Aklief is a brand-name prescription medication. It’s prescribed to treat acne in adults and in children ages 9 years and older.

Acne is a common condition that affects your skin. It occurs when your pores (small openings in the skin that release oils and sweat) become clogged.

Drug details

Aklief comes as a cream that you apply to your skin. It contains the active drug trifarotene. It’s available in one strength: 0.005%. This strength means that each gram of Aklief cream contains 50 micrograms of trifarotene.

Aklief belongs to a drug class called retinoids. (A drug class is a group of medications that work in a similar way.)

FDA approval

In 2019, the Food and Drug Administration (FDA) approved Aklief for treating acne in adults and in children ages 9 years and older.

To learn more about how Aklief is used to treat acne, see the “Aklief uses” section further below.

Effectiveness

For information about the effectiveness of Aklief, see the “Aklief uses” section below.

Aklief is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name drugs.

Aklief cream contains the active drug trifarotene.

Aklief can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Aklief. These lists do not include all possible side effects.

For more information about the possible side effects of Aklief, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Aklief, you can do so through MedWatch.

Mild side effects

Mild side effects* of Aklief can include:

  • sunburn
  • reactions on your skin where you apply Aklief, including:

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Aklief. To learn about other mild side effects, talk with your doctor or pharmacist, or view Aklief’s prescribing information.
† For more information about this side effect, see “Side effect details” below.

Serious side effects

Serious side effects from Aklief aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects of Aklief which are discussed in further detail below include:

* For more information about this side effect, see “Side effect details” below.

Side effect details

Here’s some detail on certain side effects this drug may cause.

Dry skin

Dry skin is a possible side effect from using Aklief. This side effect was seen in people using the drug in clinical studies, but it was rare.

There are ways to help lower your risk for dry skin while using Aklief. For more information, see the “How to lower your risk for skin side effects while using Aklief” section below.

Irritation, itchiness, or redness or discoloration on your skin

Some people may experience skin reactions while using Aklief. Besides dry skin (see section above), these reactions can include:

  • irritation
  • itchiness
  • redness or discoloration
  • scaling
  • stinging or burning

Irritation at the application site (where you apply Aklief cream) was the most common side effect reported by people using the drug in clinical studies. However, most people using Aklief didn’t have skin irritation.

In studies, skin itchiness and redness or discoloration also occurred. However, they happened less often than skin irritation.

In rare cases, skin reactions can be severe. If you experience a skin side effect that you think may be severe, talk with your doctor or dermatologist right away.

­There are ways to help lower your risk for skin side effects. For more information, see the “How to lower your risk for skin side effects while using Aklief” section below.

Sunburn

Using Aklief cream may raise your risk for sunburn. Among people using the drug in clinical studies, this was one of the most common side effects. However, it didn’t occur in many people using Aklief.

During your Aklief treatment, you’ll also want to minimize or avoid exposure to sunlight. This includes tanning beds, sun lamps, and other sources of ultraviolet (UV) light. If you have to be in the sun, you should use a sunscreen with a skin protection factor (SPF) of at least 15. You should also wear protective clothing (such as a wide-brimmed hat) to cover any areas of skin you apply Aklief to that may be exposed to sunlight.

For other ways to lower your risk for skin side effects, including sunburn, see the section directly below.

How to lower your risk for skin side effects while using Aklief

Aklief can cause certain skin side effects in some people. But there are ways to help prevent these side effects during your treatment.

First, keep in mind that these side effects tend to be more severe during your first 4 weeks of using Aklief. These side effects may go away on their own with some time.

Certain skin products may be more likely to contribute to dry skin while you’re taking Aklief. During your Aklief treatment, you should avoid using skin products that dry out or irritate your skin. Examples include:

  • products containing high alcohol amounts or added fragrances
  • abrasive or medicated cleansers or soaps (unless your doctor or dermatologist tells you it’s OK)
  • products containing synthetic dyes
  • cosmetics, cleansers, and soaps with strong drying effects (such as products containing salicylic acid)
  • products with the ingredient sodium lauryl sulfate

Avoid applying Aklief to sunburned skin, or any skin affected by cuts, abrasions, or eczema. Applying Aklief to these areas can cause skin irritation, which could be severe in rare cases. You should also avoid waxing as a form of hair removal on any area where you apply Aklief. This is because Aklief could make your skin more sensitive to irritation from waxing.

What to do if you have skin side effects while taking Aklief

If you’re concerned about dry skin, or if you experience this side effect while using Aklief, talk with your doctor or dermatologist. They can review possible factors that could be contributing to your dry skin, including Aklief and any other products you use. Then, they can help find the best skin care routine for you, including the best way to manage your acne.

