Transparency Submission

FDA Clearance: QUZYTTIR (cetirizine hydrochloride for injection) is FDA approved for the treatment of acute urticaria [1], but is not FDA approved for the prevention of hypersensitivity infusion reactions.

Rationale for Requested Change:  A number of anticancer therapies are associated with infusion-related reactions that may result in discontinuation of therapy [2]. For older adults who require premedication for prevention of infusion reactions, an intravenous (IV) second-generation antihistamine – ie, IV cetirizine – may be preferred for rapid achievement of peak plasma concentrations and fewer anticholinergic effects than first-generation antihistamines such as diphenhydramine [3] [4] [5]. In a phase 2 premedication study comparing IV cetirizine to IV diphenhydramine, IV cetirizine was as effective as IV diphenhydramine in preventing infusion reactions in an oncology setting, and was associated with less sedation, a shorter infusion stay, and fewer adverse events – both in the overall population and in a subgroup of patients =65 years of age [4]. An injectable formulation of a second-generation antihistamine is an important treatment option in the premedication setting, especially for older patients in whom first-generation antihistamines such as diphenhydramine are strongly recommended against due to anticholinergic side effects [6].