Aklief (trifarotene)

No dosing information is available for this tab.

Trifarotene is administered topically as a 0.005% cream. Trifarotene cream is not recommended for oral, ophthlamic, or intravaginal use. Avoid contact with the eye, lips, paranasal creases, and mucous membranes.

Apply the cream in a thin layer to clean, dry skin.

One pump actuation should be enough to cover the face (i.e., forehead, cheeks, nose, chin); 2 pump actuations should be enough to cover the upper trunk (i.e., reachable upper back, shoulders, chest). One additional pump actuation may be used for the middle and lower back if needed.

Store the cream at 20--25oC; excursions permitted between 15--30degreesC.

No dosing information is available for this tab.

In vitro, trifarotene is primarily metabolized via cytochrome P-450 (CYP) isoenzymes 2C9, 3A4, and 2C8. Trifarotene also undergoes metabolism to a lesser extent via CYP2B6. In vitro data indicate that trifarotene is not expected to inhibit or induce CYP1A2, CYP2B6, or CYP3A4; it is also not expected to inhibit CYP2C8, CYP2C9, CYP2C19, or CYP2D6. Trifarotene is not expected to inhibit multidrug and toxin extrusion (MATE) protein, organic anion transporter polypeptide (OATP), organic anion transporter (OAT), organic cation transporter (OCT), breast cancer resistance protein (BCRP), P-glycoprotein (P-gp), bile salt export pump (BSEP), or mannose phosphate receptor (MPR).

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*None.

There are no contraindication contraindications for this drug.

• Eczema
• Sunburn

There are no moderate contraindications for this drug.

The most common adverse reactions (occurring in >=1% of patients receiving trifarotene cream) were application site irritation, application site pruritus, and sunburn.

There are no severe adverse reactions for this drug.

More Frequent

• Dry skin
• Erythema
• Pruritus of skin
• Skin irritation
• Skin scaling
• Stinging of skin
• Sunburn

Rare or Very Rare

• Acute pain at drug application site
• Allergic dermatitis
• Dyschromia
• Skin rash
• Skin swelling

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Safety and efficacy of trifarotene cream have been established in pediatric patients 9-17 years of age based on evidence from well-controlled clinical studies, a long-term safety study, and a pharmacokinetic study.

Safety and efficacy of trifarotene cream have not been established in pediatric patients <9 years of age.

A drug-associated risk of major birth defects, miscarriage, or adverse fetal or maternal outcomes has not been identified with trifarotene cream based on available clinical data in pregnancy.

Some case reports have noted major birth defects similar to those observed with oral retinoid exposure in pregnant women exposed to other topical retinoids; however, these reports do not establish a pattern or association with retinoid-related embryopathy.

No data are available on the presence of trifarotene in human milk. The effects of trifarotene on the breastfed infant and the effects on milk production are not known.

After oral administration, trifarotene was present in the milk of lactating rats. If a drug is present in animal milk, it is likely present in human milk. Topical application of large amounts of trifarotene could possibly result in substantial systemic absorption and detectable levels in human milk. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for the drug and any potential adverse effects from trifarotene on the breastfed infant.

Advise breastfeeding patients to use trifarotene cream on the smallest area of skin and for the shortest duration possible to minimize potential infant exposure. To prevent direct infant exposure, advise breastfeeding patients to avoid applying trifarotene cream directly to the nipple or areola.

The manufacturer makes no specific dosage recommendations for geriatric patients.

Patients >=65 years of age were not included in clinical trials of trifarotene cream; differences in response compared to younger adults cannot be assessed.