| Betaseron®: Descriptives1 |
|
Method of administration |
Subcutaneuos (under the skin) injection |
| Indication |
For the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations |
|
Needle size |
½" length2 |
|
Delivery information |
Requires reconstitution (mixing) and filling syringes before injection |
|
Injection aids(s) |
Autoinjection device available |
|
Pregnancy category |
Category C1 (when administered to pregnant animals, there was some harm to the fetus)3 |
| Black box warning |
No |
| Betaseron®: Common side effects/reactions1 |
| Clinically significant difference in flu-like symptoms when compared to placebo (an inactive substance) |
Yes |
| Fatigue/Malaise (bodily discomfort) increased while on therapy |
Yes |
| Warning for use in people with depression |
Yes |
| Warning for use in people with suicidal thoughts |
Yes |
| Warning or precaution for liver impairment |
Yes |
| Recommended monitoring of liver function or complete blood count |
Yes |
| Associated with localized site reactions |
Yes |
| Associated with neutralizing antibodies (proteins produced by the body that may decrease the effectiveness of therapy) |
Yes |
Additional important information about Betaseron®
The most commonly reported adverse reactions are lymphopenia, injection site reaction, asthenia, flu-like symptom complex, headache, and pain. Betaseron should be used with caution in patients with depression. Injection site necrosis has been reported in 5% of patients in controlled trials. Patients should be advised of the importance of rotating injection sites. Female patients should be warned about the potential risk to pregnancy. Cases of anaphylaxis have been reported rarely.
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