PIVYA Pivmecillinam 185 mg Tablet, Coated, 9-count — NDC 62332-966-09 (Billing 62332-0966-09)
This is a package of 9 tablets of PIVYA Pivmecillinam 185 mg Tablet, Coated from Alembic Pharmaceuticals Inc., marketed since Feb 2026 and currently FDA-listed. It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 018568
- GCN: 61123
- GPI-14 (Medi-Span): 01500070400315
- HICL (First Databank): 007565
- AHFS class code: 08:12.16.00
- RxCUI (RxNorm): 2715865
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Penicillins with extended spectrum class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Pivmecillinam is used for the treatment of certain types of urinary tract infections (UTIs; infection of the bladder or kidney). Pivmecillinam is in a class of medications called penicillins. It works by killing bacteria.
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Pivmecillinam — tap one for details:
Pivmecillinam may be associated with lower levels of 10 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 62332-0966-09 You're viewing this Main listing | 1 BLISTER PACK in 1 CARTON / 9 TABLET, COATED in 1 BLISTER PACK | 2026-02-02 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Pivya 185 mgthis 62332-0966-09 | Alembic | 9 tablets | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 9XZ8H6N6OH
A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII I9O0E3H2ZE
Paraffin is a waxy, petroleum-derived substance used as a coating, lubricant, and hardening agent in tablets and capsules. It helps protect the medicine from moisture and gives pills a smooth finish.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
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Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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 )
1.1Uncomplicated 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. coli) , Proteus mirabilis, and Staphylococcus saprophyticus.
1.2Usage 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 susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
⏱️ Dosage and Administration ▾
2. DOSAGE AND ADMINISTRATION The recommended dosage of PIVYA is one 185 mg tablet orally 3 times a day for 3 to 7 days as clinically indicated. ( 2.1 ) Administer PIVYA with or without food. ( 2.1 )
2.1Recommended Dosage The recommended dosage of PIVYA is one 185 mg tablet orally 3 times a day for 3 to 7 days as clinically indicated. Administer PIVYA with or without food [see Clinical Pharmacology ( 12.3 )] . PIVYA (pivmecillinam) is a prodrug of mecillinam (the active antibacterial agent) [see Clinical Pharmacology ( 12.3 )] .
2.2Recommendations Regarding Missed Dose(s) If a dose of PIVYA is missed, instruct patients to take the dose as soon as possible. Do notdouble the dose to make up for the missed dose.
💊 Dosage Forms and Strengths ▾
3. DOSAGE FORMS AND STRENGTHS Each film-coated tablet contains 185 mg pivmecillinam (equivalent to 200 mg pivmecillinam hydrochloride). The tablet is a white, circular film-coated tablet with a diameter of 9.5 mm, debossed with “P” on one side and blank on the other. Tablets: 185 mg pivmecillinam. ( 3 )
⛔ Contraindications ▾
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). ( 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 propionic acidemia).
( 4.2 ) Acute porphyria. ( 4.3 )
4.1Serious Hypersensitivity Reactions PIVYA is contraindicated in patients who have experienced a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to PIVYA or other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins) [ see Warnings and Precautions ( 5.1 ) ].
4.2Carnitine Deficiency PIVYA is contraindicated in patients with 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 propionic acidemia) [ see Warnings and Precautions ( 5.3 ) ].
4.3Acute Porphyria PIVYA is contraindicated in patients suffering from porphyria as pivmecillinam has been associated with acute attacks of porphyria [see Warnings and Precautions ( 5.4 )] .
⚠️ Warnings and Cautions ▾
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.
In patients with significant renal impairment or decreased muscle mass and those patients requiring long term antimicrobial treatment, consider alternative antibacterial therapies. PIVYA is not recommended when prolonged antibacterial treatment is necessary. Avoid concurrent treatment with valproic acid, valproate or other pivalate-generating drugs due to increased risk of carnitine depletion.
