Epilepsy is a common diagnosis and can quickly progress to status epilepticus which requires rapid treatment. Levetiracetam is a frequent treatment choice in these situations. The approved administration of intravenous levetiracetam is an infusion over 15 min. In recent years, studies have been published on faster infusion rates of levetiracetam. The objective of this review is to discuss the safety of levetiracetam as an intravenous push at a rate quicker than recommended. A literature search using PubMed, Cochrane Library, ClinicalTrials.gov, and Google Scholar resulted in 192 articles. Inclusion criteria consisted of English language, human studies, use of levetiracetam administered intravenously at a rate faster than 15 min, discussion of safety, and full‐text availability. After screening, nine articles remained for inclusion. Of the nine articles, one was a prospective, open‐label study, six were retrospective studies, and two were open‐label, randomized controlled trials. The most common rapid infusion speed was 5 min and doses ranged from 280 to 4500 mg. Some of these trials used undiluted levetiracetam and many reported that peripheral access was used for a portion or all of the administrations. There were few adverse effects, including specific adverse effects relating to medication concentration and speed of infusion, in all the studies. Administration of intravenous levetiracetam at a rate faster than recommended in the labeling information appears to be safe and tolerable and can be given via a peripheral line. Rapid infusion of levetiracetam is a beneficial method of administration in an acute care setting where patients need rapid attainment of therapeutic levels of antiepileptic medications. Additional research is needed to ensure that rapid administration of intravenous levetiracetam is as efficacious as the traditional dosing method.

The safety of rapid infusion levetiracetam: A systematic review

In patients who experience a seizure, the seizure duration is a strong indicator of prognosis. Thus, reducing time to antiepileptic medications in patients who are actively seizing is critical. While findings from retrospective studies suggest that the rapid administration of undiluted intravenous (IV) levetiracetam may be safe, some gaps in the literature remain.The purpose of this research study was to prospectively assess adverse events associated with the rapid administration of undiluted IV levetiracetam.This was a prospective, observational cohort study of adult patients who received rapid administration of undiluted IV levetiracetam at doses up to 4500 mg in the emergency department (ED) of a large community, teaching hospital. The primary endpoint was the incidence of any pre-defined adverse event. Secondary endpoints included the incidence of each type of adverse event, the incidence of seizure termination, and the time to completion of drug administration in patients actively seizing at the time of study inclusion.A total of 321 doses of IV push levetiracetam were ordered for 318 patients and 250 patients were subsequently included. Fourteen (5.6%) patients experienced an adverse event, most commonly due to injection site reactions (9/14). Clinically relevant hypotension, tachycardia, and hypertension occurred in five patients. For actively seizing patients, 79% (15/19) achieved seizure termination and the median time from medication order to completion of therapy was 12 min.This study found that the rapid administration of undiluted IV levetiracetam in ED patients was associated with few adverse events. 

Adverse events of undiluted intravenous push levetiracetam – A prospective observational study

OBJECTIVE
Rapid administration of anti-seizure medications is a critical concept in the treatment of status epilepticus. Although undiluted LEV doses of up to 2500 mg have been evaluated, minimal data exists to support the safety of loading doses up to 4500 mg. This study will evaluate IV push administration of undiluted LEV from 2500 mg to 4500 mg for safety outcomes as well as tolerability.


METHODS
This is a retrospective, observational, cohort analysis of adult patients who received at least one loading dose of undiluted IV push LEV from October 15, 2019, to April 30, 2022, at a large academic medical center in Phoenix, Arizona. Relevant outcomes include the safety and tolerability of rapid administration of undiluted LEV at higher loading doses.


RESULTS
We evaluated 518 loading doses in 518 unique patients included during the study period. LEV was a new medication for witnessed or suspected seizures in 80.3% of patients, with 31.2% having a documented history of epilepsy or seizure disorder. At the time of LEV administration, 52.9% of patients were on a general medicine floor, 34.3% were in the intensive care unit and 12.7% were in the emergency department. The median loading dose of LEV was 3600 mg [3000 mg-4000 mg], with 4000 mg being the most common loading dose given. Peripheral IV lines were documented as the only available line in 78.6% of patients for loading dose administration. No adverse events associated with LEV administration were documented.


SIGNIFICANCE
Rapid IV administration of undiluted doses of LEV is both safe and tolerable in loading doses of 2500 mg to 4500 mg, allowing for rapid drug administration in the setting of status epilepticus.

Rapid Administration of Undiluted Loading Doses of Levetiracetam.

BACKGROUND AND OBJECTIVES
Failure of initial benzodiazepine therapy in patients with status epilepticus warrants urgent administration of a second-line antiseizure medication. Recent studies suggest rapid administration of high-dose, undiluted levetiracetam is safe in adults; however, no information exists in pediatric patients. The purpose of this study was to evaluate the safety and tolerability of undiluted levetiracetam at a pediatric institution.


