What is Otezla?

Otezla (apremilast) is a brand-name prescription medication. It comes as a tablet you take by mouth. Otezla is used to treat plaque psoriasis and psoriatic arthritis, a form of arthritis that can occur in people with psoriasis.

Otezla belongs to a class of medications called disease-modifying antirheumatic drugs (DMARDs). Drugs in this class can slow down or stop certain conditions that are caused by an overactive immune system.

In people with plaque psoriasis, research has shown Otezla to completely or nearly completely clear plaques in about 20 percent of people. About 30 percent of people have clearer skin and fewer plaques.

Research has also shown that for people with psoriatic arthritis, Otezla improved symptoms by 20 percent in about 30–40 percent of people who took it.

Otezla generic

Otezla contains the drug apremilast.

Apremilast isn’t available as a generic drug. It’s only available as Otezla.

Otezla side effects

Otezla can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Otezla. This list doesn’t include all possible side effects.

For more information on the possible side effects of Otezla, or for tips on how to deal with a troubling side effect, talk with your doctor or pharmacist.

More common side effects

The more common side effects of Otezla include:

Most of these effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

Suicide prevention

  • If you know someone at immediate risk of self-harm, suicide, or hurting another person:
  • Call 911 or the local emergency number.
  • Stay with the person until professional help arrives.
  • Remove any weapons, medications, or other potentially harmful objects.
  • Listen to the person without judgment.
  • If you or someone you know is having thoughts of suicide, a prevention hotline can help. The National Suicide Prevention Lifeline is available 24 hours a day at 1-800-273-8255.

Weight loss

Loss of appetite and weight loss are common side effects of Otezla. They can occur in 10–12 percent of people who take it. The loss of 5–10 percent of body weight is most common, but some people have had weight loss of over 10 percent of their body weight.

If you experience severe weight loss while taking Otezla, talk to your doctor. They may recommend that you stop taking this drug.

Cancer

People who have psoriasis have a slightly increased risk of certain types of cancer. There’s also a concern that some of the medications used for treating psoriasis might increase the risk of some types of cancer.

Clinical studies on apremilast, the drug contained in Otezla, so far show that it doesn’t increase the risk of cancer in people who have psoriasis.

Headaches

Headache is a common side effect reported by people who take Otezla. It occurs in up to 6 percent of people who take it.

In most cases, people experience a milder tension-type headache. About 2 percent of people may experience a migraine headache, which is more severe.

These side effects usually go away with continued use of Otezla. If they don’t go away or become bothersome, talk with your doctor.

Depression

Although not common, depressed mood can occur in some people who take Otezla. Less than 2 percent of people experience this side effect, and less than 1 percent experience serious or more severe depression. Suicidal thoughts or behaviors occur in less than 1 percent of people taking Otezla.

Depression in people taking Otezla might be more likely for those who have had depression in the past.

If you experience mood changes or depressed mood while taking Otezla, be sure to talk with your doctor.

Diarrhea

Diarrhea commonly occurs in people who take Otezla, affecting up to 17 percent of people taking the drug. Most of the time, the diarrhea isn’t severe and usually goes away with continued use of the drug.

However, severe diarrhea has occurred in some people taking Otezla, and in some cases, it can lead to dehydration and electrolyte imbalances.

If your diarrhea doesn’t go away or you have severe diarrhea while taking Otezla, talk with your doctor. They may lower your dosage or have you stop taking the drug.

Nausea

Nausea is a common side effect of Otezla. It occurs in up to 17 percent of people who take the drug. In most cases, the nausea isn’t severe and usually goes away with continued use of the drug.

However, in some cases, it can be severe and may include vomiting. Severe nausea and vomiting can lead to dehydration and electrolyte imbalances.

If your nausea doesn’t go away or you have severe nausea or vomiting while taking Otezla, talk with your doctor. Your doctor may lower your dosage, or have you stop taking Otezla.

Otezla and alcohol

Drinking alcohol while taking Otezla might add to or worsen some side effects from Otezla, especially if you drink too much.

Worsened side effects can include diarrhea, nausea, vomiting, headache, and fatigue.

Otezla interactions

Otezla can interact with several medications. It can also interact with certain supplements.

Otezla and other medications

Below is a list of medications that can interact with Otezla. This list doesn’t contain all drugs that may interact with Otezla.

Different drug interactions can cause different effects. For instance, some can interfere with how well a drug works, while others can cause increased side effects.

