- What is apremilast, and how does it work (mechanism of action)?
- What brand names are available for apremilast?
- Is apremilast available as a generic drug?
- Do I need a prescription for apremilast?
- What are the side effects of apremilast?
- What is the dosage for apremilast?
- Which drugs or supplements interact with apremilast?
- Is apremilast safe to take if I'm pregnant or breastfeeding?
- What else should I know about apremilast?
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 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).
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Apremilast (Otezla) is a medication prescribed to treat active psoriatic arthritis in adults, and to treat moderate to severe plaque psoriasis in individuals who are not candidates for phototherapy or systemic therapy. Side effects, drug interactions, dosage, storage, and pregnancy safety information should be reviewed prior to taking this medication.
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Related Disease Conditions
Psoriasis is a long-term skin condition that may cause large plaques of red, raised skin, flakes of dry skin, and skin scales. There are several types of psoriasis, including psoriasis vulgaris, guttate psoriasis, inverse psoriasis, and pustular psoriasis. Symptoms vary depending on the type of psoriasis the patient has. Treatment of psoriasis may include creams, lotions, oral medications, injections and infusions of biologics, and light therapy. There is no cure for psoriasis.
Arthritis (Joint Inflammation)
Arthritis is inflammation of one or more joints. When joints are inflamed they can develop stiffness, warmth, swelling, redness and pain. There are over 100 types of arthritis, including osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, lupus, gout, and pseudogout.
Psoriatic arthritis is a disease that causes skin and joint inflammation. Symptoms and signs include painful, stiff, and swollen joints, tendinitis, and organ inflammation. Treatment involves anti-inflammatory medications and exercise.
Scalp Psoriasis (Psoriasis of the Scalp)
Scalp psoriasis causes red, raised, scaly patches that may extend from the scalp to the forehead and the back of the neck and ears. Symptoms and signs include itching, hair loss, flaking, silvery scales, and red plaques. Treatment includes topical medicated shampoos, creams, gels, oils, ointments, and soaps, medications, and light therapy.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
REFERENCE: FDA Prescribing Information.