A side effect is usually regarded as an undesirable secondary effect that occurs in addition to the desired therapeutic effect of a drug or medication. Side effects may vary for each individual depending on the person’s disease state, age, weight, gender, ethnicity, and general health.
Side effects can occur when commencing, decreasing/increasing dosages, or ending a drug or medication regimen. Side effects may also lead to non-compliance with prescribed treatment. When side effects of a drug or medication are severe, the dosage may be adjusted or a second medication may be prescribed. Lifestyle or dietary changes may also help to minimize side effects.
What is Otezla?
Otezla is the first FDA-approved pill recommended for the treatment of mild, moderate, and severe plaque psoriasis. It contains the active ingredient apremilast, a prescription medicine used to treat adult patients with:
- Plaque psoriasis for whom phototherapy or systemic therapy is appropriate.
- Active psoriatic arthritis.
- Oral ulcers associated with Behçet’s Disease.
Otezla comes as tablets you take by mouth. It’s available as 10-mg, 20-mg, and 30-mg tablets.
Otezla is manufactured by Amgen Inc, located in Thousand Oaks, California. Otezla is expensive because it is a brand-name drug. The lower-cost generic option called apremilast was approved by the FDA in February 2021, but it is not yet on the U.S. market, possibly due to ongoing patent protection.
How Otezla works
Apremilast, the active ingredient in Otezla belongs to a class of medications called disease-modifying antirheumatic drugs (DMARDs). A medication class describes a group of drugs that work in the same way. 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% of people after 16 weeks. And about 30% of people have clearer skin and fewer plaques after 16 weeks.
Research has also shown that for people with psoriatic arthritis, Otezla improved symptoms by 20% in about 30% to 40% of people who took it.
And in people with Behçet’s disease, research has shown that Otezla completely cleared mouth ulcers in:
- about 53% of people after 12 weeks
- about 30% of people after 6 weeks of treatment; in these people, their mouth ulcers stayed completely clear for another 6 weeks
Who should not take Otezla?
You must not take Otezla if you are allergic to apremilast or to any of the ingredients in Otezla.
How is Otezla taken
Otezla is available as an oral tablet. The standard recommended dosage is 30 mg twice per day, but treatment is usually started with low doses to reduce the risk of side effects.
- Tablets: 10 mg, 20 mg, 30 mg
People who are beginning treatment will be started on low doses, which are gradually increased (titrated) each day to reach the recommended dose. The dose is titrated over the first five days to reduce the risk of gastrointestinal side effects, like diarrhea and nausea. Otezla is available as a 14-day or 28-day starter pack to make it easy to start treatment. Follow the instructions as indicated on the starter pack.
- 14-day starter pack: This starter pack contains four 10 mg tablets, four 20 mg tablets, and five 30 mg tablets for the first week. It also comes with an additional supply of 30 mg tablets for the second week of treatment.
- 28-day starter pack: This starter pack contains four 10 mg tablets, four 20 mg tablets, and five 30 mg tablets for the first week. The pack comes with an additional supply of 30 mg tablets for the second, third, and fourth week of treatment.
Otezla dosage for adults
Otezla is FDA-approved to treat plaque psoriasis, active psoriatic arthritis, and oral ulcers associated with Behcet’s disease. Healthcare providers may, however, prescribe Otezla off-label for various autoimmune skin diseases, such as atopic dermatitis.
No matter what condition is being treated, the initial dose of Otezla is usually 10 mg for the first day. This daily dose will be increased by 10 mg each day until the final recommended dose of 30 mg twice per day is reached. The initial dosage schedule is as follows:
- Day 1: 10 mg taken once in the morning
- Day 2: 10 mg taken once in the morning and once in the evening
- Day 3: 10 mg taken once in the morning and 20 mg taken once in the evening
- Day 4: 20 mg taken once in the morning and once in the evening
- Day 5: 20 mg taken once in the morning and 30 mg taken once in the evening
- Day 6: 30 mg taken once in the morning and once in the evening
To make this easier, people starting Otezla may be prescribed either a 14-day or 28-day starter pack with four 10 mg tablets, four 20 mg tablets, and the remainder will be 30 mg tablets. All the pills in the starter blister packs will be organized by the day on which they need to be taken.
