August 28, 2015
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Peg-Intron

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Peg-Intron




Indications
Dosage
How Supplied

INDICATIONS

Chronic Hepatitis C (CHC)

PegIntron®, as part of a combination regimen, is indicated for the treatment of Chronic Hepatitis C (CHC) in patients with compensated liver disease.

  • PegIntron in combination with REBETOL® (ribavirin) and an approved Hepatitis C Virus (HCV) NS3/4A protease inhibitor is indicated in adult patients with HCV genotype 1 infection (see labeling of the specific HCV NS3/4A protease inhibitor for further information).
  • PegIntron in combination with REBETOL is indicated in patients with genotypes other than 1, pediatric patients (3-17 years of age), or in patients with genotype 1 infection where use of an HCV NS3/4A protease inhibitor is not warranted based on tolerability, contraindications or other clinical factors.

PegIntron monotherapy should only be used in the treatment of CHC in patients with compensated liver disease if there are contraindications to or significant intolerance of REBETOL and is indicated for use only in previously untreated adult patients. Combination therapy provides substantially better response rates than monotherapy [see Clinical Studies].

DOSAGE AND ADMINISTRATION

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).

The recommended dose of REBETOL for use with PegIntron is 800 to 1400 mg orally based on patient body weight. REBETOL should be taken with food. REBETOL should not be used in patients with creatinine clearance less than 50 mL/min.

See labeling of the specific HCV NS3/4A protease inhibitor for information regarding dosing regimen and administration of the protease inhibitor in combination with PegIntron and ribavirin.

Duration of Treatment – Treatment with PegIntron/REBETOL of Interferon Alpha-na´ve 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/REBETOL of Prior Treatment Failures

For patients with genotype 1 infection, PegIntron and REBETOL 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].

Table 1: Recommended PegIntron Combination Therapy Dosing (Adults)

Body Weight kg (lbs) PegIntron REDIPEN Prefilled pen or Vial Strength to Use Amount of PegIntron to Administer (mcg) Volume* of PegIntron to Administer (mL) REBETOL Daily Dose REBETOL Number of Capsules
< 40 ( < 88) 50 mcg per 0.5 mL 50 0.5 800 mg/day 2 x 200 mg capsules A.M.
2 x 200 mg capsules P.M.
40-50 (88-111) 80 mcg per 0.5 mL 64 0.4 800 mg/day 2 x 200 mg capsules A.M. 2 x 200 mg capsules P.M.
51-60 (112-133) 80 0.5 800 mg/day 2 x 200 mg capsules A.M.
2 x 200 mg capsules P.M.
61-65 (134-144) 120 mcg per 0.5 mL 96 0.4 800 mg/day 2 x 200 mg capsules A.M.
2 x 200 mg capsules P.M.
66-75 (145-166) 96 0.4 1000 mg/day 2 x 200 mg capsules A.M.
3 x 200 mg capsules P.M.
76-80 (167-177) 120 0.5 1000 mg/day 2 x 200 mg capsules A.M.
3 x 200 mg capsules P.M.
81-85 (178-187) 1200 mg/day 3 x 200 mg capsules A.M. 3 x 200 mg capsules P.M.
86-105 (188-231) 150 mcg per 0.5 mL 150 0.5 1200 mg/day 3 x 200 mg capsules A.M.
3 x 200 mg capsules P.M.
> 105 ( > 231) 1400 mg/day 3 x 200 mg capsules A.M.
4 x 200 mg capsules P.M.
* 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.

Pediatric Patients

Dosing for pediatric patients is determined by body surface area for PegIntron and by body weight for REBETOL. The recommended dose of PegIntron 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/REBETOL 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.

Table 2: Recommended REBETOL* Dosing in Combination Therapy (Pediatrics)

Body Weight kg (lbs) REBETOL Daily Dose REBETOL Number of Capsules
< 47 ( < 103) 15 mg/kg/day Use REBETOL oral solution†
47-59 (103-131) 800 mg/day 2 x 200 mg capsules A.M.
2 x 200 mg capsules P.M.
60-73 (132-162) 1000 mg/day 2 x 200 mg capsules A.M.
3 x 200 mg capsules P.M.
> 73 ( > 162) 1200 mg/day 3 x 200 mg capsules A.M.
3 x 200 mg capsules P.M.
*REBETOL to be used in combination with PegIntron 60 mcg/m² weekly.
† REBETOL oral solution may be used for any patient regardless of body weight.

