Is Otezla a biologic? What is Otezla used for?

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 skin 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 recurring ulcers in the mouth, on the genitals, and inflammation in the eye. It can lead to arthritis, skin lesions, bowel disease, blindness, stroke and inflammation in the brain and spinal cord.

How do I use Otezla?

Otezla is approved to treat plaque psoriasis in adults and children 6 years of age and older (and weighing at least 20 kg), adults with psoriatic arthritis, and adults with oral ulcers associated with Behçet’s disease.

Your doctor will slowly increase your dose of Otezla over the first 5 days when you start treatment will help to reduce the gastrointestinal (stomach) symptoms, such as diarrhea, nausea, vomiting and stomach pain.

In adults, the oral dose will start at 10 mg per day and increase over 5 days to the recommended maintenance dose of 30 mg orally twice daily (in the morning and evening) starting on Day 6.

In children 6 years of age and older (and weighing at least 20 kg [44 pounds]) being treated for plaque psoriasis, the dosage is based on their weight.

• For children weighing at least 50 kg (110 pounds), the oral dose will start at 10 mg per day and increase over the next 5 days to the recommended maintenance dose of 30 mg orally twice daily (in the morning and evening) starting on Day 6.
• For children weighing 20 kg to less than 50 kg (44 to 110 pounds), the oral dose will start at 10 mg per day and increase over the next 5 days to the recommended maintenance dose of 20 mg orally twice daily (in the morning and evening) starting on Day 6.

Your healthcare provider will inform you of the exact titration schedule over the first 5 days to reach your maintenance dose.

In patients with serious kidney impairment, a dose reduction may be needed. Let your doctor know if you have kidney problems or disease.

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Side effects

Most stomach side effects, like diarrhea, nausea and vomiting and stomach pain, occur within the first weeks of starting Otezla treatment when they occur. 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.

Other serious side effects may include severe allergic reactions.

Have your pharmacist or doctor review for Otezla drug interactions, as some “CYP inducers” medications that increase the action of CYP450 3A4 enzymes may lower the effectiveness of Otezla. Use of Otezla with these types of drugs is not recommended, and include carbamazepine, phenobarbital, phenytoin and rifampin.

Tell your doctor and pharmacist about all of the medicines you take, including prescription, over-the-counter, vitamins and herbal or dietary supplements.

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.
• In patients with serious kidney impairment, a dose reduction may be needed. Let your doctor know if you have kidney disease before you start treatment.