Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands
Otezla, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy (see section 5.1).
Otezla is indicated for the treatment of moderate to severe chronic plaque psoriasis (PSOR) in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).
Otezla 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.
Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s disease (BD) who are candidates for systemic therapy.
Treatment with Otezla should be initiated by specialists experienced in the diagnosis and treatment of psoriasis, psoriatic arthritis or Behçet’s disease.
The recommended dose of apremilast for adult patients is 30 mg taken orally twice daily. An initial titration schedule is required as shown below in table 1.
Table 1. Dose titration schedule for adult patients:
| 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 |
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 2.
Table 2. 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.
No dose adjustment is required for this patient population (see sections 4.8 and 5.2).
Adult patients with psoriatic arthritis, psoriasis, or Behçet’s disease:
No dose adjustment is needed in adult patients with mild and moderate renal impairment. The dose of apremilast should be reduced to 30 mg once daily in adult 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).
Paediatric patients with moderate to severe psoriasis:
No dose adjustment is needed in paediatric patients 6 years of age and older with mild or moderate renal impairment. In paediatric patients 6 years of age and older with severe renal impairment (creatinine clearance of less than 30 mL per minute estimated by the Cockroft–Gault equation), dose adjustment is recommended. The apremilast dose should be reduced to 30 mg once daily for paediatric patients who weigh at least 50 kg and to 20 mg once daily for paediatric patients who weigh 20 kg to less than 50 kg. For initial dose titration in these groups, it is recommended that apremilast be titrated using only the AM schedule listed in table 2 above for the appropriate body weight category and the PM doses be skipped.
No dose adjustment is necessary for patients with hepatic impairment (see section 5.2).
The safety and efficacy of apremilast have not been established in children with moderate to severe plaque psoriasis below the age of 6 years or with a body weight less than 20 kg, or in other paediatric indications. No data are available.
Otezla is for oral use. The film-coated tablets should be swallowed whole, and can be taken either with or without food.
No dose adjustment is necessary for patients with hepatic impairment (see section 5.2).
Apremilast was studied in healthy subjects at a maximum total daily dose of 100 mg (given as 50 mg twice daily) for 4.5 days without evidence of dose limiting toxicities. In case of an overdose, it is recommended that the patient is monitored for any signs or symptoms of adverse effects and appropriate symptomatic treatment is instituted. In the event of overdose, symptomatic and supportive care is advised.
3 years.
Do not store above 30°C.
Otezla treatment initiation packs:
PVC/aluminium foil blisters containing 27 film-coated tablets (4 × 10 mg, 23 × 20 mg).
PVC/aluminium foil blisters containing 27 film-coated tablets (4 × 10 mg, 4 × 20 mg, 19 × 30 mg).
Otezla 20 mg packs:
PVC/aluminium foil blisters containing 14 film-coated tablets, in a pack size of 56 tablets.
Otezla 30 mg packs:
PVC/aluminium foil blisters containing 14 film-coated tablets, in pack sizes of 56 tablets and 168 tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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