METHODS
Retrospective, single-center, cohort analysis of patients who received high-dose >60 mg/kg (-10%) up to 4500 mg diluted or undiluted intravenous levetiracetam between May 6, 2020 to July 31, 2022 at a large pediatric academic medical center. The primary outcome was the assessment of hemodynamic disturbances (bradycardia, hypotension) and/or infusion-related reactions after administration of the levetiracetam infusion.


RESULTS
A total of 776 levetiracetam doses were included, 358 doses administered and 418 doses wasted. The doses administered (61 undiluted and 297 diluted) accounted for a total of 252 patients (39 received undiluted and 213 received diluted levetiracetam) (median [minimum-maximum range] age, 2 y [1 d-32.7 y]; mean (standard deviation [SD]) weight, 20.1 kg (22.1 kg)). The incidence of hemodynamic disturbances and infusion-related reactions was not statistically significant between diluted and undiluted groups (p= 0.87). The median (interquartile range [IQR]) time difference between first-line antiseizure medication and levetiracetam administration in patients with status epilepticus was 18 minutes (10.5-30.5) in the undiluted group versus 36.5 minutes (21.8-67.3) in the diluted group; p<0.01. Additionally, there was a significant amount of drug waste from dispensed but not administered doses of the diluted bag compared to undiluted vials (57.6% diluted versus 18.7% undiluted, p<0.001).


CONCLUSION
Undiluted levetiracetam was not associated with an increased incidence of adverse effects compared to diluted levetiracetam in high-doses, up to 4500 mg given over 5 minutes in pediatric patients.

Evaluation of the safety and tolerability of intravenous undiluted levetiracetam at a pediatric institution.

Background and Objectives IV thrombolysis (IVT) for suspected ischemic stroke in patients with intracranial neoplasms is off-label. However, data on risks of intracranial hemorrhage (ICH) are scarce. Methods In a multicenter registry-based analysis within the European Thrombolysis in Ischemic Stroke Patients (TRISP) collaboration, we assessed frequencies of symptomatic and fatal ICH after IVT for suspected ischemic stroke in patients with intracranial tumors by descriptive statistics and analyzed associations with clinical and imaging characteristics by binary logistic regression. Definition of symptomatic ICH was based on the clinical criteria of the European Cooperative Acute Stroke-II trial including hemorrhage at any site in cranial imaging and concurrent clinical deterioration. Results Screening data of 21,289 patients from 14 centers, we identified 105 patients receiving IVT; among them were 29 patients (28%) with additional endovascular treatment, with suspected, that is, imaging-based, or histologically confirmed diagnosis of intracranial tumors. Among 104 patients with CT or MRI after IVT available, symptomatic and fatal ICH were observed in 9 and 4 patients (9% and 4%, respectively). Among 82 patients with suspected or confirmed meningioma, symptomatic and fatal ICH occurred in 6 and 3 patients (7% and 4%), respectively. In 18 patients with intra-axial suspected or confirmed primary or secondary brain tumors, there was 1 symptomatic nonfatal ICH (6%). Of 4 patients with tumors of the pituitary region, 2 patients (50%) had symptomatic ICH including 1 fatal ICH (25%). Tumor size was not associated with the occurrence of symptomatic ICH (odds ratio 2.8, 95% CI 0.3–24.8, p = 0.34). Discussion In our dataset from routine clinical care, we provide insights on the safety of IVT for suspected ischemic stroke in patients with intracranial tumors, a population that is commonly withheld thrombolysis in clinical practice and prospective trials. Except for a potential high risk of symptomatic ICH after IVT in patients with tumors of the pituitary region, frequencies of symptomatic ICH in patients with intracranial tumors in our cohort seem to be in the upper range of rates observed in previous studies within the TRISP cooperation. These results may guide individual treatment decisions in patients with acute stroke and intracranial tumors with potential benefit of IVT.

IV Thrombolysis With or Without Endovascular Treatment for Suspected Ischemic Stroke in Patients With Intracranial Tumors

