SORILUX

Clinical safety rating: caution

Comprehensive clinical and safety monograph for SORILUX (SORILUX).

How it works

Topical synthetic retinoid that binds to retinoic acid receptors (RAR-gamma) in epidermal cells, regulating gene transcription and reducing abnormal keratinocyte proliferation and differentiation.

What the body does with it

Metabolism	Primarily hepatic via CYP450 isoenzymes; excreted in bile and urine.
Excretion	Primarily fecal elimination (~95%) as unchanged drug; renal excretion accounts for <1%.
Half-life	Approximately 140 hours (range 120-160 h) following topical application; supports once-daily dosing.
Protein binding	>99% bound to plasma proteins, primarily albumin.
Volume of Distribution	Vd/F approximately 800 L (or ~10 L/kg for a 70 kg individual) indicating extensive tissue distribution.
Bioavailability	Topical bioavailability is low; systemic absorption <1% of applied dose under normal use.
Onset of Action	Within 1 week of topical application for plaque psoriasis; maximal effect typically seen after 2-4 weeks.
Duration of Action	Sustained improvement for several weeks after cessation; may require continued application for maintenance.

Classification & Brands

Dosing & administration

Apply a thin layer to affected areas once daily, not to exceed 4.5 g per application. Topical.

Dosage form	AEROSOL, FOAM
Renal impairment	No dose adjustment required for renal impairment.
Liver impairment	No dose adjustment required for hepatic impairment.
Pediatric use	Not recommended for use in pediatric patients below 18 years of age.
Geriatric use	No specific dose adjustment recommended; use caution due to potential for increased absorption in elderly patients with thin or damaged skin.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for SORILUX (SORILUX).

Breastfeeding	No data on excretion in human milk. M/P ratio unknown. Caution recommended; use only if benefit outweighs risk.
Teratogenic Risk	Sorilux (calcipotriene) is a vitamin D analogue. Animal studies have shown fetal abnormalities at high doses. There are no adequate human studies. Risk cannot be ruled out. Use only if clearly needed. First trimester potential risk, second and third trimester unknown but similar caution.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

No black box warning.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to tazarotene or any component of the formulation.","Pregnancy or females planning to become pregnant due to teratogenic effects (retinoid exposure)."]

Clinical Precautions

Precautions

["Avoid excessive exposure to UV light (including sunlight and artificial UV) due to photosensitivity risk.","Not recommended for use on intertriginous or eczematous skin.","May cause local skin irritation (e.g., erythema, scaling, burning)."]

Clinical Tips & Counseling

Drug interactions

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SORILUX

Clinical safety rating: caution

Comprehensive clinical and safety monograph for SORILUX (SORILUX).

How it works

Topical synthetic retinoid that binds to retinoic acid receptors (RAR-gamma) in epidermal cells, regulating gene transcription and reducing abnormal keratinocyte proliferation and differentiation.

What the body does with it

Metabolism	Primarily hepatic via CYP450 isoenzymes; excreted in bile and urine.
Excretion	Primarily fecal elimination (~95%) as unchanged drug; renal excretion accounts for <1%.
Half-life	Approximately 140 hours (range 120-160 h) following topical application; supports once-daily dosing.
Protein binding	>99% bound to plasma proteins, primarily albumin.
Volume of Distribution	Vd/F approximately 800 L (or ~10 L/kg for a 70 kg individual) indicating extensive tissue distribution.
Bioavailability	Topical bioavailability is low; systemic absorption <1% of applied dose under normal use.
Onset of Action	Within 1 week of topical application for plaque psoriasis; maximal effect typically seen after 2-4 weeks.
Duration of Action	Sustained improvement for several weeks after cessation; may require continued application for maintenance.

Classification & Brands

Dosing & administration

Apply a thin layer to affected areas once daily, not to exceed 4.5 g per application. Topical.

Dosage form	AEROSOL, FOAM
Renal impairment	No dose adjustment required for renal impairment.
Liver impairment	No dose adjustment required for hepatic impairment.
Pediatric use	Not recommended for use in pediatric patients below 18 years of age.
Geriatric use	No specific dose adjustment recommended; use caution due to potential for increased absorption in elderly patients with thin or damaged skin.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for SORILUX (SORILUX).

Breastfeeding	No data on excretion in human milk. M/P ratio unknown. Caution recommended; use only if benefit outweighs risk.
Teratogenic Risk	Sorilux (calcipotriene) is a vitamin D analogue. Animal studies have shown fetal abnormalities at high doses. There are no adequate human studies. Risk cannot be ruled out. Use only if clearly needed. First trimester potential risk, second and third trimester unknown but similar caution.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

No black box warning.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to tazarotene or any component of the formulation.","Pregnancy or females planning to become pregnant due to teratogenic effects (retinoid exposure)."]