Safety Profile of HTX-019 Administered as an Intravenous Infusion in Patients With Cancer

Calcanes, George; Vacirca, Jeffrey L.

doi:10.1097/nan.0000000000000341

Cited by 4 publications

(4 citation statements)

References 6 publications

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“…Aprepitant currently represents the only NK-1 RA that can be administered as both a 2-min IV push and a 30-min infusion. Consistent with presenting a tolerable safety profile when administered as a 30-min infusion [23][24][25][26][27], aprepitant administered as a 2-min IV push was well tolerated in healthy volunteers [28] and in patients with various cancer types receiving a range of HEC and MEC chemotherapy regimens [26,29,30]. The 2-min IV push administration of aprepitant offers a convenient method of administering an NK-1 RA for CINV prophylaxis, which has multifold implications.…”

Section: Discussionmentioning

confidence: 80%

Best Practice Approach to Successful Conversion of Fosaprepitant to Aprepitant IV in a Large Multisite Community Oncology Infusion Center: A Retrospective Analysis

et al. 2020

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Purpose: To evaluate the impact on cost, time, resource use, and clinic workflow of converting the route of drug administration from a neurokinin-1 receptor antagonist (NK-1 RA) 30-min intravenous (IV) infusion to aprepitant IV, and more specifically to IV push, within a multicenter community oncology practice. Methods: This was a retrospective, multicenter time, motion, and resource/cost evaluation study. Conversion to aprepitant IV was determined by calculating number of doses of aprepitant IV versus fosaprepitant administered in patients receiving moderately or highly emetogenic chemotherapy regimens. Operational advantages (i.e., supply costs, time saved) of switching from fosaprepitant IV infusion to aprepitant administered as a 2-min IV push were assessed. Results: A total of 12,908 doses of aprepitant IV 130 mg were administered at 13 Rocky Mountain Cancer Centers clinics over an 18-month period. Conversion from fosaprepitant to aprepitant IV reached 90% after 9 months of aprepitant IV initiation. Supply costs per administration were reduced ($2.51 to $0.52) when aprepitant was prepared as an IV push versus an NK-1 RA infusion. The overall time savings per administration of aprepitant was reduced by 90% (from 36.5 to 3.5 min, 33 min saved) as an IV push rather than an infusion. Most of the time saved per administration (30 min) pertained to the infusion nurse, and 3 min was saved by the pharmacy technician. Conclusion: Successful conversion to aprepitant, and specifically to a 2-min IV push, provides time, cost, and resource savings, improves operational efficiency, and avoids the negative impact of potential future IV fluid shortages.

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Section: Discussionmentioning

confidence: 80%

Best Practice Approach to Successful Conversion of Fosaprepitant to Aprepitant IV in a Large Multisite Community Oncology Infusion Center: A Retrospective Analysis

et al. 2020

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“…Finally, another retrospective study evaluated the safety profile of IV HTX-019 after a 30minute infusion in 147 patients; no ISRs were reported, but here also patients were monitored for only 1 hour following HTX-019 administration. 47 Because fosnetupitant is rapidly and nearly completely transformed to netupitant, IV 235-mg fosnetupitant is expected to follow PK similar to oral 300-mg netupitant, except for differences intrinsic to the different administration routes (absorption). Similar to PK studies of IV NEPA in patients with cancer, 24 in the present study fosnetupitant C max was reached at the end of the 30-minute infusion, with <1% of the prodrug being detectable 30 minutes after the end of infusion.…”

Section: Discussionmentioning

confidence: 99%

“…Finally, another retrospective study evaluated the safety profile of IV HTX‐019 after a 30‐minute infusion in 147 patients; no ISRs were reported, but here also patients were monitored for only 1 hour following HTX‐019 administration. 47 …”

Section: Discussionmentioning

confidence: 99%

“…In addition, the majority of patients (76%) had a central IV line, which may decrease the likelihood of ISRs compared with a peripheral line. Finally, another retrospective study evaluated the safety profile of IV HTX‐019 after a 30‐minute infusion in 147 patients; no ISRs were reported, but here also patients were monitored for only 1 hour following HTX‐019 administration 47 …”

Section: Discussionmentioning

confidence: 99%

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Challenges in the Development of Intravenous Neurokinin‐1 Receptor Antagonists: Results of a Safety and Pharmacokinetics Dose‐Finding, Phase 1 Study of Intravenous Fosnetupitant

Tyler

Schultz

Venturini

et al. 2022

Clinical Pharm in Drug Dev

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Oral NEPA is the fixed‐combination antiemetic comprising netupitant (neurokinin‐1 receptor antagonist [NK1RA]) and palonosetron (5‐hydroxytryptamine‐3 receptor antagonist [5‐HT3 RA]). Intravenous (IV) NEPA, containing fosnetupitant, a water‐soluble N‐phosphoryloxymethyl prodrug of netupitant, has been developed. Fosnetupitant does not require excipients or solubility enhancers often used to increase IV NK1RA water solubility, preventing the occurrence of hypersensitivity and infusion‐site reactions associated with these products. In this phase 1 study, subjects received a 30‐minute placebo or fosnetupitant (17.6–353 mg) infusion and an oral NEPA or placebo capsule, with 2‐sequence crossover treatment for fosnetupitant 118‐ to 353‐mg dose cohorts. IV fosnetupitant safety and pharmacokinetics were evaluated, and its equivalence to an oral netupitant 300‐mg dose was defined. Overall, 158 healthy volunteers were enrolled. All adverse events (AEs) were mild or moderate in intensity. Doppler‐identified infusion‐site asymptomatic thrombosis occurred in 5.4% (fosnetupitant) and 1.2% (oral NEPA) of subjects. The frequency or number of treatment‐related AEs did not increase with ascending fosnetupitant doses. The most common treatment‐related AEs were headache (fosnetupitant, 8.1%; oral NEPA, 12.7%) and constipation (fosnetupitant, 1.4%; oral NEPA, 7.5%). A fosnetupitant 235‐mg dose was equivalent, in terms of netupitant exposure, to 300‐mg oral netupitant. The safety profile of a single fosnetupitant 235‐mg infusion was similar to that of single‐dose oral NEPA.

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Safety profile of HTX-019 administered as an intravenous push in cancer patients: a retrospective review

Navari

2019

Expert Opinion on Drug Safety

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Safety Profile of HTX-019 Administered as an Intravenous Infusion in Patients With Cancer

Cited by 4 publications

References 6 publications

Best Practice Approach to Successful Conversion of Fosaprepitant to Aprepitant IV in a Large Multisite Community Oncology Infusion Center: A Retrospective Analysis

Best Practice Approach to Successful Conversion of Fosaprepitant to Aprepitant IV in a Large Multisite Community Oncology Infusion Center: A Retrospective Analysis

Challenges in the Development of Intravenous Neurokinin‐1 Receptor Antagonists: Results of a Safety and Pharmacokinetics Dose‐Finding, Phase 1 Study of Intravenous Fosnetupitant

Safety profile of HTX-019 administered as an intravenous push in cancer patients: a retrospective review

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