Pivya
Pivya (pivmecillinam) is a penicillin antibiotic. It’s used to treat uncomplicated urinary tract infections (e.g., no pregnancy or fever) in females who are 18 years and older. Pivya (pivmecillinam) is a tablet that’s taken by mouth three times a day, typically for 3 to 7 days depending on how serious the infection is. It might be a good option for people who can’t take first-choice antibiotics due to resistance. Common side effects of this medication include nausea and diarrhea. Currently, there’s no generic for Pivya (pivmecillinam) available.
Note: Pivya (pivmecillinam) has been FDA-approved in April 2024, but it’s not yet available in pharmacies.
What is Pivya (pivmecillinam)?
What is Pivya (pivmecillinam) used for?
Treatment of uncomplicated urinary tract infections (UTIs)
How Pivya (pivmecillinam) works
Pivya (pivmecillinam) is a penicillin antibiotic. It’s a prodrug, meaning it only works after your body changes it into an active form. When you take Pivya (pivmecillinam) by mouth, your body turns it into mecillinam, the active form of the antibiotic. Mecillinam works by preventing bacteria from making their protective covering. This makes them weaker to their surroundings and eventually kills the bacteria.
Drug Facts
What are the side effects of Pivya (pivmecillinam)?
Common Side Effects
- Nausea (4%)
- Diarrhea (2%)
Other Side Effects
- Dizziness
- Headache
- Vaginal yeast infection
- Vaginal itchiness
- Rash
- Stomach pain
- Mouth or esophageal ulcers
Serious Side Effects
- Serious allergic reactions: swelling of the lips, mouth, throat or tongue, difficulty breathing
- Serious skin reactions: sore throat, cough, fever, fatigue, body aches, rash, hives, blisters, skin reddening or peeling
- Infectious (C. difficile-related) diarrhea: fever, nausea, foul-smelling diarrhea, frequent bowel movements (even up to 15 times per day)
- Low carnitine levels: muscle weakness, fatigue, irregular heartbeat, low blood sugar (e.g., shakiness, sweating, dizziness)
- Serious nerve-related problem (acute porphyria): anxiety, confusion, seizures, stomach or limb pain, nausea and vomiting, dark or reddish-brown urine, muscle weakness
Source: FDA
Pros and cons of Pivya (pivmecillinam)
Pros
Taken by mouth
Can be taken with or without food
Lower resistance rates; possible option for UTIs that are resistant to other antibiotics
Cons
Not approved for more serious UTIs (complicated UTIs)
Must be taken 3 times a day
Might not be a good option for those who had serious allergic reactions to penicillins or beta-lactam antibiotics
Pharmacist tips for Pivya (pivmecillinam)
Take Pivya (pivmecillinam) exactly as prescribed. Make sure to finish your treatment course, even if you're feeling better. Stopping the medication earlier than prescribed can make your infection come back and become harder to treat.
You can take Pivya (pivmecillinam) with or without food. But if this medication is upsetting your stomach, then taking it with food can help.
It’s important to drink plenty of water while you’re taking Pivya (pivmecillinam). While the antibiotic helps kill the bacteria causing the infection, drinking more water can help flush out the bacteria from your body faster.
Talk with your prescriber if you experience pelvic pain or burning while urinating from the UTI. If appropriate, they might recommend over-the-counter (OTC) options, like acetaminophen (Tylenol), ibuprofen (Advil), or phenazopyridine (AZO). These medications can’t kill the bacteria, but they can help ease pain and discomfort as Pivya (pivmecillinam) fights the infection.
You might experience mild diarrhea after starting Pivya (pivmecillinam). It's important to stay hydrated by drinking enough water and electrolytes to avoid dehydration. You might be able to manage diarrhea with diet changes. Ask your healthcare team if it’s appropriate to try an OTC medication. If your symptoms don’t get better after 2 days, talk to your prescriber as this may be a more serious case.
Get medical help right away if you develop very watery or bloody diarrhea, fever, fatigue, or stomach cramps anytime during treatment or after stopping Pivya (pivmecillinam). These could be signs of a more serious kind of diarrhea caused by infection, called C. difficile-related diarrhea, which needs to be treated right away.
