Trifarotene (Topical application)

Trifarotene cream is used to treat acne. This medicine helps clear acne by keeping the skin pores (tiny openings on the skin) clean.

This medicine is available only with your doctor's prescription.

It is important for your doctor to check your or your child's progress during regular visits. This will help your doctor see if the medicine is working correctly and decide if you should keep using it.

Skin reactions like dryness, redness, scaling, burning, or stinging can happen when you use this medicine. Use a moisturizer as needed to reduce these skin issues.

Avoid exposing your skin to wind, cold weather, and sunlight, even on cloudy days. Your skin will be more likely to get sunburned, dry, or irritated. Do not use a sunlamp or tanning bed. Use a sunscreen or sunblock lotion with a sun protection factor (SPF) of at least 15 regularly. Wear protective clothing and hats and stay out of direct sunlight, especially between the hours of 10 a.m. and 3 p.m.

It is likely that your skin may become irritated with normal use of this medicine. You should not stop using trifarotene unless your skin becomes too red, dry, puffy, or otherwise irritated. If severe irritation occurs, contact your doctor.

Avoid using waxing as a hair removal method on the skin treated with this medicine.

Unless your doctor advises you differently, you should avoid skin products that can dry or irritate the skin. Some examples are:

• Hair products that are irritating, such as hair removal products.
• Skin products that cause sensitivity to the sun, such as those containing spices or limes.
• Skin products with a high amount of alcohol, such as astringents, shaving creams, or after-shave lotions.
• Skin products that are overly drying or abrasive, such as some cosmetics, soaps, or skin cleansers.

In deciding to use this medicine, you and your doctor need to think about the risks compared to the benefits. Here are some important points to consider:

Allergies

The dose of this medicine can vary for different patients. Always follow your doctor's instructions or the directions on the label. The information below includes only average doses. If your dose is different, do not change it unless your doctor tells you to.

The amount of medicine you take depends on its strength. The number of doses you take each day, the time between doses, and how long you take the medicine depend on the medical issue you are treating.

Pediatric

Studies so far have not shown any specific problems for children 9 years of age and older that would limit the use of trifarotene cream. However, the safety and effectiveness of trifarotene cream have not been established in children younger than 9 years.

Geriatric

Studies on how age affects the use of trifarotene cream have not been done in older adults.

Breast Feeding

There are no adequate studies in women to determine the risks to infants when using this medicine while breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction could happen. In those cases, your doctor may need to adjust the dose, or take other precautions. Inform your healthcare provider if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around mealtime or with specific foods due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare provider about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may impact the use of this medicine. Be sure to inform your doctor about any other medical conditions, especially:

• Eczema (skin problem) or
• Sunburn—These conditions may cause skin irritation and should not be treated with this medicine.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Itching or redness at the application site (severe)

Rare

• Dryness, discoloration, pain, or swelling at the application site
• skin rash, hives, itching, or redness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Burning or stinging at the application site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Aklief

Available Dosage Forms:

• Cream

Therapeutic Class: Antiacne

Chemical Class: Retinoid

It is very important that you use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause your skin to be irritated. You may need to use this medicine for several weeks or months before your skin starts to look better. Applying extra medicine will not make it work faster.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts or scrapes. If it does get on these areas, rinse it off right away.

To use the cream:

• At bedtime, gently wash your face with mild soap. Remove any makeup before applying the cream to the face. Rinse and pat your skin dry.
• Apply a pea-sized amount to lightly cover your face (1 pump actuation) or upper body (eg, chest, shoulders, upper back) (2 pump actuations). Do not get any cream into your eyes, lips, or corners of your nose. If contact occurs, rinse with water.
• Wash your hands after applying the cream.
• You may apply a moisturizing sunscreen in the morning, and wear protective clothing while using this medicine.

Do not apply this medicine to windburned or sunburned skin or on open wounds.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (cream):For acne: Adults and children 9 years of age and older—Apply a thin layer to the affected area(s) of the skin once a day, usually in the evening or at bedtime. Children younger than 9 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.