PIVYA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PIVYA (PIVYA).
Pivya (pivmecillinam) is a prodrug of mecillinam, a beta-lactam antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding protein 2 (PBP2), leading to defective cell wall formation and cell death.
| Metabolism | Pivmecillinam is hydrolyzed by esterases in the gastrointestinal tract and liver to mecillinam. Mecillinam is further metabolized to inactive metabolites via renal and hepatic pathways. |
| Excretion | Primarily renal excretion as unchanged drug (approximately 70-80%); biliary/fecal excretion accounts for 10-15%. |
| Half-life | Terminal elimination half-life of 3-4 hours in patients with normal renal function; may be prolonged to 8-12 hours in severe renal impairment (CrCl <30 mL/min). |
| Protein binding | Approximately 60-70% bound to plasma albumin. |
| Volume of Distribution | 0.5-0.7 L/kg, indicating distribution into total body water. |
| Bioavailability | Oral: 85-90% (first-pass metabolism minimal). |
| Onset of Action | Oral: 30-60 minutes; Intravenous: within 5 minutes. |
| Duration of Action | Approximately 6-8 hours; may be extended in renal impairment. |
1200 mg orally once daily.
| Dosage form | TABLET |
| Renal impairment | eGFR >= 30 mL/min/1.73 m2: 1200 mg once daily. eGFR 15-29: 600 mg once daily. eGFR < 15 or dialysis: 300 mg once daily. |
| Liver impairment | No dose adjustment required for mild to moderate hepatic impairment. Not recommended in severe hepatic impairment (Child-Pugh C). |
| Pediatric use | Age 12 years and older, weight >= 40 kg: 1200 mg once daily. Age < 12 years: not approved. |
| Geriatric use | No specific dose adjustment based on age alone; adjust for renal function per renal_adjustment. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PIVYA (PIVYA).
| Breastfeeding | Excreted into breast milk in low amounts (M/P ratio unknown). Mecillinam levels are unlikely to affect infant. Use with caution; monitor infant for diarrhea or rash. |
| Teratogenic Risk | PIVYA (pivmecillinam) is a prodrug of mecillinam. No adequate human studies. Animal studies: no teratogenicity at clinically relevant doses. Risk cannot be excluded. First trimester: avoid unless necessary. Second/third trimester: may be used if benefit outweighs risk. No known association with major malformations. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to pivmecillinam, mecillinam, or any beta-lactam antibiotic","Severe renal impairment (creatinine clearance <10 mL/min)","Phenylketonuria (due to aspartame content in some formulations)"]
| Precautions | ["Hypersensitivity reactions, including anaphylaxis and rash","Clostridioides difficile-associated diarrhea","Renal impairment: dose adjustment required","Prolonged use may lead to bacterial resistance"] |
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| Standard prenatal care; no specific monitoring required. Monitor maternal renal function and for signs of hypersensitivity. |
| Fertility Effects | No known adverse effects on human fertility. Animal studies showed no impairment. |