A urinary tract infection (UTI) is an infection that can happen anywhere in the urinary system, most commonly the bladder or urethra (the tube that carries urine out of the body). Women are more likely than men to get UTIs. A complicated UTI (cUTI) is a more serious type of UTI that may affect the bladder, kidneys, or other parts of the urinary tract. When the infection spreads to the kidneys, it is called pyelonephritis. Symptoms of a cUTI can be more severe and include lower back pain, fever, chills, nausea, and vomiting. Complicated UTIs are also more likely to be caused by bacteria that are harder to treat.
Utebzi (tebipenem pivoxil) is a newer antibiotic used to treat cUTIs, including pyelonephritis, in adults who have few or no other oral treatment options. Utebzi is a carbapenem antibiotic, a type of antibiotic in the broader penem family. It targets certain bacteria, such as Escherichia coli, Klebsiella, Enterobacter, and Enterococcus species, when testing shows they are likely to respond to the medicine.
Utebzi is unique because it is currently the only carbapenem antibiotic available as a pill in the U.S. Until now, medicines in this class were only given through a vein (IV). An oral option may help some people avoid IV treatment in the hospital.
How Does Utebzi Work for cUTIs?
Utebzi is a carbapenem antibiotic that works against several types of bacteria that commonly cause cUTIs, including Escherichia coli, Klebsiella, Enterobacter, and Enterococcus species. Carbapenems are a powerful group of antibiotics often used to treat difficult infections. Utebzi kills bacteria by damaging their protective outer wall, which is important for their survival. Utebzi starts in an inactive form (tebipenem pivoxil). After you take it, your body absorbs it and changes it into the active form (tebipenem) that fights the infection.
Is Utebzi Right for Me?
Utebzi may be a treatment option if you have a cUTI and your health care provider sees that the bacteria causing your infection are likely to respond to it.
Utebzi may not be the right antibiotic for everyone. People with a seizure disorder can be more sensitive to it. Antibiotics like Utebzi can, in rare cases, raise the risk of seizures. It can also reduce the effect of certain seizure medicines. If you have a history of seizures or take medicine to control them, let your provider know so they can decide whether Utebzi is safe for you or whether another option would be better.
The best antibiotic for you depends on factors such as the type of bacteria causing the infection, your medical history, allergies, and other medicines you take. Your health care provider may use urine culture results to help decide if Utebzi is right for you.
How Was Utebzi Studied for cUTIs?
Utebzi was studied in a clinical trial called PIVOT-PO. The study compared Utebzi with imipenem-cilastatin, another IV carbapenem antibiotic used to treat cUTIs.
Adults were eligible to join the study if they were hospitalized with a cUTI and/or pyelonephritis (kidney infection). People whose infections were not expected to respond to the antibiotics were not included in the study.
Participants were treated with Utebzi or imipenem-cilastatin for 7-10 days. Doses were based on each participant’s kidney function.
A total of 1690 adults took part in the study, and 929 adults were included in the main analysis. At the start of the study:
- The average age of participants was 68 years.
- About 22% of participants had cUTI with pyelonephritis, 43% had cUTI without pyelonephritis, and 34% had pyelonephritis alone.
- Most participants were White (97%), 2% were Black or African American, and less than 1% were Asian.
The study was conducted in many countries around the world, with most participants (90%) enrolled from Central and Eastern Europe.
The goal of the study was to see how well Utebzi treated the infection compared to imipenem-cilastatin. The study’s main measure of success was a composite response, which means participants had to achieve both of the following:
- Clinical cure: Symptoms of infection improved or went away.
- Microbiological response: the bacteria causing the infection were reduced or cleared.
What Are the Benefits of Utebzi Based on the PIVOT-PO Study?
Overall, the PIVOT-PO study found that Utebzi and imipenem-cilastatin had similar composite response rates. The table below summarizes the results. The percentages represent the proportion of people who experienced each outcome during the study.
| Utebzi | Imipenem-cilastatin | |
|---|---|---|
| Composite response (main result) | 58.5% | 60.2% |
| Clinical cure | 93.5% | 95.2% |
| Microbiological response | 60.3% | 61.3% |
Utebzi met the bar for “non-inferiority,” which means it worked as well as the IV antibiotic. This showed that Utebzi worked as well as imipenem-cilastatin in hospitalized adults with cUTIs.
How Do I Take Utebzi?
Utebzi comes as a 300-milligram (mg) tablet that is taken by mouth. You need to swallow the tablet whole, and the medicine can be taken with or without food. If you have trouble swallowing tablets, talk to your health care provider; they may prescribe a different medicine for you.
The exact Utebzi dose depends on how well your kidneys work, so your health care provider may check your kidney function before and during treatment and decide the right dose for you. For most adults, the usual dose is two tablets (600 mg total) taken every six hours for 7-10 days. The tablets can be taken with or without food.
Always take Utebzi exactly as prescribed. This will lower your chances of getting future infections that are resistant to Utebzi or other similar medicines. Do not stop taking it early, even if you start to feel better. This helps make sure all the bacteria are killed off so you do not get sick again. Also, do not take it for a longer time than what your health care provider suggests.