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Travere Therapeutics, Inc.

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San Diego, CA 92130

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To report a negative side effect to a Travere Therapeutics product, please call 877-659-5518. Side effects may also be reported to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

THIOLA EC® (tiopronin, delayed-release tablets)

Important Safety Information

What is THIOLA EC® (tiopronin, delayed-release tablets)?

THIOLA EC is a prescription medication provided in a delayed-release tablet. It is used in combination with high fluid intake, alkali (low acid), and dietary changes to help prevent the formation of one type (cystine) of kidney stones in certain adult and pediatric patients that weigh at least 44 pounds (20 kg) and who do not respond to these measures alone.

Who should not take THIOLA EC?

THIOLA EC should not be taken if you:

  • Are allergic to THIOLA EC, or any of the ingredients in THIOLA EC.

What should I tell my doctor before taking THIOLA EC?

THIOLA EC may not be right for you. Before taking THIOLA EC, tell your doctor about:

  • all health conditions you may have and any medications you may be taking
  • if you are pregnant or plan to become pregnant
  • if you are breastfeeding or plan to breastfeed

What should I avoid while taking THIOLA EC?

You should avoid drinking alcohol 2 hours before and 3 hours after taking THIOLA EC.

What are possible side effects of THIOLA EC?

Serious Side Effects: THIOLA EC can cause proteinuria (high amounts of protein in urine), including serious kidney problems, and hypersensitivity reactions (including fever, rash, joint pain and enlarged or swollen lymph nodes).

Most Common Side Effects: Nausea, diarrhea or soft stools, sores in the mouth, rash, fatigue, fever, muscle or joint pain, high amounts of protein in urine, vomiting.

These are not all the possible side effects of THIOLA EC. Call your doctor for medical advice about side effects.

You may report negative side effects to Travere Therapeutics Medical Information at 1-877-659-5518, or to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see accompanying full Prescribing Information for additional Important Safety Information.

THIOLA® (tiopronin)

Important Safety Information

What is THIOLA® (tiopronin tablets)?

THIOLA is a prescription medicine. It is used in combination with high fluid intake, alkali (low acid), and dietary changes to help prevent the formation of one type (cystine) of kidney stone in certain adult and pediatric patients that weigh at least 44 pounds (20 kg) and who do not respond to these measures alone.

Who should not take THIOLA?

THIOLA should not be taken if you:

  • Are allergic to THIOLA, or any of the ingredients in THIOLA.

What should I tell my doctor before taking THIOLA?

THIOLA may not be right for you. Before taking THIOLA, tell your doctor about:

  • all health conditions you may have and any medications you may be taking
  • if you are pregnant or plan to become pregnant
  • if you are breastfeeding or plan to breastfeed

What are possible side effects of THIOLA?

Serious Side Effects: THIOLA can cause proteinuria (high amounts of protein in urine), including serious kidney problems, and hypersensitivity reactions (including fever, rash, joint pain and enlarged or swollen lymph nodes).

Most Common Side Effects: Nausea, diarrhea or soft stools, sores in the mouth, rash, fatigue, fever, muscle or joint pain, high amounts of protein in urine, vomiting.

These are not all the possible side effects of THIOLA. Call your doctor for medical advice about side effects.

You may report negative side effects to Travere Therapeutics Medical Information at 1-877-659-5518, or to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see accompanying full Prescribing Information for additional Important Safety Information.