Otezla
Generic name: apremilast [a-PRE-mi-last]
Dosage form: tablets (10 mg, 20mg, 30mg)
Drug class: Antirheumatics
What is Otezla?
Otezla (apremilast) tablets are used to treat plaque psoriasis to improve scaling, itching, and redness of skin, and it helps improve nail and scalp psoriasis. Otezla tablets are also used for psoriatic arthritis to improve inflammation, joint swelling, and pain, and for Behcet's disease, it helps mouth ulcer symptoms.
Otezla is an oral tablet that reduces inflammation and symptoms by inhibiting an enzyme called PDE4 within inflammatory cells. Otezla mechanism of action is by inhibiting phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP), this increases intracellular cAMP levels which is thought to reduce levels of inflammatory proteins (cytokines). Otezla is not a biologic agent.
Otezla received FDA approval on March 21, 2014, for psoriatic arthritis. Since then, it has also been FDA-approved to treat types of plaque psoriasis and Behcet’s disease in specific patients. It is not available as a generic medicine.
What is Otezla used for?
- Plaque Psoriasis in adult patients with plaque psoriasis who require systemic therapy or light treatment (phototherapy). It can also be used for pediatric patients 6 years of age and older and weighing at least 20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
- Psoriatic Arthritis in adult patients with active psoriatic arthritis.
- Behçet's Disease for Oral Ulcers in adult patients.
Otezla side effects
Common Otezla side effects
Common Otezla side effects may include:
- nausea (8.9%)
- diarrhea (7.7%)
- headache (5.9%)
- cold symptoms such as stuffy nose, sneezing, sore throat (3.9%)
- vomiting( 3.2%) or
- upper abdominal pain (2%).
These were the side effects that occurred for Otezla 30mg twice daily from day 6 to day 112 in the psoriatic arthritis clinical trials (PsA-1, PsA-2, and PsA-3). Side effects that caused patients to stop taking tablets during the trials included nausea (1.8%), diarrhea (1.8%) and headache (1.2%).
Serious Otezla side effects
Get emergency medical help if you have signs of an allergic reaction to this medicine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Otezla may cause other serious side effects. Call your doctor at once if you have:
- severe diarrhea, nausea, and vomiting;
- unexplained weight loss, or if you lose a lot of weight;
- mood changes, new or worsening depression; or
- thoughts of suicide or hurting yourself.
This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Warnings
Depression: Some people have thoughts about suicide while taking this medicine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor. Carefully weigh the risks and benefits of treatment in patients with a history of depression and/or suicidal thoughts or behavior.
Nausea, vomiting, and diarrhea can be a severe complication of Otezla and patients should contact their doctor if this occurs.
Hypersensitivity: Cases of swelling (angioedema) and anaphylaxis have been reported. Do not use this medicine in patients with known hypersensitivity to apremilast or any of the inactive ingredients:
Otezla weight loss: Otezla may cause weight loss. Monitor weight regularly. If clinically significant or unexpected weight loss occurs, evaluate the reason for weight loss and consider stopping this medicine.
Drug interactions: Medications that are strong cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) are not recommended because loss of efficacy may occur. See the Interactions section below.
Otezla copayment card
With the Otezla copay card you may pay as little as $0, if you have private or commercial insurance and meet the criteria. You can enrol in the Otezla copay program using the links on our Otezla Prices, Coupons, Copay Cards & Patient Assistance page.
The cost of prescription drugs varies depending on your insurance plan, if you have insurance, and which pharmacy you use. For more information of cost see “How much does Otezla cost?” which covers prices with or without insurance.
Before taking this medicine
You should not use Otezla if you are allergic to the active ingredient apremilast or any of the inactive ingredients.
To make sure this medicine is safe for you, tell your doctor if you have ever had:
- kidney disease; or
- depression or suicidal thoughts or actions.
Pregnancy:
Otezla may harm an unborn baby. It is important to use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of apremilast on the baby.
Breastfeeding:
It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.
How should I take Otezla?
Otezla tablets should be swallowed whole; do not crush, chew, or break the tablet.
This medicine can be taken with or without food.
The Otezla dose is usually slowly increased over the first week to reduce gastrointestinal symptoms that may occur when this medication is first started. You may be given a Treatment Initiation Pack, with your starting doses pre-packed.
Take this medicine exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
Dosing information
Usual Adult Otezla Dose for Psoriatic Arthritis, Plaque Psoriasis, and Behcet’s disease
Adults starting dose:
- Day 1: 10 mg once a day in the morning
- Day 2: 10 mg twice a day (morning and evening)
- Day 3: 10 mg in the morning and 20 mg in the evening
- Day 4: 20 mg twice a day (morning and evening)
- Day 5: 20 mg in the morning and 30 mg in the evening, then maintenance dose.
Maintenance dose:
- 30 mg orally twice a day (morning and evening)
Usual Otezla Dose Pediatric Patients with Moderate to Severe Plaque Psoriasis who are 6 Years of Age and Older and Weighing at Least 20kg.
Pediatric Patients 20kg to less than 50 kg:
- Day 1: 10 mg once a day in the morning
- Day 2: 10 mg twice a day (morning and evening)
- Day 3: 10 mg in the morning and 20 mg in the evening
- Day 4: 20 mg twice a day (morning and evening), then maintenance dose.
