Overall Incidence of Adverse Reactions
|SUNBEAM AND RADIANCE: POOLED DATA|
|Upper respiratory infectionb||23%||26%|
|Hepatic transaminase elevationc||5%||10%|
|Urinary tract infection||3%||4%|
|Abdominal pain upper||1%||2%|
Adverse reactions are sorted by decreasing incidence in patients treated with ZEPOSIA.
For adverse reactions pertaining to liver function tests, increases were transient and generally resolved without discontinuation.4
Elevations of 3-fold the ULN or greater occurred in 5.5% of patients taking ZEPOSIA and in 3.1% of patients taking Avonex. The majority (79%) continued treatment with ZEPOSIA with values returning to less than 3 times the ULN within approximately 2 to 4 weeks.3
aData are not an adequate basis for comparison of rates between ZEPOSIA and the active control.
bIncludes the following terms: nasopharyngitis, upper respiratory tract infection, pharyngitis, respiratory tract infection, bronchitis, rhinitis, respiratory tract infection viral, viral upper respiratory tract infection, rhinorrhea, tracheitis, and laryngitis.
cIncludes the following terms: alanine aminotransferase increased, gamma-glutamyl transferase increased, aspartate aminotransferase increased, hepatic enzyme increased, liver function test abnormal, and transaminases increased.
dIncludes hypertension, essential hypertension, and orthostatic hypertension.
ULN=upper limit of normal.
Overall Discontinuation Rates3
|ALT increased||0 (0)||2 (0.4)|
|Back pain||1 (0.2)||2 (0.4)|
|Headache||0 (0)||2 (0.4)|
|ALT increased||3 (0.7)||2 (0.5)|
|Urticaria||0 (0.0)||2 (0.5)|
aIncludes all adverse reactions ≥0.4% that led to discontinuation of ZEPOSIA.
JCV=John Cunningham virus.
ALC=absolute lymphocyte count; BL=baseline; LLN=lower limit of normal.
This information is intended for U.S. Healthcare Professionals.