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Be In Charge is a Schering sponsored program for people like you who have been diagnosed with chronic hepatitis C. Be In Charge has been expanded to include and replace the former program called Moving ForwardTM.
The Be In Charge® Program is a free service designed to help you:
- Cope with side effects
- Understand and talk more easily with your doctor
- Feel confident about your therapy
Be In Charge provides you with a Nurse Counselor who will listen to your concerns, and answer your questions via telephone.
The program also offers you support materials to help you get through therapy and adjust to living with hepatitis C. The support materials offered to you are based on where you are in therapy. When you enroll in The Be In Charge® Program, you will receive any of the following:
- Personal Nurse Counselor-You will be teamed with your own Nurse Counselor, who will answer your questions by telephone. Plus, you can call our Nurse Counseling Service toll-free, 24 hours a day, 7 days a week.
- Patient Therapy Management Binder-This one-stop reference guide helps you progress through your therapy more easily.
- The Hepatitis Workbook: A Guide to Living with Chronic Hepatitis B and C-This comprehensive reference book offers detailed information about hepatitis and treatment options.
- Coaching Booklet-This booklet is intended for family members, close friends, or coworkers, explaining hepatitis C, your therapy, and how to offer you better support.
- Other Educational Materials - educational reference materials about hepatitis C and its treatment.
Other Available Resources
- Schering's COMMITMENT TO CARE® - Schering's COMMITMENT TO CARE® is a drug reimbursement assistance program for all eligible patients taking either PEGINTRON™ (Peginterferon alfa-2b) Powder for Injection therapy, REBETRON® Combination Therapy containing REBETOL® (Ribavirin, USP) capsules and INTRON® A (Interferon alfa-2b, Recombinant) Injection, or INTRON® A (Interferon alfa-2b, Recombinant) for Injection Therapy. This program is available whether you enroll in The Be In Charge® Program or not. Since its inception in September 1995, COMMITMENT TO CARE® has helped over 6,000 patients by providing reimbursement assistance for their medication. For information and enrollment, call 1-800-521-7157.
- If you have been diagnosed with hepatitis C, join The Be In Charge® Program today, by calling 1-888-HEP-2608 (437-2608).
Please see full Prescribing Information.
Package Inserts
PEGINTRON™ (Peginterferon alfa-2b) Powder for Injection and REBETOL® (Ribavirin, USP) Capsules
Indication:
PEGINTRON™ is indicated for use alone or with ribavirin for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and who are at least 18 years of age.
WARNING
Alpha interferons, including PEGINTRON™ and INTRON® A, may 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 PEGINTRON™ and/or INTRON® A therapy.
Use with Ribavirin: Ribavirin may cause birth defects and/or death of the unborn child. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with REBETOL® therapy may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen.
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Contraindications
PEGINTRON™ is contraindicated in patients with hypersensitivity to PEGINTRON™ or any other component of the product, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score >6 [class B and C]) in cirrhotic CHC patients before or during treatment. INTRON® A (Interferon alfa-2b, recombinant) for Injection is contraindicated in patients with hypersensitivity to INTRON® A or any component of the product, autoimmune hepatitis, and decompensated liver disease. PEGINTRON™ or INTRON® A in combination with REBETOL® therapy is additionally contraindicated in patients with hypersensitivity to ribavirin or any other component of the product, women who are pregnant, men whose female partners are pregnant, patients with hemoglobinopathies (eg, thalassemia major, sickle-cell anemia), and patients with creatinine clearance < 50 mL/min.
Avoid Pregnancy
REBETOL® therapy should not be started until a report of a negative pregnancy test has been obtained immediately prior to planned initiation of therapy. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients during therapy and 6 months posttreatment. Patients should use at least two effective forms of contraception and have monthly pregnancy tests during therapy and for 6 months after completion of therapy. A Ribavirin Pregnancy Registry has been established to monitor maternal-fetal outcomes of pregnancies in female patients and female partners of male patients exposed to ribavirin during treatment, and for 6 months following cessation of treatment. Physicians and patients are encouraged to report such cases by calling 1-800-593-2214.
Incidence of adverse events
There are no new adverse events specific to PEGINTRON™ as compared to INTRON® A; however, the incidence of some (eg, injection site reactions, fever, rigors, nausea) were higher. The most common adverse events associated with PEGINTRON™ 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 PEGINTRON™. Alopecia (thinning of the hair) is also often associated with alpha interferons including PEGINTRON™.
Psychiatric adverse events, which include insomnia, were common (57%) with PEGINTRON™ 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 PEGINTRON™.
The following serious or clinically significant adverse events have been reported at a frequency ≤ 1% with PEGINTRON™ 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.
In the PEGINTRON™/REBETOL® combination trial, the incidence of serious adverse events was 17% in the PEGINTRON™/REBETOL® groups compared to 14% in the INTRON® A/ REBETOL® group. The incidence of severe adverse events in the PEGINTRON™/REBETOL® combination therapy trial was 23% in the INTRON® A/REBETOL® group and 31-34% in the PEGINTRON™/REBETOL® groups. Dose reductions due to adverse reactions occurred in 42% of patients receiving PEGINTRON™ (1.5 mcg/kg)/REBETOL® and in 34% of those receiving INTRON® A/REBETOL®.
Additional Safety Information
Relapse of drug addiction/overdose has occurred in patients on PEGINTRON™ therapy. Aggressive behavior sometimes directed towards others has occurred in patients with and without a previous psychiatric disorder during PEGINTRON™ and/or INTRON® A treatment and follow-up. If patients develop psychiatric problems, including clinical depression, it is recommended that patients be carefully monitored during treatment and in the 6-month follow-up period. If psychiatric symptoms persist or worsen, or suicidal ideation or aggressive behavior towards others is identified, it is recommended that treatment with PEGINTRON™ and/or INTRON® A be discontinued, and the patient be carefully followed with psychiatric intervention, as appropriate. Cases of encephalopathy have been observed in some patients, usually elderly, treated with higher doses of PEGINTRON™ and/or INTRON® A. Ischemic and hemorrhagic cerebrovascular events have been observed in patients treated with interferon alpha therapies, including PEGINTRON™ and INTRON® A. Dental and periodontal disorders have been reported in patients receiving PEGINTRON™ or INTRON® A in combination with REBETOL® therapy.
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