Your doctor or dermatologist may recommend certain products, such as a moisturizer, to help treat dryness or other skin-related side effects. They could also recommend you apply Aklief less frequently, or temporarily stop using it until your side effects clear up. If your side effects are severe or don’t go away with time, your doctor may recommend you stop using Aklief.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Aklief. Mild allergic reactions were very rare in people taking the drug in clinical trials, though.

Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (temporary warmth, redness, or deepening of skin color)

A more severe allergic reaction wasn’t reported by anyone using Aklief in clinical trials, but like with any drug, it is possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have an allergic reaction to Aklief, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

The Food and Drug Administration (FDA) approves prescription drugs such as Aklief to treat certain conditions. Aklief may also be used off-label for other conditions. Off-label drug use means using a drug for a purpose other than what it’s been approved for by the FDA.

Aklief for acne

Aklief is approved by the FDA to treat acne in adults, as well as in children ages 9 years and older.

Acne is a common condition that affects your skin. It occurs when your pores (small openings in the skin that release oils and sweat) become clogged. Acne outbreaks are most common on your face, but acne can also affect your back, chest, or shoulders.

Effectiveness for acne

Clinical studies have shown Aklief to be effective for treating acne in adults and in children ages 9 years and older. For information about how the drug performed in studies, see the drug’s prescribing information.

Aklief and children

Aklief is approved to treat acne in children ages 9 years and older. Clinical studies have shown the drug to be effective for use in children in this age range.

Other drugs are available that can treat acne. Some may be a better fit for you than others. If you’re interested in finding an alternative to Aklief, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label drug use is when an FDA-approved drug is used for a purpose other than what it’s approved for.

Alternatives for acne

Examples of other drugs that may be used to treat acne include:

  • topical dapsone (Aczone)
  • other topical retinoids, such as:
    • tazarotene (Tazorac, Arazlo, Fabior)
    • tretinoin (Retin-A, Avita, Altreno, Atralin)
    • adapalene (Differin)
    • adapalene/benzoyl peroxide (Epiduo, Epiduo Forte)
  • topical antibiotics, such as:
    • erythromycin (Erygel)
    • erythromycin/benzoyl peroxide (Benzamycin)
    • clindamycin (Evoclin, Cleocin T, Clindagel)
    • clindamycin/tretinoin (Veltin, Ziana)
    • clindamycin/benzoyl peroxide (Acanya, Benzaclin, Duac, Onexton)
    • minocycline (Amzeeq)
  • antibiotics taken by mouth, such as:
    • doxycycline (Vibramycin, Doryx, Acticlate)
    • tetracycline (Achromycin V)
    • minocycline (Solodyn, Minolira, Ximino)
    • azithromycin
  • birth control pills, such as:
    • drospirenone/ethinyl estradiol/levomefolate calcium (Beyaz)
    • drospirenone/ethinyl estradiol (Yaz)
    • ethinyl estradiol/norgestimate (Ortho Tri-Cyclen 21, Ortho Tri-Cyclen 28)
  • topical azelaic acid
  • topical salicylic acid
  • isotretinoin

As with all medications, the cost of Aklief can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Keep in mind that you may be able to get a 90-day supply of Aklief. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If you’re interested in this option, check with your doctor or your insurance company.

Before approving coverage for Aklief, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Aklief, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Aklief, or if you need help understanding your insurance coverage, help is available.

Galderma Laboratories, the manufacturer of Aklief, offers a savings card that may help lower the cost of the drug for you. For more information and to find out if you’re eligible for support, visit the program website.

Mail-order pharmacies

Aklief may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home.

If recommended by your doctor, you may be able to receive a 90-day supply of Aklief, so there’s less concern about running out of the medication. If you’re interested in this option, check with your doctor and your insurance company. Some Medicare plans may help cover the cost of mail-order medications.

If you don’t have insurance, you can ask your doctor or pharmacist about online pharmacy options.

Generic version

Aklief is a brand-name drug. It’s not currently available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

Aklief contains the active drug trifarotene.

Here are answers to some frequently asked questions about Aklief.

Does Aklief contain retinol?

No, but the drug is similar to retinol.

Retinol and Aklief both belong to a drug class called retinoids. (A drug class is a group of drugs that work together in the same way.) Retinoids are made from vitamin A. Both Aklief and retinol are available as creams. Both medications may be used to treat acne.

Retinol can be bought over the counter without a prescription. Aklief requires a prescription.

If you have other questions about how Aklief and retinol compare, talk with your doctor or dermatologist. They can also help determine the best treatment for your acne.

Is Aklief used to reduce wrinkles?

No, Aklief isn’t FDA-approved to reduce wrinkles. The drug hasn’t been studied for this use.

