Details for: AKLIEF
Company: GALDERMA CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02494175 | AKLIEF | TRIFAROTENE | 50 MCG / G | CREAM | TOPICAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is 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.
What it does
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.
When it should not be used
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”).
What the medicinal ingredient is
Trifarotene 0.005% w/w (50 mcg/g)
What the non-medicinal ingredients are
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.
What dosage form it comes in
AKLIEF is available in 2 g tube (sample) and 75 g pump
Warnings and precautions
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.
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.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
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.
Proper use of this medication
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.
Overdose
If you think you have taken too much AKLIEF, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
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.
Side effects and what to do about them
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
How to store
Store AKLIEF at room temperature (15°C to 30°C). Keep from freezing.
Keep out of reach and sight of children.
Reporting 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 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 0701D
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available at 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
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.
This leaflet was prepared by Galderma Canada Inc.
Last Revised November 25, 2019