Pegintron Information
Pegintron (Peginterferon alfa-2b)
Pegintron (Peginterferon alfa-2b) Dosage And Administration
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 60mcg/m/week subcutaneously in combination with 15 mg/kg/day of REBETOL orally in 2 divided doses ( 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 genotype 2 and 3 should be treated for 24 weeks.
If a serious adverse reaction develops during the course of treatment 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 . 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 1 mcg/kg/week to 0.5 mcg/kg/week. Dose reduction of Pegintron (Peginterferon alfa-2b) in adults may be accomplished by utilizing a lower dose strength or administering a lesser volume as shown in .
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 0.5 mcg/kg due to adverse events .
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/m/week, to 40 mcg/m/week, then to 20 mcg/m/week, if needed In the pediatric combination therapy trial, dose reductions occurred in 25% of subjects receiving Pegintron (Peginterferon alfa-2b) 60 mcg/m weekly plus REBETOL 15 mg/kg daily.
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 tablet-shaped solid that is whole or in pieces, or powder.
To reconstitute the lyophilized peginterferon alfa-2b in the REDIPEN:
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 . . 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.
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.
The reconstituted solution should be used immediately and cannot be stored for more than 24 hours at 2°–8°C . . 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.
Pegintron (Peginterferon alfa-2b) Contraindications
Pegintron (Peginterferon alfa-2b) is contraindicated in patients with:
Pegintron (Peginterferon alfa-2b) /REBETOL combination therapy is additionally contraindicated in:
Pegintron (Peginterferon alfa-2b) Warnings And Precautions
Patients should be monitored for the following serious conditions, some of which may become life threatening. Patients with persistently severe or worsening signs or symptoms should be withdrawn from therapy.
Life-threatening or fatal neuropsychiatric events, including suicide, suicidal and homicidal ideation, depression, relapse of drug addiction/overdose, and aggressive behavior sometimes directed towards others have occurred in patients with and without a previous psychiatric disorder during Pegintron (Peginterferon alfa-2b) treatment and follow-up. Psychoses, hallucinations, bipolar disorders, and mania have been observed in patients treated with interferon alpha.
Pegintron (Peginterferon alfa-2b) should be used with caution in patients with a history of psychiatric disorders. Treatment with interferons may be associated with exacerbated symptoms of psychiatric disorders in patients with co-occurring psychiatric and substance use disorders. If treatment with interferons is initiated in patients with prior history or existence of psychiatric condition or with a history of substance use disorders, treatment considerations should include the need for drug screening and periodic health evaluation, including psychiatric symptom monitoring. Early intervention for re-emergence or development of neuropsychiatric symptoms and substance use is recommended.
Patients should be advised to report immediately any symptoms of depression or suicidal ideation to their prescribing physicians. Physicians should monitor all patients for evidence of depression and other psychiatric symptoms. If patients develop psychiatric problems, including clinical depression, it is recommended that the patients be carefully monitored during treatment and in the 6-month follow-up period. If psychiatric symptoms persist or worsen, or suicidal ideation or aggressive behavior towards others is identified, it is recommended that treatment with Pegintron (Peginterferon alfa-2b) be discontinued, and the patient followed, with psychiatric intervention as appropriate. In severe cases, Pegintron (Peginterferon alfa-2b) should be stopped immediately and psychiatric intervention instituted . Cases of encephalopathy have been observed in some patients, usually elderly, treated at higher doses of Pegintron (Peginterferon alfa-2b) .
Dyspnea, pulmonary infiltrates, pneumonia, bronchiolitis obliterans, interstitial pneumonitis, pulmonary hypertension, and sarcoidosis, some resulting in respiratory failure or patient deaths, may be induced or aggravated by Pegintron (Peginterferon alfa-2b) or alpha interferon therapy. Recurrence of respiratory failure has been observed with interferon rechallenge. Pegintron (Peginterferon alfa-2b) combination treatment should be suspended in patients who develop pulmonary infiltrates or pulmonary function impairment. Patients who resume interferon treatment should be closely monitored.