If you have questions about treatment options for reducing wrinkles, talk with your doctor or dermatologist.

Can I use Aklief to treat acne scars?

No, Aklief hasn’t been shown to treat current acne scars. But using Aklief may help prevent future scars from forming.

If you have questions about treating acne scars, talk with your doctor or dermatologist.

Will Aklief get rid of blackheads?

It’s possible. In clinical studies, people who used Aklief had more of their lesions (such as blackheads) go away during treatment than people who used a placebo. (A placebo is a treatment with no active drug.)

For more information on Aklief’s effectiveness, see the “Aklief uses” section above. You can also ask your doctor or dermatologist for more information about blackhead treatments such as Aklief.

The Aklief dosage your doctor prescribes will depend on the size of the area(s) on your body affected by acne.

The following information describes dosages that are commonly used or recommended. However, be sure to use the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Aklief comes as a cream you apply to your skin. It contains the active drug trifarotene. It’s available in one strength: 0.005%. This strength means that each gram of Aklief cream contains 50 micrograms of trifarotene.

Aklief cream comes in a pump, available in three sizes: 30 grams (g), 45 g, and 75 g.

Dosage for acne

The recommended Aklief dosage for acne is one thin layer applied to the area affected by acne once a day, in the evening.

Aklief cream comes in a bottle with a pump. In general:

  • For treating acne on your face (cheeks, chin, forehead, or nose), use one pump.
  • For treating acne on your upper trunk (chest, shoulders, and upper back), use two pumps.
  • For treating acne on your middle or lower back, use one pump.

If you have questions about how much Aklief to use, talk with your doctor or pharmacist.

Children’s dosage

Aklief is approved to treat acne in children ages 9 years and older.

The children’s dosage of Aklief for treating acne is the same as the dose used in adults. See the “Dosage for acne” section directly above.

What if I miss a dose?

Aklief cream should be applied in the evening. If you forget to apply your dose, apply it as soon as you remember. But if you realize you missed a dose and it’s the next day, skip the missed dose and wait until your next scheduled dose that evening.

You shouldn’t apply Aklief twice a day or use a larger dose to try to make up for a missed dose. Doing so may raise your risk for side effects, such as skin irritation.

To help make sure you don’t miss a dose, try using a medication reminder. This can include setting an alarm or timer on your phone, or downloading a reminder app. A kitchen timer can work, too.

Will I need to use this drug long term?

Aklief may be used long term to treat your acne. If you and your doctor agree that Aklief is working well for you, you’ll likely use it long term.

For many teens and young adults, acne goes away as they get older. Your doctor (or your child’s doctor) will determine how long Aklief should be used.

Your doctor or dermatologist may prescribe Aklief on its own to treat acne, or they may prescribe it with other medications. According to the American Academy of Dermatology, using multiple topical medications that work differently to treat acne can be effective.

During your Aklief treatment, you should avoid using other topical products (medicated or not) that can irritate your skin. One of Aklief’s side effects is skin irritation, so using other products that could also irritate your skin may raise your risk for this side effect.

Before you start using Aklief, tell your doctor or dermatologist if you use any other medications for acne. They can make sure the drugs are safe to use together.

There isn’t a known interaction between alcohol and Aklief. There also isn’t evidence that drinking alcohol directly causes acne.

However, drinking alcohol does cause side effects that may indirectly raise your risk for acne, or make existing acne worse. These side effects include:

If you drink alcohol, talk with your doctor about how much may be safe for you to drink with your condition and treatment plan.

Aklief isn’t known to interact with other medications, herbs, supplements, or foods. However, while using Aklief, you should avoid using skin products that contain high amounts of alcohol. (See below to learn more.)

Before using Aklief, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Products containing alcohol

During your Aklief treatment, it’s very important to avoid skin products that contain high amounts of alcohol. Many topical skin products, including astringents, facial cleansers, and toners, contain alcohol. The alcohol in these products can irritate or dry your skin, making your acne worse. Instead, the American Academy of Dermatology recommends using gentle, non-abrasive cleansers and products that don’t contain alcohol.

If you have questions about finding skincare products you can use along with Aklief, talk with your doctor or dermatologist.

You should use Aklief according to the instructions your doctor or other healthcare professional gives you.

Aklief cream comes in a bottle with a pump. The recommended dosage for acne is one thin layer applied to the area affected by acne once every evening.

Here are some important tips to keep in mind when applying Aklief cream:

  • Be sure to first clean the area where you’re going to apply Aklief. You can pat the area to help make sure it’s fully dry, but be gentle.
  • When applying Aklief, be careful to avoid applying it to:

To help reduce your risk for skin irritation, the manufacturer of Aklief recommends using a moisturizer starting on your first day of Aklief treatment. Your doctor or dermatologist can help recommend a moisturizer for you.

