Posology : מינונים

4.2 Posology and method of administration

Treatment with apremilast should be initiated by specialists experienced in the diagnosis and treatment of psoriasis, psoriatic arthritis or Behçet’s disease.

Posology
The recommended dose of apremilast is 30 mg taken orally twice daily, approximately 12 hours apart (morning and evening), with no food restrictions. An initial titration schedule is required as shown below in Table 1. No re-titration is required after initial titration.

Table 1: Dose titration schedule
Day 1            Day 2                   Day 3                Day 4                 Day 5              Day 6 & thereafter

AM          AM         PM         AM           PM      AM           PM       AM           PM       AM        PM 
10 mg       10 mg      10 mg     10 mg      20 mg      20 mg      20 mg      20 mg      30 mg      30 mg     30 mg 

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. If a patient shows no evidence of therapeutic benefit after 24 weeks, treatment should be reconsidered. The patient's response to treatment should be evaluated on a regular basis.

Special populations

Elderly patients
No dose adjustment is required for this patient population (see sections 4.8 and 5.2).
Patients with renal impairment
No dose adjustment is needed in patients with mild and moderate renal impairment. The dose of apremilast should be reduced to 30 mg once daily in patients with severe renal impairment (creatinine clearance of less than 30 mL per minute estimated by the Cockcroft-Gault equation). For initial dose titration in this group, it is recommended that apremilast be titrated using only the AM schedule listed in Table 1 and the PM doses be skipped (see section 5.2).

Patients with hepatic impairment
No dose adjustment is necessary for patients with hepatic impairment (see section 5.2).

Pediatric population
The safety and efficacy of apremilast in children aged 0 to 17 years have not been established. No data are available.
Method of administration
Apremilast is for oral use. The film-coated tablets should be swallowed whole, and can be taken either with or without food.