Because of the fever and other "flu-like" symptoms associated with Pegintron (Peginterferon alfa-2b) administration, it should be used cautiously in patients with debilitating medical conditions, such as those with a history of pulmonary disease (e.g., chronic obstructive pulmonary disease).
Pegintron (Peginterferon alfa-2b) alone or in combination with ribavirin may cause severe decreases in neutrophil and platelet counts, and hematologic, endocrine (e.g., TSH), and hepatic abnormalities. Transient elevations in ALT (2- to 5-fold above baseline) were observed in 10% of subjects treated with Pegintron (Peginterferon alfa-2b) , and were not associated with deterioration of other liver functions. Triglyceride levels are frequently elevated in patients receiving alpha interferon therapy including Pegintron (Peginterferon alfa-2b) and should be periodically monitored.
Patients on Pegintron (Peginterferon alfa-2b) or Pegintron (Peginterferon alfa-2b) /REBETOL combination therapy should have hematology and blood chemistry testing before the start of treatment and then periodically thereafter. In the adult clinical trial CBC (including hemoglobin, neutrophil, and platelet counts) and chemistries (including AST, ALT, bilirubin, and uric acid) were measured during the treatment period at Weeks 2, 4, 8, and 12, and then at 6-week intervals or more frequently if abnormalities developed. In pediatric subjects, the same laboratory parameters were evaluated with additional assessment of hemoglobin at treatment Week 6. TSH levels were measured every 12 weeks during the treatment period. HCV-RNA should be measured periodically during treatment .
Patients who have pre-existing cardiac abnormalities should have electrocardiograms done before treatment with Pegintron (Peginterferon alfa-2b) /REBETOL.
Data on the effects of Pegintron (Peginterferon alfa-2b) plus REBETOL on growth come from an open-label trial in subjects 3 through 17 years of age, and weight and height changes are compared to US normative population data. In general, the weight and height gain of pediatric subjects treated with Pegintron (Peginterferon alfa-2b) plus REBETOL lags behind that predicted by normative population data for the entire length of treatment. After about 6 months post-treatment (follow-up Week 24), subjects had weight gain rebounds and regained their weight to 53 percentile, above the average of the normative population and similar to that predicted by their average baseline weight (57 percentile). After about 6 months post-treatment, height gain stabilized and subjects treated with Pegintron (Peginterferon alfa-2b) plus REBETOL had an average height percentile of 44 percentile, which was less than the average of the normative population and less than their average baseline height (51 percentile). Severely inhibited growth velocity (less than 3 percentile) was observed in 70% of the subjects while on treatment. Of the subjects experiencing severely inhibited growth, 20% had continued inhibited growth velocity (less than 3 percentile) after 6 months of follow-up.
Among the boys studied, the age groups of 3 to 11 years old and 12 to 17 years old had similar height percentile decreases of approximately 5 percentiles after 6 months post-treatment; weight gain continued to be similar to their average baseline percentile. Girls who were 3 to 11 years old and treated for 48 weeks had the largest average drop in height and weight percentiles (13 percentiles and 7 percentiles, respectively), whereas girls 12 to 17 years old continued along their average baseline height and weight percentiles after 6 months post-treatment.
Pegintron (Peginterferon alfa-2b) Adverse Reactions
Clinical trials with Pegintron (Peginterferon alfa-2b) alone or in combination with REBETOL have been conducted in over 6900 subjects from 3 to 75 years of age.
Serious adverse reactions have occurred in approximately 12% of subjects in clinical trials with Pegintron (Peginterferon alfa-2b) with or without REBETOL . The most common serious events occurring in subjects treated with Pegintron (Peginterferon alfa-2b) and REBETOL were depression and suicidal ideation each occurring at a frequency of less than 1%. The most common fatal events occurring in subjects treated with Pegintron (Peginterferon alfa-2b) and REBETOL were cardiac arrest, suicidal ideation, and suicide attempt , all occurring in less than 1% of subjects.
