Active Ingredient: Leriglitazone
Leriglitazone is indicated for the treatment of Cerebral Adrenoleukodystrophy (cALD) in males with Adrenoleukodystrophy (ALD) aged 2 to 12 years with non-Gadolinium (Gd) enhancing lesions (i.e. Gd negative) in brain Magnetic Resonance Imaging (MRI), with a Neurological Functional Score (NFS) of 0 or 1.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A, in the case that patient age in years is ≥ 2 and patient age in years is ≤ 5 :
Suspension oral, between 2 milliliters leriglitazone and 4.5 milliliters leriglitazone, once daily.
Regimen B, in the case that patient age in years is ≥ 6 and patient age in years is ≤ 12 :
Suspension oral, between 3.5 milliliters leriglitazone and 8.5 milliliters leriglitazone, once daily.
Leriglitazone is administered once daily. The recommended doses are based on height and body weight as shown below in Table 1 (children 2 to 5 years of age) and Table 2 (children 6 to 12 years of age).
The doses refer to a 13.7 mg/mL oral suspension.
Table 1. Recommended doses in mL for children 2 to 5 years of age:
| Body weight (kg) | |||||||
| Height (cm) | 9-10 | 11-13 | 14-16 | 17-20 | 21-26 | 27-32 | 33-41 |
| 81-86 | 2 | 2.5 | 2.5 | 2.5 | 3 | 3 | 3.5 |
| 87-92 | 2 | 2.5 | 2.5 | 3 | 3 | 3.5 | 3.5 |
| 93-99 | 2.5 | 2.5 | 3 | 3 | 3 | 3.5 | 4 |
| 100-106 | 2.5 | 2.5 | 3 | 3 | 3.5 | 3.5 | 4 |
| 107-113 | 2.5 | 3 | 3 | 3.5 | 3.5 | 4 | 4 |
| 114-121 | 3 | 3 | 3 | 3.5 | 4 | 4 | 4.5 |
| 122-131 | 3 | 3 | 3.5 | 3.5 | 4 | 4.5 | 4.5 |
Table 2. Recommended doses in mL for children 6 to 12 years of age:
| Body weight (kg) | |||||||
| Height (cm) | 16-20 | 21-26 | 27-35 | 36-46 | 47-61 | 62-80 | 81-106 |
| 107-113 | 3.5 | 4 | 4 | 4.5 | 5 | 5.5 | 6 |
| 114-121 | 3.5 | 4 | 4.5 | 5 | 5.5 | 6 | 6.5 |
| 122-129 | 4 | 4.5 | 4.5 | 5 | 5.5 | 6.5 | 7 |
| 130-138 | 4 | 4.5 | 5 | 5.5 | 6 | 6.5 | 7.5 |
| 139-148 | 4.5 | 5 | 5.5 | 6 | 6.5 | 7 | 7.5 |
| 149-158 | 4.5 | 5 | 5.5 | 6 | 6.5 | 7.5 | 8 |
| 159-170 | 5 | 5.5 | 6 | 6.5 | 7 | 8 | 8.5 |
Checks on paediatric patients' growth are recommended every 6 months to adjust the dose, with monitoring of height and weight.
Before initiation and during treatment, patients should be monitored for increased hepatic enzymes, with dose modifications according to the recommendations outlined in Table 3. Appropriate hepatic function tests should be performed in patients both prior to the initiation of treatment and monitored regularly during treatment.
Table 3. Recommended leriglitazone dose discontinuation:
| Adverse reaction | Severity | Recommended dose modifications |
| Increased hepatic enzymes | Alanine aminotransferase (ALT) > 3.0 times upper limit of normal (ULN) confirmed in 2 measurements. The second measurement should be performed within 3 to 5 days following the first elevated result. | Treatment should be suspended at the first measurement of a major increase until normalisation. After normalisation, consider resumption of treatment and continued monitoring of hepatic enzymes. If relapses in hepatic enzyme increase occur, the management should be repeated as above. |
If a dose is missed, the patients should be advised not to take a double dose and to take the next dose as prescribed.
The suspension is administered once daily, preferably after breakfast at the same time of the day. The bottle should be shaken well for about 30 seconds before each dose.
The suspension should be administered using the provided graduated oral syringe to measure the appropriate volume of suspension corresponding to the prescribed dose for the patient.
Liability Disclaimer : RxReasoner has utilized reasonable care in providing content and services that are accurate, complete and up to date. However, RxReasoner does not accept any responsibility or liability about it. The content and services of RxReasoner are for informational purposes only and they are not intended to be a substitute for the knowledge, expertise, skill, and judgment of physicians, pharmacists, nurses, or other healthcare professionals involved in patient care. RxReasoner offers no medical advice. Users are responsible for the use of the provided content. A shown indication or treatment should not be construed to indicate that the medication is safe, appropriate, or effective in any given patient or under any particular circumstances. The absence of an indication or treatment should not roule out the existence of other appropriate medications. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition or medicament. RxReasoner is not liable for any damages allegedly sustained arising out of the use of its content and services.