Safety profile of HTX-019 administered as an intravenous push

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HTX-019 administered by 2-minute injection has a tolerable safety profile in patients with cancer, representing a viable method of HTX-019 administration for CINV prevention” Navari (2019).

Abstract:

Objectives: HTX-019 (Cinvanti®) is a novel injectable emulsion formulation of the neurokinin 1 receptor antagonist (RA) aprepitant, approved (as 30-minute infusion and 2-minute injection) for preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV). This retrospective analysis evaluated the safety of HTX-019 administered by 2-minute injection in patients with cancer.

Methods: At a single center, HTX-019 was evaluated as a 2-minute injection within a guideline-recommended three-drug regimen for CINV prophylaxis in patients receiving highly (HEC) or moderately emetogenic chemotherapy (MEC). Treatment-emergent adverse events (TEAEs) were assessed 0-60 minutes following initiation of HTX-019 administration, focusing on infusion-site adverse events and hypersensitivity reactions.

Results: Among 600 patients (78 MEC, 522 HEC), the most common diagnoses were lung(172) and breast (129) cancer. Patients received a 2-minute injection of HTX-019, followed by a 5-hydroxytryptamine type 3 RA intravenously (IV) (palonosetron or ondansetron), dexamethasone IV, and chemotherapy regimen (most common was cisplatin-containing) via a central (76%) and peripheral line (24%). No TEAEs occurred within 60 minutes after start of HTX-019 administration.

Conclusion: HTX-019 administered by 2-minute injection has a tolerable safety profile in patients with cancer, representing a viable method of HTX-019 administration for CINV prevention.

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Reference:

Navari, R.M. (2019) Safety profile of HTX-019 administered as an intravenous push in cancer patients: a retrospective review. Expert Opinion on Drug Safety. November 11th. doi: 10.1080/14740338.2020.1691521. .

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