( 5.3 ) Clostridioides difficile -Associated Diarrhea (CDAD) : This has been reported for nearly all systemic antibacterial agents, including PIVYA. Evaluate if diarrhea occurs. ( 5.5 ) 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.
Prompt follow-up of a positive newborn screening result for isovaleric acidemia is recommended. ( 5.7 )
5.1Hypersensitivity Reactions Serious hypersensitivity reactions (anaphylaxis) have been reported in patients treated with PIVYA [see Adverse Reactions ( 6.1 )] . These reactions are more likely to occur in individuals with a history of penicillin, cephalosporin, or carbapenem hypersensitivity or a history of sensitivity to multiple allergens. Before initiating therapy with PIVYA, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, carbapenems, and other beta-lactams because cross-hypersensitivity has been reported.
PIVYA is contraindicated in patients who have experienced a serious hypersensitivity reaction [see Contraindications ( 4.1 )] . If an allergic reaction occurs, discontinue PIVYA and institute appropriate therapy.
5.2Severe Cutaneous Adverse Reactions Severe Cutaneous Adverse Reactions (SCAR) including Acute Generalized Exanthematous Pustulosis (AGEP), Drug Reactions with Eosinophilia and Systemic Symptoms (DRESS), Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) have been reported with PIVYA [see Adverse Reactions ( 6.2 )]. Monitor patients closely and discontinue PIVYA at the first signs or symptoms of SCAR or other signs of hypersensitivity.
5.3Carnitine Depletion Clinical manifestations of carnitine depletion may occur with pivalate-containing compounds, including PIVYA. Symptoms of carnitine depletion include hypoglycemia, muscle aches, fatigue, and confusion. PIVYA is contraindicated in patients with primary or secondary carnitine deficiency due to inherited metabolic disorders known to cause carnitine depletion [see Contraindications ( 4.2 )] .
No clinical effects of decreased carnitine have been associated with short-term treatment of PIVYA. Clinically significant hypocarnitinemia has been observed in patients receiving long term treatment with pivmecillinam. PIVYA is not recommended when prolonged antibacterial treatment is necessary.
The effects on carnitine concentrations of repeated short-term courses of PIVYA are not known. In patients at risk for reductions in serum carnitine (e.g., patients with significant renal impairment or decreased muscle mass consider alternative antibacterial therapies. Avoid concurrent treatment with valproic acid, valproate or other piv… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
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.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of PIVYA was evaluated in 579 adult female patients with uUTI who received PIVYA at a dose of 185 mg three times daily, or at higher daily doses (not approved for PIVYA) for 3 to 10 days in a placebo controlled trial (Trial 1, N=282), an active controlled trial (Trial 2, N=213) and an open label trial (Trial 3, N=84).
The majority of patients were White women between 18 and 91 years of age. No serious adverse reactions were reported in patients treated with PIVYA in the trials. In Trial 1, the most common adverse reactions observed in ≥2% of the patients receiving PIVYA included nausea (4.3%) and diarrhea (2.1%).
In Trial 2 and Trial 3, the most common adverse reaction occurring in ≥1% of patients receiving PIVYA was nausea with an incidence of 1.4% in Trial 2 and 3.6% in Trial 3. Table 1 lists the most frequently reported adverse reactions occurring in ≥1% of patients receiving PIVYA in Trial 1. Table 1 Adverse Reactions Occurring in ≥1% of Patients Receiving PIVYA in Trial 1 Adverse Reactions (AR) PIVYA* N=282 n (%) Placebo N=288 n (%) Nausea 12 (4.3) 6 (2.1) Diarrhea 6 (2.1) 2 (0.7) Vulvovaginal candidiasis 5 (1.8) 0 Genital pruritus 5 (1.8) 4 (1.4) Headache 4 (1.4) 1 (0.3) *PIVYA 185 mg three times per day for 7 days Selected adverse reactions occurring in ≤1% of patients who received PIVYA in the clinical trials were vomiting, rash, dyspepsia, and abdominal pain.
