Mecillinam

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 (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.

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.

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.

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.

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.

0.071 to 0.214 mg/kg (0.14 (0.1425)) 6 hourly IM — - 0.071 to 0.214 mg/kg (0.14 (0.1425)) 6 hourly Slow IV — -

5 to 15 mg/kg (10 (10)) 8 hourly Intra Muscular — - 5 to 15 mg/kg (10 (10)) 8 hourly Intra Venous — -

5 to 15 mg/kg (10 (10)) 8 hourly Intra Muscular — - 5 to 15 mg/kg (10 (10)) 8 hourly Intra Venous — -

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.

Tab Store Below 25°C. Protect from Moisture.