PEG-INTRON® treatment for hepatitis C

If you are considering using the PEG-INTRON REDIPEN®, you may have some specific questions before taking the next step. Here are answers to some of the most common questions about the PEG-INTRON REDIPEN®.

Q: If I'm currently being treated with the PEG-INTRON vial and syringe, can I begin using the PEG-INTRON REDIPEN®?
A: Schering Corporation encourages you to ask your doctor about whether the PEG-INTRON REDIPEN® is right for you. We expect that many patients will probably want to take advantage of this new easy-to-use product.

Q: How is the PEG-INTRON REDIPEN® different from a syringe?
A: The PEG-INTRON REDIPEN® is not a traditional syringe. It is the first and only pen delivery system approved for administering pegylated interferon.

The PEG-INTRON REDIPEN® is designed to be more patient-friendly than a traditional syringe, with advanced features such as an easy-to-read dial-up dosing button for precise, individualized, weight-based dosing of PEG-INTRON®, a self-priming action that automatically removes air bubbles from the pen, and a small needle size (30-gauge) to help minimize discomfort.

Q: How can I tell if I have injected the correct amount of medication with the PEG-INTRON REDIPEN®?
A: First, during administration, you "dial" your prescribed individualized dose by turning the dosing button until the dose number aligns with the dosing tab's solid line. Then, during the delivery process, you depress the dosing button completely and hold for five seconds. The five-second period ensures that you have injected the proper amount of medication.

Q: Can I get more detailed instructions on how to use the PEG-INTRON REDIPEN®?
A: You will be shown how to use the PEG-INTRON REDIPEN® during office visits with your health care provider. Demonstration pens are available for this purpose, and detailed instructions are provided in the Medication Guide that comes with every PEG-INTRON REDIPEN package. You may also find it helpful to review our step-by-step instructional video which demonstrates how to use the PEG-INTRON REDIPEN®.

In addition, Schering Corporation, the maker of the PEG-INTRON REDIPEN®, has created a special instructional brochure and video, which is available from your doctor.

Schering Corporation also offers The Be In Charge® Program - with specially trained nurses available on the phone 24 hours a day - to answer patient questions about hepatitis C, PEG-INTRON®, and the PEG-INTRON REDIPEN®. See www.beincharge.com for more information about this useful program.

Q: Does the PEG-INTRON REDIPEN® have to be refrigerated?
A: Yes, the PEG-INTRON REDIPEN® must be refrigerated. When you are ready to take your PEG-INTRON medication, you should allow time for it to reach room temperature before administration. Your health care provider will go over this process with you before you use the PEG-INTRON REDIPEN® for the first time.

Q: Where can I learn more about the PEG-INTRON REDIPEN®?
A: To learn more about the PEG-INTRON REDIPEN®, talk to your health care provider and read the detailed instructions in the Medication Guide. You may also find it helpful to review our step-by-step instructional video which demonstrates how to use the PEG-INTRON REDIPEN®.

Schering Corporation, maker of the PEG-INTRON REDIPEN®, has created a special instructional brochure and video on the PEG-INTRON REDIPEN® use, which is available from your doctor. The Be In Charge program - with specially trained nurses available on the phone 24 hours a day - is a patient support program developed by Schering Corporation to answer patient questions about hepatitis C, PEG-INTRON®, and the PEG-INTRON REDIPEN®. Please visit www.beincharge.com for more 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.