TIOPRONIN

Other

Brand names: VENXXIVA

Oral

Mechanism of Action

12.1 Mechanism of Action The goal of therapy is to reduce urinary cystine concentration below its solubility limit. Tiopronin is an active reducing agent which undergoes thiol-disulfide exchange with cystine to form a mixed disulfide of tiopronin-cysteine. From this reaction, a water-soluble mixed disulfide is formed and the amount of sparingly soluble cystine is reduced.

Indications

1 INDICATIONS AND USAGE VENXXIVA is indicated

in combination with high fluid intake

alkali

and diet modification

for the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria

who are not responsive to these measures alone. Additional pediatric use information is approved for Mission Pharmacal Company’s Thiola EC (tiopronin delayed-release) tablets. However

FDA Warnings

5 WARNINGS AND PRECAUTIONS 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
Pediatric patients receiving greater than 50 mg/kg of tiopronin per day may be at increased risk for proteinuria

Known Side Effects

12 documented side effects by frequency

Drug Not Working

>10%

Nausea

1-10%

Rash

1-10%

Fatigue

1-10%

Fever

1-10%

Joint Pain

0.1-1%

Vomiting

0.1-1%

Headache

0.1-1%

Itching

0.1-1%

Diarrhea

0.1-1%

Indigestion

0.1-1%

Muscle Pain

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral