Drugs List

Therapeutic Indications

Uses

Acne vulgaris

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.

Contraindications

Children under 12 years
Breastfeeding
Pregnancy

Precautions and Warnings

Females of childbearing potential
Patients over 65 years
Hepatic impairment
Renal impairment

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

Pregnancy

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.

Lactation

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.

Side Effects

Acne
Allergic dermatitis
Asteatotic eczema
Burning sensation (local)
Cheilitis
Dry skin
Erosion
Erythema
Erythema at application site
Eyelid exfoliation
Eyelid oedema
Flushing
Hyperpigmentation of skin
Irritation at application site
Localised urticaria
Pain at application site
Pruritus
Rash
Scaling of skin
Seborrhoeic dermatitis
Skin discolouration
Skin fissures
Skin irritation
Stinging (transient)
Sunburn
Swelling
Vesicles

Presentation

Topical formulation of trifarotene.

Drugs List

Therapeutic Indications

Uses

Acne vulgaris

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.

Dosage

Adults

Contraindications

Children under 12 years
Breastfeeding
Pregnancy

Precautions and Warnings

Females of childbearing potential
Patients over 65 years
Hepatic impairment
Renal impairment

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

Pregnancy

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.

Lactation

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.

Counselling

Advise patient to avoid contact with the eyes, eyelids, lips and mucous membranes and to wash their hands after applying trifarotene.

Side Effects

Acne
Allergic dermatitis
Asteatotic eczema
Burning sensation (local)
Cheilitis
Dry skin
Erosion
Erythema
Erythema at application site
Eyelid exfoliation
Eyelid oedema
Flushing
Hyperpigmentation of skin
Irritation at application site
Localised urticaria
Pain at application site
Pruritus
Rash
Scaling of skin
Seborrhoeic dermatitis
Skin discolouration
Skin fissures
Skin irritation
Stinging (transient)
Sunburn
Swelling
Vesicles

Overdosage

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 ).

Further Information

Last Full Review Date: July 2022

Reference Sources

Summary of Product Characteristics: Aklief 50 microgram/g cream. Galderma (U.K) Ltd. Revised December 2020.