Aklief

Aklief is a prescription medication used to treat acne on the face, chest, shoulders and back. 

Aklief belongs to a group of drugs called retinoids. It works by removing dead skin cells from the surface to help unclog pores, and help prevent new acne from forming. It also reduces the inflammation often experienced with pimples.

This medication is a topical cream that comes in a pump. It is to be applied to the affected area(s) once daily in the evening.

Common side effects include application site irritation, itching, and sunburn.

Aklief Cream is a prescription retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

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

The most common side effects of Aklief Cream include: application site irritation, itching, and sunburn.

Aklief Cream may cause serious side effects, including:

Local skin irritation. Local skin reactions are common with Aklief Cream, are most likely to happen during the first 4 weeks of treatment and may decrease with continued use of Aklief Cream. Signs and symptoms of local skin reactions include:

• redness
• scaling
• dryness
• stinging or burning

To help reduce your risk of developing these local skin reactions, when you begin treatment with Aklief Cream, you should begin applying a moisturizer on your skin as often as needed.

Tell your healthcare provider if you develop symptoms of a local skin reaction. Your doctor may tell you to use Aklief Cream less often, or to temporarily, or permanently stop your treatment with Aklief Cream.

These are not all the possible side effects of Aklief Cream. For more information, ask your healthcare provider or pharmacist.

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

Tell your healthcare provider about all the medicines you take, including prescription and over-the-couter medicines, vitamins and herbal supplements. 

Especially tell your healthcare provider if you use any other medicine for acne.

​​​​​​Aklief Cream may cause serious side effects including:

• Local skin irritation. Local skin reactions are common with Aklief Cream, are most likely to happen during the first 4 weeks of treatment and may decrease with continued use of Aklief Cream. Signs and symptoms of local skin reactions include:
  • redness
  • scaling
  • dryness
  • stinging or burning

To help reduce your risk of developing these local skin reactions, when you begin treatment with Aklief Cream, you should begin applying a moisturizer on your skin as often as needed. 

Tell your healthcare provider if you develop symptoms of a local skin reaction. Your doctor may tell you to use Aklief Cream less often, or temporarily, or permanently stop your treatment with Aklief Cream.

• Avoid application of Aklief Cream to cuts, abrasions or eczematous or sunburned skin.
• Use of “waxing” as a depilatory method should be avoided on skin treated with Aklief Cream.
• Minimize exposure to sunlight and sunlamps.
• Use sunscreen and protective clothing over treated areas when exposure cannot be avoided.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of this medication, there are no specific foods that you must exclude from your diet.

Before using Aklief Cream, tell your healthcare provider about all of your medical conditions, including if you :

• have skin problems, including eczema, cuts or sunburn
• are pregnant or planning to become pregnant. It is not known if Aklief Cream can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Aklief Cream passes into your breast milk. Breastfeeding women should use Aklief Cream on the smallest area of skin and for the shortest time needed while breastfeeding. Do not apply Aklief Cream to the nipple and areola to avoid contact with your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-couter medicines, vitamins and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

In clinical trials, pregnant women who used topical Aklief cream did not experience miscarriage or adverse maternal or fetal outcomes.

In animal studies, pregnant animals were given an oral form of this medication in very high dosages and some adverse fetal effects, including fetal deaths were observed.

Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Aklief Cream passes into your breast milk. Breastfeeding women should use Aklief Cream on the smallest area of skin and for the shortest time needed while breastfeeding. Do not apply Aklief Cream to the nipple and areola to avoid contact with your baby.

In animal studies, trifarotene (the active ingredient in Aklief) was present in rat milk with oral administration of the drug. When a drug is present in animal milk, it is likely that the drug will be present in human milk. It is possible that topical administration of large amounts of Aklief Cream could result in sufficient systemic absorption to produce detectable quantities in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Aklief Cream and any potential adverse effects on the breastfed infant from Aklief Cream or from the underlying maternal condition.

Use Aklief Cream exactly as your healthcare provider tell you to use it. 

Cleanse the areas to be treated with a mild or soapless cleanser and pat dry.

Apply a thin layer of Aklief Cream to the affected areas once a day in the evening. One pump for the face, two pumps for the chest, shoulders, and back. Avoid contact with your eyes, lips, mouth, the corners of your nose, and vagina.

Moisturize as often as needed to help minimize skin dryness and irritation.

Avoid sunlight. If you have to be in sunlight, or are sensitive to sunlight, use a sunscreen with an SPF (sun protection factor) of 15 or more, and wear protective clothing and a wide-brimmed hat to cover the treated areas.

If you miss a dose, don’t double the dose to make up for the forgotten one. Just continue the next day with the same amount of product. Try and keep using it as your doctor instructed to get the most out of your treatment.

Take this medication exactly as prescibed by your doctor. Follow the directions on your prescription label carefully. 

Apply a thin layer of Aklief Cream to the affected areas once daily, in the evening, on clean and dry skin. 

• One pump actuation should be enough to cover the face (i.e., forehead, cheeks, nose, and chin).
• Two actuations of the pump should be enough to cover the upper trunk (i.e., reachable upper back, shoulders and chest). One additional pump actuation may be used for middle and lower back if acne is present.

If you apply too much Aklief Cream, call your healthcare provider or local poison control center, or seek emergency medical attention right away.

Store Aklief Cream at room temperature, 68° to 77°F (20° to 25°C).

• Keep Aklief Cream away from heat
• If you receive a sample tube of Aklief Cream from your doctor, keep the tube tightly closed

Keep Aklief Cream and all medicines out of the reach of children.