Name: Emcitate (tiratricol) in MCT8 deficiency: Special populations
Published: 2026-09-14T15:39:06-04:00

Pregnancy

“There are no available data on the use of tiratricol for the treatment of MCT8 deficiency during pregnancy to inform a drug-related risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with tiratricol.” (opens the prescribing information at this quote)

Pregnancy restriction: European Union

“MCT8 deficiency is an X-linked disease that almost exclusively affects males.” (opens the source at this quote in a new tab)
“Tiratricol crosses the placenta. There are no or limited amount of data from the use of tiratricol in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3).” (opens the source at this quote in a new tab)
“Emcitate is contraindicated during pregnancy (see section 4.3).” (opens the source at this quote in a new tab)
“Women of childbearing potential have to use effective contraception during treatment.” (opens the source at this quote in a new tab)

Lactation

“There are no data regarding the presence of tiratricol in human or animal milk, the effects on the breastfed infant, or the effects on milk production.” (opens the prescribing information at this quote)

Pediatric use

“The safety and effectiveness of EMCITATE for the treatment of peripheral thyrotoxicosis have been established in pediatric patients with MCT8 deficiency.” (opens the prescribing information at this quote)
“Use of EMCITATE in pediatric patients is supported by a single-arm trial and a double-blind, placebo-controlled, randomized withdrawal trial that included pediatric patients with MCT8 deficiency ages 10 months to less than 2 years (n=5), ages 2 years to less than 12 years (n=38), and ages 12 years to less than 17 years (n=12)” (opens the prescribing information at this quote)
“Pediatric patients (5 to 16 years of age) with a lower body weight had a lower clearance and volume of distribution as compared to adult patients.” (opens the prescribing information at this quote)

“Safety data were evaluated in 63 patients between 0 and 17 years of age, in Triac Trial I and Triac Trial II combined. Thirty (30) patients were below 2 years of age at start of treatment, 25 patients were between 2 and 11 years of age and 8 patients were between 12 and 17 years of age. There is no indication from clinical trial data that the safety profile in any subset of the paediatric population is different from the safety profile in adult patients.” (opens the source at this quote in a new tab)

Geriatric use

“MCT8 deficiency is largely a disease of children and young adults; therefore, there are insufficient data on the use of EMCITATE in patients aged 65 years and older to determine whether they respond differently from younger patients.” (opens the prescribing information at this quote)

Renal and hepatic impairment

“No clinical studies have been performed in subjects with renal and hepatic impairment.” (opens the prescribing information at this quote)

“No specific studies have been performed in patients with hepatic impairment. In these patients, careful dose titration and regular monitoring of serum concentrations of T3 are recommended” (opens the source at this quote in a new tab)
“No specific studies have been performed in patients with renal impairment. In these patients, careful dose titration and regular monitoring of serum concentrations of T3 are recommended” (opens the source at this quote in a new tab)