Pivya
Pronunciation: piv-yah
Generic name: pivmecillinam
Dosage form: oral tablets
What is Pivya
Pivya (pivmecillinam) is an oral penicillin-type antibiotic that may be used to treat uncomplicated urinary tract infections (UTIs) in females aged 18 years and older that are caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus.
Infections should be proven or strongly suspected to be caused by bacteria, to reduce the development of drug-resistant bacteria and maintain the effectiveness of Pivya.
Pivya (pivmecillinam) is a beta-lactam antibiotic that works by interfering with the biosynthesis of the bacterial cell wall. It is a pro-drug that is hydrolyzed in the body to its active antibacterial agent, mecillinam, by enzymes in the blood, gastrointestinal tract, and other tissues. Pivya is mainly active against gram-negative bacteria.
Pivya was FDA-approved on 24th April 2024. It has been available in Europe for more than 40 years and was brought to market in the U.S. because of growing drug resistance to standard UTI antibiotics.
Pivya side effects
Pivya may cause serious side effects. See warnings below.
The most common side effects seen in 2% or more people receiving Pivya in clinical trials are nausea and diarrhea.
To report suspected side effects, contact UTILITY Therapeutics Ltd at 1-888-353-3180 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Warnings
Pivya may cause allergic reactions, including serious allergic reactions, such as anaphylaxis. You should not take Pivya if you have previously reacted to other beta-lactam antibiotics such as penicillins, cephalosporins, or carbapenems. Stop taking Pivya and tell your healthcare provider immediately if you develop a new rash, urticaria (hives), drug eruptions, swelling of the face, difficulty in breathing, or other symptoms of allergic reactions.
Pivya can also cause severe skin reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) or Stevens-Johnson syndrome. Stop taking Pivya and seek immediate medical attention if you develop a skin rash, lesions in your mouth, or any other skin reactions.
Should not be used in people with carnitine deficiency caused by inherited disorders or other inborn metabolic conditions, because Pivya may cause clinically significant low carnitine levels in people at risk. Other antibacterial treatments should be considered in people with significant kidney disease or decreased muscle mass and those requiring long-term antibiotics. Use of certain other medications, such as valproic acid, valproate, or other pivalate-generating drugs can increase the risk of low carnitine depletion levels.
Pivya should not be used by people requiring long-term antibiotic treatment.
Clostridioides difficile-Associated Diarrhea (CDAD) has been reported for nearly all antibiotics, including Pivya. Seek medical attention as soon as possible if you develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after taking the last dose of the drug.
Treating pregnant females with Pivya before delivery may cause a false positive test for isovaleric acidemia in the newborn as part of newborn screening. Your healthcare provider should follow this up immediately if a positive result occurs.
Should not be taken by people with acute porphyria.
Before taking
Tell your doctor about all your medical conditions including if you have:
- ever had an allergic or skin reaction to a penicillin, cephalosporin, or carbapenem antibiotic
- a carnitine deficiency
- kidney problems
- a low muscle mass
- acute porphyria
- a urinary tract infection that has not responded to antibiotics
- have had antibiotics recently
- have a long-term problem with UTIs
- are pregnant or intending to become pregnant
- are breastfeeding.
Pregnancy
Observational studies do not show an increased risk of birth defects with Pivya, but there are limited studies. Treatment of pregnant women before delivery with Pivya may cause a false positive test for isovaleric acidemia in the newborn as part of newborn screening. Talk to your healthcare provider about the risks versus benefits of taking Pivya during pregnancy.
Breastfeeding
It is unknown if Pivya passes into human milk. Talk to your healthcare provider about the best way to feed your baby if you are breastfeeding.
How do I take Pivya?
Take Pivya exactly as your healthcare provider tells you to take it. Do not take more or less.
- Skipping doses or not completing the full course of therapy may decrease the effectiveness of this treatment and increase the likelihood that bacteria will develop resistance and will not be treatable by Pivya or other antibacterial agents in the future.
The recommended dosage of Pivya is 1 tablet 3 times a day for 3 to 7 days.
- May be taken with or without food.
Pivya will not treat a viral infection, such as the common cold.
What happens if I miss a dose?
If a dose of Pivya is missed, take the dose as soon as possible. If it is almost time for your next dose, skip that dose. Do not double the dose to make up for the missed dose.
What other drugs will affect Pivya?
Other drugs may interact with Pivya, including prescription and over-the-counter medicines, vitamins, and herbal products.
- Do not take Pivya with valproic acid, valproate, or other pivalate-generating drugs due to increased risk of carnitine depletion
Tell your pharmacist or healthcare provider about all the medicines you take, including any prescription and over-the-counter medicines, vitamins, or herbal supplements. See the prescribing information for a full list of interactions.
Storage
Store Pivya tablets at room temperature 20°C to 25°C (59°F to 86°F) in the original packet.
Ingredients
Active: 185 mg pivmecillinam equivalent to 200mg pivmecillinam hydrochloride
Inactive: cellulose microcrystalline, hydroxypropyl cellulose, hypromellose, magnesium stearate, paraffin, and simethicone.
Manufacturer
Utility Therapeutics Ltd.
References
More about Pivya (pivmecillinam)
Related treatment guides
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
