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Most infections are due to injection drug use. Intravenous drug use accounts for about two thirds of all cases of hepatitis C. People who have injected drugs, even once, are at highest risk for hepatitis C. In fact, the risk of getting HCV through IV drug use is much higher than the risk of getting HIV--about 60% to 80% of IV drug users are infected with the hepatitis C virus. Only 30% of IV users are infected with HIV.
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Schering's COMMITMENT TO CARE®
Schering's COMMITMENT TO CARE is a drug reimbursement assistance program for all eligible patients taking either PEG-INTRON® (peginterferon alfa-2b) Powder for Injection alone or in combination with REBETOL® (Ribavirin, USP) Capsules; REBETRON® Combination Therapy containing REBETOL® and INTRON® A (Interferon alfa-2b, recombinant) Injection; or INTRON® A for Injection therapy.
This COMMITMENT TO CARE reimbursement assistance is available to eligible patients 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.
You can contact a COMMITMENT TO CARE reimbursement assistance consultant in two ways:
- By phone, call 1-800-521-7157
- By mail or fax,
- Complete this form and be sure to include your phone information.
- Print out the form and sign it.
- Mail or fax it to:
Schering's COMMITMENT TO CARE®
PO Box 18725
Louisville, KY 40261
Fax: 1-800-683-7855
To: Schering's COMMITMENT TO CARE®
Once you mail or fax this form, you will be contacted by a COMMITMENT TO CARE consultant. The consultant will call you to collect additional information and discuss your specific situation.
Signature: __________________________________________
Date: _________________________________________
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Important Safety Information
WARNING
Alpha interferons, including PEG-INTRON® and INTRON® A, 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 Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy.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 or INTRON A therapy.
REBETOL monotherapy is not effective for the treatment of chronic hepatitis C and should not be used alone for this indication.
Ribavirin causes hemolytic anemia. Anemia associated with REBETOL therapy may exacerbate cardiac disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with REBETOL®. It is advised that complete blood counts (CBC) be obtained at baseline and at weeks 2 and 4 of therapy or more frequently if clinically indicated.
REBETOL and combination PEG-INTRON/REBETOL or INTRON A therapy must not be used by women, or male partners of women, who are or may become pregnant during therapy and during the 6 months after stopping therapy. REBETOL and combination PEG-INTRON/REBETOL or INTRON A therapy should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Women of childbearing potential and men must use effective contraception (at least two reliable forms) during treatment and during the 6-month posttreatment follow-up period. Significant teratogenic and/or embryocidal effects have been demonstrated for ribavirin in all animal species in which adequate studies have been conducted. These effects occurred at doses as low as one twentieth of the recommended human dose of REBETOL®. If pregnancy occurs in a patient or partner of a patient during treatment or during the 6 months after treatment stops, physicians are encouraged to report such cases by calling (800)727-7064.
PEG-INTRON®
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®/REBETOL® is contraindicated in patients with autoimmune hepatitis, decompensated liver disease, and in patients with hemoglobinopathies (eg, thalassemia major, sickle-cell anemia).
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.
In the PEG-INTRON/REBETOL combination trial the incidence of serious adverse events was 17% in the PEG-INTRON/REBETOL groups compared to 14% in the INTRON A/REBETOL group. The incidence of severe adverse events in the PEG-INTRON/REBETOL combination therapy trial was 23% in the INTRON A/REBETOL group and 31-34% in the PEG-INTRON/REBETOL groups. Dose reductions due to adverse reactions occurred in 42% of patients receiving PEG-INTRON® (1.5 µg/kg)/REBETOL® and in 34% of those receiving INTRON® A/REBETOL®.
REBETOL® should not be used in patients with creatinine clearance < 50 ml/min.
INTRON® A
All patients receiving INTRON A therapy experienced mild-to-moderate side effects. Some patients experienced more severe side effects, including neutropenia, fatigue, myalgia, headache, fever, chills, and increased SGOT. Other frequently occurring side effects were nausea, vomiting, depression, alopecia, diarrhea, and thrombocytopenia. DEPRESSION AND SUICIDAL BEHAVIOR, INCLUDING SUICIDAL IDEATION, SUICIDAL ATTEMPTS, AND COMPLETED SUICIDES, HAVE BEEN REPORTED IN ASSOCIATION WITH TREATMENT WITH ALFA INTERFERONS, INCLUDING INTRON A THERAPY.
See Also:
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