In general, INTRON A therapy should be administered to elderly patients cautiously, reflecting the greater frequency of decreased hepatic, renal, bone marrow, and/or cardiac function and concomitant disease or other drug therapy. INTRON A is known to be substantially excreted by the kidney, and the risk of adverse reactions to INTRON A may be greater in patients with impaired renal function. Because elderly patients often have decreased renal function, patients should be carefully monitored during treatment, and dose adjustments made based on symptoms and/or laboratory abnormalities (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).

ADVERSE REACTIONS

General
The adverse experiences listed below were reported to be possibly or probably related to INTRON® A therapy during clinical trials. Most of these adverse reactions were mild to moderate in severity and were manageable. Some were transient and most diminished with continued therapy.

The most frequently reported adverse reactions were "flu-like" symptoms, particularly fever, headache, chills, myalgia, and fatigue. More severe toxicities are observed generally at higher doses and may be difficult for patients to tolerate.

TREATMENT-RELATED ADVERSE EXPERIENCES BY INDICATION  Dosing Regimens
Percentage (%) of Patients*
 MALIGNANT MELANOMA FOLLICULAR LYMPHOMA HAIRY CELL LEUKEMIA CONDYLOMATA ACUMINATA AIDS-RELATED KAPOSI'S SARCOMA CHRONIC HEPATITIS C†  CHRONIC HEPATITIS B
 Adults Pediatrics
 20 MIU/m2 Induction (IV)
10 MIU/m2 Maintenance (SC) 5 MIU TIW/SC 2 MIU/m2 TIW/SC 1 MIU/lesion 30 MIU/m2 TIW/SC 35 MIU QD/SC 3 MIU TIW  5 MIU QD 10 MIU TIW 6 MIU/m2 TIW
ADVERSE EXPERIENCE N=143 N=135 N=145 N=352 N=74 N=29 N=183 N=101 N=78 N=116
*
Dash (- -) indicates not reported
†
Percentages based upon a summary of all adverse events during 18 to 24 months of treatment
‡
Vomiting was reported with nausea as a single term
§
Includes stomatitis/mucositis
¶
Amnesia was reported with confusion as a single term
#
Predominantly lethargy 
Application-Site Disorders   20       
  injection site   inflammation - - 1 - - - - - - - - 5 3 - - - -
  other (≤5%) burning, injection site bleeding, injection site pain, injection site reaction (5% in chronic hepatitis B pediatrics), itching
Blood Disorders (<5%) anemia, anemia hypochromic, granulocytopenia, hemolytic anemia, leukopenia, lymphocytosis, neutropenia (9% in chronic hepatitis C, 14% in chronic hepatitis B pediatrics), thrombocytopenia (10% in chronic hepatitis C) (bleeding 8% in malignant melanoma), thrombocytopenia purpura
Body as a Whole
  facial edema - - 1 - - <1 - - 10 <1 3 1 <1
  weight   decrease 3 13 <1 <1 5 3 10 2 5 3
  other (≤5%) allergic reaction, cachexia, dehydration, earache, hernia, edema, hypercalcemia, hyperglycemia, hypothermia, inflammation nonspecific, lymphadenitis, lymphadenopathy, mastitis, periorbital edema, poor peripheral circulation, peripheral edema (6% in follicular lymphoma), phlebitis superficial