6.2Post-Marketing Experience The following adverse reactions have been identified during post-approval use of pivmecillinam outside of the United States. Because these adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and lymphatic system disorder: Thrombocytopenia Ear and labyrinth disorder: Vertigo Gastrointestinal disorders: Esophageal ulcer, esophagitis, mouth ulceration Hepatobiliary disorders: Hepatic function abnormal Immune system disorders: Anaphylactic reaction, Angioedema Infections and infestations: Clostridioides difficile- associated diarrhea Metabolism and nutrition disorders: Carnitine decreased Nervous system disorders: Dizziness Skin and subcutaneous tissue disorders : Urticaria, pruritus, Severe Cutaneous Adverse Reactions (SCAR) including Acute Generalized Exanthematous Pustulosis (AGEP), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)
🔄 Drug Interactions ▾
7. DRUG INTERACTIONS
7.1Other 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 pivalate-generating prodrug [see Clinical Pharmacology ( 12.3 )] .
Pivalate can be activated to a coenzyme-A thioester in cells which is further converted to pivaloylcarnitine and excreted in urine. Pivalate elimination associated with concomitant use of pivmecillinam with other pivalate-generating drugs decreases carnitine concentrations in plasma which may increase the risk of carnitine depletion-associated adverse reactions [see Warnings and Precautions ( 5.3 )] .
7.2Methotrexate Clearance of methotrexate from the body can be reduced by concurrent use of drugs in the penicillin class, including PIVYA. Where possible, consider alternative therapy.
7.3Drug 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. Prompt follow-up of a positive newborn screening result for isovaleric acidemia is recommended.
👥 Use in Specific Populations ▾
8. USE IN SPECIFIC POPULATIONS
8.1Pregnancy 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) . Developmental toxicity studies with pivmecillinam or mecillinam administered during organogenesis to rats and mice showed no evidence of embryo-fetal toxicity, including drug-induced fetal malformations, at doses approximately 3.4 or 7.9 times (rats) or 5.1 or 3.9 times (mice) higher than given to patients receiving the maximum recommended daily dose. Evidence of slight fetotoxicity (reduced ossification) was seen in offspring of rats that were given pivmecillinam during organogenesis at a dose approximately 10.2-fold higher than the maximum recommended daily human dose (see Data) .
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations 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 [see Warnings and Precautions ( 5.7 ) and Drug Interactions ( 7.3 )]. Dose Adjustments During Pregnancy and the Postpartum Period No dosage adjustment is recommended for pregnant females (see Data) . Data Human data Two cohort studies in 42,223 pregnant women who were exposed to PIVYA during the first trimester did not observe an increased risk of major birth defects when compared to 50,099 pregnant women exposed to other antibacterial drugs.
These two studies were limited by potential exposure misclassification. No clinically significant differences in mecillinam C max and AUC were observed in pregnant adult women (10 to 32 weeks gestation) administered PIVYA 185 mg orally in a published study. Animal data Pivmecillinam administered during the period of organogenesis (gestation days 6-15) had no adverse effects on embryofetal development in rats or mice at oral doses up to 194 mg/kg/day in rats and 582 mg/kg/day in mice.
These doses are approximately 3.4-fold and 5.1-fold higher than the maximum recommended daily human dose based on body surface area, respectively. There was a skeletal variation (reduced ossification of sternebrae, possibly indicating slight fetotoxicity) in offspring of rats treated at 582 mg/kg/day (approximately 10.2-fold higher than the maximum recommended daily human dose based on body surface area). Mecillinam did not cause adverse effects on embryofetal development in rats and mice when administered by subcutaneous injection at doses up to 450 mg/kg/day (approximately 7.9-fold and 3.9-fold higher than the maximum recommended daily human dose based on body surface area, respectively).
