- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Topical formulation of trifarotene.
Treatment of Acne Vulgaris of the face and/or trunk in patients from 12 years of age and older, when many comedones, papules and pustules are present.
One application to the affected area in the evening, on clean and dry skin.
The physician should assess the continued improvement of the patient after 3 months of treatment.
Children under 12 years
Precautions and Warnings
Females of childbearing potential
Patients over 65 years
Contains propylene glycol: may cause irritation
Advise patient to wash hands after use
Avoid administration to eczematous or inflamed skin
Avoid application to broken skin
Avoid contact with eyes, lips or mouth
Avoid contact with mucous membranes
Review treatment after 3 months then periodically thereafter
Discontinue if burning sensation occurs
Discontinue if sensitisation occurs
Pregnancy confirmed: Discontinue this medication
Reduce application frequency/temporarily discontinue if irritation occurs
Advise patient that the use of topical moisturisers may be necessary
Advise patient to avoid exposure to sunlight and UV rays during treatment
Use of 'waxing' as a depilatory method should be avoided on skin treated with trifarotene.
Caution should be exercised if cosmetics or acne medications with desquamative, irritant or drying effects are concomitantly used with trifarotene, as they may produce additive irritant effects.
Pregnancy and Lactation
Trifarotene is contraindicated during pregnancy.
Use of trifarotene during pregnancy is contraindicated by the manufacturer. Animal studies with trifarotene by the oral route have shown reproductive toxicity at high systemic exposure. If the patient is pregnant or becomes pregnant while taking this drug, treatment should be discontinued.
Trifarotene is contraindicated during breastfeeding.
The manufacturer recommends that a decision must be made whether to discontinue breastfeeding or to discontinue trifarotene treatment taking into account the benefit of breastfeeding for the child and the benefit of treatment for the woman. It is unknown whether trifarotene or its metabolites are excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of trifarotene in milk. Effects on exposed infants are unknown.
To avoid the risk of ingestion by, and/or contact exposure of, an infant, nursing women should not apply trifarotene cream to the chest or breast area.
Advise patient to avoid contact with the eyes, eyelids, lips and mucous membranes and to wash their hands after applying trifarotene.
Burning sensation (local)
Erythema at application site
Hyperpigmentation of skin
Irritation at application site
Pain at application site
Scaling of skin
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: July 2022
Summary of Product Characteristics: Aklief 50 microgram/g cream. Galderma (U.K) Ltd. Revised December 2020.
Already a member? Log in
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.