in severity as treatment continues. Application site
disorders were common (47 percent), but all were mild (44 percent)
or moderate (4 percent) and no patient discontinued, and included
injection site inflammation and reaction (i.e., bruise, itchiness,
irritation). Injection site pain was reported in 2 percent 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 percent) with PEGINTRON but similar to INTRON A (58 percent).
Depression was most common at 29 percent. Suicidal behavior
including ideation, suicidal attempts, and completed suicides
occurred in 1 percent of patients during or shortly after
completing treatment with PEGINTRON.
PEGINTRON/REBETOL is contraindicated in patients with autoimmune
hepatitis, decompensated liver disease, and in patients with
hemoglobinopathies (e.g., thalassemia major, sickle-cell
anemia).
The following serious or clinically significant adverse events
have been reported at a frequency less than 1 percent 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 percent in the PEGINTRON/REBETOL
groups compared to 14 percent in the INTRON A/REBETOL group. The
incidence of severe adverse events in the PEGINTRON/REBETOL
combination therapy trial was 23 percent in the INTRON A/REBETOL
group and 31-34 percent in the PEGINTRON/R
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