Active Ingredient: Tiratricol
Tiratricol is indicated for the treatment of peripheral thyrotoxicosis in patients with monocarboxylate transporter 8 (MCT8) deficiency (Allan-Herndon-Dudley Syndrome), from birth.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 350 micrograms tiratricol, divided 1 to 3 times daily, over the duration of 2 weeks. Afterwards, oral, 700 micrograms tiratricol, divided 1 to 3 times daily, over the duration of 2 weeks. Afterwards, oral, 1,050 micrograms tiratricol, divided 1 to 3 times daily, over the duration of 2 weeks. Afterwards, oral, 1,400 micrograms tiratricol, divided 1 to 3 times daily, over the duration of 2 weeks. Afterwards, oral, 1,750 micrograms tiratricol, divided 1 to 3 times daily, over the duration of 2 weeks. Afterwards, oral, 2,100 micrograms tiratricol, divided 1 to 3 times daily.
Dosing of tiratricol should be titrated on an individual patient basis based on the patient’s thyroid hormone levels.
The dose should be increased stepwise approximately every two weeks during a titration period until a maintenance dose has been reached. It is generally recommended to titrate the dose until the serum T3 level is below the midpoint of the normal range for age. The dose may be further adjusted based on the patient’s response to treatment on clinical features of MCT8 deficiency.
The need for further dose adjustments should be reassessed on a regular basis in accordance with clinical practice.
TSH and (F)T4 levels may provide further information to guide individual dosing.
The recommended starting dose is 350 micrograms daily.
A recommended dose titration regimen is shown in Table 1. The daily dose should be gradually increased by 350 micrograms every two weeks until a maintenance dose has been reached. It is generally recommended to titrate the dose until the serum T3 level is below the midpoint of the normal range for age. Smaller dose escalation steps may be used when a patient is approaching target serum T3 levels, as appropriate. The dose may be further adjusted based on the patient’s response to treatment on clinical features of MCT8 deficiency. The total daily dose should be administered in 1 to 3 doses, spread throughout the day (e.g. morning, midday, evening).
Table 1. Recommended dose titration regimen in patients with a body weight of 10 kg or above:
| Titration | Total daily dose (micrograms) |
|---|---|
| Starting dose | 350 |
| Week 2 | 700 |
| Week 4 | 1 050 |
| Week 6 | 1 400 |
| Week 8 | 1 750 |
| Week 10 | 2 100 |
Dose titration should continue in increments of 350 micrograms until a maintenance dose has been reached. It is not recommended to exceed a daily dose of 80 micrograms/kg in patients with a body weight between 10 and 40 kg; 60 micrograms/kg in patients with a body weight between 40 and 60 kg; and 50 micrograms/kg in patients with a body weight above 60 kg.
The dose of tiratricol is titrated on an individual basis until a maintenance dose has been reached. It is generally recommended to titrate the dose until the serum T3 level is below the midpoint of the normal range for age. The dose may be further adjusted based on the patient’s response to treatment on clinical features of MCT8 deficiency. The need for further dose adjustments should be reassessed on a regular basis in accordance with clinical practice.
If a dose is missed and there are more than 4 hours to the next scheduled dose, it should be taken as soon as possible. If a dose is missed and the next dose is scheduled within 4 hours, the dose should be omitted and the next dose taken according to the regular schedule. Laboratory tests (T3 measurements) It is recommended to measure individual T3 levels using a liquid chromatography tandem mass spectrometry (LC/MS/MS) method. Tiratricol cross-reacts with T3 when assessed by immunoassay, which may cause unreliable test results. Expert advice should be sought for test result interpretation when initiating, titrating and adjusting the dose of tiratricol using immunoassay method.
If hypermetabolic signs and symptoms (such as hyperhidrosis, irritability, anxiety, insomnia, nightmares, hyperthermia, tachycardia, transient elevations in systolic blood pressure (SBP), or diarrhoea) either occur for the first time or worsen, and do not resolve within 2 weeks, the dose should be reduced according to the steps in the dose titration regimen until signs and symptoms resolve (see Table 1 or Table 2). Following the resolution of hypermetabolic signs and symptoms, dose titration may be resumed, as clinically appropriate.
For:
Regimen A: In case that patient weight is ≥ 10 kg, oral, 350 micrograms tiratricol, divided 1 to 3 times daily, over the duration of 2 weeks. Afterwards, in case that patient weight is ≥ 10 kg, oral, 700 micrograms tiratricol, divided 1 to 3 times daily, over the duration of 2 weeks. Afterwards, in case that patient weight is ≥ 10 kg, oral, 1,050 micrograms tiratricol, divided 1 to 3 times daily, over the duration of 2 weeks. Afterwards, in case that patient weight is ≥ 10 kg, oral, 1,400 micrograms tiratricol, divided 1 to 3 times daily, over the duration of 2 weeks. Afterwards, in case that patient weight is ≥ 10 kg, oral, 1,750 micrograms tiratricol, divided 1 to 3 times daily, over the duration of 2 weeks. Afterwards, in case that patient weight is ≥ 10 kg, oral, 2,100 micrograms tiratricol, divided 1 to 3 times daily.
