Generic name: apremilast [a-PRE-mi-last]
Dosage form: tablets (10 mg, 20mg, 30mg)
Drug class: Antirheumatics
What is Otezla?
Otezla (apremilast) is used to treat plaque psoriasis, psoriatic arthritis, and mouth ulcers in Behcet’s disease. Otezla improves plaque psoriasis symptoms of scaling, itching, and skin redness, and reduces nail and scalp psoriasis symptoms. When used for psoriatic arthritis, Otezla improves inflammation, joint swelling, and pain.
Otezla works by blocking an enzyme called PDE4 that drives inflammation and the processes that cause plaque psoriasis, psoriatic arthritis symptoms, and Behcet’s disease mouth ulcers.
Otezla is an oral phosphodiesterase-4 (PDE-4) inhibitor; it is a selective immunosuppressant agent and is considered a class of immunomodulatory or immunosuppressive medication. It is not a biologic or steroid.
Otezla tablets are usually taken twice a day, after an initial dose increase over 5 days.
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.
Otezla Uses
- 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.
How does Otezla work?
Otezla mechanism of action is by inhibiting phosphodiesterase 4 (PDE4), leading to an increase in intracellular cAMP levels, which is thought to reduce inflammatory proteins (cytokines) and increase anti-inflammatory mediators. This results in clinical improvements for the conditions being treated.
Otezla side effects
Common Otezla side effects
Common Otezla side effects are nausea, diarrhea, headache, vomiting, upper respiratory tract infection, upper abdominal pain, and cold symptoms such as a stuffy nose, sneezing, and sore throat.
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 (NCT01172938), PsA-2 (NCT01212757), and PsA-3 (NCT01212770). Side effects that caused patients to stop taking tablets during the trials included nausea (1.8%), diarrhea (1.8%), and headache (1.2%).
Gastrointestinal side effects can occur when first starting therapy. To help reduce these side effects, the dose is started low and increased over the first 5 days. Otezla starter packs are available with the first 5 days of tablets, which makes initial dosing easy and convenient.
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.
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.
What is the cost of Otezla?
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 .
The cost of prescription drugs varies depending on your insurance plan, whether you have insurance, and which pharmacy you use. For more information on 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
Adult 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.
Adult maintenance dose:
- 30 mg orally twice a day (morning and evening)
Usual Otezla Dose for Pediatric Patients
For Moderate to Severe Plaque Psoriasis who are 6 Years of Age and Older and Weighing at Least 20kg.
Starting dose for 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 pediatric patients (20kg to less than 50 kg):
- 20 mg twice a day (morning and evening)
Starting dose for 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 for pediatric patients (50 kg or more):
- 30 mg orally twice a day (morning and evening).
Otezla starter pack
Otezla starter packs contain the tablets required for the 5-day titration period, making initial dosing easier, but it is still important to follow your doctor’s instructions carefully.
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.
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 .
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.
Does Otezla interact with my other drugs?
Enter medications to view a detailed interaction report .Drug nameAdd a drug to check interactionsAdd
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.
