PEGINTRON

PEGINTRON- peginterferon alfa-2b injection, powder, lyophilized, for solution
PEGINTRON- peginterferon alfa-2b
Merck Sharp & Dohme Corp.

WARNING: RISK OF SERIOUS DISORDERS

Alpha interferons, including PEGINTRON, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many, but not all cases, these disorders resolve after stopping PEGINTRON therapy [see Warnings and Precautions (5) and Adverse Reactions (6.1)].

1 INDICATIONS AND USAGE

1.1 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 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 ribavirin 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 ribavirin and is indicated for use only in previously untreated adult patients. Combination therapy provides substantially better response rates than monotherapy [see Clinical Studies (14.1, 14.2)].

2 DOSAGE AND ADMINISTRATION

2.1 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 Weightkg (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.

2.2 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 Weightkg (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

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