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 3).

Table 3: 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)*
≤ 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
* When reconstituted as directed.

Dose Reduction

If a serious adverse reaction develops during the course of treatment discontinue or modify the dosage of PegIntron and REBETOL until the adverse event abates or decreases in severity [see WARNINGS AND PRECAUTIONS]. 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 in adult patients on PegIntron/REBETOL combination therapy is accomplished in a twostep 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 6 (Monotherapy: REDIPEN/Vial) and 7 (Combination therapy: REDIPEN/Vial).

In the adult combination therapy Study 2, dose reductions occurred in 42% of subjects receiving PegIntron 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 to 1 mcg/kg in combination with REBETOL, with an additional 4% requiring the second dose reduction of PegIntron to 0.5 mcg/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 20 mcg/m²/week, if needed (see Tables 4 and 5). In the pediatric combination therapy trial, dose reductions occurred in 25% of subjects receiving PegIntron 60 mcg/m² weekly plus REBETOL 15 mg/kg daily.

Table 4: Guidelines for Modification or Discontinuation of PegIntron or PegIntron/REBETOL 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
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/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 or PegIntron/REBETOL 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:
WBC 1.0 to < 1.5 x 109/L N/A < 1.0 x 109/L
Neutrophils 0.5 to < 0.75 x 109/L N/A < 0.5 x 109/L
Platelets 25 to < 50 x 109/L (adults) N/A < 25 x 109/L (adults)
50 to < 70 x 109/L (pediatrics) N/A < 50 x 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
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 /REBETOL combination therapy [see WARNINGS AND PRECAUTIONS].

Table 6: 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)
≤ 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
* When reconstituted as directed.
† Must use vial. Minimum delivery for REDIPEN 0.3 mL.

Table 7: 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
< 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
* Must use vial. Minimum delivery for REDIPEN 0.3 mL.
† When reconstituted as directed.

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-na´ve patients receiving PegIntron, alone or in combination with REBETOL, 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)

It is recommended that patients receiving PegIntron/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 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 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/REBETOL 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 the physician 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].

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.

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.
  • REDIPEN® single-use pre-filled pen: 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 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 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 (Sterile Water for Injection USP), 2 BD Safety Lok syringes with a safety sleeve and 2 alcohol swabs. (NDC 0085-136801)
A box containing one 80 mcg per 0.5 mL vial of PegIntron Powder for Injection and one 1.25 mL vial of Diluent (Sterile Water for Injection USP), 2 BD Safety Lok syringes with a safety sleeve and 2 alcohol swabs. (NDC 0085-129101)
A box containing one 120 mcg per 0.5 mL vial of PegIntron Powder for Injection and one 1.25 mL vial of Diluent (Sterile Water for Injection USP), 2 BD Safety Lok syringes with a safety sleeve and 2 alcohol swabs. (NDC 0085-130401)
A box containing one 150 mcg per 0.5 mL vial of PegIntron Powder for Injection and one 1.25 mL vial of Diluent (Sterile Water for Injection USP), 2 BD Safety Lok syringes with a safety sleeve and 2 alcohol swabs. (NDC 0085-127901)

Storage

PegIntron REDIPEN Single-use Pre-filled Pen

PegIntron REDIPEN pre-filled pen should be stored at 2-8°C (36-46°F).

After reconstitution, 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. Keep away from heat.

PegIntron Vials

PegIntron 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. Keep away from heat.

Disposal Instructions

Patients should be thoroughly instructed in the importance of proper disposal. After preparation and administration of PegIntron for Injection, patients should be advised to use a puncture-resistant container for the disposal of used syringes, needles, and the REDIPEN pre-filled pen. 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 pre-filled pen.

Manufactured by: Schering Corporation, a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA. Revised: Jan 2015

Last reviewed on RxList: 6/1/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

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