Revolade Adverse Reactions

The safety and efficacy of Revolade has been demonstrated in 2 randomized, double-blind, placebo-controlled studies (RAISE TRA102537 and TRA100773B) in adults with previously treated chronic ITP. In the RAISE study, 197 subjects were randomized 2:1, Revolade (n=135) to placebo (n=62). Subjects received study medication for up to 6 months. In TRA100773B, 114 patients were randomized and treated for up to 42 days with either placebo (n=38) or Revolade (n=76).
Most undesirable reactions associated with Revolade were mild to moderate in severity, early in onset and rarely treatment limiting.
Adverse reactions are listed as follows by MedDRA body system organ class and by frequency. The frequency categories used are: Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10,000, <1/1000).
The adverse reactions identified in subjects treated with Revolade are presented as follows: Infections and Infestations: Common: Pharyngitis, urinary tract infection.
Gastrointestinal Disorders: Very Common: Nausea, diarrhea. Common: Dry mouth, vomiting.
Hepatobiliary Disorders: Common: Increased AST and ALT.
Skin and Subcutaneous Tissue Disorders: Common: Alopecia, rash.
Musculoskeletal and Connective Tissue Disorder: Common: Back pain, musculoskeletal chest and musculoskeletal pain, myalgia.
Post-Marketing Data: No post-marketing data are currently available.