Otezla (Apremilast) – Oral

What Is Otezla?

Otezla (apremilast) is a prescription medication used to treat psoriasis, psoriatic arthritis, and oral ulcers caused by an autoimmune condition called Behcet’s disease. It belongs to a group of drugs called phosphodiesterase-4 (PDE4) inhibitors.

Inflammation is a part of many diseases, including psoriasis and psoriatic arthritis. When the immune system gets activated in a certain way, the affected area might attract immune cells and become red and swollen. In psoriasis, for example, inflammation is part of what causes itchy, flaking, and painful skin.

An enzyme called PDE4 is active in many immune cells, and it promotes inflammation. However, Otezla blocks the action of PDE4. Because of this, it decreases inflammation and symptoms.

What Is Otezla Used For?

The Food and Drug Administration (FDA) approved Otezla to treat:

• Psoriatic arthritis in adults with active disease
• Moderate to severe psoriasis
• Oral ulcers associated with Behcet’s disease in adults

Otezla isn’t the first treatment choice for psoriasis. It is typically only used in people with moderate or severe symptoms.

It might be an appropriate choice if you are already using treatments applied to your skin (topical). If your healthcare provider thinks you also need a treatment that targets the entire body (systemic therapy), Otezla might be a good option. It could also be an alternative to phototherapy (light therapy).

How to Take Otezla

Otezla is usually taken twice a day. Try to take it at roughly the same time each day to help you remember. You can take it with or without food.

When you first start taking it, your healthcare provider may have you start at a lower dose. Gradually increasing the amount you take can help reduce the risk of stomach upset. Do not crush or split the pill. If you have trouble swallowing pills, talk to your provider about a different treatment option. 

Take Otezla every day, exactly as prescribed. Unlike some other treatments, it is not meant to be taken just in response to a disease flare, or flare-up, when symptoms worsen. Keep taking it even if your symptoms are under control. Do not stop taking it suddenly without talking to your provider. This might make it more likely that your disease will flare up.

Storage

Store Otezla at room temperature (below 86 degrees Fahrenheit), safely away from small children.

Off-Label Uses

Apremilast works to reduce inflammation in the body. Because inflammation is a part of many different medical conditions, healthcare professionals have prescribed it for diseases not indicated on the FDA label. This is known as off-label use.

Off-label use means the drug hasn’t gone through a full set of clinical studies needed to get FDA approval for a particular condition. However, some evidence indicates that it may improve symptoms. It can be especially helpful to use drugs off-label if beneficial treatment options are unavailable for a specific condition.

Off-label uses of Otezla include:

• Inflammatory bowel disease (IBD, Crohn's disease and ulcerative colitis)
• Atopic dermatitis (eczema)

What Are the Side Effects of Otezla?

Many people don’t notice any side effects from Otezla. Still, it’s good to have an idea of what might happen.

This is not a complete list of side effects, and others may occur. A medical professional can advise you on side effects. If you experience other effects, contact your pharmacist or a medical professional. You may report side effects to the FDA at www.fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

The most common potential side effects from Otezla are: 

• Diarrhea
• Headache
• Nausea and vomiting
• Upper respiratory tract infection
  

Severe Side Effects

Some symptoms associated with Otezla can be severe, including:

• Depression, suicidal thinking, or decreased mood
• Hypersensitivity reactions, including angioedema (swelling under the skin) and anaphylaxis (potentially life-threatening allergic reaction)
• Severe diarrhea
• Severe nausea and vomiting
• Unexpected weight loss, significant weight loss, and loss of appetite

If you experience any signs or symptoms of hypersensitivity reactions during treatment, stop taking Otezla and seek medical care.

People can experience severe symptoms from diarrhea or vomiting. This might cause your blood pressure to get too low. If these symptoms persist, call your healthcare provider immediately.

Depression is another potentially severe effect of the drug. Some people might even have thoughts about suicide. This risk is greater in people who’ve experienced it in the past. Be sure to look for such potential symptoms, like decreased mood, if you or someone you love starts taking Otezla. Talk to your provider right away if you notice any changes like this.

In some people, Otezla seems to cause unexpected weight loss. While this isn’t a problem for many people, it could be an issue for some. Your provider will probably want to keep track of your weight while you take the drug.

Symptoms tend to go away once you stop taking the drug.

Dosage: How Much of Otezla Should I Take?

Missed Dose

If you miss a dose, take it as soon as you remember. Do not double up on doses if it is very close to the time for your next dose.

Because the drug acts over the long term, you probably won’t notice anything if you skip a dose. However, you should take your medication exactly as prescribed to you for the best results.

Overdose: What Happens If I Take Too Much Otezla?

Overdose symptoms might include severe stomach upset and nausea or vomiting. Even if you’ve just taken a few more pills than intended, it’s wise to check in with a health professional.

Precautions

What Are Reasons I Shouldn’t Take Otezla?

Having certain medical conditions can put you at an increased risk for side effects with Otezla. You may either need an alternative treatment option or a dosage adjustment.

If you have severe kidney disease, your provider may adjust your dose of Otezla or prescribe you a different medication.

Additionally, people who have ever had depression or related problems might be better off with another option.

Little is known about Otezla’s use in pregnancy. So, if you are pregnant or thinking of becoming pregnant, weigh the risks with your provider. Similarly, talk to your provider if you are breastfeeding.

You should not take Otezla if you know you are allergic to it.

What Other Medications Interact with Otezla?

Some drugs might not work as effectively while you are taking Otezla. For example, certain medications used to treat tuberculosis or medications that prevent seizures (antiepileptic drugs) may not work as well.

Drugs that may interact with Otezla include:

• Rifadin (rifampin)
• Solfoton (phenobarbital)
• Tegretol (carbamazepine)
• Dilantin (phenytoin)

Depending on the context, you might need to use another therapy instead of Otezla. Or, your provider might need to adjust the dose of your other medications.

Tell your provider about all the drugs you take, including prescription medications, over-the-counter aids, and herbal products.

What Medications Are Similar?

Otezla is currently the only approved drug in its class to treat psoriasis and psoriatic arthritis.

However, if you need a treatment like Otezla, other options exist. Otezla belongs to a group of therapies called “biologics.” Unlike pharmaceutical drugs, biologics are made from a living source.

Biologic treatments like Otezla are sometimes called disease-modifying treatments because they work directly on inflammation to help decrease your symptoms long term. Different types block slightly different parts of your immune system.

FDA-approved biologics for the treatment of both psoriasis and psoriatic arthritis include:

• TNF inhibitors, like Remicade (infliximab)
• Interleukin-17 (IL-17) inhibitors, like Cosentyx (secukinumab)
• Interleukin-12/interleukin-23 (IL-12/IL-23) inhibitors, like Stelara (ustekinumab)
• IL-23 inhibitors, like Tremfya (guselkumab)

However, a main advantage of Otezla is that you can take it as a pill. Other biologics must be taken as an injection or an infusion into your veins.

Unfortunately, these biologic therapies are usually pretty expensive. You might be able to take less expensive non-biologic therapy, such as the drug methotrexate, instead.

Your healthcare provider might prescribe Otezla by itself. In other cases, they might recommend you take it along with one of these other treatments. Ask your provider about your options.

How Can I Stay Healthy While Taking Otezla?

Otezla is a relatively safe therapy, one that can reduce challenging symptoms in many people. An uncommon but significant potential side effect is depression. If you are someone who is prone to depression, consider another therapy or make sure that you know what signs to look out for. Reach out promptly to your healthcare team if you notice any changes to your overall mental health.