Apremilast

Author: Anoma Ranaweera, Medical Writer, Auckland, New Zealand. Chief Editor: Dr Amanda Oakley, Dermatologist, Hamilton, New Zealand, January 2015.

Apremilast (Otezla®; Celgene, New Jersey, USA) is an oral small molecule inhibitor of the enzyme phosphodiesterase 4, which plays an important role in chronic inflammation associated with psoriasis.

What is apremilast used for?

In September 2014, the US Food and Drug Administration (FDA) approved the use of apremilast in patients with plaque psoriasis. It was approved for use in New Zealand in psoriasis in November 2016.

Apremilast was approved for treatment of plaque psoriasis in patients:

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for apremilast for:

It has been reported to be particularly effective in palmoplantar psoriasis.

How does apremilast work in psoriasis?

How is apremilast administered?

The recommended dose of apremilast is 30 mg twice daily. To reduce the risk of gastrointestinal symptoms the recommended dose is titrated according to the following schedule:

Day 1: 10 mg in morning
Day 2: 10 mg in morning and 10 mg in evening
Day 3: 10 mg in morning and 20 mg in evening
Day 4: 20 mg in morning and 20 mg in evening
Day 5: 20 mg in morning and 30 mg in evening
Day 6 and thereafter: 30 mg twice daily

For patients with severe renal impairment the recommended dose is 30 mg once daily, titrated using the morning schedule only, as listed above.

Link to key clinical-trial evidence about apremilast...

Potential drug interactions with apremilast

What are the adverse effects with apremilast

Apremilast is well tolerated. No monitoring or testing is required.

Use in pregnancy

Use in nursing mothers

It is not known whether apremilast or its metabolites are present in human milk.

Paediatric use

The safety and effectiveness of apremialst have not been established in patients less than 18 years of age.

Geriatric use

No overall differences were observed in efficacy and safety of apremilast in elderly subjects ≥65 years of age compared with those <65 years of age in clinical trials involving 1257 plaque psoriasis patients.

Renal impairment

The dose of apremialst should be reduced to 30 mg once daily in patients with severe renal impairment (creatinine clearance of less than 30 mL per minute).

Hepatic impairment

No dose adjustments of apremilast is necesary in patients with moderate and severe hepatic impairment.

Allergic reactions

Apremilast is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation.

Depression

Treatment with apremilast is associated with an increase in depression. Patients, their caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and if such changes occur to contact their healthcare provider.

Weight loss

Patients treated with apremilast should have their body weight monitored regularly. In clinical trials in psoriasis, weight decrease between 5%-10% of body weight occurred in 12% (96/784) of subjects treated with apremilast compared to 5% (19/382) treated with placebo.

If unexplained or clinically significant weight loss occurs, discontinuation of apremilast should be considered.

New Zealand approved datasheets are the official source of information for these prescription medicines, including approved uses and risk information. Check the individual New Zealand datasheet on the Medsafe website.

Related information

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