Adult Dosing

Extensively depigmented vitiligo [8-MOP]

• 20 mg PO per session; 2-4 hrs prior to UVA exposure. Therapy should be on alternate days and never two consecutive days

Severe, recalcitrant, disabling psoriasis [8-MOP, Oxsoralen ultra]

• Approx. 0.6 mg/kg
• <30 kg: 10 mg/session PO not more often than q48h
• 30-50 kg: 20 mg/session PO not more often than q48h
• 51-65 kg: 30 mg/session PO not more often than q48h
• 66-80 kg: 40 mg/session PO not more often than q48h
• 81-90 kg: 50 mg/session PO not more often than q48h
• 90-115 kg: 60 mg/session PO not more often than q48h
• >115 kg: 70 mg/session PO not more often than q48h

• Administer 8-MOP capsules 2 hrs prior to UVA exposure and Oxsoralen ultra capsule 1.5-2 hrs prior to UVA exposure
• Increase the dose by 10 mg after 15 session if minimal or no response
• Treatment should not be given more often than once every other day because the full extent of phototoxic reactions may not be evident until 48 hours after each exposure

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• With long wave UVA radiation, for the symptomatic control of severe, recalcitrant, disabling psoriasis not adequately responsive to other forms of therapy [8-Mop, Oxsoralen-Ultra]
• In combination with long wave UVA radiation, for the repigmentation of idiopathic vitiligo [8-Mop]
• With long-wave UV radiation of white blood cells (photopheresis) with the UVAR photopheresis system is indicated in the palliative treatment of skin manifestations of cutaneous T-cell lymphoma in people not responsive to other forms of treatment [8-Mop]

• Hypersensitivity to any of the ingredients of the product
• Patients exhibiting idiosyncratic reactions to psoralen compounds
• History of light sensitive disease states (e.g. lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum, and albinism)
• Melanoma or with a history of melanoma
• Invasive squamous cell carcinomas
• Aphakia, because of the significantly increased risk of retinal damage due to the absence of lenses

• Methoxsalen with UV radiation should only be used by physicians experienced in the diagnosis and treatment of psoriasis and vitiligo and who have special training and experience in photochemotherapy and should be administered under constant supervision of such physician
• Restrict the use only for patients with severe, recalcitrant, disabling psoriasis which is not responsive to other forms of therapy, and only when the diagnosis is confirmed
• Due to possibilities of ocular damage, aging of the skin, and skin cancer including melanoma, the patient should be fully informed by the physician of the risks inherent in this therapy
• When methoxsalen is used in combination with photopheresis, refer to the UVAR System Operator’s Manual for specific warnings, cautions, indications, and instructions related to photopheresis [8-MOP]
• Do not interchange 8-MOP Capsules (Methoxsalen Hard Gelatin Capsules) with Oxsoralen-Ultra Capsules (Methoxsalen Soft Gelatin Capsules) without retitration of the patient
• Oxsoralen-Ultra Capsules exhibits significantly greater bioavailability and earlier photosensitization onset time, use in accordance with the dosimetry specifically recommended for this product. Determine the minimum phototoxic dose (MPD) and phototoxic peak time after drug administration, prior to onset of photochemotherapy with this dosage form [Oxsoralen-Ultra]

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Caution advised, dose adjustments not defined

