Mint-Apremilast: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

MINT-APREMILAST is used in adults to treat:

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

MINT-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).

What it does:

MINT-APREMILAST belongs to a class of drugs called phosphodiesterase 4 (PDE4) inhibitors. It contains the active ingredient apremilast which works by reducing the activity of PDE4. This results in less inflammation in the skin and joints.

When it should not be used:

Do not take MINT-APREMILAST if you:

• are allergic to apremilast or to any non-medicinal ingredient in the formulation.

• have one of the following rare hereditary diseases:

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

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

• are breastfeeding. It is not known if MINT-APREMILAST passes into your breast milk. MINT-APREMILAST should not be used if you are breastfeeding.

  • are younger than 18 years old.
  • are pregnant or intend to become pregnant. It is not known if MINT-APREMILAST will harm your unborn baby. If you take MINT-APREMILAST while you are pregnant, talk to your doctor about how you can be included in the MINT-APREMILAST Enhanced Surveillance Program for Adverse Pregnancy Outcomes.

What the medicinal ingredient is:

apremilast

What the nonmedicinal ingredients are:

croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide red, iron oxide yellow and iron oxide black.

What dosage forms it comes in:

Tablets: 30 mg.

WARNINGS AND PRECAUTIONS

BEFORE you use MINT-APREMILAST talk to your doctor or pharmacist if you:

• have kidney problems.
• have a history of the heart condition, tachyarrhythmia (fast heartbeat or heart palpitations).
• have heart disease or congestive heart failure.
• have tuberculosis or a viral infection such as viral hepatitis, herpes infection or shingles.
• are using immunosuppressive drugs (such as cyclosporine).
• 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.

MINT-APREMILAST can cause weight loss. Your doctor will need to regularly monitor your weight.

INTERACTIONS WITH THIS MEDICATION

As with most medicines, interactions with other drugs are possible. Tell your doctor or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.

The following may interact with MINT-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 to treat your psoriasis
• Biological therapies, such as TNF antagonists and anti-IL-12/23 p40 antibodies.
• The botanical medicine St. John’s Wort.

PROPER USE OF THIS MEDICATION

Take MINT-APREMILAST exactly as your healthcare provider tells you to take it. MINT-APREMILAST should be taken by mouth and swallowed whole, with or without food. The tablets should not be crushed, split, or chewed.

Usual adult dose:

The recommended dose is 30 mg twice a day. When you first start taking MINT-APREMILAST, the dose needs to be increased gradually; therefore, you must follow the instructions below.

Dose titration schedule:

Please note: MINT-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:

Missed Dose:

If you miss a dose of MINT-APREMILAST, take it as soon as you remember. If it is close to the time for your next dose, just skip the missed dose. Take the next dose at your regular time. Do not double dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, MINT-APREMILAST can have side effects. If any of these side effects affect you severely, tell your doctor, nurse or pharmacist:

• diarrhea
• nausea
• vomiting
• headache

• upper respiratory tract infection (eg, common cold)

  • flu (body aches and pains, tiredness, fever)
  • decreased appetite
  • abdominal discomfort, indigestion
  • fatigue, trouble sleeping
  • back pain
  • joint discomfort or pain
  • dizziness.

This is not a complete list of side effects. For any unexpected effects while taking MINT-APREMILAST, contact your doctor or pharmacist.

HOW TO STORE IT

Store MINT-APREMILAST at 15°C to 30°C.

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

MORE INFORMATION

For more information or to obtain the full product monograph that is prepared for health professionals and includes this Consumer Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada.html); the manufacturer’s website www.mintpharmaceuticals.com, or by calling 1-877-398-9696.

Mint Pharmaceuticals Inc.

6575 Davand Drive,

Mississauga, ON L5T 2M3

Last Prepared: March 2, 2022

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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

Note: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.