Does slowing the infusion rate of liposomal amphotericin from 2 hours to 4-6 hours reduce the incidence or severity of infusion reactions?

Comment by InpharmD Researcher

Limited data suggest a slower infusion of liposomal amphotericin B may reduce the risk of infusion-related adverse events compared to the standard 2-hour infusion rate. An infusion period of 5-6 hours or a stepwise increase in infusion rate every 15 minutes may be viable strategies to avoid infusion-related reactions. However, there is a lack of a quality controlled study to confirm these findings.

Background

As various authors have pointed out, there have not been extensive investigations as to whether slowing the infusion rate of liposomal amphotericin B can reduce the risk of infusion-related reactions. Most investigations are limited to studies and case reports with protocols in place to reduce the infusion rate when patients experience an infusion reaction, not to proactively reduce infusion rates if patients are considered at risk. Generally, these reports suggest that reducing the infusion rate does ameliorate infusion-related reactions, but studies comparing rapid versus reduced rates are scarce. [1], [2], [3]

A 2021 pilot study investigated whether slowing the infusion rate of amphotericin B-containing lipid complex (Abelcet®) can reduce the risk of infusion-related reactions in pediatric patients. A total of 22 children were included for the treatment of various indications at the recommended rate of 2.5 mg/kg/hour. All but one child received a prolonged infusion rate 2-3x more than the standard infusion rate of 2 hours (e.g., 4-6 hours of prolonged infusion). Despite this, 7 of 22 patients developed a reaction (32%), with 6 of 10 patients who received 2-4 hour infusions developing the reaction. Only 1 of 14 patients who received a 5-6 hour infusion developed a reaction. Therefore, the authors suggest that a very slow infusion of 5-6 hours may be more safe in pediatric patients. Note that Abelcet® is not interchangeable with liposomal amphotericin B (AmBisome®) as they have different dosing recommendations. The results of this study on Abelcet® may not directly correlate with AmBisome®. [4]

A 1998 case series reported on three intravenous (IV) liposomal amphotericin B (AmBisome®) recipients who developed chest discomfort and pulmonary symptoms during a planned 1-hour infusion. Patient 1, a 15-year-old boy, experienced chest tightness accompanied by tremors and a reduction in oxygen saturation, all emerging shortly after the infusion began. Meanwhile, Patient 2, a 40-year-old man, developed acute dyspnea and hypoxia during the infusion, which improved after stopping the infusion and slowing down subsequent infusions to 2 hours with the next scheduled dose. Similarly, Patient 3, a 60-year-old man, complained of chest pain radiating to his groin during the infusion, which was resolved after stopping the infusion. These reactions occurred within minutes of the infusion starting and were all resolved upon discontinuation. The authors noted that the patients' reactions were not consistently related to histamine-mediated allergic responses or specific lot variations. Factors such as lipid composition, particle size, infusion rate, and concentration of the drug in the IV solution could have potentially contributed to these reported toxicities. Overall, the reports suggested that slowing the infusion rate of liposomal amphotericin B could reduce the incidence or severity of infusion reactions, as noted in patient 2. However, factors such as lipid composition and patient characteristics could have also played a role in the likelihood and severity of these reactions. The authors concluded that further investigation was needed to fully understand the mechanisms behind these infusion-related reactions and to establish optimal strategies for preventing and managing them. [5]

References:

[1] Craddock C, Anson J, Chu P, et al. Best practice guidelines for the management of adverse events associated with amphotericin B lipid complex [published correction appears in Expert Opin Drug Saf. 2011 Mar;10(2):335]. Expert Opin Drug Saf. 2010;9(1):139-147. doi:10.1517/14740330903418430
[2] Nath P, Basher A, Harada M, et al. Immediate hypersensitivity reaction following liposomal amphotericin-B (AmBisome) infusion. Trop Doct. 2014;44(4):241-242. doi:10.1177/0049475514543655
[3] Clevenbergh P, Jacobs F, Kentos A, et al. Compassionate use of amphotericin B lipid complex (Abelcet) in life-threatening fungal infections: report of 30 courses. Clin Microbiol Infect. 1998;4(4):192-198. doi:10.1111/j.1469-0691.1998.tb00668.x
[4] Milosevits G, Mészáros T, Őrfi E, et al. Complement-mediated hypersensitivity reactions to an amphotericin B-containing lipid complex (Abelcet) in pediatric patients and anesthetized rats: Benefits of slow infusion. Nanomedicine. 2021;34:102366. doi:10.1016/j.nano.2021.102366
[5] Johnson MD, Drew RH, Perfect JR. Chest discomfort associated with liposomal amphotericin B: report of three cases and review of the literature. Pharmacotherapy. 1998;18(5):1053-1061.

