PRECAUTIONS

Since the use of type-I interferons has been associated with depression, DRUG A should not be used in patients with a history of severe psychiatric disorders and should be discontinued in patients developing severe depression, suicidal ideation, or other severe psychiatric disorders.

DRUG A should be used with caution in patients with a history of cardiac disease. Hypertension (5%), tachycardia (4%), and palpitation (3%) were the most common cardiovascular adverse events reported for 9 μg DRUG A, with 1% of patients reporting tachyarrhythmias which were dose-limiting.

DRUG A should be used cautiously in patients with abnormally low peripheral blood cell counts or who are receiving agents that are known to cause myelosuppression. Leukopenia, particularly granulocytopenia, may be severe in patients treated with interferons, including DRUG A, and may necessitate dose reduction or temporary dose cessation. Thrombocytopenia is a common, but less severe, event often associated with interferon therapy. Therapy should be withheld if the absolute neutrophil count is < 500 x 10⁶/L or if the platelet count is < 50 x 10⁹/L. Transplantation patients, or other chronically immunosuppressed patients, should receive DRUG A with caution.

Serious acute hypersensitivity reactions have been reported in rare instances following treatment with interferons. If hypersensitivity reactions occur (eg, urticaria, angioedema, bronchoconstriction, anaphylaxis), the drug should be discontinued immediately and appropriate medical treatment instituted.

Ophthalmologic disorders have been reported with treatment with interferons. Investigators using interferons have reported the occurrence of retinal hemorrhages, cotton wool spots, and retinal artery or vein obstruction in rare instances. Any patient complaining of loss of visual acuity or visual field should have an eye examination. Because these ocular events may occur in conjunction with other disease states, a visual exam prior to initiation of interferon therapy is recommended in patients with diabetes mellitus or hypertension.

Exacerbation of autoimmune disease has been reported in patients receiving type-I interferon therapy. DRUG A should not be used in patients with autoimmune hepatitis and be used with caution in patients with other autoimmune disorders.

While fever may be related to the flu-like symptoms reported in patients treated with DRUG A, when fever occurs, other possible causes of persistent fever should be ruled out.

◆添削内容および訳例は第三者に開示しないようにお願いいたします。