Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Celgene Europe B.V., Winthontlaan 6 N, 3526 KV Utrecht, 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 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).
Treatment with Otezla should be initiated by specialists experienced in the diagnosis and treatment of psoriasis or psoriatic arthritis.
The recommended dose of apremilast is 30 mg twice daily taken orally, morning and evening, approximately 12 hours apart, 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 | Day2 | 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. Clinical experience beyond 52 weeks is not available (see section 5.1).
No dose adjustment is required for this patient population (see sections 4.8 and 5.2).
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).
No dose adjustment is necessary for patients with hepatic impairment (see section 5.2).
The safety and efficacy of apremilast in children aged 0 to 17 years have not been established. 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.
Apremilast was studied in healthy subjects at a maximum total daily dose of 100 mg (given as 50 mg BID) 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.
Shelf life: 24 months.
Do not store above 30°C.
The treatment initiation pack contains 27 film-coated tablets (4 x10 mg, 4x 20 mg, 19 × 30 mg).
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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