FDA OKs Cetirizine Injection (Quzyttir ) for Acute Urticaria

Megan Brooks

October 15, 2019

The US Food and Drug Administration (FDA) has approved cetirizine hydrochloride for intravenous injection (Quzyttir, JDP Therapeutics) for treatment of acute urticaria in adults and children 6 months of age or older.

Quzyttir will be available as 10-mg/mL single-use vials.

According to OptumRx, the approval was based on results of a phase 3 double-blind, randomized, active-controlled clinical trial involving 262 patients aged 18 or older with acute urticaria. Patients were randomly assigned to receive cetirizine or diphenhydramine injection. The primary efficacy endpoint was change from baseline in patient-rated pruritus score assessed 2 hours following treatment.

Results showed that cetirizine injection was noninferior to diphenhydramine, based on change from baseline in patient-rated pruritus score (primary outcome).

Fewer cetirizine-treated patients than diphenhydramine-treated patients returned to the emergency department or clinic (6% vs 14%).

The efficacy of cetirizine injection for the treatment of urticaria in children aged 6 months or older is based on extrapolation of the efficacy in adults with acute urticaria and supported by pharmacokinetic data with oral cetirizine hydrochloride. Cetirizine injection is not recommended in children aged younger than 6 years with impaired renal or hepatic function.

Treatment-emergent adverse reactions included dysgeusia, headache, paresthesia, presyncope, dyspepsia, feeling hot, and hyperhidrosis.

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