Ask your prescriber if you should start a probiotic while taking Pivya (pivmecillinam). Taking a probiotic might lower your risk of diarrhea by helping to maintain your normal gut flora. If your prescriber says you can take a probiotic, make sure to separate it from Pivya (pivmecillinam) by at least 2 hours. The antibiotic could kill the bacteria in the probiotic, making it work less well.
Tell your prescriber and pharmacist about all of the medications and supplements you're taking before and during treatment with Pivya (pivmecillinam). This antibiotic can interact with other medications, increasing their effects. For example, it can raise the risk of bleeding with warfarin (Coumadin) or worsen toxicities associated with methotrexate.
Your prescriber will typically ask you to take Pivya (pivmecillinam) for 3 to 7 days to treat your UTI. Your symptoms (e.g., burning or pain during urination, more frequent urination) should start to improve within 3 days after you start this antibiotic. Tell your prescriber if you don’t feel better or if your symptoms worsen after 3 days. This might mean your infection needs more medical attention.
Frequently asked questions about Pivya (pivmecillinam)
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What are the risks and warnings for Pivya (pivmecillinam)?
Pivya (pivmecillinam) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Severe allergic reactions
Risk factors: Allergy to penicillin or other beta-lactam antibiotics
Severe allergic reactions to Pivya (pivmecillinam) can occur. Some reactions can be life-threatening and can include facial swelling, shock, and anaphylaxis (e.g., closing of the throat). Let your prescriber know if you’ve had an allergic reaction to penicillins, cephalosporins, carbapenems, or other beta-lactam antibiotics. Also, let them know what symptoms you experienced. This will help them check your risk of having an allergic reaction to Pivya (pivmecillinam). Get medical attention right away if you notice hives, rash, red skin, swelling of the lips or tongue, or difficulty breathing while you're taking this medication.
Severe skin reactions
Although rare, Pivya (pivmecillinam) can cause a rash or other severe skin reactions, like Stevens-Johnson Syndrome (SJS) and Drug Reaction with Eosinophilia and Systemic Syndrome (DRESS). Some early signs of these skin reactions include a sore throat, fever, fatigue, body aches, and a cough. Stop taking Pivya (pivmecillinam) and get medical help right away if you notice these symptoms or changes in your skin, such as rash, blisters, redness, or peeling. These skin reactions may happen within a few days but can also appear weeks after you stop this medication.
Low carnitine levels
Risk factors: Kidney problems | Less muscle mass | Also taking valproic acid, valproate, or other pivalate-containing medications
Carnitine deficiency (low carnitine levels) was reported in people who took Pivya (pivmecillinam) for a few months or longer. Carnitine is a nutrient that helps turn fat into energy. Low carnitine levels can cause muscle aches, fatigue, and confusion. Your risk for this side effect might be higher if you have kidney problems or have less muscle mass.
You’re unlikely to experience lower carnitine levels from Pivya (pivmecillinam) if you take it as directed for UTIs because treatment is typically short term. This medication isn't approved or recommended for long-term treatment. More research is needed to understand whether taking repeated courses of this antibiotic for UTI can also lead to lower carnitine levels.
Pivya (pivmecillinam) shouldn't be taken if you are also taking any pivalate-containing medications, or valproic acid. Make sure to tell your prescriber about what medications you take, and if you have any medical conditions to make sure this antibiotic is the right option for you.
Serious nerve problem (acute porphyria)
Risk factors: Drink alcohol | Eat less carbs | Have higher levels of sex hormones
Pivya (pivmecillinam) can cause acute porphyria, which often affects your nervous system. Porphyrias are rare genetic conditions where your body can’t properly use chemicals called porphyrins, causing them to build up in your body and cause illness. Your risk might be higher if you smoke, drink alcohol, eat less carbs, or have higher levels of sex hormones like progesterone. Tell your prescriber right away if you experience new anxiety, confusion, seizures, stomach or limb pain, nausea and vomiting, dark or reddish-brown urine, or muscle weakness.
Infectious diarrhea
Taking antibiotics, including Pivya (pivmecillinam), can cause diarrhea. This is because taking antibiotics changes the balance of gut bacteria. Symptoms can be mild. But sometimes, people experience severe symptoms caused by Clostridioides difficile (C. diff) infection. This bacteria is naturally found in your gut and its growth is typically held in check by other gut bacteria. When you take an antibiotic, the changes in the make up of gut bacteria can allow C. diff to overgrow, leading to an infection.
