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GLN-Apremilast: Uses, Side Effects and Dosage

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Facts
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Prescription (Rx)
Strength:
10 mg / 20 mg / 30 mg
Active ingredient:
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Source: Health Canada – Drug Product Database (DPD) and product monographs · About this document

Patient Medication Information: uses, side effects, how to take - GLN-Apremilast

What GLN-APREMILAST is used for:

GLN-APREMILAST is used in adults to treat:

  • moderate to severe plaque psoriasis.
  • psoriatic arthritis. For these patients, GLN-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.

GLN-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 GLN-APREMILAST works:

GLN-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 GLN-APREMILAST are:

Medicinal ingredient: Apremilast

Non-medicinal ingredients: Corn starch, crospovidone, lactose monohydrate, magnesium stearate,hypromellose, titanium dioxide and polyethylene glycol Additionally, 30 mg tablets contains iron oxide red, ferrosoferric oxide and iron oxide yellow.

GLN-APREMILAST comes in the following dosage forms:

Tablets: 10 mg, 20 mg and 30 mg.

Do not use GLN-APREMILAST if you:

  • are allergic to apremilast or to any non-medicinal ingredient in the formulation (see The ingredients in GLN-APREMILAST are:)

  • are breastfeeding. It is not known if GLN-APREMILAST passes into your breast milk.

  • are pregnant or planning to become pregnant. It is not known if GLN-APREMILAST will harm your unborn baby. If you take GLN-APREMILAST while you are pregnant, talk to your healthcare professional about how you can be included in the GLN-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 GLN-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.

  • have one of the following rare hereditary diseases:

    • Galactose intolerance
    • Lapp lactase deficiency
    • Glucose-galactose malabsorption

because lactose is a non-medicinal ingredient in GLN-APREMILAST.

Other warnings you should know about:

Weight loss: GLN-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 GLN-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 GLN-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 GLN-APREMILAST:

  • Take GLN-APREMILAST exactly as your healthcare professional tells you to take it.

  • GLN-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 GLN-APREMILAST, the dose needs to be increased gradually; therefore, you must follow the instructions below.

Dose titration schedule:

Day 1Day 2Day 3
AM
AMPM
AMPM
10 mg
10 mg10 mg
10 mg20 mg
Day 4Day 5Day 6
AM
PM
AMPM
AMPM
20 mg
20 mg
20 mg30 mg
30 mg30 mg

Overdose:

If you think you, or a person you are caring for, have taken too much GLN-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 GLN-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 GLN-APREMILAST:

These are not all the possible side effects you may have when taking GLN-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/SymptomTalk to your healthcare professionalStop taking this drug and get immediate medical help
Frequency/Side Effect/SymptomTalk to your healthcare professionalStop taking this drug and get immediate medical help
Only if severeIn all cases
Only if severeIn all cases
Common
Migraine: headache that may be severe and/or accompanied by nausea, vomiting and sensitivity to lightX
Depression: feeling sad or other changes in mood, suicidal thoughts or behavioursX
Weight loss: unexpected weight lossX
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 breathingX
Pneumonia (infection of the lungs): shortness of breath, chest pain when you breathe or cough, cough which may produce phlegm, fatigue, wheezing, feverX
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 theX
rectum, blood in vomit
Severe diarrhea: loose, watery stoolX
Severe nausea: feeling the need to throw-upX
Severe vomiting: throwing upX

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:

  • Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
  • Calling toll-free at 1-866-234-2345.

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.

Storage:

Store GLN-APREMILAST at 15°C to 30°C.

Keep GLN-APREMILAST tablets and all medicines out of the reach and sight of children.

If you want more information about GLN-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 (https://glenmarkpharma.ca); or by calling 1-844-801-7468.

Date of Authorization: 2026-09-11

About this document

Source: Health Canada – Drug Product Database (DPD) and product monographs · DIN (Drug Identification Number): 02518929

Approved according to the text: September 11, 2026

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for GLN-Apremilast

Rx or OTC
Prescription (Rx)?
DIN 02518929
Schedule(s) PRESCRIPTION
Active ingredient(s) Apremilast 10 MG / 20 MG / 30 MG
Dosage form(s) Tablet
Route(s) of administration Oral
Drug class (WHO ATC)
  1. L Antineoplastic and immunomodulating agents
    1. L04 Immunosuppressants
      1. L04A Immunosuppressants
        1. L04AA Selective immunosuppressants
          1. L04AA32 Apremilast
Company GLENMARK PHARMACEUTICALS CANADA INC.
Current status Approved
Current status date November 14, 2022

Source: Health Canada – Drug Product Database (DPD) and product monographs, data as of November 1, 2026. Data from the Health Canada Drug Product Database, as published there. Not a substitute for the advice of a doctor or pharmacist.