Urinary tract infections (UTIs) are one of the most common infections in the world. They happen more often in women. UTIs include bladder and kidney infections. Bladder infections are sometimes also called cystitis or referred to as uncomplicated UTIs. Common symptoms with bladder infections can include a burning feeling when you pee (dysuria), frequently feeling the need to pee even though not much comes out when you do (urgency), and pain in your lower belly area. Kidney infections are sometimes also called pyelonephritis. Common symptoms with kidney infections can include the symptoms above plus fever, chills, nausea, vomiting, or pain in your back or side.
Antibiotics are commonly used to treat UTIs. Pivya (pivmecillinam) is known as a penicillin antibiotic. It has been used in Europe for years and is now approved in the United States. Pivya is approved to treat uncomplicated UTIs or bladder infections in adult women caused by certain bacteria. These bacteria include susceptible isolates of Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus.
How Does Pivya Work?
Pivya is a prodrug. Prodrugs have to be converted in your body to the active form in order for them to work. Pivmecillinam is the generic name for Pivya. After swallowing a Pivya tablet, your body absorbs it and converts pivmecillinam into mecillinam. Mecillinam is the actual medicine that works to treat bladder infections. Mecillinam blocks the ability of certain bacteria to make their cell wall. Without a cell wall, these bacteria die.
Is Pivya Right for Me?
To decide if Pivya is right for you, your health care provider will look at things like your age, medical history, medicine allergies, and the cause of your bladder infection. Specifically, Pivya is FDA-approved to treat simple (uncomplicated) bladder infections caused by certain types of bacteria in adult women.
Pivya should not be used in people who have any of the following.
- A carnitine deficiency
- Acute porphyria
- A serious allergy to any of the ingredients
A carnitine deficiency is when you do not have enough carnitine in your body. Your body can make carnitine, but it is also commonly found in foods, such as red meat, poultry, and dairy products. Carnitine helps your body make energy. A carnitine deficiency can happen if you have certain genetic conditions. Pivya should not be used if you have a carnitine deficiency.
Pivya should also be avoided if you have acute porphyria, which is a group of genetic disorders, because it can lead to an acute attack of porphyria. Porphyria attacks can be life threatening.
Finally, you should tell your health care provider if you have any allergies to antibiotics, including beta-lactams. Beta-lactams include penicillin-related antibiotics and cephalosporins, such as cephalexin. Pivya is related to these types of antibiotics, so if you have an allergy to them, your health care provider may want to know more details about what type of reaction you had to know if Pivya is a good choice for you.
Along with avoiding Pivya in people with certain allergies or medical conditions, it is also important to know if Pivya is likely to cure your UTI. Pivya may not be the right medicine for some urinary tract infections, depending on which germs are causing the infection. Pivya does not work for UTIs that are caused by a fungus or a virus. It only works against certain bacteria. Bacteria in some locations may be resistant to Pivya, which will cause it to not work as well. Before prescribing Pivya, your health care provider may do tests, such as a urine culture, to find out which bacteria are causing the infection. Sensitivity tests can tell your health care provider if the bacteria are resistant to certain antibiotics. Your health care provider will likely use these test results to choose or adjust your treatment. If test results are not available, your health care provider may choose the best treatment for your UTI based on your history and what usually works for UTIs in your area.
How Was Pivya Studied for UTIs?
The efficacy and safety of Pivya for UTIs was studied in several clinical trials. One trial looked at which dose of Pivya worked to treat UTIs, compared to a placebo (a tablet with no medicine in it). Another trial looked at how Pivya worked when compared to another antibiotic, called cephalexin. The most common bacteria causing the UTIs in these trials was E. coli.
The first trial compared three different doses of Pivya to a placebo in adult women with a UTI.
- Pivya 185 mg taken three times per day for seven days
- Pivya 185 mg taken two times per day for seven days
- Pivya 370 mg taken two times per day for three days
The average age of the people in this study was 45 years old. Note that neither Pivya 185 mg taken twice daily nor Pivya 370 mg taken twice daily are approved dosing plans. Therefore, the results for these plans are not discussed below.
The second trial compared Pivya 185 mg taken three times per day for three days to cephalexin 250 mg four times per day for seven days in adult women with a UTI. The average age of the people in this study was 31 years old.
Efficacy for both studies was measured using clinical cure and microbiological response. A clinical cure means the UTI symptoms that people had at the beginning of the study are gone and no new UTI symptoms have appeared. Microbiological response or a negative urine culture means there are few or no bacteria in a new urine sample. Overall response required both a clinical cure and microbiological response.
What Were the Results of the Studies?
The results of the first study are presented below:
Pivya 185 mg taken three times a day for seven days (137 people) | Placebo taken three times a day for seven days (134 people) | |
| Clinical cure (symptoms gone) | 87 people (63.5%) | 31 people (23.1%) |
| Microbiological response (negative urine culture) | 119 people (86.9%) | 35 people (26.1%) |
| Overall response (symptoms gone and negative urine culture) | 85 people (62%) | 14 people (10.4%) |
The take-home message from this study was that Pivya 185 mg taken three times a day for seven days works better than a placebo (a pill with no medicine in it) to treat uncomplicated urinary tract infections in women with UTIs caused by certain bacteria.
The results of the second study are presented below:
Pivya 185 mg taken three times a day for three days (127 people) | Cephalexin 250 mg taken four times a day for seven days (132 people) | |
| Clinical cure (symptoms gone) | 105 people (82.7%) | 112 people (84.8%) |
| Microbiological response (negative urine culture) | 97 people (76.4%) | 106 people (80.3%) |
| Overall response (symptoms gone and negative urine culture) | 91 people (71.7%) | 100 people (75.8%) |
The take-home message from this study is that Pivya 185 mg taken three times a day for three days works similarly to cephalexin 250 mg taken four times a day for seven days to treat uncomplicated urinary tract infections in women with UTIs caused by certain bacteria.
From a safety perspective, Pivya seems to be very well tolerated. The most common side effects reported in the studies were mild to moderate and usually involved either nausea or diarrhea.
Your results may differ from what was seen in clinical studies.
How Should I Take Pivya?
Pivya comes in 185-milligram (mg) tablets. The usual dose is 185 mg taken by mouth three times a day for three to seven days. It can be taken with or without food.
Even if the symptoms of your bladder infection start to improve, it is important to take Pivya exactly as your health care provider prescribed it. Do not skip doses or stop the medicine early. If you do, it could make the treatment less effective and increase the chances of the bacteria becoming resistant. This means Pivya may not work for you in the future, and other antibiotics might also become less effective. Follow your health care provider's directions while taking Pivya.
If you have any questions about how to get Pivya or if you need help affording your medicine, talk to your health care provider.
What Can I Do to Reduce My Risk of a UTI?
It can be frustrating if you get UTIs, especially if you get them often. Here are some simple things you can do to help prevent UTIs in the first place.
- Stay hydrated. Drink plenty of water. By drinking water, your bladder will fill up and you will need to empty it (pee). The more often you pee, the less time bacteria have to sit in your bladder and cause an infection.
- Wipe properly. Wiping from front to back reduces your risk of transferring bacteria from your anus (butthole) to your urethra (where pee comes out). Less bacteria means less risk of infection.
- Stay clean. Wash your private parts with soap and water before sex. This helps keep bacteria away from the urethra. Empty your bladder after having sex. Peeing helps carry any bacteria that entered the urinary tract back out.
- Limit feminine products. Limit the use of irritating feminine products. Chemicals and fragrances can be irritating for some people. Try to avoid douches and scented deodorant sprays or powders.
Talk with your health care provider about other ways you may be able to help prevent UTIs.