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Pivmecillinam

Also known as: Pivya

Route: Oral

4 interactions on record

Pivmecillinam has 4 known drug interactions based on U.S. FDA drug labeling data. 2 are classified as major interactions requiring close medical supervision. Notable interactions include combinations with Valproate, Valproic Acid, Methotrexate. Patients taking Pivmecillinam should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 4
Major: 2
Moderate: 1

Major (2)

Pivmecillinam + Valproate— Concurrent use may decrease carnitine concentrations and increase risk of carnitine depletion-associated adverse reactio…
Pivmecillinam + Valproic Acid— Concurrent use may decrease carnitine concentrations and increase risk of carnitine depletion-associated adverse reactio…

Moderate (1)

Pivmecillinam + Methotrexate— Concurrent use of pivmecillinam may reduce clearance of methotrexate from the body. Consider alternative therapy where p…

Pivmecillinam + Valproate⚠️Major

Concurrent use may decrease carnitine concentrations and increase risk of carnitine depletion-associated adverse reactions including hypoglycemia, muscle aches, fatigue, and confusion.

Pivmecillinam + Valproic Acid⚠️Major

Concurrent use may decrease carnitine concentrations and increase risk of carnitine depletion-associated adverse reactions including hypoglycemia, muscle aches, fatigue, and confusion.

Pivmecillinam + Methotrexate🟡Moderate

Concurrent use of pivmecillinam may reduce clearance of methotrexate from the body. Consider alternative therapy where possible.

Pivmecillinam + Penicillinℹ️Unknown

7.2 Methotrexate Clearance of methotrexate from the body can be reduced by concurrent use of drugs in the penicillin class, including PIVYA.

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 ) 4.1 Serious 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 ) ]. 4.2 Carnitine 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 ) ]. 4.3 Acute 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 )] .

Pregnancy & Breastfeeding

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) . 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

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.