In pre- and postnatal studies in rats where maternal animals were dosed beginning during gestation (Day 15) and continuing throughout the weaning period, neither pivmecillinam nor mecillinam had adverse effects on the maternal animals or on the survival and development of the offspring. Pivmecillinam was given orally at doses up to 582 mg/kg/day and mecillinam was given subcutaneously at doses up to 450 mg/kg/day (approximately 10.2-fold and 7.9-fold higher than the maximum recommended daily human dose of PIVYA, based on body surface area, respectively).
8.2Lactation Risk Summary There are insufficient data to exclude the presence of mecillinam in human milk. Mecillinam is… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy 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) . Developmental toxicity studies with pivmecillinam or mecillinam administered during organogenesis to rats and mice showed no evidence of embryo-fetal toxicity, including drug-induced fetal malformations, at doses approximately 3.4 or 7.9 times (rats) or 5.1 or 3.9 times (mice) higher than given to patients receiving the maximum recommended daily dose. Evidence of slight fetotoxicity (reduced ossification) was seen in offspring of rats that were given pivmecillinam during organogenesis at a dose approximately 10.2-fold higher than the maximum recommended daily human dose (see Data) .
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations 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 [see Warnings and Precautions ( 5.7 ) and Drug Interactions ( 7.3 )]. Dose Adjustments During Pregnancy and the Postpartum Period No dosage adjustment is recommended for pregnant females (see Data) . Data Human data Two cohort studies in 42,223 pregnant women who were exposed to PIVYA during the first trimester did not observe an increased risk of major birth defects when compared to 50,099 pregnant women exposed to other antibacterial drugs.
These two studies were limited by potential exposure misclassification. No clinically significant differences in mecillinam C max and AUC were observed in pregnant adult women (10 to 32 weeks gestation) administered PIVYA 185 mg orally in a published study. Animal data Pivmecillinam administered during the period of organogenesis (gestation days 6-15) had no adverse effects on embryofetal development in rats or mice at oral doses up to 194 mg/kg/day in rats and 582 mg/kg/day in mice.
These doses are approximately 3.4-fold and 5.1-fold higher than the maximum recommended daily human dose based on body surface area, respectively. There was a skeletal variation (reduced ossification of sternebrae, possibly indicating slight fetotoxicity) in offspring of rats treated at 582 mg/kg/day (approximately 10.2-fold higher than the maximum recommended daily human dose based on body surface area). Mecillinam did not cause adverse effects on embryofetal development in rats and mice when administered by subcutaneous injection at doses up to 450 mg/kg/day (approximately 7.9-fold and 3.9-fold higher than the maximum recommended daily human dose based on body surface area, respectively).
In pre- and postnatal studies in rats where maternal animals were dosed beginning during gestation (Day 15) and continuing throughout the weaning period, neither pivmecillinam nor mecillinam had adverse effects on the maternal animals or on the survival and development of the offspring. Pivmecillinam was given orally at doses up to 582 mg/kg/day and mecillinam was given subcutaneously at doses up to 450 mg/kg/day (approximately 10.2-fold and 7.9-fold higher than the maximum recommended daily human dose of PIVYA, based on body surface area, respectively).
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of PIVYA have not been established in pediatric patients. Carnitine Depletion Symptomatic hypocarnitinemia has been reported in pediatric patients outside the United States on long term pivmecillinam therapy. In these cases, irritability, altered mental status, fatigue, muscle weakness, and vomiting have been observed.
PIVYA is not recommended when prolonged antibacterial treatment is necessary [see Warnings and Precautions ( 5.3 )]. PIVYA is contraindicated in patients with primary or secondary carnitine deficiency [see Contraindications ( 4.2 )] . Interference with Newborn Screening Test Newborns exposed to PIVYA in utero prior to delivery may have a false positive newborn screening test for isovaleric acidemia.
Prompt follow-up of a positive newborn screening result for isovaleric acidemia is recommended [see Warnings and Precautions ( 5.7 ) and Drug Interactions ( 7.3 )] .