Greater than 96% of all subjects in clinical trials experienced one or more adverse events. The most commonly reported adverse reactions in adult subjects receiving either Pegintron (Peginterferon alfa-2b) or Pegintron (Peginterferon alfa-2b) /REBETOL were injection-site inflammation/reaction, fatigue/asthenia, headache, rigors, fevers, nausea, myalgia, and emotional lability/irritability. The most common adverse events in pediatric subjects, ages 3 and older, were pyrexia, headache, vomiting, neutropenia, fatigue, anorexia, injection-site erythema, and abdominal pain.
Pegintron (Peginterferon alfa-2b) Overdosage
There is limited experience with overdosage. In the clinical trials, a few subjects accidentally received a dose greater than that prescribed. There were no instances in which a participant in the monotherapy or combination therapy trials received more than 10.5 times the intended dose of Pegintron (Peginterferon alfa-2b) . The maximum dose received by any subject was 3.45 mcg/kg weekly over a period of approximately 12 weeks. The maximum known overdosage of REBETOL was an intentional ingestion of 10 g (fifty 200 mg capsules). There were no serious reactions attributed to these overdosages. In cases of overdosing, symptomatic treatment and close observation of the patient are recommended.
Pegintron (Peginterferon alfa-2b) Description
Pegintron (Peginterferon alfa-2b) , peginterferon alfa-2b, Powder for Injection is a covalent conjugate of recombinant alfa-2b interferon with monomethoxy polyethylene glycol (PEG). The average molecular weight of the PEG portion of the molecule is 12,000 daltons. The average molecular weight of the Pegintron (Peginterferon alfa-2b) molecule is approximately 31,000 daltons. The specific activity of peginterferon alfa-2b is approximately 0.7 × 10 IU/mg protein.
Interferon alfa-2b is a water-soluble protein with a molecular weight of 19,271 daltons produced by recombinant DNA techniques. It is obtained from the bacterial fermentation of a strain of bearing a genetically engineered plasmid containing an interferon gene from human leukocytes.
Pegintron (Peginterferon alfa-2b) Clinical Pharmacology
The pharmacodynamic effects of peginterferon alfa-2b include inhibition of viral replication in virus-infected cells, the suppression of cell cycle progression/cell proliferation, induction of apoptosis, anti-angiogenic activities, and numerous immunomodulating activities, such as enhancement of the phagocytic activity of macrophages, activation of NK cells, stimulation of cytotoxic T-lymphocytes, and the upregulation of the Th1 T-helper cell subset.
Pegintron (Peginterferon alfa-2b) raises concentrations of effector proteins such as serum neopterin and 2′5′ oligoadenylate synthetase, raises body temperature, and causes reversible decreases in leukocyte and platelet counts. The correlation between the and pharmacologic and pharmacodynamic and clinical effects is unknown.
Following a single subcutaneous dose of Pegintron (Peginterferon alfa-2b) , the mean absorption half-life (t ½ k) was 4.6 hours. Maximal serum concentrations (C) occur between 15 and 44 hours postdose, and are sustained for up to 48 to 72 hours. The Cand AUC measurements of Pegintron (Peginterferon alfa-2b) increase in a dose-related manner. After multiple dosing, there is an increase in bioavailability of Pegintron (Peginterferon alfa-2b) . Week 48 mean trough concentrations (320 pg/mL; range 0, 2960) are approximately 3-fold higher than Week 4 mean trough concentrations (94 pg/mL; range 0, 416). The mean Pegintron (Peginterferon alfa-2b) elimination half-life is approximately 40 hours (range 22–60 hours) in patients with HCV infection. The apparent clearance of Pegintron (Peginterferon alfa-2b) is estimated to be approximately 22 mL/hr∙kg. Renal elimination accounts for 30% of the clearance.
Pegylation of interferon alfa-2b produces a product (Pegintron (Peginterferon alfa-2b) ) whose clearance is lower than that of non-pegylated interferon alfa-2b. When compared to INTRON A, Pegintron (Peginterferon alfa-2b) (1 mcg/kg) has approximately a 7-fold lower mean apparent clearance and a 5-fold greater mean half-life, permitting a reduced dosing frequency. At effective therapeutic doses, Pegintron (Peginterferon alfa-2b) has approximately 10-fold greater C and 50-fold greater AUC than interferon alfa-2b.
