INDICATIONS AND USAGE: Tiopronin Delayed-Release Tablets are indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients ≥20 kg with severe homozygous cystinuria, who are not responsive to these measures alone.

Important Safety Information

CONTRAINDICATIONS: Tiopronin Delayed-Release Tablets are contraindicated in patients with hypersensitivity to tiopronin or any other components of Tiopronin Delayed-Release Tablets.

WARNINGS AND PRECAUTIONS:

• Proteinuria: Proteinuria, including nephrotic syndrome, and membranous nephropathy, has been reported with tiopronin use. Pediatric patients receiving >50 mg/kg of tiopronin per day may be at increased risk for proteinuria. Monitor patients for the development of proteinuria and discontinue therapy in patients who develop proteinuria.
• Hypersensitivity Reactions: Hypersensitivity reactions (drug fever, rash, fever, arthralgia and lymphadenopathy) have been reported.

ADVERSE REACTIONS: The most common adverse reactions (≥10%) are nausea, diarrhea or soft stools, oral ulcers, rash, fatigue, fever, arthralgia, proteinuria, and emesis.

DRUG INTERACTIONS: Avoid alcohol consumption 2 hours before and 3 hours after taking Tiopronin Delayed-Release Tablets as Tiopronin Delayed-Release Tablets are released faster in the presence of alcohol.

SPECIFIC POPULATIONS:

• Lactation: Breastfeeding is not recommended during treatment with Tiopronin Delayed-Release Tablets.
• Geriatric Use: Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

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