STEPS

New Drug Reviews

Delafloxacin (Baxdela) for Skin Infections

 

Am Fam Physician. 2018 Aug 15;98(4):246-247.

Delafloxacin (Baxdela) is a fluoroquinolone antibiotic labeled for the treatment of adults with serious acute bacterial skin and skin structure infections, including those caused by Staphylococcus aureus (methicillin-sensitive and methicillin-resistant), Enterococcus faecalis, and Pseudomonas aeruginosa.1 Although delafloxacin is approved by the U.S. Food and Drug Administration for a strictly oral regimen, patients enrolled in the clinical trials that led to approval required three days of initial intravenous therapy followed by oral therapy.1

Safety

As with all fluoroquinolones, the most significant risks of delafloxacin therapy include rare but serious tendinitis/tendon rupture, peripheral neuropathy, and central nervous system adverse effects.1 Treatment should be discontinued if any of these reactions occur. As with other antimicrobials, delafloxacin can cause Clostridium difficile–associated diarrhea. Delafloxacin has not been studied in pregnant or breastfeeding women, and it should not be used in patients younger than 18 years.1

 Enlarge     Print

DrugDosageDose formCost

Delafloxacin (Baxdela)

300 mg intravenously every 12 hours for three days

Lyophilized powder

$800*

then

plus

450 mg orally every 12 hours for two to 11 days

Tablets

$700 for 10 tablets†


*—Estimated retail price of three days of treatment based on personal correspondence with Sonia Talwar, PharmD, Director of Global Health Science at Melinta Therapeutics (accessed May 30, 2018).

†—Estimated retail price of five days of treatment based on information obtained at http://www.goodrx.com (accessed June 6, 2018).

DrugDosageDose formCost

Delafloxacin (Baxdela)

300 mg intravenously every 12 hours for three days

Lyophilized powder

$800*

then

plus

450 mg orally every 12 hours for two to 11 days

Tablets

$700 for 10 tablets†


*—Estimated retail price of three days of treatment based on personal correspondence with Sonia Talwar, PharmD, Director of Global Health Science at Melinta Therapeutics (accessed May 30, 2018).

†—Estimated retail price of five days of treatment based on information obtained at http://www.goodrx.com (accessed June 6, 2018).

Tolerability

Delafloxacin was well-tolerated by most patients in clinical trials. Some patients (8%) experienced nausea and/or vomiting.1 In premarketing studies, the discontinuation rate was 0.9% for patients taking delafloxacin vs. 2.8% for patients in the comparator groups. The most commonly reported reasons for discontinuation were urticaria (0.3%) and hypersensitivity (0.3%).1

Effectiveness

Delafloxacin has been studied in two trials that enrolled adults with cellulitis/erysipelas, wound infection, major cutaneous abscess, or burn infection requiring initial intravenous therapy,

Address correspondence to Sarah Eudaley, PharmD, BCPS, at seudaley@uthsc.edu. Reprints are not available from the author.

Author disclosure: No relevant financial affiliations.

References

1. Daily Med. Drug label information: Baxdela—delafloxacin meglumine tablet and delafloxacin meglumine injection, powder, lyophilized, for solution. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fb77637a-88d9-4aea-958f-e270030ce30d. Accessed August 29, 2017.

2. Pullman J, Gardovskis J, Farly B, et al. Efficacy and safety of delafloxacin compared with vancomycin plus aztreonam for acute bacterial skin and skin structure infections: a phase 3, double-blind, randomized study. J Antimicrob Chemother. 2017;72(12):3471–3480.

3. U.S. National Library of Medicine. Delafloxacin versus vancomycin and aztreonam for the treatment of acute bacterial skin and skin structure infections. https://clinicaltrials.gov/ct2/show/results/NCT01811732?term=delafloxacin&view=results. Accessed July 6, 2018.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

This series is coordinated by Allen F. Shaughnessy, PharmD, MMedEd, Contributing Editor.

A collection of STEPS published in AFP is available at https://www.aafp.org/afp/steps.

 

 

Copyright © 2018 by the American Academy of Family Physicians.
This content is owned by the AAFP. A person viewing it online may make one printout of the material and may use that printout only for his or her personal, non-commercial reference. This material may not otherwise be downloaded, copied, printed, stored, transmitted or reproduced in any medium, whether now known or later invented, except as authorized in writing by the AAFP. Contact afpserv@aafp.org for copyright questions and/or permission requests.

Want to use this article elsewhere? Get Permissions

CME Quiz

More in AFP


Editor's Collections


Related Content


More in Pubmed

MOST RECENT ISSUE


Nov 15, 2018

Access the latest issue of American Family Physician

Read the Issue


Email Alerts

Don't miss a single issue. Sign up for the free AFP email table of contents.

Sign Up Now

Navigate this Article