What is apremilast, and how does it work (mechanism of action)?
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.
What brand names are available for apremilast?
Otezla
Is apremilast available as a generic drug?
GENERIC AVAILABLE: No
Do I need a prescription for apremilast?
Yes
What are the side effects of apremilast?
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.
What is the dosage for apremilast?
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.
Which drugs or supplements interact with apremilast?
: 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.
Is apremilast safe to take if I’m pregnant or breastfeeding?
It is not known whether apremilast is secreted into
breast
milk.
What else should I know about apremilast?
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).