- Otezla (apremilast) is a prescription medicine approved for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate.
- Otezla is a prescription medicine approved for the treatment of adult patients with active psoriatic arthritis.
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 side effects
- Otezla can cause mild or serious side effects.
The more common side effects of Otezla include:
- respiratory infection
- stomach pain
- decreased appetite
- weight loss
- back pain
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.
- severe diarrhea, nausea, or vomiting
- suicidal thoughts
- 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.
- 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.
- 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.
- 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 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 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 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)
- 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
- 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:
Morning: 10 mg
Morning: 10 mg
Evening: 10 mg
Morning: 10 mg
Evening: 20 mg
Morning: 20 mg
Evening: 20 mg
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.
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.
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.
- 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, 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.
- 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.
- Several types of drugs can be used to treat psoriasis and psoriatic arthritis, the conditions that Otezla is approved to treat.
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
- 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.
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.
- 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.
- Taking too much of this medication can increase your risk of serious side effects.
Symptoms of an overdose of Otezla may include:
- severe diarrhea, nausea, and vomiting
What to do in case of overdose
If you think you or your child has taken too much of this drug, call your doctor. But if your symptoms are severe, call 999 or go to the nearest emergency room right away.
- 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.
- 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.