What to Know About Otezla (Apremilast)

This oral drug is used to treat psoriasis and psoriatic arthritis

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Otezla (apremilast) is an oral drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of psoriasis and psoriatic arthritis. Used only for adults, Otezla is taken twice daily with or without food. Otezla works by selectively inhibiting certain inflammatory compounds that contribute to the recurrence of psoriatic disease symptoms.

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Otezla can cause depression and significant weight loss, both of which may warrant the discontinuation of treatment. Research is ongoing as to whether Otezla can be used to treat other inflammatory diseases.

How It Works

Otezla is a selective inhibitor of phosphodiesterase-4 (PDE4), an enzyme that's used to make tumor necrosis factor (TNF), which promotes tissue inflammation. By blocking the PDE4 enzyme, Otezia reduces TNF levels and decreases the TNF- associated inflammation that's involved in mediating symptoms of psoriasis and psoriatic arthritis.

Otezla is quickly absorbed in the gut and reaches peak concentration in the blood within two to three hours. It has a relatively short drug half-life (six to eight hours), so it needs to be taken twice daily to ensure a steady drug concentration.

The drug is metabolized in the liver and excreted from the body in urine and, to a lesser degree, in feces.

Uses

Otezla is approved for adults for treating moderate to severe psoriasis when topical medications have not provided relief. It is also used in adults with active psoriatic arthritis (a form of arthritis caused by inflammatory effects of psoriasis).

Otezla is not approved for children, and it remains untested in children under 8.

Dosage

Otezla comes in a diamond-shaped, film-coated tablet in three strengths: 10 milligrams (mg), 20 mg, and 30 mg.

Otezla requires a five-day loading dose during which you slowly increase the dose each day to reach the optimal drug concentration. This process reduces the risk of gastrointestinal side effects. Thereafter, you would take a maintenance dose to sustain the concentration.

The dose and dosing schedule is the same for both psoriasis and psoriatic arthritis. As recommended by the manufacturer:

Day Morning Evening
1 10 mg  n/a
2 10 mg  10 mg 
3 10 mg  20 mg
4 20 mg 20 mg
5 20 mg 30 mg
6 and beyond 30 mg 30 mg

You can take Otezla with or without food. Do not crush, split, or chew the pill.

If you miss a dose, take it as soon as you remember. However, if it is close to the time of your next dose, just skip the dose and continue as normal. Never double up the dose.

Special Consideration

If you have severe kidney impairment (with diminished kidney mediated clearance of the drug from your body), your dosage would need to be reduced to prevent drug toxicity. In this instance, your loading dose would be 10 mg for the first three days, and 20 mg for the next two days; thereafter, you would take 30 mg once daily as your maintenance dose.

People with mild to moderate kidney impairment do not require a dose adjustment unless creatinine clearance (CrCl) is less than 30 milliliters per minute (mL/min).

Speak to your doctor about what's right for you and never adjust your prescribed dosage without your physician's guidance.

Side Effects

In clinical trials, side effects associated with Otezla (the first three of which were the most common) were:

  • Diarrhea
  • Headache
  • Nausea
  • Stomachache
  • Sore throat
  • Cough
  • Fever
  • Nasal congestion

Most of the adverse events occurred within the first two weeks of treatment and resolved over time with continued use of the drug.

Uncommon side effects, like depression and weight loss, can be far more severe. In some cases, the symptoms may be serious enough to require a change in treatment. According to premarket research issued by the FDA:

  • Depression and suicidal thoughts were reported in 0.8% of users. Of these, 0.3% stopped treatment as a result of the side effect. As a result, patients with a history of depression, especially if not adequately treated, should consider an alternative medication.
  • Weight loss of 10% to 15% was reported in 10% of users. This is three times the incidence seen in people provided a placebo.

Due to the risk of weight loss, your body weight should be monitored throughout treatment and treatment should be stopped if the weight loss becomes extreme.

Contraindications

The only absolute contraindication to Otezla is known hypersensitivity to apremilast or any of the drug's inactive ingredients. With that being said, drug hypersensitivity was not reported in any of the premarket studies but was identified, albeit rarely, in postmarket research.

While Otezla is not contraindicated for use during pregnancy, it is classified as a Pregnancy Category C drug. This means that animal studies have shown that Otezla may cause fetal harm, though there are no well-controlled studies in humans.

Most of the harm occurred at doses two to four times greater than that used in humans. Miscarriage was the most common pregnancy complication. It is unknown whether Otezla can be transmitted through breastmilk and what harm, if any, that may cause.

Because of the potential harm, Otezla should only be used during pregnancy if the benefits outweigh the risks. Speak with your rheumatologist to obtain all the facts you need to make an informed choice.

Interactions

Otezla relies on a liver enzyme, known as cytochrome P450 (CYP450), for metabolism. Many other drugs are processed by the same enzyme. If Otezla is taken with some of these drugs, they may compete for this enzyme, and the concentration of one or both drugs may be affected.

In some cases, the interaction can slow metabolism, leading to the accumulation of the drug and toxic side effects. In others, it can speed metabolism, reducing the drug concentration, as well as the effectiveness of treatment.

Among some of the drugs and supplements that can interact with Otezla:

Tell your doctor about any and all drugs and supplements you are taking, whether pharmaceutical or over-the-counter, to avoid interactions and unexpected side effects.

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