Topical JAK1/2 Inhibitor Pregnancy: §4.6: contraindicated during pregnancy and during breast-feeding. Women of childbearing potential have to use effective contraception during treatment and for 4 weeks after discontinuation. There are no or limited data in pregnant women and data on systemic absorption of topical ruxolitinib during pregnancy are lacking; animal studies show ruxolitinib is embryotoxic and foetotoxic after oral administration (teratogenicity was not observed in rats or rabbits). Treatment must be discontinued approximately 4 weeks before the beginning of breastfeeding.

Ruxolitinib Cream

Brand names: Opzelura

Ruxolitinib cream is a topical Janus kinase (JAK) inhibitor applied to the skin for conditions such as mild-to-moderate atopic dermatitis and non-segmental vitiligo.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Non-segmental vitiligo (adults): apply a thin layer of ruxolitinib 15 mg/g cream twice daily to the depigmented skin areas, up to a maximum of 10% of body surface area (BSA), with a minimum of 8 hours between two applications.

Route: Cutaneous (topical) use only — not for ophthalmic, oral or intravaginal use

Frequency: Twice daily, with a minimum of 8 hours between applications

Max: Treat no more than 10% of body surface area — '10% BSA represents an area as large as 10 times the palm of one hand with the 5 fingers' — and use the smallest skin area necessary. 'No more than two tubes of 100 grams a month should be used.'

UK SPC for Opzelura 15 mg/g cream (https://www.medicines.org.uk/emc/product/14903/smpc). Treatment should be initiated and supervised by physicians with experience in the diagnosis and treatment of non-segmental vitiligo. DURATION AND RESPONSE: satisfactory repigmentation may require treatment beyond 24 weeks; if there is less than 25% repigmentation in treated areas at week 52, treatment discontinuation should be considered; once satisfactory repigmentation is achieved, treatment in those areas can be stopped; if depigmentation recurs after discontinuation, therapy can be reinitiated on the affected areas; there is no need to consider tapering therapy. ADMINISTRATION: avoid washing treated skin for at least 2 hours after application; do not apply to the lips, to avoid ingestion; patients should wash their hands after applying the cream unless it is their hands that are being treated, and anyone else applying the cream should wash their hands afterwards. In cases of accidental exposure in the eyes or mucous membranes, the cream should be thoroughly wiped off and/or rinsed with water. PAEDIATRIC: §4.2 states that for adolescents (12-17 years) the posology is the same as for adults; the safety and efficacy in children below 12 years of age have not been established and no data are available. No per-kg paediatric dose exists for this topical product, so paedDose is null; verify any under-18 use against a children's formulary. HEPATIC IMPAIRMENT: no studies have been performed, but due to limited systemic exposure, dose adjustment is not necessary. MONITORING (§4.4): non-melanoma skin cancers, predominantly basal cell carcinomas, have been reported with topical ruxolitinib (most patients had risk factors such as prior phototherapy or prior NMSC; causality not established) — periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. Cases of herpes zoster reactivation have been reported; if a patient develops herpes zoster, temporary interruption of therapy should be considered until the episode resolves.

Dose adjustments

Renal

§4.2: no studies have been performed in patients with renal impairment, but due to limited systemic exposure dose adjustment is not necessary; as a precautionary measure, ruxolitinib cream should not be used by patients with end stage renal disease, due to lack of safety data.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance or to any of the excipients (§4.3)
Pregnancy (§4.3)
Breast-feeding (§4.3)

Side effects

Common — application site acne (the most common adverse reaction, 5.8%)
Uncommon — herpes zoster (reactivation reported; consider temporary interruption until the episode resolves)
§4.4 — non-melanoma skin cancers, predominantly basal cell carcinomas, have been reported in patients treated with topical ruxolitinib (causal relationship not established)
Excipient-related local reactions — propylene glycol may cause skin irritation; cetyl alcohol, stearyl alcohol and butylated hydroxytoluene may cause local skin reactions such as contact dermatitis
Excipient-related allergy — methyl and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed) and polysorbate 20 may cause allergic reactions

Interactions

§4.5: no interaction studies have been performed with topically administered ruxolitinib; the potential for interactions is considered low because of the limited systemic exposure following topical administration
CYP3A4 — based on in vitro data ruxolitinib is predominantly cleared by CYP3A4 metabolism; for ORAL ruxolitinib, plasma AUC is approximately doubled with a potent CYP3A4 inhibitor and only modestly increased with a moderate inhibitor
Other topical medicines used to treat vitiligo — the combination has not been evaluated and co-application on the same skin areas is not recommended
Narrow-band ultraviolet B (NB-UVB) phototherapy — efficacy and safety of the combination has not been established; no recommendation can be made

Clinical monograph

How it works

It inhibits JAK1 and JAK2 within the skin, blocking cytokine signalling that drives inflammation in eczema and the melanocyte-directed immune response in vitiligo, supporting repigmentation.

Prescribing in practice

Although systemic absorption from the cream is low, oral JAK inhibitors carry class warnings for serious infection, thrombosis and malignancy, so limit treated body-surface area and duration as directed and avoid in serious active infection.
Apply a thin layer to affected areas only and avoid the eyes and mucous membranes; in vitiligo, repigmentation develops slowly over months.
Avoid concurrent use with other immunosuppressive biologics or potent immunosuppressants unless specialist-advised.

Monitoring

Monitoring is mainly clinical, reviewing skin response, extent of application and any signs of infection, with reassessment if there is no benefit after an adequate trial.

Counselling the patient

Apply a thin layer only to the affected skin and do not exceed the area advised.
In vitiligo, colour returns gradually over many months, so persistence is important.
Report any signs of infection and keep the cream away from your eyes.

Evidence & guidelines

Topical ruxolitinib's efficacy was demonstrated in the TRuE-AD trials for atopic dermatitis and the TRuE-V trials for non-segmental vitiligo.

Reference: TRuE-V1 & V2 trials (Hamzavi et al. NEJM 2022); TRuE-AD trials (Kim et al. NEJM 2021); MHRA SPC Opzelura 2023; NICE TA955 (vitiligo, 2024); Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways