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PEG-INTRON Therapy
PEG-INTRON REDIPEN®
  Prescribing Information
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For Health Care Professionals
 
 
 
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Health Care Professionals - Q&A;

Can my patients use the PEG-INTRON REDIPEN™ in place of PEG-INTRON vials?
 
How is the PEG-INTRON® REDIPEN™ different from a syringe?
 
Is there any difference in the medication used in the PEG-INTRON REDIPEN™ vs the vial?
 
Can I still offer my patients individualized dosing with the PEG-INTRON REDIPEN™?
 
Can patients currently being treated with PEG-INTRON® by vial and syringe be changed to the PEG-INTRON REDIPEN™?
 
Are some doctors going to prescribe the PEG-INTRON® REDIPEN™ while others prescribe vials and syringes?
 
Are the NDC numbers for the PEG-INTRON® REDIPEN™ and vials different?
 
Are there cost issues associated with the PEG-INTRON REDIPEN™?
 
When was the PEG-INTRON® REDIPEN™ approved in the United States?
 

Q: Can my patients use the PEG-INTRON REDIPEN™ in place of PEG-INTRON vials?
A: The PEG-INTRON® REDIPEN™ contains the same medication as the PEG-INTRON vial. Health care providers can use the PEG-INTRON® REDIPEN™ in place of the PEG-INTRON vial and syringe.

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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 patient-friendly, 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.

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Q: Is there any difference in the medication used in the PEG-INTRON REDIPEN™ vs the vial?
A: No. The PEG-INTRON® in the PEG-INTRON REDIPEN™ and the vials is the same formulation.

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Q: Can I still offer my patients individualized dosing with the PEG-INTRON REDIPEN™?
A: Yes. The PEG-INTRON® REDIPEN™ is available in four different dosage strengths - 50 mcg, 80 mcg, 120 mcg, and 150 mcg. Patients of all sizes can be given the appropriate dose of PEG-INTRON® with an injection volume of 0.4 or 0.5 mL.

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Q: Can patients currently being treated with PEG-INTRON® by vial and syringe be changed to the PEG-INTRON REDIPEN™?
A: Yes. Health care providers can choose to change patients from the PEG-INTRON vial and syringe to the PEG-INTRON REDIPEN™.

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Q: Are some doctors going to prescribe the PEG-INTRON® REDIPEN™ while others prescribe vials and syringes?
A: Based on Schering Corporation's previous experience, it is likely that most future PEG-INTRON prescriptions will be for the PEG-INTRON REDIPEN™. In the meantime, however, there may be some patients who are currently on PEG-INTRON therapy using the vial and syringe system and, in consultation with their doctor, decide not to change to the PEG-INTRON REDIPEN™.

Based on Schering Corporation's previous experience with the INTRON® A (Interferon alfa-2b, recombinant) for Injection pen for hepatitis C, we anticipate that the PEG-INTRON® REDIPEN™ will become the preferred delivery system and account for the majority of new PEG-INTRON prescriptions.

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Q: Are the NDC numbers for the PEG-INTRON® REDIPEN™ and vials different?
A: Yes. Each of the four PEG-INTRON REDIPEN™ products - 50mcg, 80 mcg, 120 mcg, and 150 mcg - has its own NDC number.

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Q: Are there cost issues associated with the PEG-INTRON REDIPEN™?
A: Schering Corporation has priced the PEG-INTRON® REDIPEN™ the same as for the equivalent strength PEG-INTRON vial. However, if your patients have concerns about financial issues associated with treatment, inform them that they may be eligible for Schering Corporation's reimbursement assistance program, Schering's COMMITMENT TO CARE®. Learn more about Schering Corporation's support programs.

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Q: When was the PEG-INTRON® REDIPEN™ approved in the United States?
A: PEG-INTRON® REDIPEN™ was approved by the U.S Food and Drug Administration (FDA) on October 10, 2003.

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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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