Before taking Otezla, be sure to tell your doctor and pharmacist about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Drug metabolism inducers

Several medications can make an enzyme called cytochrome P450 3A4 more active in your body. Taking these drugs with Otezla can cause your body to get rid of Otezla more quickly. It can also make Otezla less effective.

Examples of these medications include:

  • carbamazepine (Carbatrol, Epitol, Equetro, Tegretol)
  • phenobarbital
  • phenytoin (Dilantin, Phenytek)
  • primidone (Mysoline)
  • rifampin (Rifadin)

Herbs and supplements

Herbs and supplements can sometimes interact with medications.

St. John’s wort

St. John’s wort can make an enzyme called cytochrome P450 3A4 more active in your body. Because of this, taking St. John’s wort with Otezla can cause your body to get rid of Otezla more quickly. This can make Otezla less effective.

Dosage for Otezla

When you start taking Otezla, your doctor will gradually increase your dosage until you reach the standard dose. Your doctor may follow a specific schedule recommended by the drug manufacturer.

The following information describes the dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you.

Forms and strengths

  • Oral tablet:
    • 10 mg
    • 20 mg
    • 30 mg

Dosage for psoriatic arthritis and plaque psoriasis

When you first start taking Otezla, your doctor will likely increase your dosage gradually over a 5-day schedule, as follows:

  • Day 1:
    • Morning: 10 mg
  • Day 2:
    • Morning: 10 mg
    • Evening: 10 mg
  • Day 3:
    • Morning: 10 mg
    • Evening: 20 mg
  • Day 4:
    • Morning: 20 mg
    • Evening: 20 mg
  • Day 5:
    • Morning: 20 mg
    • Evening: 30 mg

On day 6 and later, the typical dosage is 30 mg twice daily, given in the morning and evening.

Dosage considerations

If you have kidney disease, your doctor may prescribe a different dosage. During the five-day starting period, you may only take the morning doses and skip the evening dose. On day 6 and after, your dosage would then be 30 mg once daily.

Your doctor may also prescribe a lower dosage if you’ve experienced troubling side effects such as serious diarrhea, nausea, or vomiting.

What if I miss a dose?

If you miss a dose, take it as soon as you remember. If it’s almost time for your next dose, just take that one dose. Don’t try to catch up by taking two doses at once.

Uses for Otezla

The Food and Drug Administration (FDA) approves prescription drugs such as Otezla to treat certain conditions.

Approved uses

Otezla is FDA-approved to treat two conditions: plaque psoriasis and psoriatic arthritis.

For these conditions, Otezla is often used in combination with other medications such as methotrexate (Otrexup, Rasuvo, Trexall), sulfasalazine (Azulfidine), leflunomide (Arava), or others.

Otezla and plaque psoriasis

Otezla is approved to treat moderate to severe plaque psoriasis — the most common form of psoriasis — in adults.

In clinical studies, about 30 percent of people taking Otezla had clearer skin and fewer plaques. For about 20 percent of people, their plaques cleared completely or almost completely.

Otezla and psoriatic arthritis

Otezla is approved for treating active psoriatic arthritis in adults.

In clinical studies, Otezla improved symptoms of this condition by 20 percent in about 30–40 percent of people who took it.

Unapproved uses

Otezla isn’t approved to treat other conditions, even if they’re similar to plaque psoriasis or psoriatic arthritis.

Other forms of psoriasis

There are several forms of psoriasis, but Otezla is only approved to treat plaque psoriasis.

However, Otezla is used off-label for adults with guttate psoriasis, nail psoriasis, palmoplantar psoriasis, pustular psoriasis, and scalp psoriasis. It’s not recommended for off-label use in treating erythrodermic psoriasis.

Eczema/Atopic dermatitis

Eczema, which is also known as atopic dermatitis, can result in long-lasting or recurring rashes on the face, head, or arms and legs.

In 2012, one small study evaluated Otezla for treating adults with eczema and found that it reduced itching and the severity of eczema. However, Otezla isn’t currently recommended by the American Academy of Dermatology for treating eczema.

Rheumatoid arthritis

Otezla isn’t currently recommended by the American College of Rheumatology for the treatment of rheumatoid arthritis (RA).

One clinical study evaluated Otezla in people with RA who didn’t respond adequately to treatment with methotrexate. Otezla didn’t improve symptoms any better than taking a placebo pill.

How to take Otezla

Otezla is typically taken twice daily: once in the morning and once in the evening. For some people, such as those with kidney problems, it may be taken just once per day, in the morning.

Otezla can be taken on an empty stomach or with food.

