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Is Otezla a biologic? What is Otezla used for?

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on April 26, 2020.

Official Answer

by Drugs.com

No, Otezla is not classified as a biologic agent. Otezla (apremilast) is a small molecule phosphodiesterase 4 (PDE4) inhibitor approved by the FDA for the treatment of plaque psoriasis, psoriatic arthritis, and oral ulcers associated with Behçet’s Disease. It is taken as an oral tablet.

Otezla, from Amgen, works by blocking the phosphodiesterase type 4 (PDE4) enzyme to lower inflammation in the body. Patients may see an improvement within the first few weeks of treatment, but its exact mechanism is not known.

  • Plaque psoriasis is a chronic (long-term) autoimmune disease in which the cells of your skin are replaced at an unusually fast rate. Due to this rapid turnover, extra skins cells cause raised silvery plaques that can be flaky, red, and itchy. In autoimmune diseases the body's immune system starts to mistakenly attack healthy cells and tissues.
  • Psoriatic arthritis is a long-lasting autoimmune inflammatory joint condition that often occurs in association with plaque psoriasis. Symptoms include joint inflammation, pain and an overproduction of skin cells.
  • Behçet’s Disease is a rare, chronic inflammatory disorder that can cause recurrent ulcers in the mouth, on the genitals, and inflammation in the eye. It can affect many parts of the body and lead to arthritis, skin lesions, bowel disease, and inflammation in the brain and spinal cord. It can lead to blindness and stroke.

How do I use Otezla?

After an initial titration starting at 10 mg per day and increasing your dose over 5 days, the recommended maintenance dosage is 30 mg twice daily starting on Day 6.

Slowly increasing your dose of Otezla when you first start will help to reduce the gastrointestinal (stomach) symptoms.

Side effects

Most stomach stomach side effects, like diarrhea, nausea and vomiting and stomach pain due to Otezla occur within the first weeks of starting treatment. In some cases, patients were hospitalized for these effects.

In addition, weight loss can be a significant side effect with Otezla. Your doctor will monitor your body weight regularly, and decide if it is safe for you to remain on Otezla.

Tell your doctor if you have ever had problems with mood or depression. You and your family members should be on the alert for signs of worsening depression, suicidal thoughts or other mood changes. If such changes should occur with your treatment, your doctor should be contacted immediately.

Bottom Line

  • Otezla (apremilast) is a small molecule phosphodiesterase 4 (PDE4) inhibitor but is not classified as a biologic. It is an oral tablet used to treat plaque psoriasis, psoriatic arthritis, and oral ulcers associated with Behçet’s Disease.
  • Your initial dose of Otezla is started gradually to help minimize stomach side effects like diarrhea and nausea.
  • Weight loss and depression are other significant side effects for this drug.
References
  • Otezla [package insert]. Thousands Oak, CA: Amgen, 2020. https://www.pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/otezla/otezla_pi_english.ashx
  • Purple Book: Database of Licensed Biological Products. US Food and Drug Administration (FDA). April 25, 2020. https://purplebooksearch.fda.gov/

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