During your Aklief treatment, you’ll also want to minimize or avoid exposure to sunlight. This includes tanning beds, sun lamps, and other sources of ultraviolet (UV) light. If you have to be in the sun, you should use a sunscreen with a skin protection factor (SPF) of at least 15. You should also wear protective clothing (such as a wide-brimmed hat) to cover any areas of skin you apply Aklief to that may be exposed to sunlight.

When to use

The recommended Aklief dosage for treating acne is one thin layer applied to the area affected by acne once every evening.

To help make sure you don’t miss a dose, try using a medication reminder. This can include setting an alarm or timer on your phone or downloading a reminder app. A kitchen timer can work, too.

Aklief is approved by the Food and Drug Administration (FDA) to treat acne in adults and children ages 9 years and older.

About acne

Acne is a common condition that affects your skin. Acne outbreaks are most common on your face, but acne can also affect your back, chest, or shoulders.

Acne occurs when your pores (small openings in the skin that release oils and sweat) become clogged. Your pores can become clogged by things such as oil and dead skin cells.

When pores clog, this creates an environment for bacteria to grow in. When this bacteria grows in your pores, it begins making chemicals that trigger your immune system to respond. Your immune system increases inflammation (swelling and damage) where the clogged pore is.

Inflammation and a buildup of dead skin causes lesions to form. These lesions are commonly called pimples or zits.

What Aklief does

Aklief contains the active drug trifarotene, which is a retinoid.

The way Aklief works to treat acne isn’t fully known, but it’s thought that it helps reduce inflammation. It also unclogs pores and prevents new lesions from forming.

How long does it take to work?

Aklief begins working the first time you apply the cream. But it’s not known exactly when you may see improvement in your acne symptoms. This is because researchers didn’t measure how people’s acne responded to Aklief in clinical studies of the drug until after they had used it for 12 weeks.

If you have questions about when you should expect to see results from Aklief, talk with your doctor or pharmacist.

It’s not known if Aklief is safe to use while pregnant. Clinical studies of Aklief didn’t find any increased risks when the drug was used during pregnancy.

However, there have been a few rare reports of other retinoid medicated creams causing birth defects. (Aklief is a type of retinoid cream). Because these reports happened outside clinical studies, it’s not known whether the retinoid cream was the cause of the birth defects.

If you’re pregnant or planning to become pregnant, talk with your doctor or dermatologist before using Aklief.

It’s not known if Aklief is safe to use during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Aklief.

For more information about taking Aklief during pregnancy, see the “Aklief and pregnancy” section above.

It isn’t known whether Aklief is safe to use while breastfeeding. It’s not known if trifarotene, the active drug in Aklief, passes into human breast milk. It was present in breast milk in animal studies, but these studies don’t always predict what will occur in humans.

If your doctor prescribes Aklief while you’re breastfeeding, you should apply the smallest amount to the affected area for the shortest time possible. You also should avoid applying it directly to the area where a child would come in direct contact with the cream while breastfeeding. This includes the nipple and the darkened area surrounding it.

If you’re currently breastfeeding or planning to breastfeed, talk with your doctor before using Aklief.

Before taking Aklief, talk with your doctor about your health history. Aklief may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Skin problems, including eczema, sunburn, or cuts. Using Aklief cream can cause skin irritation, itchiness, redness or discoloration, and sunburn. If you already have skin problems, including eczema, you may have a higher risk for skin irritation. Aklief shouldn’t be applied to skin affected by eczema, cuts, or sunburn. Before you start using Aklief, talk with your doctor about any skin problems you have.
  • Allergic reaction. If you’ve had an allergic reaction to Aklief or any of its ingredients, you shouldn’t use Aklief. Ask your doctor what other medications are better options for you.
  • Pregnancy. It isn’t known if Aklief is safe to use during pregnancy. For more information, see the “Aklief and pregnancy” section above.
  • Breastfeeding. It’s not known whether Aklief is safe to use while breastfeeding. For more information, see the “Aklief and breastfeeding” section above.

Note: For more information about the potential negative effects of Aklief, see the “Aklief side effects” section above.

Do not use more Aklief than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you use too much Aklief

If you think you’ve used too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

When you get Aklief from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk with your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good to use can depend on many factors, including how and where you store the medication.

Aklief cream should be stored at a room temperature of 68˚F to 77˚F (20˚C to 25˚C), in a tightly sealed container away from heat. Avoid storing this medication in areas where it could get damp or wet, such as the bathroom.

Disposal

If you no longer need to use Aklief and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

This article provides several useful tips on medication disposal. You can also ask your pharmacist for information about how to dispose of your medication.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

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