Otezla side effects
Otezla can cause allergic reactions, sometimes severe. Stop using Otezla and call your healthcare provider or seek emergency help right away if you develop any of the following symptoms of a serious allergic reaction: trouble breathing or swallowing, raised bumps (hives), rash or itching, swelling of the face, lips, tongue, throat or arms.
Common side effects of Otezla include:
- Severe Diarrhea
- Vomiting especially within the first few weeks of treatment.
- Upper respiratory tract infection
- Tension headache, and headache.
Use in elderly patients and the use of certain medications with Otezla appears to increase the risk of complications from having severe diarrhea, nausea, or vomiting. Tell your doctor if any of these conditions occur.
Otezla is associated with an increase in depression. In clinical studies, some patients reported depression, or suicidal behavior while taking Otezla. Some patients stopped taking Otezla due to depression. Before starting Otezla, tell your doctor if you have had feelings of depression, or suicidal thoughts or behavior. Be sure to tell your doctor if any of these symptoms or other mood changes develop or worsen during treatment with Otezla.
Some patients taking Otezla lost body weight. Your doctor should monitor your weight regularly. If unexplained or significant weight loss occurs, your doctor will decide if you should continue taking Otezla.
Some medicines may make Otezla less effective and should not be taken with Otezla. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines.
These are not all the possible side effects of Otezla. Ask your doctor about other potential side effects. Tell your doctor about any side effect that bothers you or does not go away.
Tell your doctor if you are pregnant, planning to become pregnant, or planning to breastfeed.
You are encouraged to report the negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-332-1088.
Do Otezla’s side effects include cancer?
Yes, a review of Otezla side effects from studies indicates that there is an increased risk of cancer especially when Otezla is used in the long-term given the immunosuppressive action of apremilast the active ingredient in the drug.
What are Otezla side effects with alcohol?
Taking Otezla and alcohol can affect the way the medication works and increase the risk of unwanted side effects. Taking Otezla and alcohol can also lead to nausea, vomiting, diarrhea, and indigestion. However, Otezla does not usually cause fatigue.
What are Otezla’s long-term side effects?
Cancer is one of the major long term-term side effects of Otezla according to studies, even though Otezla is considered safe for prolonged use. Other people may also experience unwanted or severe side effects, and they may want to stop taking the drug or switch to a different treatment.
What to do when Otezla is not working for you?
Sometimes, when people say their medication isn’t working, what they mean is that they have side effects they can’t tolerate. If the problem is side effects, then you definitely need to change treatments, perhaps to a more tolerable drug.
There are many other signals that it may be time to switch your psoriasis treatment. Maybe the treatment doesn’t work from the beginning, or it stops working after a period of successful use. Maybe there are safety concerns about toxicity.
There may be side effects that are more uncomfortable than you want to deal with or maybe you just don’t like some aspect of the treatment.
There’s no single set of symptoms that say it’s time to switch and no general timetable for when to switch from Otezla to other drugs.
Each therapy differs in:
- safety concerns
- how long it takes to work
- when it might stop working
Every person is different, too. For reasons medical researchers don’t entirely understand, the same medication can affect different people differently.
This explains why some treatments may not work for you. If you’ve administered Otezla regularly and given it enough time to work, and you still don’t see improvement, it may be time for a change.
Research published in the Journal of Drugs in Dermatology in 2018 points out that some cases of psoriasis can remain stable for years. In other cases, the condition can advance quickly to involve organs, including the heart, liver, kidney, and intestines, as well as joints and muscles.
If your psoriasis advances despite treatment with Otezla, the drug may have become less effective. At that point, you’ll want to talk to your doctor or healthcare provider about alternative treatments.