🧓 Geriatric Use ▾
8.5Geriatric Use Of the total number of PIVYA-treated patients in the clinical trials evaluated for safety, 80/579 (14%) were 65 years of age and older, and 48/369 (13%) were 65 years of age and older in the PIVYA-treated patients evaluated for efficacy. A total of 19/579 (3%) of the PIVYA-treated patients evaluated for safety were 75 years of age and older and 12/369 (3%) were 75 years of age and older in the PIVYA-treated patients evaluated for efficacy [see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14 )] .
No overall differences in safety or effectiveness of PIVYA have been observed between patients 65 years of age and older and younger adult patients. Mecillinam pharmacokinetics data from geriatric patients are not available. PIVYA is known to be substantially excreted by the kidneys, and geriatric patients are anticipated to have reduced renal function.
The clinical significance of these changes on efficacy or safety is unknown. The available safety information does not suggest a need for dosage adjustment [see Clinical Pharmacology ( 12.3 ) and Use in Specific Populations ( 8.6 )].
🧬 Clinical Pharmacology ▾
12. CLINICAL PHARMACOLOGY
12.1Mechanism of Action PIVYA is an antibacterial drug [see Microbiology ( 12.4 )] .
12.2Pharmacodynamics Like other beta-lactam antibacterial drugs, the bacteriological effect of PIVYA in the treatment of uUTI is dependent on time above minimum inhibitory concentration (MIC), which has been shown to best correlate with efficacy in animal models of infection against E. coli .
12.3Pharmacokinetics 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 2: Summary 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 ±
1.1AUC 0-8 hours (mcg∙min/mL) 214 ± 44 Accumulation No clinically significant accumulation Absorption Oral bioavailability of mecillinam* 25-35% T max (min) 90 ± 33 Effect of food No clinically significant effect on Mecillinam PK Distribution % plasma protein binding <25% Apparent volume of distribution (L) 51 Elimination Oral clearance (mL/min) 580 ± 100 Terminal half-life (min) 61 ± 32 Metabolism Metabolic pathways Pivmecillinam is converted to mecillinam (active antibacterial moiety) and pivalic acid by non-specific esterases.
Mecillinam undergoes minimal metabolism. Excretion Major route of elimination Urinary excretion , primarily as mecillinam (80% of dose) C max =maximum plasma concentration; AUC 0-8 hours =area under the plasma concentration-time curve from time zero to 8 hours;T max =time to C max * Bioavailability estimate based on comparison of dose normalized mecillinam exposure after 185 mg oral pivmecillinam administration and 200 mg IV mecillinam. † Excretion estimate based on PK data following intravenous administration of mecillinam Specific Populations The effect of age, sex, race and body weight on pivmecillinam or mecillinam pharmacokinetics is unknown.
Patients with Hepatic Impairment The effects of hepatic impairment on the pharmacokinetics of mecillinam have not been evaluated. Hepatic impairment is not expected to alter the elimination of mecillinam as hepatic metabolism/excretion represents a minor pathway of elimination for mecillinam. Dosage adjustments are not necessary in patients with impaired hepatic function.
Patients with Renal Impairment In published pharmacokinetic studies, mecillinam systemic elimination and urinary excretion decreases with degree of renal function. Drug Interaction Studies Clinical Studies OAT1/3 inhibitors: Mean mecillinam C max increased by approximately 80% and AUC by approximately 40% following concomitant use of oral probenecid (OAT1/3 inhibitor) with pivmecillinam in two published studies. MATE1 or MATE2K inhibitors: The effect of concomitant use on pivmecillinam or mecillinam pharmacokinetics is unknown.
