apremilast

Apremilast is an oral medication used to treat adults with active psoriatic arthritis (a form of arthritis that affects some people with psoriasis). It is also used to treat moderate to severe plaque psoriasis in patients who are candidates for phototherapy or systemic therapy. Apremilast works by reducing production of an enzyme known as phosphodiesterase 4(PDE4). This may lead to a reduction in chemicals that cause inflammation in the body. However the exact mechanism in treating psoriatic arthritis and plaque psoriasis is not known. In clinical studies, patients with psoriatic arthritis had improvement in tender and swollen joints, as well as physical function. Patients with plaque psoriasis had reductions in redness, scaliness and thickness of the skin. The FDA approved apremilast in March 2014.

Otezla

GENERIC AVAILABLE: No

Yes

The most common side effects associated with apremilast are diarrhea, nausea, and headache. It also can cause upper respiratory tract infections. Depression, upper abdominal pain, and weight loss were also reported in clinical studies.

Apremilast tablets should be swallowed whole and should not be broken, chewed or crushed before swallowing. Apremilast tablets can be taken with or without food.

Treatment is started with a 14-day starter pack. The starting dose is 10 mg taken on the first day. The dose is gradually increased for 5 days until the recommended dose of 30 mg twice a day is reached.

• Day 1: 10 mg in the morning
• Day 2: 10 mg in the morning and 10 mg in the evening
• Day 3: 10 mg in the morning and 20 mg in the evening
• Day 4: 20 mg in the morning and 20 mg in the evening
• Day 5: 20 mg in the morning and 30 mg in the evening
• Day 6 and thereafter: 30 mg twice a day

After the starter pack is complete, the rest of the tablets will be supplied by a specialty pharmacy. The recommended dose long term dose is 30 mg twice a day. Patients with renal failure should have only a maximum of 30 mg per day; pm doses should be skipped.

: Rifampin, St. John's Wort and carbamazepine (Tegretol, Tegretol XR, Equetro, Carbatrol, Epitol, Teril) may reduce blood levels of apremilast by increasing its break down.

It is not known whether apremilast is secreted into breast milk.

What preparations of apremilast are available?

Tablets: 10, 20, and 30 mg

How should I keep apremilast stored?

Apremilast tablets should be stored at room temperature below 30 C (86 F).