PEG-INTRON® treatment for hepatitis C

PEG-INTRON® is a treatment for some people who are infected with the hepatitis C virus. However, PEG-INTRON® can have serious side effects that may cause death in rare cases. Before starting treatment, you should talk to your doctor about the possible side effects to decide if PEG-INTRON® is right for you. While taking PEG-INTRON®, you will need to see your doctor regularly for medical examinations and lab tests to make sure your treatment is working and to check for side effects.

It is not unusual to experience side effects to HCV therapy within six to eight hours of injection. The most common side effect of HCV therapy is mild-to-moderate "flu-like" symptoms - fever, headache, and muscle aches. This combination of effects is also called "flu-like syndrome". These symptoms are very likely to appear at the start of therapy and can be treated. The good news is that, as the body gets used to therapy, some of the symptoms usually lessen after a few weeks.

Considerably less common are more serious side effects, the most important of which is the possibility of harm to an unborn fetus. Other serious possible side effects to HCV therapy include:

Mental health problems and suicide. PEG-INTRON® may cause patients to develop mood or behavioral problems. These can include irritability (getting easily upset) and depression (feeling bad about yourself, or feeling hopeless). Some patients may have aggressive behavior. Former drug addicts may fall back into drug addiction or overdose. Some patients think about hurting or killing themselves or other people and some have killed (suicide) or hurt themselves or others. You must tell your doctor if you are being treated for a mental illness or had treatment in the past for any mental illness, including depression and suicidal behavior. You should tell your doctor if you have ever been addicted to drugs or alcohol.

Heart problems. Some patients taking PEG-INTRON® may develop problems with their heart, including low blood pressure, fast heart rate, and very rarely, heart attacks. Tell your doctor if you have had any heart problems in the past.

Blood problems. PEG-INTRON® commonly lowers two types of blood cells (white blood cells and platelets). In some patients, these blood counts may fall to dangerously low levels. If your blood counts become very low, this could lead to infections or bleeding.

Body organ problems. Certain symptoms like severe stomach pain may mean that your internal organs are being damaged.

New or worsening autoimmune disease. Some patients taking PEG-INTRON® or PEG-INTRON/REBETOL® (Ribavirin, USP) Capsules combination therapy develop autoimmune diseases (a condition where the body's immune cells attack other cells or organs in the body), including rheumatoid arthritis, systemic lupus erythematosus, and psoriasis. In some patients who already have an autoimmune disease, the disease worsens on PEG-INTRON® and PEG-INTRON/REBETOL combination therapy.

While taking PEG-INTRON®, you should call your doctor immediately if you develop any of these symptoms: new or worsening mental health problems such as thoughts about hurting or killing yourself or others, trouble breathing, chest pain, severe stomach or lower back pain, bloody diarrhea or bloody bowel movements, high fever, bruising, bleeding, or decreased vision.

One of the best ways to succeed with your treatment is to know what to expect. Here are a few simple things you can do to BE READY:

Remember, it's important for you to stay on your medication for the entire time your doctor has prescribed. If you continue to have difficulty, tell your doctor or clinical nurse specialist. In some cases, your doctor may delay or reduce your dose to help you through the side effects.

While you're undergoing therapy, work closely with your health care team. Share your progress, any side effects you may have, and ask questions. This is a very challenging time for you. Don't be embarrassed or afraid to ask your family or friends for help. Work with them to plan activities, get rest, and schedule daily exercise.

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.

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 REBETOL/PEG-INTRON 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 REBETOL/PEG-INTRON 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 post treatment 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 mg/kg)/REBETOL® and in 34% of those receiving INTRON® A/REBETOL®.

PEG-INTRON® is indicated for use alone or in combination with REBETOL® 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.