In Vitro Studies Where Drug Interaction Potential Was Not Further Evaluated Clinically Cytochrome P450 (CYP) enzymes: Mecillinam does not inhibit nor induce CYP 1A1, 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, or 3A4/5. Transporter systems: Mecillinam is a substrate of the renal transporters organic anion transporter-3 (OAT3), multidrug and extrusion protein-1 (MATE1), multidrug and extrusion protein-2K (MATE2-K). Mecillinam does not inhibit breast cancer resistance protein (BCRP), P-glycoprotein (PgP), MATE1, MATE2-K, organic anion transporter-1 (OAT1), OAT3, organic anion transporting polypeptides -1B1 and 1B3 (OATP1 B1/B3), and organic cation transporter-2 (OCT2) drug transporters.
12.4Microbiology Mechanism of Action Pivmecillinam is the pro-drug containing the pivaloyloxymethylester of the amidinopenicillanic acid, mecillinam. Orally administered, pivmecillinam is well absorbed and subsequently rapidly hydrolyzed to mecillinam, the active antibacterial agent, by non-specific esterases present in blood, gastrointestinal mucosa and other tissues. Mecillin… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action PIVYA is an antibacterial drug [see Microbiology ( 12.4 )] .
📦 How Supplied / Storage and Handling ▾
16. HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied PIVYA tablets are supplied as 185 mg pivmecillinam tablets, film-coated in child-resistant aluminum-aluminum push-through blisters. Available pack sizes: 9 tablets (1 blister sheet with 9 tablets) NDC: 62332-966-09. 50 tablets (5 blister sheets with 10 tablets per blister) NDC: 62332-966-10. The tablet is white, circular, film-coated, debossed with "P" on one side and blank on the other. Size: Approx. 9.5 mm in diameter.
16.2Storage and Handling Store PIVYA tablets at 20 o C to 25 o C (68 o F to 77 o F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Store and dispense tablets in the unit-dose blisters.
📦 Storage and Handling ▾
16.2Storage and Handling Store PIVYA tablets at 20 o C to 25 o C (68 o F to 77 o F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Store and dispense tablets in the unit-dose blisters.
📋 Description ▾
11. DESCRIPTION PIVYA tablets contain pivmecillinam (as pivmecillinam hydrochloride), a penicillin class antibacterial for oral administration. The chemical name of pivmecillinam hydrochloride is methylene 2,2-dimethylpropanoate (2S,5R,6R)-6-[[(hexahydro-1H-azepin-1-yl)methylene]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate hydrochloride.
The molecular formula for pivmecillinam hydrochloride is C21H33N3O5S·HCl. The molecular weight of pivmecillinam hydrochloride is 476.0 g/mol. Figure 1: Chemical Structure of Pivmecillinam Hydrochloride Each film-coated PIVYA tablet for oral administration contains 185 mg pivmecillinam (equivalent to 200 mg pivmecillinam hydrochloride), and the following inactive ingredients: cellulose microcrystalline, hydroxypropyl cellulose, hypromellose, magnesium stearate, paraffin, and simethicone. image description
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics 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 2: Summary 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 ±
1.1AUC 0-8 hours (mcg∙min/mL) 214 ± 44 Accumulation No clinically significant accumulation Absorption Oral bioavailability of mecillinam* 25-35% T max (min) 90 ± 33 Effect of food No clinically significant effect on Mecillinam PK Distribution % plasma protein binding <25% Apparent volume of distribution (L) 51 Elimination Oral clearance (mL/min) 580 ± 100 Terminal half-life (min) 61 ± 32 Metabolism Metabolic pathways Pivmecillinam is converted to mecillinam (active antibacterial moiety) and pivalic acid by non-specific esterases.
Mecillinam undergoes minimal metabolism. Excretion Major route of elimination Urinary excretion , primarily as mecillinam (80% of dose) C max =maximum plasma concentration; AUC 0-8 hours =area under the plasma concentration-time curve from time zero to 8 hours;T max =time to C max * Bioavailability estimate based on comparison of dose normalized mecillinam exposure after 185 mg oral pivmecillinam administration and 200 mg IV mecillinam. † Excretion estimate based on PK data following intravenous administration of mecillinam Specific Populations The effect of age, sex, race and body weight on pivmecillinam or mecillinam pharmacokinetics is unknown.
