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methoxsalen (Rx)Brand and Other Names:8MOP, Oxsoralen, more...Oxsoralen Ultra, Uvadex

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 10mg

soft capsule

  • 10mg

lotion

  • 1%

solution for injection

  • 20mcg/mL (10mL vial)
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Vitiligo

PO

  • 20 mg with milk or food 2-4 hr before UV exposure
  • UV exposure: initial 15-25 min (based on skin color); add 5 min on each subsequent exposure (qOD) up to erythema/tenderness tolerance

Topical

  • Apply 1% lotion to affected area 2 hr before UV exposure q3-7 days

Psoriasis

Take PO with milk or food 2 hr before UVA exposure (qOD)

Body weight guidelines

  • <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

May increase dose by 10 mg after 15 therapy sessions (do not increase any more than this)

Cutaneous T-Cell Lymphoma

PO

  • Take PO with milk or food 2 hr before UVA exposure
  • Initial dose 0.6 mg/kg
  • If serum concentration <50 ng/mL, administer initial dose + 10 mg after 24 hr

Parenteral

  • Inject 200 mcg (10 mL) into photoactivation bag of UVAR photopheresis system
  • Treatment on two consecutive days q 4 weeks for a min. of 7 treatment cycles

Systemic Sclerosis (Orphan)

Uvadex indicated in conjunction with the UVAR photopheresis to treat diffuse systemic sclerosis

Orphan indication sponsor

  • Therakos, Inc; Oaklands Corporate Center; 437 Creamery Way; Exton, PA 19341"

Cardiac Allograft Rejection (Orphan)

Uvadex designated orphan indication for prevention of acute rejection of cardiac allografts

Orphan indication sponsor

  • Therakos, Inc; Oaklands Corporate Center; 437 Creamery Way; Exton, PA 19341"

Graft Versus Host Disease (Orphan)

For use in conjunction with the UVAR photopheresis system to treat GVHD

Orphan indication sponsor

  • Therakos, Inc; Oaklands Corporate Center, 437 Creamery Way; Exton, PA 19341

Other Information

See Manufacturer label for complete UVA therapy information

<12 years old: safety and efficacy not established

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Interactions

Interaction Checker

methoxsalen and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            All Patients

            Mild-moderate erythema x 24-48 hrs

            1-10%

            Nausea

            Pruritis

            Frequency Not Defined

            Edema

            Dizziness

            Headache

            Malaise

            Depression

            Hypopigmentation

            Bullae formation

            Rash

            Herpes simplex

            Uritcaria

            GI disturbances

            Leg cramps

            Hypotension

            Extension of psoriasis

            Postmarketing Reports

            Rash

            Allergic reaction

            Pyrexia

            Nausea

            Dysgeusia

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            Warnings

            Black Box Warnings

            Injection

            • Should be prescribed only by physicians who have competence in both the diagnosis and treatment of cutaneous T-cell lymphoma and the UVAR Photopheresis System

            PO

            • Use with UV radiation should be done only by physicians competent in photochemistry and in the diagnosis and treatment of psoriasis and vitiligo
            • Reserve photochemotherapy for patients with severe, recalcitrant, disabling psoriasis unresponsive to other therapy
            • Risks include ocular damage, aging of the skin, and skin cancer
            • Do not interchange Oxsoralen-Ultra (Methoxsalen Soft Gelatin Capsules) with Oxsoralen or 8-MOP (Methoxsalen Hard Gelatin Capsules), as Oxsoralen-Ultra has a greater bioavailability and earlier photosensitization

            Topical lotion

            • Potent drug capable of producing severe burns if used improperly
            • Should be applied only by a healthcare provider under controlled conditions

            Contraindications

            Hypersensitivity to psoralen compounds

            Photosensitive disease states (SLE, etc.), history of melanoma, squamous cell carcinoma (SCC), aphakia

            Cautions

            Dosages of hard and soft capsules are NOT interchangeable

            Tests prior to Tx and then q6-12mth: ophthalmologic exam, CBC, ANA, LFTs, RFTs

            Overdose &/or overexposure could lead to serious burns from UVA or sunlight

            Use appropriate shielding of eyes and unaffected skin during Tx

            Increased risk of SCC, basal cell carcinoma (esp. if history of radiation Tx or arsenic Tx)

            Wear UVA-absorbing sunglasses for 24 hr post-Tx to avoid cataract formation

            Avoid sun exposure 8 hr post-Tx

            Hepatic dz (hepatic metabolism), cardiac dz (heat stress)

            Caution with concomitant photosensitizing agents

            Do not sunbathe for 24 hr prior to Tx & for 48 hr post-Tx

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: not known whether excreted in breast milk; use caution

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Half-Life: 0.75-2.4 hr

            Onset: 1-2 hr

            Duration: 3-8 hr

            Peak Plasma:

            Time: 3 hr (conventional cap); 1.8 hr (liquid-filled cap)

            Concentration: liquid-filled cap 2-3 x more than conventional cap

            Other Information

            Bioavailability: variable; enhanced by food

            Protein Bound: 75-91%

            Metabolism: hepatic

            Metabolites: 8-hydroxypsoralen; glucuronide & sulfate conjugates

            Excretion: urine

            Mechanism of Action

            Photosensitizer; preferentially taken up by epidermal cells and binds to DNA, making it more susceptible to ultraviolet radiation damage

            8-methoxypsoralen - photoactive derivative of Ammi majus and Heraclem candicans plants

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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