Quzyttir (cetirizine injection) / TerSera Therap - LARVOL DELTA

Intravenous Cetirizine Premedication to Mitigate Infusion-Related Reactions. (PubMed, J Adv Pract Oncol) - "For over 60 years, diphenhydramine has been the only H1 antihistamine for intravenous (IV) administration...As more therapeutics have premedication required or recommended, IV cetirizine should be considered an antihistamine for preventing and treating IRRs. In this article, we describe a patient whose IRR was successfully managed with IV cetirizine and discuss first- vs. second-generation H1 antihistamines and their use in treating and preventing IRRs."

Journal • Anesthesia • Dermatology • Immunology • Urticaria

Exploratory Study on Effect of Repackaging Intravenous Cetirizine Hydrochloride Solution into Syringes on Drug Stability and Microbial Challenge Hold Time (ASHP 2022) - No abstract available

Intravenous Cetirizine vs Intravenous Diphenhydramine for the Prevention of Hypersensitivity Infusion Reactions: Results of an Exploratory Phase 2 Study. (PubMed, J Infus Nurs) - "A randomized, exploratory phase 2 study evaluated intravenous (IV) cetirizine 10 mg versus IV diphenhydramine 50 mg as pretreatment in patients receiving an anti-CD20 agent or paclitaxel. In the overall population (N = 34) and an elderly subgroup (n = 21), IV cetirizine was as effective as IV diphenhydramine in preventing infusion reactions (primary outcome) and associated with less sedation at all time points, a shorter infusion center stay, and fewer treatment-related adverse events."

Journal • P2 data • Anesthesia • Dermatology • Immunology • Urticaria

[VIRTUAL] Optimizing chair time in infusion centers using intravenous cetirizine premedication for the prevention of hypersensitivity infusion reactions. (ASCO 2021) - P2 | " A randomized, double-blind phase 2 study evaluating premedication with single dose IV cetirizine 10 mg versus IV diphenhydramine 50 mg was conducted in 34 patients receiving paclitaxel, rituximab, its biosimilar or obinutuzumab (first cycle, retreatment after 6 months or with persistent IRs)... This was the first randomized, controlled trial evaluating IV antihistamine premedication for IRs and chair time . It was shown that IV cetirizine can prevent IRs, with less sedation, fewer related AEs and reduced chair time compared to IV diphenhydramine . This improves infusion center operations and patient experience."

Anesthesia • Dermatology • Immunology • Infectious Disease • Novel Coronavirus Disease • Oncology • Urticaria

Gradishar Highlights Cetirizine as Management Tool for Hypersensitivity Infusion Reactions in Breast Cancer and Beyond (OncLive) - P2, N=NA; "William Gradishar, MD, discusses the phase 2 data evaluating the activity with IV cetirizine and its potential use in patients with breast cancer."

Interview • P2 data

Dr. Gradishar on Pretreatment With Cetirizine to Prevent Infusion Reactions in Breast Cancer and Other Malignancies (OncLive) - P2, N=NA; "William Gradishar, MD, discusses the efficacy of pretreatment with intravenous cetirizine in the prevention of infusion reactions in patients with breast cancer and other malignancies."

P2 data • Video

Phase 2 Study IV QUZYTTIR™ (Cetirizine Hydrochloride Injection) vs V Diphenhydramine (clinicaltrials.gov) - P2; N=34; Completed; Sponsor: TerSera Therapeutics LLC; Active, not recruiting ➔ Completed

Trial completion • Immunology • Oncology

TerSera Presents Data on cetirizine HCL Injection (QUZYTTIR) in the Prevention of Hypersensitivity Infusion Reactions in Patients with Breast Cancer and Other Malignancies (PRNewswire) - "TerSera Therapeutics...today the presentation of data from their Phase 2 study of intravenous (IV) cetirizine versus IV diphenhydramine in the prevention of hypersensitivity infusion reactions in patients with breast cancer and other malignancies. The data were presented in virtual poster sessions during the 38th Annual Miami Breast Cancer Conference on March 4-7, 2021."

P2 data • Breast Cancer • Hematological Malignancies • Oncology

Phase 2 Study IV QUZYTTIR™ (Cetirizine Hydrochloride Injection) vs V Diphenhydramine (clinicaltrials.gov) - P2; N=34; Active, not recruiting; Sponsor: TerSera Therapeutics LLC; Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Oncology

Intravenous Cetirizine Versus Intravenous Diphenhydramine for the Treatment of Acute Urticaria: A Phase III Randomized Controlled Noninferiority Trial. (PubMed, Ann Emerg Med) - "Intravenous cetirizine is an effective alternative to intravenous diphenhydramine for treating acute urticaria, with benefits of less sedation, fewer adverse events, shorter time spent in treatment center, and lower rates of revisit to treatment center."

Clinical • Head-to-Head • Journal • P3 data • Anesthesia • Dermatology • Pruritus • Urticaria

Phase 2 Study IV QUZYTTIR™ (Cetirizine Hydrochloride Injection) vs V Diphenhydramine (clinicaltrials.gov) - P2; N=34; Recruiting; Sponsor: TerSera Therapeutics LLC; Trial primary completion date: Jul 2020 ➔ Dec 2020

Trial primary completion date • Immunology • Oncology

Phase 2 Study IV QUZYTTIR™ (Cetirizine Hydrochloride Injection) vs V Diphenhydramine (clinicaltrials.gov) - P2; N=34; Recruiting; Sponsor: TerSera Therapeutics LLC; Trial completion date: Aug 2020 ➔ Dec 2020

Trial completion date • Immunology • Oncology

Intravenous Cetirizine (Quzyttir) for Acute Urticaria. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Dermatology • Dermatopathology • Immunology • Urticaria

Phase 2 Study IV QUZYTTIR™ (Cetirizine Hydrochloride Injection) vs V Diphenhydramine (clinicaltrials.gov) - P2; N=34; Recruiting; Sponsor: TerSera Therapeutics LLC; Not yet recruiting ➔ Recruiting

Enrollment open

The effect of cetirizine, a histamine 1 receptor antagonist, on bone remodeling after calvarial suture expansion. (PubMed, Korean J Orthod) - "Cetirizine injection facilitated bone formation after suture expansion, mostly by suppressing osteoclastic activity. Histamine 1 receptor antagonists may aid in bone formation after calvarial suture expansion in the rat model."

Journal • TRAP

A Phase 2 Exploratory Study of Intravenous QUZYTTIR™ (Cetirizine Hydrochloride Injection) Versus Intravenous Diphenhydramine in the Prevention of Hypersensitivity Infusion Reactions (clinicaltrials.gov) - P2; N=34; Not yet recruiting; Sponsor: JDP Therapeutics, Inc.

New P2 trial

"FDA OKs Cetirizine Injection (Quzyttir) for Acute Urticaria https://t.co/3AQ46vjNoo via @medscape" (@JasonBellakMD)

Quzyttir approved for the treatment of acute urticaria (eMPR) - "The Food and Drug Administration (FDA) has approved Quzyttir (cetirizine hydrochloride injection; JDP Therapeutics) for the treatment of acute urticaria in adults and children 6 months of age and older....Quzyttir will be supplied in single-use vials containing 1mL of drug solution with 10mg cetirizine hydrochloride (equivalent to 8.42mg of cetirizine)."

NDA