Patient Medication Information: uses, side effects, how to take - Apo-Apremilast Tablets
ABOUT THIS MEDICATION
What the medication is used for:
APO-APREMILAST TABLETS is used in adults to treat:
- moderate to severe plaque psoriasis.
- psoriatic arthritis. For these patients, APO-APREMILAST TABLETS 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.
APO-APREMILAST TABLETS 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:
APO-APREMILAST TABLETS 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 APO-APREMILAST TABLETS 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 APO-APREMILAST TABLETS.
are breastfeeding. It is not known if APO-APREMILAST TABLETS passes into your breast milk. APO-APREMILAST TABLETS 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 APO-APREMILAST TABLETS will harm your unborn baby. If you take APO-APREMILAST TABLETS while you are pregnant, talk to your doctor about how you can be included in the APO-APREMILAST TABLETS Enhanced Surveillance Program for Adverse Pregnancy Outcomes.
What the medicinal ingredient is:
apremilast
What the non-medicinal ingredients are:
colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hydroxypropyl methylcellulose, iron oxide black (30 mg only), iron oxide red, iron oxide yellow (20 mg and 30 mg only), lactose monohydrate, microcrystalline cellulose, magnesium stearate, titanium dioxide
What dosage forms it comes in:
Tablets: 10 mg, 20 mg and 30 mg.
WARNINGS AND PRECAUTIONS
BEFORE you use APO-APREMILAST TABLETS 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.
APO-APREMILAST TABLETS 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 APO-APREMILAST TABLETS:
- 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 APO-APREMILAST TABLETS exactly as your healthcare provider tells you to take it. APO-APREMILAST TABLETS 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 APO-APREMILAST TABLETS, 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 | |
Overdose:
Missed Dose:
If you miss a dose of APO-APREMILAST TABLETS, 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, APO-APREMILAST TABLETS 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.
SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||||
|---|---|---|---|---|---|---|
| Only if severe | In all cases | |||||
| COMMON | ||||||
| Migraine | ✓ | |||||
| Depression | ✓ | |||||
| Weight loss | ✓ | |||||
If you think you have taken too much APO-APREMILAST TABLETS, contact your doctor, nurse or pharmacist, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |||||
|---|---|---|---|---|---|---|---|
| Only if severe | In all cases | ||||||
| UNCOMMON | |||||||
| Palpitations: Fast and/or irregular heartbeat | ✓ | ||||||
| Allergic reaction: Rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | ✓ | ||||||
| Infection of the lungs: Shortness of breath, difficult and painful breathing, cough, wheezing and fever | ✓ | ||||||
| Gastrointestinal hemorrhage (bleeding in the digestive tract): black, tarry stool; blood coming from the rectum, blood in vomit | ✓ | ||||||
| Severe diarrhea: Loose, watery stool | ✓ | ||||||
| Severe nausea: Feeling the need to throw-up | ✓ | ||||||
| Severe vomiting: Throwing up | ✓ | ||||||
This is not a complete list of side effects. For any unexpected effects while taking APO-APREMILAST TABLETS, contact your doctor or pharmacist.
HOW TO STORE IT
Store APO-APREMILAST TABLETS at controlled room temperature 15°C to 30°C.
Keep APO-APREMILAST TABLETS and all medicines out of the reach and sight of children.
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.html) for information on how to report online, by
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. |
|---|
MORE INFORMATION
If you want more information about APO-APREMILAST TABLETS:
- 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). Find the Consumer Information on the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.