Pegintron (Peginterferon alfa-2b) Clinical Studies
Pegintron (Peginterferon alfa-2b) Monotherapy-Study 1
A randomized trial compared treatment with Pegintron (Peginterferon alfa-2b) (0.5, 1, or 1.5 mcg/kg once weekly subcutaneously) to treatment with INTRON A (3 million units 3 times weekly subcutaneously) in 1219 adults with chronic hepatitis from HCV infection. The subjects were not previously treated with interferon alpha, had compensated liver disease, detectable HCV-RNA, elevated ALT, and liver histopathology consistent with chronic hepatitis. Subjects were treated for 48 weeks and were followed for 24 weeks post-treatment.
Seventy percent of all subjects were infected with HCV genotype 1, and 74 percent of all subjects had high baseline levels of HCV-RNA (more than 2 million copies per mL of serum), 2 factors known to predict poor response to treatment.
Response to treatment was defined as undetectable HCV-RNA and normalization of ALT at 24 weeks post-treatment. The response rates to the 1 and 1.5 mcg/kg Pegintron (Peginterferon alfa-2b) doses were similar (approximately 24%) to each other and were both higher than the response rate to INTRON A (12%) .
Subjects with both viral genotype 1 and high serum levels of HCV-RNA at baseline were less likely to respond to treatment with Pegintron (Peginterferon alfa-2b) . Among subjects with the 2 unfavorable prognostic variables, 8% (12/157) responded to Pegintron (Peginterferon alfa-2b) treatment and 2% (4/169) responded to INTRON A. Doses of Pegintron (Peginterferon alfa-2b) higher than the recommended dose did not result in higher response rates in these subjects. Subjects receiving Pegintron (Peginterferon alfa-2b) with viral genotype 1 had a response rate of 14% (28/199) while subjects with other viral genotypes had a 45% (43/96) response rate.
Ninety-six percent of the responders in the Pegintron (Peginterferon alfa-2b) groups and 100% of responders in the INTRON A group first cleared their viral RNA by Week 24 of treatment .
The treatment response rates were similar in men and women. Response rates were lower in African-American and Hispanic subjects and higher in Asians compared to Caucasians. Although African Americans had a higher proportion of poor prognostic factors compared to Caucasians, the number of non-Caucasians studied (9% of the total) was insufficient to allow meaningful conclusions about differences in response rates after adjusting for prognostic factors.
Liver biopsies were obtained before and after treatment in 60% of subjects. A modest reduction in inflammation compared to baseline that was similar in all 4 treatment groups was observed.
Pegintron (Peginterferon alfa-2b) /REBETOL Combination Therapy-Study 2
A randomized trial compared treatment with 2 Pegintron (Peginterferon alfa-2b) /REBETOL regimens [Pegintron (Peginterferon alfa-2b) 1.5 mcg/kg subcutaneously once weekly/REBETOL 800 mg orally daily (in divided doses); Pegintron (Peginterferon alfa-2b) 1.5 mcg/kg subcutaneously once weekly for 4 weeks then 0.5 mcg/kg subcutaneously once weekly for 44 weeks/REBETOL 1000 or 1200 mg orally daily (in divided doses)] with INTRON A [3 MIU subcutaneously thrice weekly/REBETOL 1000 or 1200 mg orally daily (in divided doses)] in 1530 adults with Chronic Hepatitis C. Interferon-naïve subjects were treated for 48 weeks and followed for 24 weeks post-treatment. Eligible subjects had compensated liver disease, detectable HCV-RNA, elevated ALT, and liver histopathology consistent with chronic hepatitis.
Response to treatment was defined as undetectable HCV-RNA at 24 weeks post-treatment. The response rate to the Pegintron (Peginterferon alfa-2b) 1.5 mcg/kg plus ribavirin 800 mg dose was higher than the response rate to INTRON A/REBETOL (. The response rate to Pegintron (Peginterferon alfa-2b) 1.5→0.5 mcg/kg/REBETOL was essentially the same as the response to INTRON A/REBETOL (data not shown).