• Serious burns from either UVA or sunlight have been reported, if the recommended dosage of the drug and/or exposure schedules are exceeded
• Cutaneous squamous-cell carcinoma has been observed in psoriasis patients treated with oral methoxsalen and photochemotherapy (PUVA). Patients receiving more than 250 PUVA treatments and those who have been treated for more than 15 yrs are at higher risk. Closely monitor all PUVA patients for skin tumors throughout their lives
• Keratoses were keratotic papules, actinic keratosis-like macules, nonscaling dome-shaped papules, and lichenoid porokeratotic-like papules have been reported in the depigmented, vitiliginous areas of the vitiligo patients treated with oral methoxsalen
• Patients can develop cataract when exposed to UVA within 24 hrs of ingestion of methoxsalen. Patients should be advised to wear UVA absorbing, wrap-around sunglasses for the 24 hour period following ingestion of methoxsalen whether exposed to direct or indirect sunlight
• Exposure to sunlight and/or ultraviolet radiation can cause premature aging of the skin
• Closely monitor and treat the patients exhibiting multiple basal cell carcinomas or having a history of basal cell carcinomas
• Patients with history of previous x-ray therapy or grenz ray therapy or history of previous arsenic therapy should be carefully observed for signs of carcinoma
• As methoxsalen is extensively metabolized by liver, use cautiously in patients with hepatic insufficiency
• Patients with cardiac diseases or those who are unable to tolerate prolonged standing or exposure to heat stress should not be treated in a vertical UVA chamber
• Elderly patients, especially those with a pre-existing history of cataracts, cardiovascular conditions, kidney and/or liver dysfunction, or skin cancer should be used cautiously
• The total cumulative dose of UVA that can be given over long periods of time with safety has not as yet been established
• Use with extreme caution in patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents such as anthralin, coal tar or coal tar derivatives, griseofulvin, phenothiazines, nalidixic acid, fluoroquinolone antibiotics, halogenated salicylanilides (bacteriostatic soaps), sulfonamides, tetracyclines, thiazides and certain organic staining dyes such as methylene blue, toluidine blue, rose bengal, and methyl orange

Cautions: Use cautiously in

• Breast feeding
• Hepatic insufficiency
• Cardiac diseases
• Multiple basal cell carcinomas
• History of basal cell carcinomas
• Elderly patients
• History of x-ray therapy or grenz ray therapy
• History of arsenic therapy
• Concomitant photosensitizing agents
• Tartrazine (FD & C Yellow No. 5) sensitivity

8-MOP, Oxsoralen, Oxsoralen-Ultra interacts with :

	Afinitor
	Astagraf XL
	Cyclosporine
	Everolimus
	Gengraf
	Hecoria
	Neoral
	Prograf
	Protopic
	Rapamune
	Restasis
	Sandimmune
	Sirolimus
	Tacrolimus

Pregnancy Category:D

Breastfeeding: Safety unknown; because many drugs are excreted in human milk manufacturer advises caution.

• GI: Nausea, gastrointestinal disturbances
• CV: Hypotension
• CNS: Dizziness, headache, nervousness, insomnia, psychological depression, malaise
• DERM: Pruritus, severe burns, actinic degeneration, cutaneous squamous-cell carcinoma, transient erythema, hypopigmentation, vesiculation and bullae formation, non-specific rash, herpes simplex, miliaria, urticaria, folliculitis, cutaneous tenderness, extension of psoriasis, photosensitivity
• MUSC: Leg cramps, hepatotoxicity (rare)
• EENT: Cataract

• Photosensitizing agent; inhibits DNA synthesis and function, by binding to the guanine and cytosine moieties of DNA, leading to cross-linking of DNA
• Extensively metabolized by liver
• Renally excreted: 95%
• Half-life: 2 hrs

US Trade Name(s)

• 8-MOP
• Oxsoralen-Ultra

US Availability

8-MOP, Oxsoralen-Ultra

• CAPS: 10 mg

Canadian Trade Name(s)

• Oxsoralen
• Oxsoralen-Ultra
• Ultramop

Canadian Availability

Oxsoralen, Oxsoralen-Ultra, Ultramop

• CAPS: 10 mg

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Dermatologic

Antipsoriatic Agents

Psoralens

Pricing data from www.DrugStore.com in U.S.A.

• 8-Mop 10 MG CAPS [Bottle] (VALEANT)
  50 mg = $1665.97
  100 mg = $3322.03

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: 8-MOP 10 MG Oral Capsule

Ingredient(s): Methoxsalen

Imprint: ICN;600

Color(s): Pink

Shape: Capsule

Size (mm): 19.00

Score: 1

Inactive Ingredient(s): corn starch

Drug Label Author:
Valeant Pharmaceuticals, Inc.

DEA Schedule:
Non-Scheduled

Drug Name: Oxsoralen-Ultra 10 MG Oral Capsule

Ingredient(s): Methoxsalen

Imprint: VRX;650

Color(s): Green

Shape: Capsule

Size (mm): 19.00

Score: 1

Inactive Ingredient(s): polyethylene glycol 400 / sorbital special / gelatin / glycerin / water / titanium dioxide / methyl & propylparaben / d & c yellow #10 / fd & c blue #1 / fd & c yellow #6

Drug Label Author:
Valeant Pharmaceuticals North America

DEA Schedule:
Non-Scheduled