Patients with Hepatic Impairment The effects of hepatic impairment on the pharmacokinetics of mecillinam have not been evaluated. Hepatic impairment is not expected to alter the elimination of mecillinam as hepatic metabolism/excretion represents a minor pathway of elimination for mecillinam. Dosage adjustments are not necessary in patients with impaired hepatic function.
Patients with Renal Impairment In published pharmacokinetic studies, mecillinam systemic elimination and urinary excretion decreases with degree of renal function. Drug Interaction Studies Clinical Studies OAT1/3 inhibitors: Mean mecillinam C max increased by approximately 80% and AUC by approximately 40% following concomitant use of oral probenecid (OAT1/3 inhibitor) with pivmecillinam in two published studies. MATE1 or MATE2K inhibitors: The effect of concomitant use on pivmecillinam or mecillinam pharmacokinetics is unknown.
In Vitro Studies Where Drug Interaction Potential Was Not Further Evaluated Clinically Cytochrome P450 (CYP) enzymes: Mecillinam does not inhibit nor induce CYP 1A1, 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, or 3A4/5. Transporter systems: Mecillinam is a substrate of the renal transporters organic anion transporter-3 (OAT3), multidrug and extrusion protein-1 (MATE1), multidrug and extrusion protein-2K (MATE2-K). Mecillinam does not inhibit breast cancer resistance protein (BCRP), P-glycoprotein (PgP), MATE1, MATE2-K, organic anion transporter-1 (OAT1), OAT3, organic anion transporting polypeptides -1B1 and 1B3 (OATP1 B1/B3), and organic cation transporter-2 (OCT2) drug transporters.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Like other beta-lactam antibacterial drugs, the bacteriological effect of PIVYA in the treatment of uUTI is dependent on time above minimum inhibitory concentration (MIC), which has been shown to best correlate with efficacy in animal models of infection against E. coli .
🔬 Clinical Studies ▾
14. CLINICAL STUDIES 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-susceptible to the active comparator.
The composite response rates (composite endpoint of clinical cure and microbiological response), as well as clinical cure and microbiological response rates of the recommended 185 mg three times daily dosing regimen are summarized in Table 3, Table 4 and Table 5. Trial 1 was a multi-center, randomized, double-blinded study in Sweden evaluating the efficacy of 3 dosage regimens of PIVYA tablets (185 mg three times daily for 7 days, 185 mg two times daily for 7 days (not an approved dosing regimen for PIVYA), and 370 mg two times daily for 3 days (not an approved dosing regimen for PIVYA)) compared to placebo in women 18 years of age or older with symptoms of uUTI.
The trial enrolled patients with mean age of 45 years with E. coli as the most common baseline pathogen. PIVYA demonstrated efficacy for the composite response of clinical cure and microbiological response at Day 8-10. Clinical cure was defined as no persisting symptoms during and post-therapy.
Microbiological response for the initial pathogen at follow-up visits was defined as reduction in the number of bacteria to <10 3 CFU/mL. Composite response was achieved in 85/137 (62%) of patients in the PIVYA group and 14/134 (10%) in the placebo group at TOC in the micro-ITT population. Trial 2 was a multi-center, randomized, double-blinded study in the U.S. evaluating the efficacy and safety of PIVYA tablets 185 mg three times a day for 3 days compared to cephalexin 250 mg four times daily for 7 days in females 18 years of age or older with uUTI.
The trial enrolled patients with a mean age of 31 years, who were 85% White and 12% Black or African American with E. coli as the most common baseline pathogen. Clinical cure was defined as no persisting symptoms during and post-therapy. Microbiological response was defined as negative urine culture (<10 3 CFU/mL) for the initial pathogen at Day 10.
