What Otezla is used for and how to use it
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Otezla - Consumer Medicine Information

Manufacture: Celgene Corporation
Country: Canada
Condition: Plaque Psoriasis, Psoriatic Arthritis
Class: Antirheumatics
Form: Tablets
Ingredients: apremilast, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide red, iron oxide yellow (20 and 30 mg only), iron oxide black (30 mg only)

apremilast tablets

About This Medication

What the Medication is Used For

OTEZLA is used in adults to treat:

  • moderate to severe plaque psoriasis, and
  • psoriatic arthritis alone or in combination with methotrexate 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.

OTEZLA 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

OTEZLA 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 OTEZLA 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 OTEZLA.

  • are breastfeeding. It is not known if OTEZLA passes into your breast milk. OTEZLA should not be used if you are breastfeeding.
  • are pregnant or intend to become pregnant. It is not known if OTEZLA will harm your unborn baby. If you take OTEZLA while you are pregnant, talk to your doctor about how you can be included in the OTEZLA Pregnancy Registry.

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 (20 and 30 mg only) and iron oxide black (30 mg only).

What Dosage Forms it Comes In

Tablets: 10 mg, 20 mg and 30 mg.

Warnings and Precautions

BEFORE you use OTEZLA 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 any other medical conditions.
  • are less than 18 years old or 75 years of age or older.

OTEZLA 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 OTEZLA:

  • 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 OTEZLA exactly as your healthcare provider tells you to take it. OTEZLA should be taken by mouth and swallowed whole, with or without food. The tablets should not be rushed, plit, or chewed.

Usual Adult Dose

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

Dose Titration Schedule

Day 1Day 2Day 3
AMAMPMAMPM
10 mg10 mg10 mg10 mg20 mg
Day 4Day 5Day 6
AMPMAMPMAMPM
20 mg20 mg20 mg30 mg30 mg30 mg

Overdose

If you think you have taken too much OTEZLA, contact your doctor, nurse or pharmacist, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you miss a dose of OTEZLA, 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

Side effects may include:

  • 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
  • dizziness.

If any of these affect you severely, tell your doctor, nurse or pharmacist.

Serious Side Effects, How Often They Happen and What to Do About Them

Symptom / effectTalk with your doctor or pharmacistStop taking drug and seek immediate medical help
Only if severeIn all cases
Common (occurring in 1 to 9 patients per 100)Migraine
Depression
Weight loss
Uncommon (occurring in 1 to 9 patients per 1000)Fast heartbeat and/or heart palpitations
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

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

How to Store It

Store OTEZLA at 15 to 30 °C.

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

Reporting Suspected Side Effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
                     Health Canada
                     Postal Locator 0701E
                     Ottawa, Ontario
                     ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at
www.healthcanada.gc.ca/medeffect.

NOTE:Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More Information

This document plus the full product monograph, prepared for health professionals can be found at:

http://www.celgenecanada.net

or by contacting the sponsor, Celgene Inc., at:

1-888-712-2353