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PEG-INTRON Therapy
PEG-INTRON REDIPEN®
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Any object, such as razor, an earring, or a toothbrush, may carry enough virus-laden blood to infect another person
 
 
 
 

The Be In Charge® Program

You can turn to the Be In Charge program for a vast amount of information and support as you manage your hepatitis C treatment.

People on HCV combination therapy can find tremendous support in completing their hepatitis C treatment through Be In Charge, the most experienced hepatitis patient support program in the world. The program is designed to help chronic hepatitis C patients like you get the knowledge and support they need to tackle the challenges of the disease. Through active participation in Be In Charge, PEG-INTRON patients can:

  • Become more educated about all aspects of hepatitis C
  • Understand and talk more freely with their health care provider
  • Understand and get help with side effects
  • Explore ways to find emotional support
  • Receive one-on-one telephone consultations with nurse counselors
  • Call the 24-hour toll-free hotline for support when you need it most

Find out more about this outstanding support program at Be In Charge.

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Important Safety Information

WARNING
Alpha interferons, including PEG-INTRON®, 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 Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy.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 PEG-INTRON therapy.

There are no new adverse events specific to PEG-INTRON® as compared to INTRON® A (Interferon alfa-2b, recombinant) for Injection, however, the incidence of some (eg, injection site reactions, fever, rigors, nausea) were higher. The most common adverse events associated with PEG-INTRON® were "flu-like" symptoms, occurring in approximately 50% of patients, which may decrease in severity as treatment continues. Application site disorders were common (47%), but all were mild (44%) or moderate (4%) and no patient discontinued, and included injection site inflammation and reaction (ie, bruise, itchiness, irritation). Injection site pain was reported in 2% of patients receiving PEG-INTRON®. Alopecia (thinning of the hair) is also often associated with alpha interferons including PEG-INTRON®.

Psychiatric adverse events, which include insomnia, were common (57%) with PEG-INTRON®, but similar to INTRON® A (58%). Depression was most common at 29%. Suicidal behavior including ideation, suicidal attempts, and completed suicides occurred in 1% of patients during or shortly after completing treatment with PEG-INTRON®.

PEG-INTRON® is contraindicated in patients with autoimmune hepatitis and decompensated liver disease.

The following serious or clinically significant adverse events have been reported at a frequency < 1% with PEG-INTRON® or interferon alpha: Severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of autoimmune disorders including thyroiditis, RA, systemic lupus erythematosus, psoriasis, pulmonary disorders (dyspnea, pulmonary infiltrates, pneumonitis and pneumonia, some resulting in patient deaths), urticaria, angioedema, bronchoconstriction, anaphylaxis, retinal hemorrhages, and cotton wool spots.

Renal failure patients should be closely monitored for signs and symptoms of interferon toxicity and PEG-INTRON® should be used with caution in patients with creatinine clearance < 50 mL/min. Patients on PEG-INTRON therapy should have hematology and blood chemistry testing before the start of treatment and then periodically thereafter.

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