Composite response was achieved in 91/127 (72%) of patients in the PIVYA group and 100/132 (76%) in the cephalexin group at the TOC in the micro-ITT population. Trial 4 ( NCT01849926 ) was a multi-center, randomized, double-blinded, non-inferiority study in Denmark, Norway, and Sweden to evaluate the efficacy and safety of PIVYA tablets 185 mg three times a day for 3 days compared to ibuprofen 600 mg three times daily for 3 days in women 18 to 60 years of age with clinical symptoms of uUTI. The trial enrolled patients with mean age of 29 years with E. coli as the most common baseline pathogen.
PIVYA demonstrated efficacy for the composite response (clinical cure and microbiological response) at TOC (Day 14). Clinical cure was defined as the patient reporting no symptoms at Day 7 and reporting no symptoms at Day 14. Microbiological response was defined as negative urine culture (<10 3 CFU/mL) for the initial pathogen at Day 14.
Composite response was achieved in 69/105 (66%) in the PIVYA group and 26/119 (22%) in the ibuprofen group at TOC in the micro-ITT population. Table 3 Composite Response Rates (Clinical Cure and Microbiological Response) at TOC in the uUTI trials (Micro-ITT Population) Composite Response Rates (Clinical Cure and Microbiological Response) Trial 1 PIVYA N=137, n (%) Placebo N=134, n (%) Difference (95% CI) 85 (62) 14 (10) 52 (41,62) Trial 2 PIVYA N=127, n (%) Cephalexin N=132, n (%) 91 (72) 100 (76) -4(-16, +7) Trial 4 P… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13. NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, and Impairment of Fertility Carcinogenesis Carcinogenicity studies have not been conducted with pivmecillinam or mecillinam. Mutagenesis Pivmecillinam was mutagenic in the Ames bacterial reverse mutation assay. Pivmecillinam induced chromosome breaks in cultured human lymphocytes, but did not induce damage to mouse bone marrow cell chromosomes in vivo.
The positive findings observed in the in vitro studies are considered to be due to the release of formaldehyde from the pivoxil ester moiety of pivmecillinam because they were not observed when mecillinam was tested in the same assays. The positive findings are not considered relevant to the clinical use of PIVYA because the small amount of formaldehyde released is eliminated quickly in vivo, but not in vitro. Impairment of Fertility Mecillinam had no adverse effect on fertility in male or female rats at subcutaneous doses up to 450 mg/kg/day (approximately 7.9-fold higher than the maximum recommended daily human dose based on body surface area).
Pivmecillinam had no adverse effect on fertility in male or female rats at oral doses up to 582 mg/kg/day (approximately 10.2-fold higher than the maximum recommended daily human dose based on body surface area).
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, and Impairment of Fertility Carcinogenesis Carcinogenicity studies have not been conducted with pivmecillinam or mecillinam. Mutagenesis Pivmecillinam was mutagenic in the Ames bacterial reverse mutation assay. Pivmecillinam induced chromosome breaks in cultured human lymphocytes, but did not induce damage to mouse bone marrow cell chromosomes in vivo.
The positive findings observed in the in vitro studies are considered to be due to the release of formaldehyde from the pivoxil ester moiety of pivmecillinam because they were not observed when mecillinam was tested in the same assays. The positive findings are not considered relevant to the clinical use of PIVYA because the small amount of formaldehyde released is eliminated quickly in vivo, but not in vitro. Impairment of Fertility Mecillinam had no adverse effect on fertility in male or female rats at subcutaneous doses up to 450 mg/kg/day (approximately 7.9-fold higher than the maximum recommended daily human dose based on body surface area).
Pivmecillinam had no adverse effect on fertility in male or female rats at oral doses up to 582 mg/kg/day (approximately 10.2-fold higher than the maximum recommended daily human dose based on body surface area).
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 185 MG 9 COUNT TABLET CARTON NDC 62332-966-09 Pivya 185 mg Pivmecillinam tablet Oral use. Rx only. 9 tablets Pivya Carton 9 tablets
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