PIVYA (pivmecillinam hydrochloride) · ALEMBIC THERAP

Pivmecillinam is a pro-drug of mecillinam (the active antibacterial moiety). The pharmacokinetic information for mecillinam from published studies is summarized in Table 2.

Table 2Summary of Pharmacokinetic Parameters and Properties of Mecillinam in Healthy Females Receiving a Single Dose of 185 mg Pivmecillinam Parameter Value (Mean ± SD) General Information Exposure (Day 1) C max (mcg/mL) 1.7 ± 1.1 AUC 0-8 hours (mcg∙min/mL) 214 ± 44 Accumulation No clinically significant accumulation Absorp...

Three controlled clinical trials comparing different PIVYA dosing regimens to placebo (Trial 1), to another oral antibacterial drug (Trial 2), or to ibuprofen (Trial 4) evaluated the efficacy of pivmecillinam for the treatment of uUTI. Efficacy was assessed in the Microbiological Intent-to-Treat (micro-ITT) population which included all randomized subjects with a positive baseline urine culture defined as ≥10 5 colony-forming-units (CFU)/mL of a uropathogen where CFU count was available and no more than 2 species of microorganisms, regardless of colony count, and no baseline pathogen was non-s...

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 adver...

Serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to PIVYA or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins). ( 4.1 ) Primary or secondary carnitine deficiency resulting from inherited disorders of mitochondrial fatty acid oxidation and carnitine metabolism, and other inborn errors of metabolism (e.g., methylmalonic aciduria, or pro...

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 P...

7. DRUG INTERACTIONS 7.1 Other Pivalate-Generating Drugs Avoid concurrent treatment with valproic acid, valproate, or other pivalate-generating drugs. If concomitant use with PIVYA is necessary, counsel patients to monitor adverse reactions associated with carnitine depletion (e.g., hypoglycemia, muscle aches, fatigue, and confusion) [see Warnings and Precautions ( 5.3 )]. Pivmecillinam is a pival...