Otezla tablets should be swallowed whole. They shouldn’t be crushed, split, or chewed.

Alternatives

Several types of drugs can be used to treat psoriasis and psoriatic arthritis, the conditions that Otezla is approved to treat.

Other DMARDs

Otezla belongs to a class of medications called disease-modifying antirheumatic drugs (DMARDs). Other DMARDs that may be used to treat psoriasis or psoriatic arthritis include:

  • leflunomide (Arava)
  • methotrexate (Otrexup, Rasuvo, Trexall)
  • sulfasalazine (Azulfidine)

Medications from other drug classes

Medications in other drug classes may also be used as alternatives to Otezla. Examples of these drugs include:

  • Retinoids such as:
    • acitretin (Soriatane)
    • isotretinoin (Absorica, Amnesteem, Claravis, others)
  • Immunosuppressants such as:
    • azathioprine (Azasan, Imuran)
    • cyclosporine (Gengraf, Neoral, Sandimmune)
  • Biologics such as:
    • abatacept (Orencia)
    • adalimumab (Humira)
    • brodalumab (Siliq)
    • certolizumab (Cimzia)
    • golimumab (Simponi, Simponi Aria)
    • guselkumab (Tremfya)
    • etanercept (Enbrel)
    • infliximab (Inflectra, Remicade, Renflexis)
    • ixekizumab (Taltz)
    • secukinumab (Cosentyx)
    • ustekinumab (Stelara)

Herbs and supplements

Some people also use herbs and dietary supplements in an effort to treat psoriasis or psoriatic arthritis. Examples of these supplements include:

  • aloe cream
  • fish oil
  • saffron
  • St. John’s wort ointment

Be sure to talk with your doctor before trying any herb or dietary supplement for treating psoriasis or psoriatic arthritis. For most of these supplements, either there is very little research showing that they work, or research findings are inconsistent.

Otezla vs. Humira

You may wonder how certain drugs, such as Humira, compare to Otezla.

Otezla and Humira (adalimumab) belong to different classes of medication. Otezla is a disease-modifying antirheumatic drug (DMARD). Humira, on the other hand, is a biologic therapy that’s in a class of drugs called tumor necrosis factor-alpha (TNF-alpha) inhibitors.

Use

Both Otezla and Humira are FDA-approved for treating psoriasis and psoriatic arthritis. However, Humira is also FDA-approved to treat many other conditions, including rheumatoid arthritis, Crohn’s disease, ulcerative colitis, and others.

Both medications can be taken by themselves or along with other medications.

Forms and administration

Otezla is available as a tablet that’s taken by mouth twice daily. Humira is a self-administered injection that’s given every other week.

Effectiveness

Both Otezla and Humira are effective for treating psoriasis and psoriatic arthritis. While they haven’t been directly compared in clinical studies, one analysis of clinical research found that Humira may be more effective in treating psoriatic arthritis than Otezla.

Another analysis found that, in general, TNF-alpha inhibitors such as Humira may be more effective in treating psoriasis than DMARDs such as Otezla.

When comparing drugs, keep in mind that your doctor will make treatment recommendations based on your individual needs. They’ll consider several factors, such as your age, gender, childbearing potential, other conditions you may have, your risk of side effects, and how severe your condition is.

Side effects and risks

Otezla and Humira have some similar side effects, and some that differ. Below are examples of these side effects.

Costs

Otezla and Humira are both available only as brand-name drugs. They don’t have generic forms, which are typically less expensive than brand-name versions.

Humira usually costs more than Otezla. The actual amount you pay will depend on your insurance plan.

Otezla vs. Stelara

You may wonder how certain drugs, such as Stelara (ustekinumab), compare to Otezla.

Otezla and Stelara belong to different classes of medication. Otezla is a disease-modifying antirheumatic drug (DMARD). Stelara is a biologic therapy that’s in a class of drugs called interleukin inhibitors.

Use

Both Otezla and Stelara are FDA-approved to treat psoriasis and psoriatic arthritis. Stelara is also FDA-approved to treat Crohn’s disease.

Both medications can be taken by themselves or along with other medications.

Forms and administration

Otezla is available as a tablet that’s taken by mouth twice daily. Stelara is a self-administered injection that’s taken once every 12 weeks.

Effectiveness

Both Otezla and Stelara are effective for treating psoriasis and psoriatic arthritis. These drugs haven’t been directly compared in clinical studies.

