Active Ingredient: Apremilast
Apremilast is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years and weighing at least 20 kg who are candidates for systemic therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: In case that patient age in years is ≥ 6 and patient weight is ≥ 20 kg and patient weight is < 50 kg, oral, 10 milligrams apremilast, at morning, one dose, over the duration of 24 hours. Afterwards, in case that patient age in years is ≥ 6 and patient weight is ≥ 20 kg and patient weight is < 50 kg, oral, 10 milligrams apremilast, at morning, one dose, over the duration of 12 hours. Afterwards, in case that patient age in years is ≥ 6 and patient weight is ≥ 20 kg and patient weight is < 50 kg, oral, 10 milligrams apremilast, at evening, one dose, over the duration of 12 hours. Afterwards, in case that patient age in years is ≥ 6 and patient weight is ≥ 20 kg and patient weight is < 50 kg, oral, 10 milligrams apremilast, at morning, one dose, over the duration of 12 hours. Afterwards, in case that patient age in years is ≥ 6 and patient weight is ≥ 20 kg and patient weight is < 50 kg, oral, 20 milligrams apremilast, at evening, one dose, over the duration of 12 hours. Afterwards, in case that patient age in years is ≥ 6 and patient weight is ≥ 20 kg and patient weight is < 50 kg, oral, 20 milligrams apremilast, once every 12 hours at morning.
Regimen B: In case that patient age in years is ≥ 6 and patient weight is ≥ 50 kg, oral, 10 milligrams apremilast, at morning, one dose, over the duration of 24 hours. Afterwards, in case that patient age in years is ≥ 6 and patient weight is ≥ 50 kg, oral, 10 milligrams apremilast, at morning, one dose, over the duration of 12 hours. Afterwards, in case that patient age in years is ≥ 6 and patient weight is ≥ 50 kg, oral, 10 milligrams apremilast, at evening, one dose, over the duration of 12 hours. Afterwards, in case that patient age in years is ≥ 6 and patient weight is ≥ 50 kg, oral, 10 milligrams apremilast, at morning, one dose, over the duration of 12 hours. Afterwards, in case that patient age in years is ≥ 6 and patient weight is ≥ 50 kg, oral, 20 milligrams apremilast, at evening, one dose, over the duration of 12 hours. Afterwards, in case that patient age in years is ≥ 6 and patient weight is ≥ 50 kg, oral, 20 milligrams apremilast, at morning, one dose, over the duration of 12 hours. Afterwards, in case that patient age in years is ≥ 6 and patient weight is ≥ 50 kg, oral, 20 milligrams apremilast, at evening, one dose, over the duration of 12 hours. Afterwards, in case that patient age in years is ≥ 6 and patient weight is ≥ 50 kg, oral, 20 milligrams apremilast, at morning, one dose, over the duration of 12 hours. Afterwards, in case that patient age in years is ≥ 6 and patient weight is ≥ 50 kg, oral, 30 milligrams apremilast, at evening, one dose, over the duration of 12 hours. Afterwards, in case that patient age in years is ≥ 6 and patient weight is ≥ 50 kg, oral, 30 milligrams apremilast, once every 12 hours at evening.
The recommended dose of apremilast for paediatric patients 6 years of age and older with moderate to severe plaque psoriasis is based on body weight. The recommended dose of apremilast is 20 mg taken orally twice daily for paediatric patients who weigh from 20 kg to less than 50 kg, and 30 mg taken orally twice daily for paediatric patients who weigh at least 50 kg, following the initial titration schedule shown below in table 1.
Table 1. Dose titration schedule for paediatric patients:
| Body weight | Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 & thereafter | |||||
| AM | AM | PM | AM | PM | AM | PM | AM | PM | AM | PM | |
| 20 kg to less than 50 kg | 10 mg | 10 mg | 10 mg | 10 mg | 20 mg | 20 mg | 20 mg | 20 mg | 20 mg | 20 mg | 20 mg |
| 50 kg or more | 10 mg | 10 mg | 10 mg | 10 mg | 20 mg | 20 mg | 20 mg | 20 mg | 30 mg | 30 mg | 30 mg |
No re-titration is required after initial titration.
The recommended twice daily apremilast dose should be taken approximately 12 hours apart (morning and evening), with no food restrictions.
If patients miss a dose, the next dose should be taken as soon as possible. If it is close to the time for their next dose, the missed dose should not be taken and the next dose should be taken at the regular time.
During pivotal trials the greatest improvement was observed within the first 24 weeks of treatment for PsA and PSOR and within the first 12 weeks of treatment for BD. If a patient shows no evidence of therapeutic benefit after this time period, treatment should be reconsidered. The patient’s response to treatment should be evaluated on a regular basis.
It can be taken either with or without food.
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.
