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

Navari, Rudolph M.

doi:10.1080/14740338.2020.1691521

Cited by 5 publications

(6 citation statements)

References 20 publications

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“…A retrospective study of IV HTX‐019 evaluated the safety of the drug following a 2‐minute injection in 600 patients with cancer who received moderately emetogenic chemotherapy or HEC. 46 There were no reports of ISRs in this study, although again, safety monitoring was undertaken for only 60 minutes after injection, so the data should be interpreted with some caution. In addition, the majority of patients (76%) had a central IV line, which may decrease the likelihood of ISRs compared with a peripheral line.…”

Section: Discussionmentioning

confidence: 76%

“…However, as the AEs were monitored for only 60 minutes, events that occurred later would not have been captured in this study. A retrospective study of IV HTX‐019 evaluated the safety of the drug following a 2‐minute injection in 600 patients with cancer who received moderately emetogenic chemotherapy or HEC 46 . There were no reports of ISRs in this study, although again, safety monitoring was undertaken for only 60 minutes after injection, so the data should be interpreted with some caution.…”

Section: Discussionmentioning

confidence: 90%

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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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Section: Discussionmentioning

confidence: 76%

Section: Discussionmentioning

confidence: 90%

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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“…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 – 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: 99%

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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“…37 CINVANTI is approved for administration as a 30-minute intravenous infusion and 2-minute intravenous push in combination with other agents to prevent chemotherapyinduced nausea and vomiting. 37,38 Lipid-Based Nanomicelles Lipid-based nanomicelles are colloidal dispersions that selfassemble from amphiphilic phospholipid molecules, generally less than 100 nm in diameter, with numerous advantages including improved solubility for insoluble drugs and increased targeting to tumor areas. 39 As shown in ►Fig.…”

Section: Lipid-based Nanoemulsionsmentioning

confidence: 99%

“…37 CINVANTI is approved for administration as a 30-minute intravenous infusion and 2-minute intravenous push in combination with other agents to prevent chemotherapy-induced nausea and vomiting. 37 38…”

Section: Lipid-based Nanoemulsionsmentioning

confidence: 99%

Lipid-Based Nanocarrier Systems for Drug Delivery: Advances and Applications

Zhao

Zhou

et al. 2022

Pharmaceutical Fronts

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Lipid-based nanocarriers have been extensively investigated for drug delivery due to their advantages including biodegradability, biocompatibility, nontoxicity, and nonimmunogenicity. However, the shortcomings of traditional lipid-based nanocarriers such as insufficient targeting, capture by the reticuloendothelial system, and fast elimination limit the efficiency of drug delivery and therapeutic efficacy. Therefore, a series of multifunctional lipid-based nanocarriers have been developed to enhance the accumulation of drugs in the lesion site, aiming for improved diagnosis and treatment of various diseases. In this review, we summarized the advances and applications of lipid-based nanocarriers from traditional to novel functional lipid preparations, including liposomes, stimuli-responsive lipid-based nanocarriers, ionizable lipid nanoparticles, lipid hybrid nanocarriers, as well as biomembrane-camouflaged nanoparticles, and further discussed the challenges and prospects of this system. This exploration may give a complete idea viewing the lipid-based nanocarriers as a promising choice for drug delivery system, and fuel the advancement of pharmaceutical products by materials innovation and nanotechnology.

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

Cited by 5 publications

References 20 publications

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

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

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

Lipid-Based Nanocarrier Systems for Drug Delivery: Advances and Applications

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