Subjects with viral genotype 1, regardless of viral load, had a lower response rate to Pegintron (Peginterferon alfa-2b) (1.5 mcg/kg)/REBETOL (800 mg) compared to subjects with other viral genotypes. Subjects with both poor prognostic factors (genotype 1 and high viral load) had a response rate of 30% (78/256) compared to a response rate of 29% (71/247) with INTRON A/REBETOL.
Subjects with lower body weight tended to have higher adverse reaction rates and higher response rates than subjects with higher body weights. Differences in response rates between treatment arms did not substantially vary with body weight.
Treatment response rates with Pegintron (Peginterferon alfa-2b) /REBETOL were 49% in men and 56% in women. Response rates were lower in African American and Hispanic subjects and higher in Asians compared to Caucasians. Although African Americans had a higher proportion of poor prognostic factors compared to Caucasians, the number of non-Caucasians studied (11% of the total) was insufficient to allow meaningful conclusions about differences in response rates after adjusting for prognostic factors in this trial.
Liver biopsies were obtained before and after treatment in 68% of subjects. Compared to baseline, approximately two-thirds of subjects in all treatment groups were observed to have a modest reduction in inflammation.
Pegintron (Peginterferon alfa-2b) /REBETOL Combination Therapy-Study 3
In a large United States community-based trial (Study 3), 4913 subjects with Chronic Hepatitis C were randomized to receive Pegintron (Peginterferon alfa-2b) 1.5 mcg/kg subcutaneously once weekly in combination with a REBETOL dose of 800 to 1400 mg (weight-based dosing [WBD]) or 800 mg (flat) orally daily (in divided doses) for 24 or 48 weeks based on genotype. Response to treatment was defined as undetectable HCV-RNA (based on an assay with a lower limit of detection of 125 IU/mL) at 24 weeks post-treatment.
Treatment with Pegintron (Peginterferon alfa-2b) 1.5 mcg/kg and REBETOL 800 to 1400 mg resulted in a higher sustained virologic response compared to Pegintron (Peginterferon alfa-2b) in combination with a flat 800 mg daily dose of REBETOL. Subjects weighing greater than 105 kg obtained the greatest benefit with WBD, although a modest benefit was also observed in subjects weighing greater than 85 to 105 kg . The benefit of WBD in subjects weighing greater than 85 kg was observed with HCV genotypes 1 through 3. Insufficient data were available to reach conclusions regarding other genotypes. Use of WBD resulted in an increased incidence of anemia .
A total of 1552 subjects weighing greater than 65 kg in Study 3 had genotype 2 or 3 and were randomized to 24 or 48 weeks of therapy. No additional benefit was observed with the longer treatment duration.
Pegintron (Peginterferon alfa-2b) /REBETOL Combination Therapy-Study 4
A large randomized trial compared the safety and efficacy of treatment for 48 weeks with two Pegintron (Peginterferon alfa-2b) /REBETOL regimens [Pegintron (Peginterferon alfa-2b) 1.5 mcg/kg and 1 mcg/kg subcutaneously once weekly both in combination with REBETOL 800 to 1400 mg PO daily (in two divided doses)] and Pegasys 180 mcg subcutaneously once weekly in combination with Copegus 1000 to 1200 mg PO daily (in two divided doses) in 3070 treatment-naïve adults with Chronic Hepatitis C genotype 1. In this trial, lack of early virologic response (undetectable HCV-RNA or greater than or equal to 2 log reduction from baseline) by treatment Week 12 was the criterion for discontinuation of treatment. SVR was defined as undetectable HCV-RNA (Roche COBAS TaqMan assay, a lower limit of quantitation of 27 IU/mL) at 24 weeks post-treatment .