Background Intravenous (IV) levetiracetam (LEV) is an antiseizure medication traditionally given as an intermittent infusion to mitigate potential adverse effects given its acidic formulation. The process of compounding may lead to delays in treating status epilepticus, which is why administration of undiluted doses is of interest. Prior studies have shown safety of IV doses from 1000 mg to 4500 mg; however, assessments of adverse side effects outside IV site reactions have not been studied. Methods A retrospective analysis was completed with patients who received 1500 mg doses of undiluted IV LEV. We included patients ≥ 18 years old that received at least 1 dose of IV LEV 1500 mg from January 2018 to February 2021. Study end points included assessment of hemodynamic disturbance (bradycardia [HR less than 50 beats per minute] or hypotension [SBP less than 90 mmHg] within 1 hour or documented infusion reaction within 12 hours of LEV. Descriptive statistics were utilized. Results A total 213 doses of 1500 mg of IV LEV were administered to 107 patients. Peripheral lines were used for 85.9% of doses. Approximately half of doses (57) were administered to patients on the general wards, with the remainder in the intensive care unit or emergency department. Two patients (1.9%) experienced bradycardia; however, 1 patient had pre-existing bradycardia. Three patients (3.8%) experienced hypotension; however, those patients were receiving vasopressors prior to the dose. There were no cases of infusion reaction. Conclusion Undiluted, rapid administration of IV LEV 1500 mg was well tolerated and safe.

Evaluation of the Safety of Rapid Administration of Undiluted High-Dose Intravenous Levetiracetam

A systematic review of published cases of standard-dose IV tPA for acute ischemic stroke (AIS) within 4.5 hours of symptom onset and intracranial tumor was performed.PubMed, Embase, and Cochrane were used to identify studies that included patients given standard-dose IV tPA for presumed AIS within 4.5 hours of symptom onset who had an intracranial tumor. The primary outcome measure was rate of ICH.Twenty-three studies were included, involving 495 patient cases. One case-control study presented data only in the form of an odds ratio (OR), with OR 0.72 (p=0.16) for risk of ICH in 297 benign brain tumors, and OR for ICH of 2.33 (p value <0.001) in 119 malignant brain tumors, compared to controls. The remaining 22 sources included 79 cases; 49 were classified as benign, 16 malignant, and 14 "not otherwise specified." ICH occurred in 4; one was an asymptomatic parenchymal hematoma (5.1% total ICH, 3.8% symptomatic ICH). ICH only occurred in cases of malignant or metastatic intracranial tumors.There were no reports of ICH in cases of benign intracranial tumor, and the reported rate of ICH with standard-dose IV tPA in the setting of any brain tumor appears similar to the general AIS population. There is heterogeneity and risk of selection bias with the included studies, and findings are not confirmatory. Further research is indicated to assess the rate of ICH with IV tPA for AIS in the setting of brain tumor. 

IV tPA for acute ischemic stroke in the setting of intracranial tumor: A scoping review.


 Objective:
 Intracranial tumor is considered a contraindication to IV tPA for presumed acute ischemic stroke (AIS), though evidence differentiating rate of intracranial hemorrhage (ICH) in benign versus malignant neoplasm is lacking. A systematic review of published cases of standard-dose IV tPA for AIS within 4.5 hours of symptom onset and intracranial tumor was performed.
 
 
 Methods:
 PubMed, Embase, and Cochrane were used to identify articles for inclusion. Case reports, letters to the editor, conference proceedings, cohort studies, case series, literature reviews, and case-control studies that included patients given standard dose IV tPA for presumed AIS within 4.5 hours of symptom onset, who were found to have an intracranial tumor, were included. The primary outcome measure was the rate of ICH.
 
 
 Results:
 Twenty-three studies met inclusion criteria, involving 495 patient cases. One of the included case-control studies presented data only in the form of an odds ratio (OR), with OR 0.72 (p=0.16) for risk of ICH out of 297 benign brain tumors as compared to controls. They found an OR for ICH of 2.33 (p value <0.001) in 119 malignant brain tumors as compared to controls. The remaining 22 sources included a total of 79 cases, 49 of which were classified as benign, 16 malignant, and 14 “not otherwise specified.” Of these 79 cases, ICH occurred in 4, one of which was an asymptomatic parenchymal hematoma (5.1% total ICH, 3.8% symptomatic ICH). ICH only occurred in cases of malignant or metastatic intracranial tumors. There were no reports of ICH following IV tPA in patients with a benign intracranial tumor. Meta-analysis could not be performed due to substantial heterogeneity in study design and reported patient data in included sources.
 
 
 Conclusion:
 There were no reports of ICH in the setting of benign intracranial tumor, and the reported rate of ICH with standard-dose IV tPA in the setting of any brain tumor appears similar to the general AIS population. There is significant heterogeneity of sources and risk of selection bias with the included studies, such that these findings are not confirmatory. Further research is needed to assess the rate of ICH with IV tPA for AIS in the setting of brain tumor.


Abstract WP9: Iv Tpa For Acute Ischemic Stroke In The Setting Of Intracranial Tumor: A Systematic Review

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Evaluation of the Safety of Rapid Administration of Undiluted High-Dose Intravenous Levetiracetam

IV tPA for acute ischemic stroke in the setting of intracranial tumor: A scoping review.

Abstract WP9: Iv Tpa For Acute Ischemic Stroke In The Setting Of Intracranial Tumor: A Systematic Review