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How PEG-INTRON® Is Taken
PEG-INTRON® must be taken by injection
because it is a protein. If it were taken in
pill form, stomach acids would break down
the medicine before it reached the bloodstream. |
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 Overview
Getting Started
Sites for Injection
Preparing and injecting PEG-INTRON®
Using REDIPEN instead of Vial and Syringe injections
Diluent Vial Size Change
Traveling with PEG-INTRON®
PEG-INTRON® must be taken by injection because it is a protein. If it were taken in pill form, stomach acids would break down the medicine before it reached the bloodstream. Injection allows PEG-INTRON® to enter your bloodstream directly and begin working immediately.
Your doctor will prescribe your dose of PEG-INTRON® based on your weight. PEG-INTRON® is given once a week for one year. Take your prescribed dose of PEG-INTRON® on the same day of each week and at approximately the same time. Take the medicine for the full year and do not take more than the prescribed dose. Always follow your doctor's instructions.
Your health care provider will train you in the proper techniques for using PEG-INTRON® for the first time so that you are completely comfortable. The new REDIPEN™ delivery system makes it easy for you to measure the dose you should take and to inject yourself. Alternatively you can administer PEG-INTRON® using a traditional vial and syringe. Learn more about the REDIPEN™delivery system, which is an easy-to-use alternative for those who may be intimidated by using a traditional vial and syringe.
If you experience side effects, report them to your health care professional. He or she can suggest ways to handle them.
You must get regular blood tests to help your doctor check how the treatment is working and to check for side effects.
Tell your doctor if you are taking, or planning to take, other prescription or nonprescription medicines, including vitamin and mineral supplements and herbal medicines.
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The dosing kit accompanying the REDIPEN™ contains:
- A REDIPEN™: The pen body contains one dual-chamber cartridge. One chamber contains PEG-INTRON® and the other chamber contains sterile water.
- Two alcohol swabs: For cleaning the rubber membrane and injection site.
- A tray: Plastic tray with holder to keep pen upright while you prepare the PEG-INTRON dose.
- A self-priming injection needle.
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The best sites for injection are areas with a layer of fat between the skin and the muscle. These include:
- Thigh (upper leg)
- Outer part of the upper arm
- Abdomen, but not the navel or waist
If you are very thin you should only use the thigh or outer surface of the arm for injection. Do not inject PEG-INTRON solution in the same place all the time. You should change your injection site each time in a regular pattern.
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Using the REDIPEN™:
- Mix the medication by pushing down on the pen.
- Dial your individualized, weight-based dose; and
- Deliver the medication by pushing the dosing button.
Please see Using the REDIPEN™ for complete instructions on self-administration.
Your health care provider will instruct you on how to self-inject with the REDIPEN. 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.
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While REDIPEN™ is an easy approach to taking PEG-INTRON®, we understand you may wish to continue using the traditional vial and syringe method. We encourage you to continue to use any PEG-INTRON vial and syringe supply that you currently have. When you are ready to try the REDIPEN™, contact your doctor to make arrangements for a demonstration by a health care professional. If REDIPEN™ is right for you, your doctor will provide you with an updated prescription. We're confident you'll find the REDIPEN™ to be a convenient and easy to use alternative.
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While traveling, PEG-INTRON Redipen™ should be stored in a cooler or refrigerator (36ºF to 46ºF). After mixing the medication in the REDIPEN™ it should be used immediately, but may be refrigerated up to 24 hours. Do not allow the solution to freeze.
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See Also: 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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