Trifarotene Topical

WHY is this medicine prescribed?

Trifarotene is used to treat acne in adults and children 9 years of age and older. Trifarotene is in a class of medications called retinoids. It works by promoting peeling of affected skin areas, unclogging pores, and preventing new pimples from forming under the skin.

HOW should this medicine be used?

Trifarotene comes as a cream to apply to the skin. It is usually applied once daily at bedtime. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use trifarotene exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Trifarotene cream is only for use on the skin of your face (forehead, nose, each cheek, and chin) or upper trunk (upper back, shoulders and chest). Do not let trifarotene get into your eyes, ears, mouth, corners along your nose, or vaginal area. Do not apply on areas of sunburn, cuts, abrasions, or eczema.

Trifarotene cream comes in a pump bottle with instructions for use. Read these instructions and follow them carefully. Gently clean the affected area and pat it dry before application. Apply a thin layer of the cream to the affected skin on the face, chest, shoulders, or back. Ask your doctor or pharmacist if you have any questions about how to use trifarotene cream.

Do not use trifarotene cream along with nonmedicated or medicated cosmetics, abrasive products, or cleansers with alcohol (e.g., shaving lotions, astringents, and perfumes).

Your skin may become dry or irritated during the first 4 weeks of your treatment. If your skin stings, burns, or becomes irritated at any time during your treatment, talk to your doctor. Your doctor may tell you to use a moisturizer to help with dryness or tell you to apply it less often.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before using trifarotene,

• tell your doctor and pharmacist if you are allergic to trifarotene, any other medications, or any of the ingredients in trifarotene cream. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had eczema (a skin disease).
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using trifarotene, call your doctor. If you are breastfeeding while using trifarotene, apply the smallest amount to the skin and do not apply it directly to the nipple and areola (the colored area around each nipple).
• plan to avoid unnecessary or prolonged exposure to sunlight or ultraviolet light (tanning beds and sunlamps) and to wear protective clothing, sunglasses, and sunscreen with an SPF of 15 or higher. Trifarotene may make your skin sensitive to sunlight or ultraviolet light.
• do not use hot wax to remove unwanted hair from the area that you are treating with trifarotene during your treatment with this medication.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply extra cream to make up for a missed dose.

What SIDE EFFECTS can this medicine cause?

Trifarotene may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dryness, pain, burning, stinging, peeling, redness, itching, or flaky skin at the treatment area

Trifarotene may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

If someone swallows trifarotene, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: January 15, 2020.