Oral: Symptomatic control of severe, recalcitrant disabling psoriasis; repigmentation of idiopathic vitiligo; palliative treatment of skin manifestations of cutaneous T-cell lymphoma (CTCL)

Topical: Repigmentation of idiopathic vitiligo

Extracorporeal: Palliative treatment of skin manifestations of CTCL

CTCL: For use only if inadequate response to other forms of therapy. Used in conjunction with long wave radiation of white blood cells using the UVAR® photopheresis system. Safety and efficacy in pediatric patients have not been established.

Psoriasis: For use only if inadequate response to other therapies when the diagnosis is biopsy proven. Administer only in conjunction with scheduled controlled doses of long wave ultraviolet (UVA) radiation (combination referred to as PUVA). Safety and efficacy in pediatric patients have not been established.

Vitiligo: Used in conjunction with controlled doses of long wave ultraviolet radiation or sunlight. Lotion should only be applied under direct supervision of prescriber and should not be dispensed to the patient. Safety and efficacy in children <12 years of age have not been established.

Cardiovascular: Severe edema, hypotension

Central nervous system: Nervousness, vertigo, depression, dizziness, headache, malaise

Dermatologic: Painful blistering, burning, and peeling of skin; pruritus (10%), freckling, hypopigmentation, rash, cheilitis, erythema, itching, urticaria

Gastrointestinal: Nausea (10%)

Neuromuscular & skeletal: Loss of muscle coordination, leg cramps

Miscellaneous: Miliaria

CYP1A2 substrates: Methoxsalen may increase the levels/effects of CYP1A2 substrates. Example substrates include aminophylline, fluvoxamine, mexiletine, mirtazapine, ropinirole, theophylline, and trifluoperazine.

CYP2A6 substrates: Methoxsalen may increase the levels/effects of CYP2A6 substrates. Example substrates include dexmedetomidine and ifosfamide.

Protein binding: Reversibly bound to albumin

Metabolism: Hepatic; forms metabolites

Bioavailability: Bioavailability increased with soft-gelatin capsules compared to hard-gelatin capsules; exposure using UVAR® system is ~200 times less than with oral administration

Time to peak, serum:

Hard-gelatin capsules: 1.5-6 hours (peak photosensitivity: ~4 hours)

Soft-gelatin capsules: 0.5-4 hours (peak photosensitivity: 1.5-2 hours)

Half-life elimination: ~2 hours

Excretion: Urine (~95% as metabolites)

Children >12 years and Adults: Vitiligo: Topical: Apply lotion 1-2 hours before exposure to UVA light, no more than once weekly

Adults:

Psoriasis: Oral: 10-70 mg 11/2-2 hours before exposure to UVA light; dose may be repeated 2-3 times per week, based on UVA exposure; doses must be given at least 48 hours apart; dosage is based upon patient's body weight and skin type:

<30 kg: 10 mg

30-50 kg: 20 mg

51-65 kg: 30 mg

66-80 kg: 40 mg

81-90 kg: 50 mg

91-115 kg: 60 mg

>115 kg: 70 mg

Vitiligo: (8-MOP®): Oral: 20 mg 2-4 hours before exposure to UVA light; dose may be repeated based on erythema and tenderness of skin; do not give on 2 consecutive days

CTCL: Extracorporeal (Uvadex®): 200 mcg injected into the photoactivation bag during the collection cycle using the UVAR® photopheresis system (consult user's guide). Treatment schedule: Two consecutive days every 4 weeks for a minimum of 7 treatment cycles

Capsule:

8-MOP®: 10 mg [hard-gelatin capsule]

Oxsoralen-Ultra®: 10 mg [soft-gelatin capsule]

Lotion (Oxsoralen®): 1% (30 mL) [contains alcohol 71%]

Solution, for extracorporeal administration (Uvadex®): 20 mcg/mL (10 mL) [not for injection]