Infectious diarrhea from C. diff can cause severe symptoms like rapid heart rate, foul-smelling diarrhea, fever, nausea, bloody stools, or frequent bowel movements (even up to 15 times per day). This is considered a medical emergency. If you experience any of these symptoms, talk to your prescriber or get medical attention right away so you can be tested for C. diff infection and receive treatment.
Bacterial resistance
Take Pivya (pivmecillinam) exactly as directed by your prescriber. Taking it shorter or longer than prescribed can raise your risk for developing UTIs caused by antibiotic-resistant bacteria. This type of UTI can become severe and more difficult to treat.
Effect on newborn screening test
Pivya (pivmecillinam) is not approved to treat UTIs in pregnancy. In the case that it’s used off-label in pregnancy, there’s a chance that it’ll cause a false positive for a rare condition called isovaleric acidemia during newborn screening. Let your OB-GYN know if you ever take this antibiotic during pregnancy, they might need to do another test.
Pivya (pivmecillinam) dosage forms
Typical dosing for Pivya (pivmecillinam)
Females (ages 18 years and older): The typical dose is 185 mg by mouth three times a day for 3 to 7 days, as directed by your healthcare team.
Pivya (pivmecillinam) contraindications
Severe allergy to other penicillins or beta-lactam antibiotics
Serious nerve problem (acute porphyria)
What are alternatives to Pivya (pivmecillinam)?
Treatment or prevention of urinary tract infections
Lower respiratory tract infection (e.g., Pneumocystis pneumonia, infections related to bronchitis)
Travelers' diarrhea - tablet or liquid only
Ear infections - tablet or liquid only
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References
Best studies we foundAl Lawati, H., et al. (2024). Urinary tract infections: Core curriculum 2024. Core Curriculum in Nephrology.
Blaabjerg, S., et al. (2017). Probiotics for the prevention of antibiotic-associated diarrhea in outpatients-A systematic review and meta-analysis. Antibiotics.
Bono, M. J., et al. (2023). Uncomplicated urinary tract infections. StatPearls.
Dahash, B. A., et al. (2023). Carnitine deficiency. StatPearls.
Diep, Q. N., et al. (1993). Slow replenishment of carnitine deficiency after cessation of long-term treatment with pivaloyl-containing antibiotics. Pharmacy World & Science.
Jansåker, F., et al. (2016). The efficacy of pivmecillinam: 3 days or 5 days t.i.d against community acquired uncomplicated lower urinary tract infections - a randomized, double-blinded, placebo-controlled clinical trial study protocol. BioMed Central Infectious Diseases.
Jansåker, F., et al. (2019). Three versus five days of pivmecillinam for community-acquired uncomplicated lower urinary tract infection: A randomised, double-blind, placebo-controlled superiority trial. EClinicalMedicine.
Kresken, M., et al. (2022). Resistance to mecillinam and nine other antibiotics for oral use in Escherichia coli isolated from urine specimens of primary care patients in Germany, 2019/20. Antibiotics.
Lodise, T. P., et al. (2024). Review of the in vitro microbiological activity of mecillinam against common uropathogens in uncomplicated urinary tract infection: Focus on resistant pathogens. Open Forum Infectious Diseases.
Meyler’s Side Effects of Drugs. (2016). Carnitine and derivatives.
Muscular Dystrophy Association. (n.d.). Carnitine deficiency.
National Institute of Diabetes and Digestive and Kidney Diseases. (2020). Porphyria.
National Institutes of Health. (2023). Carnitine.
National Organization for Rare Disorders. (2020). Isovaleric acidemia.
National Organization for Rare Disorders. (2022). Acute intermittent porphyria.
National Organization for Rare Disorders. (2022). Porphyrias.
Pandey, N., et al. (2023). Beta-lactam antibiotics. StatPearls.
Tracy, J. A., et al. (2014). Chapter 56 - Porphyria and its neurologic manifestations. Handbook of Clinical Neurology.
U.S. Food and Drug Administration. (2024). FDA approves new treatment for uncomplicated urinary tract infections.
UTILITY therapeutics Ltd. (2024). Pivya (pivmecillinam) tablets, for oral use [package insert]. U.S. Food and Drug Administration.
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