Exkivity(Mobocertinib) Side Effects

EXKIVITY treatment is commonly associated with adverse reactions, particularly affecting the gastrointestinal system and skin, alongside notable laboratory abnormalities, with diarrhea being the most frequent event.

Common Adverse Reactions and Laboratory Abnormalities with EXKIVITY 

The most common adverse reactions (occurring in >20% of patients in Study AP32788-15-101, N=114) included diarrhea (92%, 22% Grade 3/4), rash (78%), stomatitis (46%), vomiting (40%), decreased appetite (39%), paronychia (39%), nausea (37%), musculoskeletal pain (34%), dry skin (32%), and fatigue (29%). Serious adverse reactions occurred in 46% of patients, with those in ≥2% including diarrhea, dyspnea, vomiting, and cardiac failure. Fatal adverse reactions (1.8%) included cardiac failure (0.9%) and pneumonitis (0.9%). 

 Permanent discontinuation due to adverse reactions occurred in 17% of patients, primarily for diarrhea and nausea. The most common (≥2%) Grade 3 or 4 laboratory abnormalities included decreased lymphocytes (15%), increased amylase (13%), increased lipase (10%), and decreased potassium (5%). Other clinically relevant adverse reactions occurring in <10% of patients included acute kidney injury (8%) and peripheral neuropathy (7%). The impact on quality of life beyond these specific adverse events is not specified in the description.