Pivmecillinam

1. INDICATIONS AND USAGE PIVYA is a penicillin class antibacterial indicated for the treatment of female patients 18 years of age and older with uncomplicated urinary tract infections (uUTI) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus . ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of PIVYA and other antibacterial drugs, PIVYA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.2 ) 1.1 Uncomplicated Urinary Tract Infections PIVYA is indicated for the treatment of female patients 18 years of age and older with uncomplicated urinary tract infections (uUTI) caused by susceptible isolates of Escherichia coli (E.

6. ADVERSE REACTIONS The following clinically significant adverse reactions are described in greater detail in the Warnings and Precautions section of labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.2 )] Carnitine Depletion [see Warnings and Precautions ( 5.3 )] Acute Porphyria [see Warnings and Precautions ( 5.4 )] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions ( 5.5 )] The most common adverse reactions observed in ≥2% of the patients receiving PIVYA in clinical trials are nausea and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Therapeutics at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

8.1 Pregnancy Risk Summary Published observational studies on PIVYA use during the first trimester do not indicate an increased risk of major birth defects ( see Data ). There are limited studies on PIVYA use during pregnancy that evaluate the risk of miscarriage and other adverse maternal or fetal outcomes. These studies have methodological limitations hindering interpretation. No dose adjustment is required in pregnant women (see Clinical Considerations) .

5. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions : Serious hypersensitivity reactions including anaphylaxis have been reported in patients treated with PIVYA. If hypersensitivity reactions occur, discontinue treatment with PIVYA and institute appropriate therapy. ( 5.1 ) Severe Cutaneous Adverse Reactions (SCAR) : Acute Generalized Exanthematous Pustulosis (AGEP), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Steven-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) have been reported with PIVYA. Monitor patients closely and discontinue PIVYA at the first signs or symptoms of SCAR or other signs of hypersensitivity. ( 5.2 ) Carnitine Depletion : Clinically significant hypocarnitinemia has been observed in patients at risk for reductions in serum carnitine. 4. CONTRAINDICATIONS Serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to PIVYA or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins).