Trifarotene

Trifarotene is a prescription medication used topically for the treatment of acne vulgaris.

• Trifarotene is available under the following different brand names: Aklief

Common side effects of Trifarotene include:

• application site reactions such as:
• irritation,
• itching,
• pain,
• redness,
• dryness,
• stinging/burning,
• discoloration,
• rash,
• swelling, and
• lesions
• sunburn,
• acne, and
• allergic dermatitis

Serious side effects of Trifarotene include:

• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

Rare side effects of Trifarotene include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Topical cream

• 0.005%

Acne Vulgaris

Adult dosage

• Apply a thin layer of cream sparingly to affected areas every day, in the evening, on clean, dry skin

Pediatric dosage

• Age less than 9 years: Safety and efficacy not established
• Age more than 9 years: Apply a thin layer of cream sparingly to affected areas every day, in the evening, on clean, dry skin

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Trifarotene has severe interactions with no other drugs.
• Trifarotene has serious interactions with no other drugs.
• Trifarotene has moderate interactions with no other drugs.
• Trifarotene has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Trifarotene?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Trifarotene?”

Cautions

• Minimize unprotected exposure to ultraviolet rays (including sunlight and sunlamps) during treatment; exercise caution in patients who normally experience high levels of sun exposure and those with inherent sensitivity to sun; use sunscreen products and protective clothing over treated areas when exposure cannot be avoided
• Skin irritation
  • May experience erythema, scaling, dryness, and stinging/burning
  • Maximum severity of these reactions typically occurred within the first 4 weeks of treatment, and severity decreased with continued use of the medication
  • Advise to use a moisturizer, reduce the frequency of application, or suspend use temporarily
• If severe reactions persist, consider discontinuing treatment

Pregnancy and Lactation

• Available data from clinical trials with use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• There are case reports of major birth defects similar to those seen in fetuses exposed to oral retinoids in pregnant women exposed to other topical retinoids, but these reports do not establish a pattern or association with retinoid-related embryopathy
• Lactation
  • There are no data on the presence of trifarotene in human milk, the effects on the breastfed infant, or the effects on milk production
  • Trifarotene was present in rat milk with oral administration of the drug
  • When present in animal milk, the drug will likely be present in human milk; topical administration of large amounts of trifarotene may result in sufficient systemic absorption to produce detectable quantities in human milk
  • Consider the developmental and health benefits of breastfeeding, along with the mother’s clinical need and any potential adverse effects on the breastfed infant from the drug or the underlying maternal condition