In separate clinical studies in people with psoriasis, about 20 percent of people taking Otezla had their skin become completely clear or almost completely clear. In people receiving Stelara, about 60–75 percent had those effects.

In other studies, Otezla improved symptoms of psoriatic arthritis by 20 percent in about 30–40 percent of people who took it. In people receiving Stelara, about 40–50 percent of people had a 20 percent improvement in symptoms.

When comparing drugs, keep in mind that your doctor will make treatment choices based on your individual needs. They’ll consider several factors, such as your age, gender, childbearing potential, other conditions you may have, your risk of side effects, and how severe your condition is.

Side effects and risks

Otezla and Stelara have some similar side effects, and some that differ. Below are examples of these side effects.

Both Otezla and Stelara Otezla Stelara
More common side effects
  • respiratory infection
  • headache
  • fatigue
  • diarrhea
  • back pain
  • nausea
  • stomach pain
  • decreased appetite
  • weight loss
  • dizziness
  • itchiness
  • throat pain
Serious side effects
  • severe diarrhea
  • severe nausea and vomiting
  • depression
  • suicidal thoughts
  • serious infection
  • cancer

Costs

Otezla and Stelara are both only available as brand-name drugs. They don’t have generic forms, which are typically less expensive than brand-name versions.

Stelara costs much more than Otezla. The actual amount you pay will depend on your insurance plan.

Otezla vs. biologics

Otezla and biologic therapies can both be used to treat psoriasis and psoriatic arthritis.

Here are some points to consider when comparing Otezla to biologic drugs:

  • Otezla hasn’t been directly compared to biologic therapy in clinical studies.
  • In some cases, biologic therapy appears to be somewhat more effective than Otezla.
  • In some cases, biologic therapy may have more risks in terms of potentially serious side effects.
  • Biologic drugs are often more expensive than Otezla.
  • Otezla is a tablet that you take by mouth. Biologic therapies are all given by injection.

Keep in mind that your doctor will make treatment choices based on your individual needs. They’ll consider several factors, such as your age, gender, childbearing potential, other conditions you may have, your risk of side effects, and how severe your condition is.

There are many different types of biologic therapies. Examples of these drugs include:

  • Tumor necrosis factor-alpha inhibitors such as:
    • certolizumab (Cimzia)
    • etanercept (Enbrel)
    • adalimumab (Humira)
    • infliximab (Inflectra, Remicade, Renflexis)
    • golimumab (Simponi, Simponi Aria)
  • Interleukin 12 and 23 inhibitors such as:
    • ustekinumab (Stelara)
  • Interleukin 17 inhibitors such as:
    • brodalumab (Siliq)
    • secukinumab (Cosentyx)
    • ixekizumab (Taltz)
  • Interleukin 23 inhibitors such as:
    • guselkumab (Tremfya)
  • T-cell inhibitors such as:
    • abatacept (Orencia)

Biologics are medications that can be made from sugars, proteins, or nucleic acids, or from microorganisms, tissues, or cells. Drugs are usually made from chemicals or plants.

Common questions

Here are answers to some frequently asked questions about Otezla.

Is Otezla an anti-inflammatory drug?

No, Otezla isn’t classified as an anti-inflammatory drug. Although it does reduce inflammation, it doesn’t belong to the class of drugs called anti-inflammatories.

Is Otezla an immunosuppressant?

Yes, Otezla is an immunosuppressant. It reduces inflammation caused by an overactive immune system.

Is Otezla a biologic?

No, Otezla isn’t a biologic.

How does Otezla cause weight loss?

Many people who take Otezla lose weight. There may be several factors that lead to Otezla-related weight loss.

Otezla blocks an enzyme called phosphodiesterase-4 (PDE4). In addition to its effects on inflammation, this enzyme is involved in energy metabolism. In animals, blocking this enzyme caused them to be leaner, with smaller fat cells. The same effect may apply in humans.

Also, some people who take Otezla may have a reduced appetite or diarrhea as side effects. These effects might also cause weight loss.

Does Otezla cause hair loss?

Hair loss isn’t a side effect that’s been found in clinical studies of Otezla. However, some people have experienced hair loss while taking Otezla. It’s not clear if Otezla is the cause.

Psoriasis, especially scalp psoriasis, can cause hair loss.

I’ve always used creams for my psoriasis. How does a pill help treat my psoriasis?

Creams and other medications applied to the skin work by being absorbed through the skin. They reduce inflammation and excessive cell growth in the area around where the medication is applied. These drugs are usually the first medications used for psoriasis.

