Aklief: Uses, Side Effects and Dosage

What is AKLIEF used for?

• AKLIEF is used to treat acne vulgaris on the face and trunk (upper, middle and lower back, shoulders and chest) for patients 12 years and older. Acne vulgaris is a skin condition that is caused when your hair follicles become plugged and inflamed. This causes your skin to break out with pimples, black heads or white heads.

How does AKLIEF work?

AKLIEF contains trifarotene which belongs to a group of medicines called retinoids. AKLIEF works by unplugging your blocked hair follicles and by preventing these plugs from forming in the first place. Your acne should improve in 4-8 weeks and you should see more improvement as you continue to use AKLIEF.

What are the ingredients in AKLIEF?

Medicinal ingredients: Trifarotene 0.005% w/w (50 mcg/g)

Non-medicinal ingredients: Allantoin, copolymer of acrylamide and sodium acryloyldimethyltaurate with isohexadecane, polysorbate 80 and sorbitan oleate, cyclomethicone 5, ethanol (96%), phenoxyethanol, propylene glycol, purified water and triglycerides medium-chain.

AKLIEF comes in the following dosage forms:

AKLIEF is available in 2 g tube (sample) and 75 g pump.

Do not use AKLIEF if:

• You have skin conditions such as eczema or seborrheic dermatitis

• You are pregnant or planning a pregnancy. If you are a female of childbearing years, you should only use AKLIEF after consulting your doctor about effective birth-control measures.

• You are allergic to the medicinal ingredients in AKLIEF or any of its ingredients (see “What are the ingredients

  • in AKLIEF”).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AKLIEF. Talk about any health conditions or problems you may have, including if:

• You are breastfeeding or plan to breastfeed. The product should not be applied to the chest, in order to avoid contact with the child.
• You intend go out in the sun. Exposure to too much sunlight including sunlamps should be avoided while using AKLIEF. If you must be out in the sun, use a good sunscreen product (SPF 15 or higher) and protective clothing over the treated areas.
• You have other skin problems, including cuts, abrasions, eczema or sunburn. You should avoid applying the product to cuts, abrasions, eczema and sunburned skin. In case of sunburn, allow the skin to heal before using AKLIEF.
• You are using any other acne medications. AKLIEF should not be used with other acne medications unless your doctor tells you to use them.

Other warnings you should know about:

Skin Care:

• Avoid electrolysis, “waxing” or chemical hair removers on skin treated with AKLIEF. This may increase your skin sensitivity.

• Avoid skin products that may dry or irritate your skin such as harsh soaps, cleansers, astringents, cosmetics that have strong skin drying effects and products containing high levels of alcohol, spices or limes.

• Use non-comedogenic cosmetics. Colour cosmetics such as blushes and powders are acceptable, however, make-up cosmetics should be water based only. Cosmetics must be removed by thoroughly cleaning the area before applying AKLIEF.

You should avoid weather extremes such as wind or cold as they may be irritating.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with AKLIEF:

• Using AKLIEF with topical medicines that contain sulfur, resorcinol or salicylic acid may cause skin irritation. Talk to your doctor about stopping your use of other acne products OR about changing the time of day that you use them.

How to take AKLIEF:

• Use AKLIEF exactly as your doctor tells you to use it.
• AKLIEF is for skin use only. Do not use AKLIEF in or on your mouth, eyes, lips, angles of nose, vagina, axillary region (or armpit) and neck. If product enters the eye, wash immediately with warm water.
• You may use moisturizer before and after applying AKLIEF as needed. Make sure to allow skin to dry before you apply AKLEIF.

Usual dose (Adults and Patients 12 years and older):

Apply a small amount of AKLIEF to provide a thin layer to the affected areas of the trunk and/or face once a day, in the evening, on clean and dry skin.

Wash your hands before and after application of the cream.

AKLIEF comes in a pump.

• Depress the pump once to dispense a small amount of cream and spread a thin layer over the face (i.e.

  • forehead, cheeks, nose and chin).
• Two pumps should be sufficient to apply a thin layer to cover the upper trunk (i.e. reachable upper back, shoulders and chest). One additional pump may be used to apply a thin layer to the middle and lower back, if acne is present.

Apply a thin layer to cover the entire affected area. Do not use more than you need to cover the treatment area. Using too much AKLIEF or using it more than one time a day may increase your chance of skin irritation.

Overdose:

Missed Dose:

If a single dose is missed, dosing should continue as per usual the following evening, and the usual amount should be applied. Do not apply extra.

What are possible side effects from using AKLIEF?

These are not all the possible side effects you may feel after receiving AKLIEF. If you experience any side effects not listed here, contact your healthcare professional.

Side effects include:

• Skin redness, dryness, itching, peeling, burning, stinging and pigment loss of the skin

The above side effects may happen when your skin is adjusting to AKLIEF’s action of unplugging clogged pores. If you have a troublesome symptom or side effect that is not listed here or becomes bad

enough to interfere with your daily activities, talk to your healthcare professional. Your doctor may recommend to increase the use of a moisturizer before or after application, a change in your dose, or a change to how often you use the medication.

Reporting Side Effects

Storage:

Store AKLIEF at room temperature (15°C to 30°C). Keep from freezing.

Keep out of reach and sight of children.

If you want more information about AKLIEF:

• Talk to your healthcare professional
• This document plus the full product monograph, prepared for health professionals can be found at: www.galderma.ca or by contacting the sponsor, Galderma Canada Inc.

Questions or concerns: 1-800-467-2081.

Last Revised November 25, 2019