The FDA-approved ACETADOTE regimen is 21 hours vs the FDA-approved 72-hour oral regimen.
A hospital-perspective analysis was performed to quantify and compare the costs of treating acetaminophen overdose with oral (PO) vs intravenous (IV) N-acetylcysteine (NAC) therapy. The analysis was based on location of care, time to treatment (<10 hours post-ingestion vs 10 to 24 hours post-ingestion), and base case, best case and worst case scenarios.
Pharmacoeconomic Modeling Results1
| Intensive Care Unit | Ward | |||||
|---|---|---|---|---|---|---|
| Post-Ingestion | PO NAC | IV NAC | Differential | PO NAC | IV NAC | Differential |
| <10 Hours | ||||||
| Base Case | $5,817 | $3,765 | $2,052 (35%) | $3,850 | $2,768 | $1,083 (28%) |
| Best Case | $5,590 | $3,527 | $2,063 (37%) | $3,624 | $2,530 | $1,094 (30%) |
| Worse Case | $6,470 | $4,211 | $2,259 (35%) | $4,503 | $3,214 | $1,290 (29%) |
| 10 to 24 Hours | ||||||
| Base Case | $6,200 | $4,293 | $1,906 (31%) | $4,233 | $3,296 | $ 937 (22%) |
| Best Case | $5,579 | $3,645 | $1,934 (35%) | $4,006 | $2,647 | $1,359 (34%) |
| Worse Case | $6,783 | $5,169 | $1,614 (24%) | $5,053 | $4,172 | $ 881 (17%) |
| All values rounded off to nearest dollar amount | ||||||
| ICU and Ward designations reflect location of care depicted in various modeling scenarios | ||||||
| Modeling based on 21-hour Acetadote I.V. Infusion and 72-hour oral administration only | ||||||
Make ACETADOTE your first-line choice
The average transition time from oral NAC to I.V. NAC (eg, due to excessive emesis) is 4.5 hours.2 Any time lost in the critical 10-hour post-ingestion maximal protection window can increase the risk of liver damage.2
NOTE:
Case scenarios are defined as:
- Base Case - the average incident probability and resource cost reported in published literature
- Best Case - the lowest incident probability and resource cost reported in published literature
- Worst Case - the highest incident probability and resource cost reported in published literature
These pharmacoeconomic modeling results are based on the following variables:
| Drug costs | ||||||
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| Emergency Department costs | ||||||
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| Adverse drug events and management costs | ||||||
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| In-patient stays | ||||||
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| Hepatotoxicity and management costs | ||||||
| Acute liver failure and management costs | ||||||
| Transplantation and management costs | ||||||
Important Safety Information
ACETADOTE is contraindicated in patients with hypersensitivity or previous anaphylactoid reactions to acetylcysteine or any components of the preparation. Serious anaphylactoid reactions, including death in a patient with asthma, have been reported in patients administered acetylcysteine intravenously.
ACETADOTE should be used with caution in patients with asthma, or where there is a history of bronchospasm. The total volume administered should be adjusted for patients less than 40 kg and for those requiring fluid restriction. To avoid fluid overload, the volume of diluent should be reduced as needed. If volume is not adjusted, fluid overload can occur, potentially resulting in hyponatremia, seizure, and death.
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References
1. Data on file, Cumberland Pharmaceuticals Inc.
2. Culley CM, Krenzelok EP. A clinical and pharmacoeconomic justification for intravenous acetylcysteine: a US perspective. Toxicol Rev 2005; 24:131-143.