VENXXIVA

Absorption VENXXIVA Tablets When tiopronin IR and VENXXIVA single doses were given to fasted healthy subjects, the median time to peak plasma levels (T max ) was 1 (range: 0.5 to 2.1) and 3 (range: 1.0 to 6.0) hours, respectively. The peak exposure (C max ) and total exposure (AUC 0-t ) of tiopronin from VENXXIVA tablets were decreased by 22% and 7% respectively compared to tiopronin IR tablets.

Elimination

ExcretionWhen tiopronin is given orally, up to 48% of dose appears in urine during the f...

The following adverse reactions are discussed in greater detail in other sections of the labeling: Proteinuria [see Warnings and Precautions ( 5.1 )] Hypersensitivity [see Warnings and Precautions ( 5.2 )] Most common adverse reactions (≥10%) are nausea, diarrhea or soft stools, oral ulcers, rash, fatigue, fever, arthralgia, proteinuria, and emesis. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals Ltd at 1-857-437-3969 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6...

VENXXIVA is contraindicated in patients with hypersensitivity to tiopronin or any other components of VENXXIVA [see Warnings and Precautions ( 5.2 )] . Hypersensitivity to tiopronin or any component of VENXXIVA ( 4 )

Proteinuria, including nephrotic syndrome, and membranous nephropathy, has been reported with tiopronin use. Pediatric patients receiving greater than 50 mg/kg of tiopronin per day may be at increased risk for proteinuria. ( 2.1 , 5.1 , 8.4 ) Hypersensitivity reactions have been reported during tiopronin treatment. ( 4 , 5.2 ) 5.1 Proteinuria Proteinuria, including nephrotic syndrome, and membranous nephropathy, have been reported with tiopronin use. Pediatric patients receiving greater than 50 ...

7 DRUG INTERACTIONS 7.1 Alcohol Tiopronin is released faster from VENXXIVA in the presence of alcohol and the risk for adverse events associated with VENXXIVA when taken with alcohol is unknown. Avoid alcohol consumption 2 hours before and 3 hours after taking VENXXIVA [see Clinical Pharmacology ( 12.3 )] .