REBETRON
Side
Effects & Response Rates
This information
was taken from the Product Information Insert that comes with REBETRON.
Don't forget, Interferon and Ribavirin effect everyone differently. These
numbers are just to give you an idea of what you may expect and in NO
WAY mean you will have ALL of these
sides. The package insert does NOT
give sustained response rates.
REBETRON
Side Effects *
|
Injection
site inflammation
|
6
|
Injection
site reaction
|
5
|
|
Headache
|
66
|
Fatigue
|
60
|
|
Rigors
|
43
|
Fever
|
32
|
|
Flu-like
symptoms
|
13
|
Asthenia
|
10
|
|
Chest
pain
|
6
|
Dizziness
|
26
|
|
Nausea
|
47
|
Anorexia
|
21
|
|
Dyspepsia
|
16
|
Vomiting
|
12
|
|
Myalgia
|
61
|
Arthralgia
|
29
|
|
Musculoskeletal
pain
|
22
|
Insomnia
|
26
|
|
Irritability
|
25
|
Depression
|
23
|
|
Emotional
lability
|
12
|
Concentration
impaired
|
10
|
|
Nervousness
|
5
|
Dyspnea
|
17
|
|
Sinusitis
|
12
|
Alopecia
|
27
|
|
Rash
|
21
|
Pruritus
|
13
|
|
Taste
perversion
|
6
|
|
|
* Number ( % ) of
patients
REBETRON
Response Rates *
|
Virologic
Response
|
%
|
Histological
Response
|
%
|
|
Responder1
|
33
|
Improvement2
|
38
|
|
Non
Responder
|
36
|
No
Improvement
|
23
|
|
Missing
|
8
|
Missing
|
16
|
*
Number ( %) of patients
1
Defined as HCVRNA below limit of detection
2
Defined as posttreatment-pretreatment liver biopsy (Knodell HAI score (I=II=III)
improvement of >2 points
WARNINGS
ANEMIA -
Anemia
(Hemoglobin <10G/DL) was observed in 10% of Rebetol/Intron A-treated
patients in clinical trials. Anemia occurred within 1-2 weeks of initiation
of Ribavirin therapy. Because of this initial acute drop in hemoglobin,
it is advised that complete blood counts (CBC) should be obtained pretreatment
and at week 2 and week 4 of therapy, or more frequently if clinically indicated.
Patients should then be followed as clinically appropriate.
PSYCHIATRIC
-
Severe
psychiatric adverse events, including depression and suicidal behavior,
(suicidal ideation, suicidal attempts and suicides) have occured during
combination Rebetol/Intron A (REBETRON) therapy and with Interferon Alpha
monotherapy, both in patients with and without a previous psychiatric illness.
SOURCE:
Schering Corp.
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