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For HCPs: Rx & Enrollment Form

NOW FDA APPROVED

EMCITATE® (tiratricol) is the first and only FDA-approved treatment of peripheral thyrotoxicosis in patients with MCT8 deficiency (Allan-Herndon-Dudley syndrome)*

*INDICATION AND USAGE
EMCITATE® (tiratricol) is a thyroid hormone receptor agonist indicated for the treatment of peripheral thyrotoxicosis in adults and pediatric patients with monocarboxylate transporter 8 (MCT8) deficiency (Allan-Herndon-Dudley syndrome).

Limitation of Use
EMCITATE is not recommended for the treatment of primary hypothyroidism

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Important Safety Information

Indication and Usage

EMCITATE® (tiratricol) is a thyroid hormone receptor agonist indicated for the treatment of peripheral thyrotoxicosis in adults and pediatric patients with monocarboxylate transporter 8 (MCT8) deficiency (Allan‑Herndon‑Dudley syndrome).

Limitation of Use

EMCITATE is not recommended for the treatment of primary hypothyroidism.

1. What is EMCITATE® (tiratricol)?

EMCITATE® (tiratricol) is a prescription medicine used to treat peripheral thyrotoxicosis in adults and pediatric patients with monocarboxylate transporter 8 (MCT8) deficiency (Allan-Herndon-Dudley syndrome). Peripheral thyrotoxicosis is a serious medical condition that occurs when your body’s tissues and organs are exposed to too much active thyroid hormone. MCT8 deficiency is a rare genetic condition that prevents thyroid hormone from properly entering your body’s cells.

EMCITATE is not recommended for treating primary hypothyroidism (a condition where an underactive thyroid is not making enough thyroid hormone on its own).

2. What is the most important information I should know about EMCITATE?

Do not take thyroid hormones, including EMCITATE, either alone or with other drugs, to treat obesity or lose weight. Doing so may cause thyrotoxicosis (a condition where there is too much thyroid hormone in your body), which could be serious or life-threatening.

Signs and symptoms of thyrotoxicosis have occurred with EMCITATE when you first start taking EMCITATE and while your healthcare provider is slowly adjusting your dose to find the right amount. Call your healthcare provider right away if you have signs and symptoms of thyrotoxicosis such as:

  • Fast heartbeat
  • Increase in blood pressure
  • Diarrhea
  • Excessive sweating
  • Irritability
  • Trouble sleeping
  • Nightmares

Your healthcare provider will monitor you and adjust your EMCITATE dose as needed.

EMCITATE can interfere with certain lab tests used to measure T3 levels, causing falsely high T3 results. Your healthcare provider should be aware of this when interpreting your blood test results.

3. Who should NOT take EMCITATE?

EMCITATE must not be taken by patients with primary hyperthyroidism (a condition where the thyroid gland makes too much thyroid hormone on its own).

4. What should I tell my healthcare provider before taking EMCITATE?

Before taking EMCITATE, tell your healthcare provider if you:

  • Have liver or kidney problems
  • Have heart problems or high blood pressure
  • Have other serious medical conditions
  • Take prescription medicines, over‑the‑counter medicines, vitamins, or herbal supplements

EMCITATE may affect the way other medicines work. Taking EMCITATE together with other thyroid medicines (such as levothyroxine, propylthiouracil, and carbimazole) may increase your risk of thyrotoxicosis or hypothyroidism and should be avoided.

See full Prescribing Information for medicines that may interact with EMCITATE and change how well it works.

5. What are the possible serious side effects with EMCITATE?

Signs and symptoms of thyrotoxicosis, such as fast heartbeat, increase in blood pressure, diarrhea, excessive sweating, irritability, trouble sleeping, and nightmares, have occurred with EMCITATE. Your healthcare provider will monitor you and adjust your EMCITATE dose as needed.

6. What are the most common side effects with EMCITATE?

The most common side effects with EMCITATE include diarrhea, vomiting, rash, and excessive sweating.

These are not all the possible side effects of EMCITATE.

Call your healthcare provider for medical advice about side effects.

You may report side effects to Egetis Therapeutics US Inc. at 1-844-4EGETIS (1-844-434-3847). You are encouraged to report negative side effects of prescription drugs to the FDA. Visit 1‑800‑FDA‑1088 or www.fda.gov/medwatch.

7. Where can I learn more about EMCITATE?

This information is not comprehensive. Talk to your healthcare provider to learn more about EMCITATE. Please see full Prescribing Information, including the Boxed WARNING and the Instructions for Use, or call 1‑844‑4EGETIS (1‑844‑434‑3847).

US-TIRA-2600128 September 2026