Pills used for psoriasis work from the inside out. They work throughout the body by blocking the body’s production of chemical messengers that cause inflammation and cell overgrowth on the skin.

I’ve heard that Otezla causes a lot of nausea and vomiting. How can I prevent this?

Yes, many people who take Otezla can have some nausea or vomiting. This is most likely to occur in the first two weeks of taking the medication. For most people, it’s not severe, and it often goes away with continued use of the drug.

To prevent nausea and vomiting, your doctor may need to lower your dosage. If your nausea doesn’t go away or becomes severe, talk with your doctor. If lowering the dose doesn’t help, you may need to stop taking Otezla.

Otezla support

The manufacturer of Otezla offers information and support for people taking Otezla through a special program. This program, called SupportPlus, also provides information on how to reduce costs for the drug.

Learn more at https://www.otezla.com/supportplus.

How Otezla works

Otezla works in a unique way compared to other medications that are used to treat plaque psoriasis or psoriatic arthritis. It blocks an enzyme called phosphodiesterase-4 (PDE4), which is found in immune cells.

By blocking this enzyme, Otezla decreases the body’s production of inflammatory molecules. The actions of these molecules can lead to the symptoms of psoriasis and psoriatic arthritis. Therefore, decreasing their production helps reduce symptoms.

Otezla and pregnancy

There haven’t been enough studies in humans to know if Otezla is safe to use during pregnancy. Studies in animals have shown potential harm to the fetus when the mother is given the drug. However, animal studies don’t always predict the way humans would respond.

If you’re pregnant, talk with your doctor to decide if Otezla is safe for you to take.

Otezla and breastfeeding

There haven’t been enough studies to show whether Otezla appears in breast milk.

Until more is known, it’s best to avoid breastfeeding while taking this drug.

Otezla withdrawal

Stopping Otezla doesn’t cause withdrawal symptoms.

However, you should still talk with your doctor before stopping this medication. If you stop taking it, the symptoms of your condition may return.

Otezla overdose

Taking too much of this medication can increase your risk of serious side effects.

Overdose symptoms

Symptoms of an overdose of Otezla may include:

  • severe diarrhea, nausea, and vomiting
  • headache
  • fatigue
  • dizziness

What to do in case of overdose

If you think you or your child has taken too much of this drug, call your doctor or seek guidance from the American Association of Poison Control Centers at 800-222-1222 or through their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

Overdose treatment

Treatment of an overdose will depend on the symptoms that occur. A doctor may do tests to monitor for side effects. In some cases, they may administer intravenous (IV) fluids.

Otezla expiration

When Otezla is dispensed from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically one year from the date the medication was dispensed.

The purpose of such expiration dates is to guarantee the effectiveness of the medication during this time.

The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. However, an FDA study showed that many medications may still be good beyond the expiration date listed on the bottle.

How long a medication remains good can depend on many factors, including how and where the medication is stored. Otezla should be stored at room temperature in a tightly sealed and light-resistant container.

If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Warnings for Otezla

Before taking Otezla, talk with your doctor about any medical conditions you have. Otezla may not be appropriate for you if you have certain medical conditions. These include:

  • Depression. Depressed mood can occur in some people who take Otezla. Some people experience thoughts of suicide while taking Otezla. Although this isn’t common, it may be more likely in people who have had depression in the past.
  • Kidney problems. If you have kidney problems, you may need to take a lower dosage of Otezla.

Professional information for Otezla

The following information is provided for clinicians and other healthcare professionals.

Mechanism of action

Otezla is classified as an immunosuppressant disease-modifying antirheumatic drug (DMARD). It is an inhibitor of phosphodiesterase-4 (PDE4) specific for cyclic adenosine monophosphate (cAMP).

By inhibiting PDE4, Otezla blocks the degradation of cAMP and increases levels of cAMP intracellularly. This reduces the expression of inflammatory mediators and increases anti-inflammatory mediators.

Pharmacokinetics and metabolism

Otezla has a bioavailability of 73 percent. Peak plasma levels occur in about 2.5 hours after oral ingestion.

Otezla is metabolized by cytochrome P450 3A4 (CYP3A4). Minor metabolic pathways are through CYP1A2 and CYP2A6. Otezla also undergoes metabolism through non-CYP hydrolysis.

The elimination half-life is six to nine hours.

Contraindications

Otezla is contraindicated in people with a known hypersensitivity to apremilast or any component of the tablet.

Storage

Otezla should be stored below 86ºF (30ºC).

Disclaimer: MedicalNewsToday has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.