Uses

This medication is used to treat acne. It may decrease the number and severity of acne pimples and speed up healing of pimples that do develop. Trifarotene belongs to a class of medications called retinoids. It works by affecting the growth of cells and decreasing swelling and inflammation.

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start using trifarotene and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Use this medication as directed by your doctor, usually once daily in the evening. Before using, gently clean the affected skin with a mild or soapless cleanser and pat dry.

Wash your hands before and after applying this medication. Apply a small amount of medication in a thin layer on the affected area(s).

Use this medication on the skin only. Avoid getting this medication in your eyes or on your lips. Do not apply to the inner lip area or inside the nose/mouth. If this medication gets in your eyes, flush with large amounts of water. Call your doctor if eye irritation develops. Do not apply to cut, scraped, or sunburned areas, or to skin affected by eczema (a skin condition).

When you begin using this medication, you should also apply a moisturizer on your skin as often as needed to help lessen skin irritation (see also Side Effects section).

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day. Do not use a larger amount or use it more often than directed. Your skin will not improve any faster, and your risk of developing side effects (such as redness, peeling, or pain) will increase.

Tell your doctor if your condition does not get better or if it gets worse.

Side Effects

Skin redness, dryness, scaling, itching, or mild stinging/burning commonly occur, especially during the first 4 weeks of using this medication. These effects usually lessen with continued use. Apply moisturizer on your skin as often as needed to lessen side effects. If any of these effects lasts or gets worse, tell your doctor or pharmacist promptly. Your doctor may direct you to use trifarotene less often, or temporarily or permanently stop using it.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• very red/irritated skin
• eye redness and watering (conjunctivitis)
• eyelid swelling
• skin discoloration

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using trifarotene, tell your doctor or pharmacist if you are allergic to it; or to vitamin A-related drugs (other retinoids such as tretinoin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• eczema

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

Avoid electrolysis, waxing, and chemical depilatories for hair removal on the treated areas while using this product.

If you have recently used products containing sulfur, resorcinol, or salicylic acid, use trifarotene with caution. Wait until the effects of such products on the skin have decreased before using trifarotene.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding. If you are using this medication while breast-feeding, do not apply it on the nipples or areolas.

Drug Interactions

See also Precautions section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Avoid using other skin products that are harsh, irritating, or drying on the treated area. These products include hair perming solutions, alcohol/lime/menthol-containing products (such as astringents, toners, shaving lotion), medicated or abrasive soaps or cleansers, soaps and cosmetics with a strong drying effect (such as alpha hydroxy acids, glycolic acid), and products containing sulfur, resorcinol, or salicylic acid.

Overdose

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Cosmetics may be used, but clean skin thoroughly before applying the medication.

Some cosmetics and soaps may worsen your acne. When buying cosmetics, moisturizers or other skin care products, check the label for "non-comedogenic" or "non-acnegenic." These products are unlikely to worsen your acne. Ask your doctor or pharmacist which products are safe to use. Remember, acne is not caused by dirt. Cleaning your skin too hard or too often can irritate your skin and make acne worse.

Missed Dose

If you forget to use this medication, use it as soon as you remember on the same day. If it is the next day, use your next dose at the regular time.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store at room temperature. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.