Hypersensitivity Reactions: Serious hypersensitivity reactions, including rash, angioedema, and anaphylactoid reactions, have been reported with Pasurta in post marketing experience. These reactions may occur within minutes, although some may occur more than one week after treatment. If a serious or severe hypersensitivity reaction occurs, discontinue administration of Pasurta and initiate appropriate therapy [see CONTRAINDICATIONS].
Constipation with Serious Complications: Constipation with serious complications has been reported with Pasurta in post-marketing experience. In a majority of cases, the onset was reported after the first dose of Pasurta treatment; however, patients also experienced events later in treatment. Many cases occurred in patients with a history of constipation or concurrent use of medications associated with decreased gastrointestinal motility. In some severe cases, hospitalization was required, including cases where surgery was necessary.
Monitor patients treated with Pasurta for severe constipation and manage as clinically appropriate. Advise patients to seek medical attention if they develop severe constipation.
Effects on ability to drive and use machines: Pasurta is expected to have no influence on the ability to drive and use machines.