INDICATION AND IMPORTANT SAFETY INFORMATIONINDICATION AND IMPORTANT SAFETY INFORMATION
PIVYA® (pivmecillinam) tablets is a penicillin class antibiotic for the treatment of female patients 18 years of age and older with uncomplicated urinary tract infections (uUTI) caused by susceptible bacteria.
Please consult with your healthcare provider before taking PIVYA.
Contraindications
Serious Hypersensitivity
Allergic reactions, including serious allergic reactions, could occur. If you have experienced serious allergic reactions to PIVYA, penicillins, cephalosporins, carbapenems or other beta-lactam antibacterials you should not take this medication.
Carnitine Deficiency
The medication should not be taken if you have primary or secondary carnitine deficiency, including those with inherited metabolic disorders like methylmalonic aciduria or propionic acidemia.
Acute Porphyria
Patients with porphyria should not use this medication due to the risk of triggering acute attacks. Porphyria is a group of rare, usually genetic disorders caused by enzyme deficiencies in heme production.
Warnings and Precautions
Hypersensitivity and Severe Skin Reactions
Allergic reactions, some serious, could occur with PIVYA and may require immediate treatment. If you have experienced severe allergic reactions to PIVYA, penicillins, cephalosporins, carbapenems or other beta-lactam antibacterials you should inform your healthcare provider. If you develop a new rash, urticaria, drug eruption, swelling of the face, difficulty in breathing or other symptoms of allergic reaction contact your healthcare provider.
Diarrhea
Diarrhea is a common problem caused by antibacterial drugs, including PIVYA. Seek medical attention if you experience watery or bloody stools, with or without stomach cramps and fever while taking PIVYA for two or more months after your last dose.
Antibacterial Resistance
It is common to feel better early in the course of therapy. If this occurs it is important to continue with treatment as directed by your healthcare provider to avoid decreasing the effectiveness of the treatment and increasing the likelihood of developing bacteria that are resistant to the drug.
Pregnancy/Newborns
While observational studies indicate no significant risks, treatment of pregnant patients shortly before delivery may cause a false positive result for isovaleric acidemia in newborn screenings.
Drug Interactions
Other Pivalate-Generating Drugs
Avoid concurrent treatment with valproic acid, valproate, or other pivalate-generating drugs. Please inform your healthcare provider of all medications you're taking and all pre-existing conditions.
Methotrexate
Clearance of methotrexate from the body can be reduced by concurrent use of drugs in the penicillin class, including PIVYA. Please inform your healthcare provider of all medications you're taking and all pre-existing conditions.
Drug Interference with Newborn Screening Test
Treatment of a pregnant individual with PIVYA prior to delivery may cause a false positive test for isovaleric acidemia in the newborn as part of newborn screening.
Common Side Effects (greater than 1%)
Gastrointestinal
Nausea, diarrhea
Genitourinary
Vulvovaginal candidiasis (yeast infection) and genital pruritus (itching).
Other
Headache.
Always consult a healthcare provider for a full evaluation of risks based on medical history.
If you believe you experienced an ADVERSE REACTION from taking PIVYA, please contact Alembic Therapeutics at 1-866-210-9797 or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Please see full Prescribing Information: pivya.com/assets/pdf/pivya-prescribing-information.pdf.