Pronunciation:

trye-FAR-oh-teen

Brand Names:

• Aklief

Dosage Forms:

• Cream

Classifications:

Therapeutic—

Antiacne

Chemical—

Retinoid

Uses of This Medicine:

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

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of trifarotene cream in children 9 years of age and older. However, safety and efficacy of trifarotene cream have not been established in children younger than 9 years of age.

Older adults—

Appropriate studies on the relationship of age to the effects of trifarotene cream have not been performed in the geriatric population.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Eczema (skin problem) or
• Sunburn—May cause skin irritation and should not be used in patients with these conditions.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is important that your doctor check your or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

Skin reactions such as dryness, redness, scaling, burning, or stinging can occur when you use this medicine. Use a moisturizer as needed to lessen these skin problems.

Avoid exposing your skin to wind, cold weather, and sunlight, even on cloudy days. Your skin will be more prone to sunburn, dryness, or irritation. Do not use a sunlamp or tanning bed. Use a sunscreen or sunblock lotion with a sun protection factor (SPF) of at least 15 on a regular basis. 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 the use of waxing as a hair removal method on the skin treated with this medicine.

Unless your doctor tells you otherwise, 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 containing a large amount of alcohol, such as astringents, shaving creams, or after-shave lotions.
• Skin products that are too drying or abrasive, such as some cosmetics, soaps, or skin cleansers.

Side Effects of 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.