Regimen B: In case that patient weight is < 10 kg, oral, 175 micrograms tiratricol, divided 1 to 3 times daily, over the duration of 2 weeks. Afterwards, in case that patient weight is < 10 kg, oral, 350 micrograms tiratricol, divided 1 to 3 times daily, over the duration of 2 weeks. Afterwards, in case that patient weight is < 10 kg, oral, 525 micrograms tiratricol, divided 1 to 3 times daily, over the duration of 2 weeks. Afterwards, in case that patient weight is < 10 kg, oral, 700 micrograms tiratricol, divided 1 to 3 times daily, over the duration of 2 weeks. Afterwards, in case that patient weight is < 10 kg, oral, 875 micrograms tiratricol, divided 1 to 3 times daily, over the duration of 2 weeks. Afterwards, in case that patient weight is < 10 kg, oral, 1,050 micrograms tiratricol, divided 1 to 3 times daily.
Dosing of tiratricol should be titrated on an individual patient basis based on the patient’s thyroid hormone levels.
The dose should be increased stepwise approximately every two weeks during a titration period until a maintenance dose has been reached. It is generally recommended to titrate the dose until the serum T3 level is below the midpoint of the normal range for age. The dose may be further adjusted based on the patient’s response to treatment on clinical features of MCT8 deficiency.
The need for further dose adjustments should be reassessed on a regular basis in accordance with clinical practice.
TSH and (F)T4 levels may provide further information to guide individual dosing.
The recommended starting dose for patients with a body weight of 10 kg or above is 350 micrograms daily.
A recommended dose titration regimen is shown in Table 1. The daily dose should be gradually increased by 350 micrograms every two weeks until a maintenance dose has been reached. It is generally recommended to titrate the dose until the serum T3 level is below the midpoint of the normal range for age. Smaller dose escalation steps may be used when a patient is approaching target serum T3 levels, as appropriate. The dose may be further adjusted based on the patient’s response to treatment on clinical features of MCT8 deficiency. The total daily dose should be administered in 1 to 3 doses, spread throughout the day (e.g. morning, midday, evening).
Table 1. Recommended dose titration regimen in patients with a body weight of 10 kg or above:
| Titration | Total daily dose (micrograms) |
|---|---|
| Starting dose | 350 |
| Week 2 | 700 |
| Week 4 | 1 050 |
| Week 6 | 1 400 |
| Week 8 | 1 750 |
| Week 10 | 2 100 |
Dose titration should continue in increments of 350 micrograms until a maintenance dose has been reached. It is not recommended to exceed a daily dose of 80 micrograms/kg in patients with a body weight between 10 and 40 kg; 60 micrograms/kg in patients with a body weight between 40 and 60 kg; and 50 micrograms/kg in patients with a body weight above 60 kg.
The recommended starting dose for patients with a body weight below 10 kg is 175 micrograms daily.
A recommended dose titration regimen is shown in Table 2. The daily dose should be gradually increased by 175 micrograms every two weeks until a maintenance dose has been reached. It is generally recommended to titrate the dose until the serum T3 level is below the midpoint of the normal range for age. The dose may be further adjusted based on the patient’s response to treatment on clinical features of MCT8 deficiency. The total daily dose should be administered in 1 to 3 doses, spread throughout the day (e.g. morning, midday, evening).
Table 2. Recommended dose titration regimen in patients with a body weight below 10 kg:
| Titration | Total daily dose (micrograms) |
|---|---|
| Starting dose | 175 |
| Week 2 | 350 |
| Week 4 | 525 |
| Week 6 | 700 |
| Week 8 | 875 |
| Week 10 | 1 050 |
Dose titration should continue in increments of 175 micrograms until a maintenance dose has been reached. It is not recommended to exceed a daily dose of 100 micrograms/kg in patients with a body weight below 10 kg.
The dose of tiratricol is titrated on an individual basis until a maintenance dose has been reached. It is generally recommended to titrate the dose until the serum T3 level is below the midpoint of the normal range for age. The dose may be further adjusted based on the patient’s response to treatment on clinical features of MCT8 deficiency. The need for further dose adjustments should be reassessed on a regular basis in accordance with clinical practice.
If a dose is missed and there are more than 4 hours to the next scheduled dose, it should be taken as soon as possible. If a dose is missed and the next dose is scheduled within 4 hours, the dose should be omitted and the next dose taken according to the regular schedule. Laboratory tests (T3 measurements) It is recommended to measure individual T3 levels using a liquid chromatography tandem mass spectrometry (LC/MS/MS) method. Tiratricol cross-reacts with T3 when assessed by immunoassay, which may cause unreliable test results. Expert advice should be sought for test result interpretation when initiating, titrating and adjusting the dose of tiratricol using immunoassay method.
If hypermetabolic signs and symptoms (such as hyperhidrosis, irritability, anxiety, insomnia, nightmares, hyperthermia, tachycardia, transient elevations in systolic blood pressure (SBP), or diarrhoea) either occur for the first time or worsen, and do not resolve within 2 weeks, the dose should be reduced according to the steps in the dose titration regimen until signs and symptoms resolve (see Table 1 or Table 2). Following the resolution of hypermetabolic signs and symptoms, dose titration may be resumed, as clinically appropriate.
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