Generic name: apremilast [ a-PRE-mi-last ]
Dosage form: tablet
Drug class: Antirheumatics
What is Otezla?
Otezla (apremilast) is a tablet taken twice a day that is used to lower inflammation in the treatment of specific types of psoriatic arthritis, plaque psoriasis and Behçet's disease.
Otezla works by inhibiting an enzyme within your immune system that can affect certain cells and contribute to inflammation in the body.
Otezla is from a group of medicines called PDE4 inhibitors (Phosphodiesterase-4 inhibitors) that lower inflammation by increasing the level of cAMP (cyclic adenosine monophosphate) which is a messenger system in our bodies. Otezla is not a biologic agent.
Otezla received FDA approval on March 21, 2014, for psoriatic arthritis and since then it has also been FDA approved for the treatment of types of plaque psoriasis and Behcet’s disease.
What is Otezla used for?
- Psoriatic Arthritis: Treatment for adult patients with active psoriatic arthritis.
- Plaque Psoriasis: Treatment for adult patients with plaque psoriasis who require systemic therapy or light treatment (phototherapy )
- Oral Ulcers Associated with Behçet's Disease: Treatment for adult patients with oral ulcers associated with Behçet's Disease.
Warnings
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.
Before taking this medicine
You should not use apremilast if you are allergic to it.
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.
This medicine is not approved for use by anyone younger than 18 years old.
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?
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.
The tablet should be swallowed whole, do not crush, chew, or break the tablet.
This medicine can be taken with or without food.
Dosing information
Usual Adult Dose for Psoriatic Arthritis, Plaque Psoriasis and Behcet’s disease
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 are different strengths, it is important to follow your doctor's instructions carefully.
Starting dose:
Day 1: 10 mg orally once a day (AM)
Day 2: 10 mg orally twice a day (AM and PM)
Day 3: 10 mg orally once a day (AM); 20 mg orally once a day (PM)
Day 4: 20 mg orally twice a day (AM and PM)
Day 5: 20 mg orally once a day (AM); 30 mg orally once a day (PM)
Maintenance dose:
30 mg orally twice a day (AM and PM)
Keep track of your body weight while you are taking this medicine, and tell your doctor about any major weight loss.
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.
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 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.
Common Otezla side effects may include:
- nausea, diarrhea;
- headache; or
- cold symptoms such as stuffy nose, sneezing, sore throat.
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 FDA at 1-800-FDA-1088.
What other drugs will affect Otezla?
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even though there may be an interaction. In these situations, your doctor may want to change the dose, or other precautions may be necessary. When you are taking Oztela 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
What are the ingredients in Otezla ?
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.
Manufactured for:
Amgen Inc. Thousand Oaks, CA 91320-1799 U.S.A
Popular FAQ
Otezla may need to be taken long-term to manage the chronic conditions it is used to treat — psoriasis and psoriatic arthritis. But exactly how long it should be taken can vary because it can depend on factors like personal preference and condition severity. Continue reading
Studies have shown Sotykto can have a meaningful effect to help clear plaque psoriasis, including scalp psoriasis, in 16 weeks. The superior efficacy of Sotyktu compared to placebo and Otezla was demonstrated at 16 and 24 weeks. Continue reading
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
The price of Otezla is around $3600 for a month’s supply of medication (60 tablets); however, most people do not pay this price. Continue reading
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
No, Otezla is not classified as a biologic agent. Otezla (apremilast) is a small molecule phosphodiesterase 4 (PDE4) inhibitor approved by the FDA for the treatment of plaque psoriasis, psoriatic arthritis, and oral ulcers associated with Behçet’s Disease. It is taken as an oral tablet. Continue reading
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