Maintenance dose:
- 20 mg twice a day (morning and evening)
Pediatric Patients 50 kg or more:
- Day 1: 10 mg once a day in the morning
- Day 2: 10 mg twice a day (morning and evening)
- Day 3: 10 mg in the morning and 20 mg in the evening
- Day 4: 20 mg twice a day (morning and evening)
- Day 5: 20 mg in the morning and 30 mg in the evening then maintenance dose.
Maintenance dose:
- 30 mg orally twice a day (morning and evening)
General Dosing Comments
Keep track of your body weight while you are taking this medicine, and tell your doctor about any major weight loss.
Dosage adjustments are required in renal impairment.
Otezla usually begins at a low dose that is increased over 5 days to the maintenance dose, this is to reduce gastrointestinal symptoms that may happen when you first start taking this medicine. You may be given your medicine in a starter pack containing tablets that have different strengths; it is important to follow your doctor's instructions carefully.it
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What other drugs will affect Otezla?
Sometimes, it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
When you are taking Otezla it is important to tell your doctor about all your current medicines and any medicine you start or stop using. It is especially important that your healthcare professional knows if you are taking any of the medications in the list below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using Otezla with any of the following medicines may not be recommended but may be necessary in some cases. If both medicines are to be used together, your doctor may change the dose or how often you use one or both of the medicines.
- Carbamazepine
- Enzalutamide
- Fosphenytoin
- Mitotane
- Phenytoin
- Primidone
- Rifabutin
- Rifampin
- Rifapentine
- St John's Wort
- Tofacitinib
This list is not complete, and many other drugs can interact with Otezla. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you. Click the link below to check for interactions with this medication.
Ingredients
Active ingredient: apremilast
Inactive ingredients:
10mg tablet: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol (unspecified), titanium dioxide, polyethylene glycol (unspecified), talc, ferric oxide red.
20mg tablet: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol (unspecified), titanium dioxide, polyethylene glycol (unspecified), talc, ferric oxide red, ferric oxide yellow.
30mg tablet: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol (unspecified), titanium dioxide, polyethylene glycol (unspecified), talc, ferric oxide red, ferric oxide yellow, ferrosoferric oxide.
Company
Otezla Amgen Inc. Thousand Oaks, CA 91320-1799 U.S.A
Popular FAQ
Sotyktu vs Otezla: How do they compare?
Sotyktu and Otezla are both oral prescription medicines used to treat moderate-to-severe plaque psoriasis, but they work in different ways. Sotyktu blocks a protein called TYK2 (tyrosine kinase 2) to help lower inflammation and improve the severity and number of psoriasis lesions. Otezla works by blocking the phosphodiesterase type 4 (PDE4) enzyme to lower inflammation. Continue reading
Do you need to take Otezla forever?
Otezla may need to be taken long-term to manage symptoms caused by the chronic conditions it is approved to treat — psoriasis, psoriatic arthritis, and Behçet's disease. But exactly how long it should be taken can vary because it can depend on factors like response, personal preference, and condition severity. Continue reading
How much does Otezla cost?
The cash price of Otezla is around $5096 for a month’s supply of medication (60 tablets) using an online coupon. Your cost will be different based on your pharmacy location, insurance, or any discounts you may have. The manufacturer Amgen offers the Otezla $0 Co-pay Card Program for eligible patients. Continue reading
Can you drink alcohol while taking Otezla?
There is no evidence that it is unsafe to drink alcohol while taking Otezla. However, there are other reasons why it can be beneficial to limit alcohol consumption if you have psoriasis or psoriatic arthritis. Continue reading
How long does it take for Otezla to work?
Otezla (apremilast) is approved to treat plaque psoriasis in adults and children 6 years and older (and weighing at least 20 kg), as well as psoriatic arthritis and Behçet’s Disease in adults. Patients may start to feel an improvement within the first few weeks, but symptoms can further improve over 12 to 16 weeks. Continue reading
How to stop taking Otezla?
Otezla does not cause withdrawal symptoms when stopped, so it may be stopped suddenly, but there have been reports of people experiencing gastrointestinal complaints such as constipation, after they have stopped Otezla. This may be because Otezla tends to help bowels move much better, with some people reporting diarrhea or loose motions while on Otezla, and their stools become a lot harder once they have stopped Otezla. Other symptoms of their condition may also return. For this reason it may be better to reduce the dose of Otezla slowly over a week or two. Continue reading
Who makes Otezla and why is it so expensive?
Otezla is made by Amgen Inc, located in Thousand Oaks, California. Otezla is expensive because it is the original, brand name drug and Otezla's manufacturer sponsored the clinical development. The lower-cost generic option called apremilast was approved by the FDA in February 2021, but may not yet be on the market. Continue reading
How does Otezla work and what's its MOA?
In your body, Otezla blocks the action of the PDE4 enzyme to help control inflammatory symptoms such as pain, redness and swelling in conditions like psoriasis and psoriatic arthritis. Continue reading
Does Otezla cause weight gain?
No, Otezla does not cause weight gain, in fact, it is more likely to cause weight loss. In a pooled analysis of two large trials, ESTEEM 1 and ESTEEM 2, the average change in weight from the start of the trial to week 16 was -1.51 kg, or -3.33 lb for patients receiving Otezla 30mg twice daily. By week 52, approximately 19% of patients had lost more than 5% of their starting weight. Nobody described their weight loss as serious although two patients discontinued treatment because of weight loss. Continue reading
References
More about Otezla (apremilast)
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- Drug class: antirheumatics
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