Pivmecillinam, also known as Pivya, is an oral antibiotic that was FDA-approved in April of 2024 for use against uncomplicated urinary tract infections (UTI) in female patients.¹

Pivmecillinam Literature

Pivmecillinam falls in the class of penicillin antibiotics. It is a prodrug that contains pivaloyloxymethylester of the amidinopenicillanic acid which is converted to mecillinam. Mecillinam is a beta-lactam antibiotic that disrupts the cell wall of gram-negative bacteria with its high specificity to the penicillin-binding protein 2 (PBP-2).^3,5

Pivmecillinam was approved based on three different randomized control trials. All trials looked at the same primary endpoint which was assessing the efficacy as composite response rate, which included clinical cure.¹ The trials included comparisons between placebo, another oral antibiotic, and ibuprofen. Pivmecillinam showed effectiveness across all three trials in achieving a clinical cure.¹ The most common side effects observed were nausea and diarrhea.¹

Dosing Regimens and Considerations

Pivmecillinam 185 mg is taken orally three times a day for 3 to 7 days. It can be taken with or without food.^3,5 There are no renal or hepatic dosing adjustments necessary however patients should avoid the use if there is a history of hypersensitivity reactions such as Steven-Johnson’s Syndrome or any reactions to other beta-lactams. ^3,5

Patients with hypocarnitinemia should avoid long-term use of the medication due to possible carnitine depletion (good board exam question!).^3,5 There is also the possibility clostridioides difficile-associated diarrhea when used long-term as well. ^3,5

Drug Interactions

There are some drug-drug interactions to be aware of, specifically, with the use of methotrexate. The response may result in increased exposure to methotrexate levels which could have severe adverse effects. 4,5  There is also a concern for concomitant use with valproic acid as this may result in the depletion of carnitine levels. Low carnitine levels can result in effects such as hypoglycemia, fatigue, muscle aches, and confusion.^4,5  Lastly, the use of pevmecillinam with aminoglycosides can result in decreased efficacy of the aminoglycoside drug. This becomes a primary concern for patients with decreased renal function. ^4,5

Summary

Pivmecillinam is a newly approved penicillin-class antibiotic for uncomplicated UTIs in females specifically against gram-negative bacteria. It may be considered for use if safe and appropriate for the patient. 

The most common bacteria found in uncomplicated UTIs is E. coli.⁶ This medication is particularly beneficial because it specifically targets a protein found in the cell wall of gram-negative bacteria. One downside is that pivmecillinam requires three times daily dosing while other common regimens of Macrobid and Bactrim are only twice daily dosing. The cost will also be a significant barrier compared to generic antibiotic options.

This article was written by McKayla Narveson in collaboration with Eric Christianson, PharmD, BCPS, BCGP

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1. FDA Approves New Treatment for Uncomplicated Urinary Tract Infections. US Food & Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-uncomplicated-urinary-tract-infections. Updated April 29, 2024. Accessed October 7, 2024
2. DynaMed. Complicated Urinary Tract Infection (UTI). EBSCO Information Services. Accessed October 7, 2024. https://www.dynamed.com/condition/complicated-urinary-tract-infection-uti
3. Pivmecillinam. Merative Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www micromedexsolutionscom.ezp3.lib.umn.edu/ (accessed: October 7, 2024)
4. Drug Interaction Dex. Merative Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www micromedexsolutionscom.ezp3.lib.umn.edu/ (accessed: October 8, 2024)
5. Pivmecillinam. Facts & Comparisons: Drug Facts and Comparisons, Monograph, Wolters Kluwer Clinical Drug Information, Inc. https://fco.factsandcomparisons.com/lco/action/home. Accessed October 8, 2024
6. Gupta MD. Acute complicated urinary tract infection (including pyelonephritis) in adults and adolescent. UpToDate, Waltham, MA: UpToDate Inc. https://www.uptodate.com (Accessed on October 8, 2024)
7. Gupta MD. Acute simple cystitis in adult and adolescent females. UpToDate, Waltham, MA: UpToDate Inc. https://www.uptodate.com (Accessed on October 8, 2024)