Relevant Prescribing Information

-If the patient experiences discomfort during infusion, the duration of infusion may be increased.
-There have been a few reports of flushing, back pain with or without chest tightness, and chest pain associated with AmBisome administration; on occasion this has been severe. Where these symptoms were noted, the reaction developed within a few minutes after the start of infusion and disappeared rapidly when the infusion was stopped. The symptoms do not occur with every dose and usually do not recur on subsequent administrations when the infusion rate is slowed. [6]

References:

[6] AMBISOME (amphotericin b injection, lyophilized). Prescribing information. Astella Pharma US, Inc.; 2020.

Literature Review

A search of the published medical literature revealed 1 study investigating the researchable question:

Does slowing the infusion rate of liposomal amphotericin from 2 hours to 4-6 hours reduce the incidence or severity of infusion reactions?

Please see Table 1 for your response.


 

Liposomal Amphotericin-B Infusion-related Reactions and Rate of Infusions: A Single Center Cohort Study

Design

Retrospective cohort study

N= 47

Objective

To determine if slowing down the infusion rate on treatment initiation would reduce the rate of infusion-related adverse events

Study Groups

Study patients (N= 47)

Inclusion Criteria

Patients prescribed and administered liposomal amphotericin B (Ambisome®)

Exclusion Criteria

Patients with unavailable medications charts

Methods

Patient data were collected from a single institution center in Australia. Liposomal amphotericin B infusions were prepared at 0.4 to 1.8 mg/mL concentrations. Low infusion rates that were initiated in patients consisted of a 15-minute increment increase if there was an absence of infusion-related AEs, but there was no set protocol. Most slow infusions started at 4 mL/hour, then increased to 10, 40, and 80 mL/hour every 15 minutes until the standard infusion rate was reached.

Duration

2012 to 2020

Outcome Measures

Primary: rate of infusion-related adverse events

Baseline Characteristics

 

Study patients (N= 47)

 

Age, years

61.7  

Male

28  

Length of stay, days

26.1  

Rate of administration

Not specified

Over 2 hours

≤ 1 hour

Reduced rate

 

26 (55.3%)

11 (23.4%)

5 (10.6%)

5 (10.6%)

 

Premedication used

2 (4.3%)  

Results

Endpoint

Study patients (n= 47)

p-Value

Infusion-related adverse events

All patients

Reduced-rate patients

 

7 (14.9%)

2/7 (40%)

0.154

Rates reduced

3 (6.4%)  

Infusion ceased

7 (14.9%)

 

Infusion restarted

4 (8.5%)

 

Adverse Events

Most common adverse events: flushing or diaphoresis (6.4%), dyspnea (6.4%), palpitations (4.3%), rash or itch (4.3%)

Study Author Conclusions

Slowing the infusion rate of liposomal amphotericin-B administration does not appear to reduce the likelihood of infusion-related reactions; however, it can be trialed for adverse-event management.

InpharmD Researcher Critique

There was no distinct protocol between those who received standard infusion rates and reduced infusion rates. Over half of the patients that were included did not specify the infusion rate at all. Therefore, extrapolation of study results is limited.



References:

Banakh I, Hua Q, Metcalfe J. Liposomal amphotericin-b infusion-related reactions and rate of infusions: a single center cohort study. J Microbil Infect Dis. Published online December 15, 2022:148-153. doi: 10.5799/jmid.1218636