile Water for Injection, USP. The Sterile Water for Injection supplied contains 5 mL and is intended for single dose only. Discard the unused portion. The reconstituted solution should be visually inspected for discoloration and particulate matter prior to administration. Do not use the solution if it is discolored or not clear, or if particulates are present.

DO NOT REUSE THE VIAL OR PRE-FILLED PEN; DISCARD THE UNUSED PORTION. Pooling of unused portions of some medications has been linked to bacterial contamination and morbidity.

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