Patient Medication Information: uses, side effects, how to take - Accel-Apremilast
What ACCEL-APREMILAST is used for:
ACCEL-APREMILAST is used in adults to treat:
- moderate to severe plaque psoriasis.
- psoriatic arthritis. For these patients, ACCEL-APREMILAST will be given alone or in combination with methotrexate. It will be given if you cannot use another type of medicine called ‘Disease-Modifying Antirheumatic Drugs’ (DMARDs) or if you have tried one of these medicines and it did not work.
- oral ulcers associated with Behçet’s disease.
ACCEL-APREMILAST is not approved for use in combination with any other medicines taken by mouth used to treat psoriasis, biological therapies (such as TNF antagonists and anti-IL-12/23 p40 antibodies) or with phototherapy (light therapy using UV light).
How ACCEL-APREMILAST works:
ACCEL-APREMILAST belongs to a class of drugs called phosphodiesterase 4 (PDE4) inhibitors. It contains the medicinal ingredient apremilast which works by reducing the activity of PDE4. This results in less inflammation in the skin and joints.
The ingredients in ACCEL-APREMILAST are:
Medicinal ingredient: apremilast
Non-medicinal ingredients: Croscarmellose sodium, Hypromellose, Iron oxide black, Iron oxide red, Iron oxide yellow, Macrogol 8000, Magnesium stearate, Mannitol, Microcrystalline cellulose, Talc, Titanium dioxide
ACCEL-APREMILAST comes in the following dosage forms:
Tablets: 30 mg.
Do not use ACCEL-APREMILAST if you:
- are allergic to apremilast or to any non-medicinal ingredient in the formulation (see The ingredients in ACCEL-APREMILAST are:)
are breastfeeding. It is not known if ACCEL-APREMILAST passes into your breast milk.
- are pregnant or planning to become pregnant. It is not known if ACCEL-APREMILAST will harm your unborn baby. If you take ACCEL-APREMILAST while you are pregnant, talk to your doctor about how you can be included in the ACCEL-APREMILAST Enhanced Surveillance Program for Adverse Pregnancy Outcomes.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ACCEL-APREMILAST. Talk about any health conditions or problems you may have, including if you:
- have kidney problems
- have a history of heart problems, including tachyarrhythmia (fast heartbeat or heart palpitations), heart disease or congestive heart failure (your heart does not pump blood as well as it should)
- have tuberculosis or a viral infection, such as viral hepatitis, herpes infection or shingles
- are using medicines that suppress the immune system, such as cyclosporine or biological therapies
- have a history of depression and/or suicidal thoughts or behaviours
- have low blood pressure
- have any other medical conditions
- 65 years of age or older. You may be at higher risk for experiencing certain side effects.
Other warnings you should know about:
Weight loss: ACCEL-APREMILAST can cause weight loss. Talk to your healthcare professional if you notice any unexpected weight loss. Your healthcare professional will regularly monitor your weight while you are taking ACCEL-APREMILAST.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with ACCEL-APREMILAST:
- rifampin, used to treat tuberculosis
- medicines used to control seizures, such as phenobarbital, carbamazepine and phenytoin
- medicines that suppress your immune system, such as cyclosporine and tacrolimus
- methotrexate used to treat your psoriasis
- biological therapies, such as TNF antagonists and anti-IL-12/23 p40 antibodies
- the herbal medicine St. John’s Wort (Hypericum perforatum)
How to take ACCEL-APREMILAST:
- Take ACCEL-APREMILAST exactly as your healthcare professional tells you to take it.
ACCEL-APREMILAST can be taken with or without food.
- The tablets should be swallowed whole. Do not crush, split, or chew the tablets.
Usual adult dose:
The recommended dose is 30 mg twice a day. When you first start taking ACCEL-APREMILAST, the dose needs to be increased gradually; therefore, you must follow the instructions below.
Dose titration schedule:
| Day 1 | Day 2 | Day 3 |
|---|---|---|
| AM | ||
| AM | PM | |
| AM | PM | |
| 10 mg | ||
| 10 mg | 10 mg | |
| 10 mg | 20 mg | |
| Day 4 | Day 5 | Day 6 |
| AM | ||
| PM | ||
| AM | PM | |
| AM | PM | |
| 20 mg | ||
| 20 mg | ||
| 20 mg | 30 mg | |
| 30 mg | 30 mg | |
Please note: ACCEL-APREMILAST is not available in the 10 mg and 20 mg strength tablets. Commercially available apremilast 10 mg and 20 mg tablets should be used for dose titration.
Overdose:
| If you think you, or a person you are caring for, have taken too much ACCEL-APREMILAST, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
|---|
Missed dose:
If you miss a dose of ACCEL-APREMILAST, take it as soon as you remember. But, if it is almost time for your next dose, skip the missed dose and continue with your next scheduled dose. Go back to the regular dosing schedule. Do not take two doses at the same time.
Possible side effects from using ACCEL-APREMILAST:
These are not all the possible side effects you may have when taking ACCEL-APREMILAST. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- diarrhea
- nausea
- vomiting
- decreased appetite
- abdominal discomfort, indigestion
- headache
- cough
- upper respiratory tract infection (e.g. common cold)
- flu (body aches and pains, tiredness, fever)
- fatigue, trouble sleeping
- back pain
- joint discomfort or pain
- dizziness
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |||||
| Only if severe | In all cases | ||||||
| Common | |||||||
| Migraine: headache that may be severe and/or accompanied by nausea, vomiting and sensitivity to light | X | ||||||
| Depression: feeling sad or other changes in mood, suicidal thoughts or behaviours | X | ||||||
| Weight loss: unexpected weight loss | X | ||||||
| Uncommon | |||||||
| Palpitations: fast, fluttering, pounding, or irregular heartbeat | X | ||||||
| Allergic reaction: rash or hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | X | ||||||
| Pneumonia (infection of the lungs): shortness of breath, chest pain when you breathe or cough, cough which may produce phlegm, fatigue, wheezing, fever | X | ||||||
| Gastrointestinal (GI) hemorrhage (bleeding anywhere along the GI tract between the mouth and anus): black, tarry stool, bright red blood in your stool or blood coming from the rectum, blood in vomit | X | ||||||
| Severe diarrhea: loose, watery stool | X | ||||||
| Severe nausea: feeling the need to throw-up | X | ||||||
| Severe vomiting: throwing up | X | ||||||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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Storage:
Store ACCEL-APREMILAST at 15°C to 30°C.
Keep ACCEL-APREMILAST tablets and all medicines out of the reach and sight of children.
If you want more information about ACCEL-APREMILAST:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html), the manufacturer’s website (www.accelpharma.com), or by calling the manufacturer, Accel Pharma., at 1-877-822-2235.
Date of Authorization: 2026-08-26