Sandoz Apremilast: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Sandoz Apremilast is used in adults to treat:

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

Sandoz 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:

Sandoz 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 Sandoz 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 Sandoz Apremilast.

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

What the medicinal ingredient is:

apremilast

What the important nonmedicinal ingredients are:

croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, hypromellose, titanium dioxide, polyethylene glycol/macrogol, iron red oxide, iron oxide yellow (20 and 30 mg only), 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 Sandoz 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.

Sandoz 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 Sandoz 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 Sandoz Apremilast exactly as your healthcare provider tells you to take it. Sandoz 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 Sandoz 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 Sandoz 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, Sandoz 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.

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

HOW TO STORE IT

Store Sandoz Apremilast at 15°C to 30°C.

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

Reporting Side Effects

MORE INFORMATION

If you want more information about Sandoz Apremilast:

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication

  Information by visiting the Health Canada website

  (https://www.canada.ca/en/health-canada.html); the

  manufacturer’s website (www.sandoz.ca), or by calling 1-800

  361-3062.

Sandoz Canada Inc.

110 de Lauzon Street

Boucherville, Quebec

J4B 1E6

Last Prepared: July 14, 2022

^® Registered trademark used under license by Sandoz Canada Inc.