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Alferon N Injection (Interferon Alfa-N3) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Adverse reactions were evaluated in 202 patients with condylomata acuminata receiving Alferon N Injection® by intralesional administration and in 31 patients with cancer receiving Alferon N Injection® by systemic administration. In the double-blind efficacy trial for the treatment of condylomata acuminata, 104 patients were treated with doses of Alferon N Injection® of 0.05 million to 2.5 million IU per treatment session (average dose = 0.92 million IU per treatment session) by intralesional injection. In open trials, an additional 98 patients received a dose range of 0.05 to 4.6 million IU of Alferon N Injection® per treatment session (average dose = 1.12 million IU per treatment session). Patients with cancer were given doses of Alferon N Injection® [Interferon alfa-n3 (human leukocyte derived)] of 3 million, 9 million, or 15 million IU per day for ten days by intramuscular injection.

Adverse Reactions in Patients with Condylomata Acuminata --A total of 104 patients with condylomata acuminata was treated with Alferon N Injection® during the double-blind clinical trial. Adverse reactions were reported to be likely, unlikely, or not known to be related to Alferon N Injection®. Adverse reactions consisted primarily of "flu-like" symptoms (myalgias, fever, and/or headache) which were in most cases mild or moderate, and transient, and did not interfere with treatment.

The "flu-like" adverse reactions, consisting of fever, myalgias, and/or headache, occurred primarily after the first treatment session and were reported by 30% of the patients. The frequency of "flu-like" adverse reactions abated with repeated dosing of Alferon N Injection® so that the incidences due to Alferon N Injection® and placebo were similar after three to four weeks of treatment (after six to eight treatment sessions). "Flu-like" symptoms were relieved by administration of acetaminophen.

Adverse reactions were reported at least once during the course of treatment in the following percentages of patients in each treatment group:

Table 2
Percent of Patients with Adverse Reactions
Adverse
Reactions:
Alferon
(n = 104)
Placebo
(n = 85)
Autonomic
Nervous
System
Sweating 2% 1%
Vasovagal Reaction 2% 0%
Body as a Whole
Fever 40% 19%
Chills 14% 2%
Fatigue 14% 6%
Malaise 9% 9%
Skin
Generalized Pruritus 2% 0%
Central & Peripheral
Nervous System
Dizziness 9% 4%
Insomnia 2% 1%
Gastrointestinal
System
Nausea 4% 7%
Vomiting 3% 0%
Dyspepsia/Heartburn 3% 1%
Diarrhea 2% 2%
Musculoskeletal
System
Arthralgia 5% 1%
Back Pain 4% 1%
Myalgias 45% 15%
Headache 31% 15%
Psychiatric
Disorders
Depression 2% 1%
Nasopharyngeal
Nose/sinus drainage 2% 2%

Most of the systemic adverse reactions were mild or moderate. Severe systemic adverse reactions were reported by 18% of Alferon N Injection® [Interferon alfa-n3 (human leukocyte derived)]-treated patients and 13% of placebo-treated patients (not a statistically significant difference). Most of the severe systemic adverse reactions reported were "flu-like". Other severe systemic adverse reactions included back pain, insomnia, and sensitivity to allergens. Those adverse reactions which were reported by 1% of patients treated with Alferon N Injection® in the double-blind trial include: left groin lymph node swelling, tongue hyperaesthesia, thirst, tingling of legs/feet, hot sensation on bottom of feet, strange taste in mouth, increased salivation, heat intolerance, visual disturbances, pharyngitis, sensitivity to allergens, muscle cramps, nosebleed, throat tightness, and papular rash on neck. Additional adverse reactions which were reported by 1% of patients treated with placebo include: pharyngitis, oral pain, penile discharge, cold, knuckle stiffness, herpes outbreak, cough, disorientation, and weight/appetite loss.

Additional adverse reactions which occurred only in open clinical trials of intralesional use of Alferon N Injection® [Interferon alfa-n3 (human leukocyte derived)] for treatment of condylomata acuminata were herpes labialis, hot flashes, nervousness, decrease in concentration, dysuria, photosensitivity, and swollen lymph nodes. These reactions occurred in 1% of the patients. One patient with a history of epilepsy, who was not taking anticonvulsant medication, had a grand mal seizure while being treated with Alferon N Injection®; this seizure was judged to be unrelated to Alferon N Injection® administration.

Application Site Disorders --The frequency of application site disorders (such as itching and pain) for patients treated with Alferon N Injection® was significantly less than that reported with placebo (12% versus 26%). No severe application site disorders were reported by patients treated with Alferon N Injection®, while 7% of placebo-treated patients reported severe disorders.

Laboratory Test Values --Abnormalities were seen with statistically equivalent frequencies in both the Alferon N Injection® and placebo groups. None of the laboratory abnormalities were considered clinically significant. The abnormalities in the Alferon N Injection®-treated patients consisted primarily of decreased WBC (11%). Decreases also occurred in 4% of the placebo patients (not a statistically significant difference). The abnormalities in Alferon N Injection®-treated patients involved increases of only one WHO grade.

Adverse Reactions in Patients with Cancer --Thirty-one (31) patients with cancer were treated with a maximum of ten intramuscular injections of Alferon N Injection® in doses of 3 million IU, 9 million IU, or 15 million IU per treatment session. The occurrence of adverse reactions was judged to be unrelated to the dose of Alferon N Injection®. The following adverse reactions were reported at least once (the percentage of patients experiencing the reaction is indicated in parentheses): chills (87%), fever (81%), anorexia (68%), malaise (65%), nausea (48%), vomiting (29%), myalgias (16%), arthralgia (10%), chest pains (10%), soreness at injection site (10%), sleepiness (10%), headache (10%), diarrhea (6%), fatigue (6%), low blood pressure (6%), sore mouth/stomatitis (6%), and blurred vision (6%). Those adverse reactions which were each reported by only one patient treated with Alferon N Injection® [Interferon alfa-n3 (human leukocyte derived)] include: stiff shoulders, flushed face, edema, dry mouth, mucositis, coughing, numbness, numbness in hands, numbness in fingers, pain on ocular rotation, shakes/shivers, ringing in ears, cramps, constipation, muscle soreness, confusion, light-headedness, depression, upset stomach, and sweating. The following adverse reactions were reported as severe by at least one patient (the percentage of patients experiencing the reaction is indicated in parentheses): fever (55%), malaise (54%), anorexia (45%), chills (45%), nausea (16%), myalgias (13%), vomiting (10%), fatigue (6%), low blood pressure (6%), chest pains (6%), sore mouth/stomatitis (6%), headache (3%), diarrhea (3%), sleepiness (3%), arthralgia (3%), blurred vision (3%), stiff shoulders (3%), numbness (3%), pain on ocular rotation (3%), muscle soreness (3%), confusion (3%), light-headedness (3%), depression (3%), and sweating (3%).

The number and percentage of patients with cancer who experienced a significant abnormal laboratory test value (values that changed from WHO Grades 0, 1, or 2 at baseline to WHO Grades 3 or 4 during or after treatment) at least once during the trials are shown in the following table:

Table 3
Abnormal Laboratory Test Values
Cancer
(n = 31)
Hemoglobin Level 2 (7%)
White Blood Cell Count 1 (3%)
Platelet Count 1 (3%)
GGT 1 (6%)
SGOT 1 (3%)
Alkaline Phosphatase 2 (8%)
Total Bilirubin 1 (4%)

Drug label data at the top of this Page last updated: 2006-06-06

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