Auro-Apremilast: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Auro-Apremilast is used in adults to treat:

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

Auro-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:

Auro-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 Auro-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 Auro-Apremilast.

• are breastfeeding. It is not known if Auro-Apremilast passes into your breast milk. Auro-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 Auro-Apremilast will harm your unborn baby. If you take Auro-Apremilast while you are pregnant, talk to your doctor about how you can be included in the apremilast Enhanced Surveillance Program for Adverse Pregnancy Outcomes.

What the medicinal ingredient is:

apremilast

What the nonmedicinal ingredients are:

Microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide red, iron oxide yellow (20 and 30 mg only) and Ferrosoferric oxide (30 mg only).

What dosage forms it comes in:

Tablets: 10 mg, 20 mg and 30 mg.

WARNINGS AND PRECAUTIONS

BEFORE you use Auro-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.

Auro-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 Auro-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 Auro-Apremilast exactly as your healthcare provider tells you to take it. Auro-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 Auro-Apremilast, the dose needs to be increased gradually; therefore, you must follow the instructions below.

Dose titration schedule:

Overdose:

Missed Dose:

If you miss a dose of Auro-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, Auro-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 (e.g. common cold)
• flu (body aches and pains, tiredness, fever)
• decreased appetite
• abdominal discomfort, indigestion
• fatigue, trouble sleeping
• back pain
• joint discomfort or pain
• dizziness.

SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM

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

HOW TO STORE IT

Store at 15°C to 30°C.

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

Reporting Side Effects

MORE INFORMATION

If you want more information about Auro-Apremilast:

• Talk to your healthcare professional
• Find the full Product Monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the
• manufacturer’s website http://www.auropharma.ca, or by calling 1-855-648-6681.

Auro Pharma Inc.

3700 Steeles Avenue West, Suite # 402

Woodbridge, Ontario, L4L 8K8,

Canada.

Last Prepared: January 6, 2022