Roferon-A Side Effects, and Drug Interactions - Peginterferon alfa-2b

Roferon-A Side Effects, and Drug Interactions - Peginterferon alfa-2b

SIDE EFFECTS

Nearly all study patients experienced one or more adverse events. The incidence of serious adverse events was similar (about 12%) in all treatment groups. In many but not all cases, events resolve after stopping PEG-Intron therapy. Some patients continued to experience adverse events for several months after discontinuation of therapy. There was one patient death, a suicide, among patients receiving PEG-Intron and two patient deaths in the INTRON A group (1 murder/suicide and 1 sudden death). Overall, 10% of patients in the PEG-Intron groups discontinued therapy due to adverse events compared to 6% in the INTRON A group. Fourteen percent of patients in the PEG-Intron groups required dose reduction compared to 6% in the INTRON A group.

The most common adverse events associated with PEG-Intron were "flu-like" symptoms which occurred in approximately 50% of patients, and may decrease in severity as treatment continues. Application site disorders occurred frequently (47%) and included injection site inflammation, and reaction (i.e. 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 PEG-Intron.

Fifty-seven percent of patients treated with PEG-Intron experienced psychiatric adverse events, most commonly depression (29%). Suicidal behavior (ideation, attempts, and suicides) occurred in 1% of all patients during or shortly after treatment with PEG-Intron. (See WARNINGS).

Patients receiving PEG-Intron appeared to experience a greater number of adverse events (e.g., injection site reaction, fever, rigors, nausea) compared to patients receiving INTRON A. The number of adverse events in all body systems in general was higher in patients receiving the higher PEG-Intron dosages.

Adverse events that occurred in the Phase 3 clinical trial at ≥5% incidence are provided in Table 2 by treatment group.

Numerous adverse events were observed at a frequency <5%. In the absence of a non-treatment control group the relationship to study drug could not be determined.

Individual serious adverse events occurred at a frequency ≤1% and included suicide attempt, suicidal ideation, severe depression; relapse of drug addiction/overdose; nerve palsy (facial, oculomotor); cardiomyopathy, myocardial infarction, retinal ischemia, retinal vein thrombosis, transient ischemic attack, supraventricular arrhythmias, loss of consciousness; neutropenia, infection (pneumonia, abscess); autoimmune thrombocytopenia, hyperthyroidism, rheumatoid arthritis, interstitial nephritis, lupus-like syndrome, aggravated psoriasis; urticaria.

Laboratory Values

Neutrophils   Neutrophil counts decreased in 70% of patients. Severe potentially life-threatening neutropenia (<0.5 × 10 ⁹ /L) occurred in 1% of patients.

Platelets   Platelet counts decreased in 20% of patients. Treatment with PEG-Intron resulted in severe decreases in platelet counts (<50,000/mm ³ ) in 1% of patients.

The incidence and severity of thrombocytopenia and neutropenia were greater in the PEG-Intron groups compared to the interferon alfa group. Platelet and neutrophil counts generally returned to pretreatment levels within 4 weeks of the cessation of therapy.

Thyroid Function   TSH abnormalities developed in 16% of patients and were associated with clinically apparent hypothyroidism (5%) or hyperthyroidism (1%). Subjects developed new onset TSH abnormalities while on treatment and during the follow-up period. At the end of the follow-up period 7% of subjects still had abnormal TSH values.

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