What to Know About Otezla (Apremilast)

This oral drug is used to treat psoriasis and psoriatic arthritis

In This Article

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 in adults, Otezla is taken twice daily with or without food. Otezla works by selectively inhibiting inflammatory compounds that contribute to the recurrence of psoriatic disease symptoms.

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

How It Works

Otezla is a selective inhibitor of an enzyme known as phosphodiesterase-4 (PDE4). PDE4 is used by the body to make tumor necrosis factor (TNF), the substance that incites inflammation in tissues. By blocking the PDE4 enzyme, TNF levels are decreased and, with them, the inflammation that triggers symptoms.

Otezla is quickly absorbed in the gut and reaches peak concentration in the blood within two to three hours. Otezla has a relatively short drug half-life (six to eight hours), meaning that it needs to be taken twice daily without fail to ensure that drug concentration remains steady.

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 use in adults with moderate to severe psoriasis for whom 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 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" in which you slowly increase the dose each day to achieve the optimal drug concentration. Doing so reduces the risk of gastrointestinal side effects. Thereafter, you 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 (in which your kidneys are less able to clear the drug from your body), the dosage will 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 OK.

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 are far more concerning. In some cases, the symptoms may be serious enough to require a treatment change. 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.
  • 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 stopped should the weight loss become extreme.

Contraindications

The only absolute contraindication to Otezla is a 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 in 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 relative 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 need the same enzyme to be metabolized and dispersed. If Otezla is taken with some of these drugs, they may "compete" for the same enzyme. If this happens, the concentration of one or both drugs may be affected.

In some cases, the interaction can slow metabolization, leading to the accumulation of the drug and toxic side effects. In others, it can speed metabolization, 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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