Learn More About Hepatitis C
PEG-INTRON Therapy
PEG-INTRON REDIPEN®
  Prescribing Information
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For Health Care Professionals
 
 
 
It is estimated that about 4 million people in the United States are infected with hepatitis C, which is about 2% of the population. This makes hepatitis C much more common than HIV.
 
 
 
 

Treatment Options

About 15% of people with hepatitis C are able to fight off the infection without treatment. The rest likely will need some form of therapy to regain their health. While several aspects of your infection will affect how treatment will help you, how much hepatitis C virus you have in your blood is important in determining whether or not treatment will help you.

In most instances, it is important to begin treatment as soon as all the tests which determine your present liver condition and virus infection are completed, and those tests which will be used to follow your response to treatment are defined.

The current treatment recommended by the National Institutes of Health for chronic hepatitis C is pegylated alpha interferons in combination with the antiviral drug ribavirin.

  • Alpha Interferons are proteins made by your body to boost your immune system.
  • Pegylated Alpha Interferons are made by attaching a large water-soluble molecule (called polyethylene glycol) to the alpha interferon molecule. These new molecules stay in the body longer and have shown to be effective in treating chronic hepatitis C. Interferon can slow chronic hepatitis C by reducing the amount of virus in your body and slowing the damage to your liver.
  • Ribavirin is an antiviral drug that, when combined with pegylated alpha interferons, has shown to be effective against chronic hepatitis C.
PEG-INTRON therapy has been proven to be more effective than standard non-pegylated interferon in treating chronic hepatitis C. That means PEG-INTRON® provides you a better chance of clearing the virus from your body and helping your liver to heal and stop progressing to further liver damage.

Not everyone benefits from interferon therapy. If you have chronic hepatitis C but no sign of liver damage, it may not be necessary to treat. Alternatively, if the hepatitis C virus has already seriously damaged your liver, drug treatment may be out of the question. In this case, the treatment can make you sicker without helping to cure the disease. Your doctor will help you make a choice about treatment and its associated side effects.

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Finding More Information Before beginning treatment -- and throughout the course of treatment -- you will have questions. Your health care provider should always be your primary source of information about your condition and treatment. When you go to your doctor, bring with you "Questions to Ask Your Doctor" to help you make sure you cover all your areas of interest.

In addition, The Be In Charge® Program, a free service sponsored by Schering Corporation, provides support and information to chronic hepatitis C patients 24 hours a day, 7 days a week by telephone. Trained Nurse Counselors can answer your questions, provide encouragement, and supply you with ongoing educational materials to help you maintain a healthy lifestyle. Get more information about Be In Charge.

Also, as you probably realize, effectively treating any illness can be expensive. To help you address this issue, Schering has developed COMMITMENT TO CARE®, a drug reimbursement assistance program for all eligible patients. COMMITMENT TO CARE has assisted over 55,000 patients since 1995 by providing reimbursement assistance to eligible patients with:

  • Researching sources of reimbursement
  • Financial assistance (in the form of an indigent drug program) if reimbursement assistance cannot be found
  • Verifying your insurance coverage
  • Acquiring pre-authorization or pre-certification for therapy from your insurance company
  • Assistance with appealing to your insurance company if coverage is denied
  • Reviewing Medicare and Medicaid benefits and regulations to ensure you have accurate and updated coverage information
  • Referring you to state and local assistance programs

Find out more about COMMITMENT TO CARE.

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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