PEG-INTRON® treatment for hepatitis C


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	PEG-INTRON Therapy


	PEG-INTRON REDIPEN®


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How to Use The
PEG-INTRON REDIPEN®

Using the PEG-INTRON REDIPEN® is as easy as Mix, Attach, Dial, and Deliver.

Your doctor will prescribe your dose of PEG-INTRON® based on your weight. Whether in PEG-INTRON REDIPEN® or vial and syringe form, PEG-INTRON® is given once a week for one year. Always follow your doctor's instructions.

You should be completely comfortable with how to prepare the PEG-INTRON REDIPEN®, how to measure the dose you take, and how to inject yourself before you use the PEG-INTRON REDIPEN® for the first time. Your health care provider will train you in the proper techniques for doing this. Be sure to view the descriptive video on how to use the PEG-INTRON REDIPEN® to mix, attach, dial, and deliver an individualized dose of PEG-INTRON®.

Preparing and injecting the PEG-INTRON REDIPEN® dose:

Using the PEG-INTRON REDIPEN®, you:

Mix the medication by pushing down on the pen to combine the PEG-INTRON powder with sterile water, both stored in the pen. View the corresponding instructional video
Attach the small gauge, self-priming needle in the PEG-INTRON REDIPEN®; a self-priming action automatically removes air bubbles from the pen prior to administration. View the corresponding instructional video
Dial to accurately select your predetermined individualized weight-based dose by turning the dosing button until the dosing button aligns with the dosing tab's solid line. View the corresponding instructional video
Deliver the medication by pushing the dosing button completely and holding for five seconds. The five-second period helps ensure that you inject the proper amount of medication. View the corresponding instructional video

Please see Using the PEG-INTRON REDIPEN® for complete instructions on self-administration.

You will also need to check the injection site 2 hours after the injection for signs of inflammation, such as redness, swelling, or tenderness. If signs of inflammation don't clear up in a few days, notify your health care professional.

For an overview of taking PEG-INTRON medication, see How PEG-INTRON Is Taken.

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.