Overall SVR rates were similar among the three treatment groups. Regardless of treatment group, SVR rates were lower in subjects with poor prognostic factors. Subjects with poor prognostic factors randomized to Pegintron (Peginterferon alfa-2b) (1.5 mcg/kg)/REBETOL or Pegasys/Copegus, however, achieved higher SVR rates compared to similar subjects randomized to Pegintron (Peginterferon alfa-2b) 1 mcg/kg/REBETOL. For the Pegintron (Peginterferon alfa-2b) 1.5 mcg/kg plus REBETOL dose, SVR rates for subjects with and without the following prognostic factors were as follows: cirrhosis (10% vs. 42%), normal ALT levels (32% vs. 42%), baseline viral load greater than 600,000 IU/mL (35% vs. 61%), 40 years of age and older (38% vs. 50%), and African American race (23% vs. 44%). In subjects with undetectable HCV-RNA at Week 12 who received Pegintron (Peginterferon alfa-2b) (1.5 mcg/kg)/REBETOL, the SVR rate was 81% (328/407).
Pegintron (Peginterferon alfa-2b) /REBETOL Combination Therapy in Prior Treatment Failures-Study 5
In a noncomparative trial, 2293 subjects with moderate to severe fibrosis who failed previous treatment with combination alpha interferon/ribavirin were retreated with Pegintron (Peginterferon alfa-2b) , 1.5 mcg/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin. Eligible subjects included prior nonresponders (subjects who were HCV-RNA positive at the end of a minimum 12 weeks of treatment) and prior relapsers (subjects who were HCV-RNA negative at the end of a minimum 12 weeks of treatment and subsequently relapsed after post-treatment follow-up). Subjects who were negative at Week 12 were treated for 48 weeks and followed for 24 weeks post-treatment. Response to treatment was defined as undetectable HCV-RNA at 24 weeks post-treatment (measured using a research-based test, limit of detection 125 IU/mL). The overall response rate was 22% (497/2293) (99% CI: 19.5, 23.9). Subjects with the following characteristics were less likely to benefit from retreatment: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection.
The retreatment sustained virologic response rates by baseline characteristics are summarized in
Achievement of an undetectable HCV-RNA at treatment Week 12 was a strong predictor of sustained virologic response (SVR). In this trial, 1470 (64%) subjects did not achieve an undetectable HCV-RNA at treatment Week 12, and were offered enrollment into long-term treatment trials, due to an inadequate treatment response. Of the 823 (36%) subjects who were HCV-RNA undetectable at treatment Week 12, those infected with genotype 1 had an SVR of 48% (245/507), with a range of responses by fibrosis scores (F4–F2) of 39–55%. Subjects infected with genotype 2/3 who were HCV-RNA undetectable at treatment Week 12 had an overall SVR of 70% (196/281), with a range of responses by fibrosis scores (F4–F2) of 60–83%. For all genotypes, higher fibrosis scores were associated with a decreased likelihood of achieving SVR.
Pegintron (Peginterferon alfa-2b) How Supplied/storage And Handling
Pegintron (Peginterferon alfa-2b) REDIPEN
Pegintron (Peginterferon alfa-2b) Vials
Storage
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.
Pegintron (Peginterferon alfa-2b) Patient Counseling Information
A patient should self-inject Pegintron (Peginterferon alfa-2b) only if it has been determined that it is appropriate, the patient agrees to medical follow-up as necessary, and training in proper injection technique has been given to him/her.
Patients should be advised that laboratory evaluations are required before starting therapy and periodically thereafter . It is advised that patients be well hydrated, especially during the initial stages of treatment. "Flu-like" symptoms associated with administration of Pegintron (Peginterferon alfa-2b) may be minimized by bedtime administration of Pegintron (Peginterferon alfa-2b) or by use of antipyretics.
Patients developing fever, cough, shortness of breath or other symptoms of a lung problem during treatment with Pegintron (Peginterferon alfa-2b) may need to have a chest X-ray or other tests to adequately treat them.
Patients receiving Pegintron (Peginterferon alfa-2b) should be directed in its appropriate preparation, handling, measurement, and injection, and referred to the Instructions for Use for Pegintron (Peginterferon alfa-2b) Powder for Solution and Pegintron (Peginterferon alfa-2b) REDIPEN.
Patients should be directed to store Pegintron (Peginterferon alfa-2b) before mixing as follows:
Patients should be instructed on the importance of site selection for self-administering the injection, as well as the importance on rotating the injection sites.
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