Version May 2024
Acne vulgaris: Topical: Apply a thin layer to affected areas once daily in the evening (Ref). Use of 1 to 4 pumps may be needed: 1 pump actuation should cover the face (forehead, cheeks, nose, and chin); 2 pump actuations should cover the upper trunk (reachable upper back, shoulders, and chest); 1 additional pump actuation may be used for middle and lower back, if needed. If skin irritation occurs, may reduce the frequency of application or temporarily interrupt therapy; permanently discontinue for severe, persistent irritation. For moderate to severe acne, may be used as part of an appropriate combination regimen (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling; however, systemic absorption is not extensive, making the need for a dose adjustment unlikely.
There are no dosage adjustments provided in the manufacturer's labeling; however, systemic absorption is not extensive, making the need for a dose adjustment unlikely.
Has not been studied in patients ≥65 years of age. Refer to adult dosing.
(For additional information see "Trifarotene: Pediatric drug information")
Acne vulgaris, treatment: Children ≥9 years and Adolescents: Topical: Apply to affected area once daily in the evening.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Dermatologic: Sunburn (3%)
Local: Application site irritation (8%), application-site pruritus (2%)
<1%: Acne vulgaris, allergic dermatitis, application site pain, application site rash, application-site edema, erythema of skin, local dryness of skin, local skin discoloration, skin erosion
There are no contraindications listed in the manufacturer's labeling.
Canadian labeling: Additional contraindications (not in the US labeling): Hypersensitivity to trifarotene or any component of the formulation or container; patients with eczema or seborrheic dermatitis; women who are pregnant or planning to become pregnant.
Concerns related to adverse effects:
• Photosensitivity: Use is associated with increased susceptibility/sensitivity to UV light; avoid or minimize excessive exposure to sunlamps or sunlight. Daily sunscreen (SPF ≥15) use and other protective measures (eg, clothing over treated areas) are recommended.
• Skin irritation: Erythema, scaling, dryness, and stinging or burning of skin may occur. Onset and worsening is most common within the first 4 weeks of treatment and often decreases with continued use. Concomitant topical medications (eg, medicated or abrasive soaps and cleansers, cosmetics with a strong drying effect, products with high concentrations of alcohol) should be avoided due to increased skin irritation. Use of a moisturizer, reduced frequency of application, or temporary discontinuation may be considered based on the reaction severity; permanent discontinuation may be considered for severe, persistent reactions.
Disease-related concerns:
• Eczema: Use with caution in patients with eczema; may cause severe irritation.
Other warnings/precautions:
• Appropriate use: For external use only; avoid contact with abraded skin, sunburned skin, mucous membranes, eyes, mouth, and angles of the nose. Hair removal via waxing should be avoided on treated areas.
Some dosage forms may contain propylene glycol; in neonates, large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External:
Aklief: 0.005% (45 g) [contains propylene glycol]
No
Cream (Aklief External)
0.005% (per gram): $18.80
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External:
Aklief: 0.005% (2 g, 15 g, 30 g, 45 g, 75 g) [contains polysorbate 80, propylene glycol]
Topical: Apply to clean, dry skin. For topical external use only; not for oral, ophthalmic, or intravaginal use. Avoid contact with abraded, broken, eczematous, or sunburned skin, mucous membranes, eyes, lips, and angles of the nose. Moisturizers may be used as necessary.
Cream: For topical use only; not for oral, ophthalmic, or intravaginal use. Apply to clean, dry skin. Avoid contact with eyes, lips, paranasal creases, and mucous membranes. One pump actuation should cover face (cheeks, chin, forehead, and nose); two pump actuations should cover upper trunk (ie, upper back, shoulders, and chest); additional pump actuation may be used if acne present on middle and lower back.
Acne vulgaris: Topical treatment of acne vulgaris in patients ≥9 years of age.
None known.
There are no known significant interactions.
In general, topical products are recommended for the treatment of acne in pregnancy due to lower systemic exposure. However, because trifarotene may share the characteristic of teratogenicity with other retinoids, other agents may be preferred. Avoid applying large amounts over prolonged periods of time to decrease the potential for systemic absorption (Kong 2013).
It is not known if trifarotene is present in breast milk following topical application.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. Because topical agents can be transferred to a breastfeeding infant, avoid applying large amounts over prolonged periods of time to decrease the potential for systemic absorption. Do not apply to nipple or surrounding area and avoid direct skin-to-skin contact with treated areas.
Trifarotene is a retinoic acid receptor (RAR) agonist, with greater selectivity at the gamma subtype. RAR stimulation results in modulation of target genes which are associated with cell differentiation and mediation of inflammation.
Protein binding: ~99.9%.
Metabolism: Primarily metabolized by CYP2C9, CYP3A4, CYP2C8.
Half-life elimination: Terminal: 2 to 9 hours.
Excretion: Feces.
آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟
