methoxsalen (Rx)

Brand and Other Names:8MOP, Oxsoralen, more...Oxsoralen Ultra, Uvadex
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 10mg

soft capsule

  • 10mg

lotion

  • 1%

solution for injection

  • 20mcg/mL (10mL vial)

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

and methoxsalen

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      Serious - Use Alternative

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              Serious - Use Alternative (4)

              • fedratinib

                methoxsalen will increase the level or effect of fedratinib by Other (see comment). Avoid or Use Alternate Drug. Avoid coadministration of fedratinib (a CYP3A4 and CYP2C19 substrate) with dual CYP3A4 and CYP2C19 inhibitor. Effect of coadministration of a dual CYP3A4 and CYP2C19 inhibitor with fedratinib has not been studied.

              • lonafarnib

                methoxsalen will increase the level or effect of lonafarnib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration of lonafarnib (a sensitive CYP3A substrate) with weak CYP3A inhibitors is unavoidable, reduce to, or continue lonafarnib at starting dose. Closely monitor for arrhythmias and events (eg, syncope, heart palpitations) since lonafarnib effect on QT interval is unknown.

              • pirfenidone

                methoxsalen will increase the level or effect of pirfenidone by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. Use of strong CYP1A2 inhibitors should be discontinued before initiating pirfenidone and avoided during treatment; if strong CYP1A2 inhibitors are the only drug of choice, dosage reductions are recommended

              • pomalidomide

                methoxsalen increases levels of pomalidomide by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug.

              Monitor Closely (40)

              • avapritinib

                methoxsalen will increase the level or effect of avapritinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.

              • axitinib

                methoxsalen increases levels of axitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • bendroflumethiazide

                methoxsalen, bendroflumethiazide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive photosensitizing effects.

              • chlorothiazide

                methoxsalen, chlorothiazide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive photosensitizing effects.

              • chlorpromazine

                methoxsalen, chlorpromazine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive photosensitizing effects.

              • chlorthalidone

                methoxsalen, chlorthalidone. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive photosensitizing effects.

              • cyclopenthiazide

                methoxsalen, cyclopenthiazide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive photosensitizing effects.

              • demeclocycline

                methoxsalen, demeclocycline. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive photosensitizing effects.

              • doxycycline

                methoxsalen, doxycycline. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive photosensitizing effects.

              • eluxadoline

                methoxsalen increases levels of eluxadoline by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. As a precautionary measure due to incomplete information on the metabolism of eluxadoline, use caution when coadministered with strong CYP1A2 inhibitors.

              • finerenone

                methoxsalen will increase the level or effect of finerenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Monitor serum potassium during initiation and dosage adjustment of either finererone or weak CYP3A4 inhibitors. Adjust finererone dosage as needed.

              • flibanserin

                methoxsalen will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Increased flibanserin adverse effects may occur if coadministered with multiple weak CYP3A4 inhibitors.

              • fluphenazine

                methoxsalen, fluphenazine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive photosensitizing effects.

              • griseofulvin

                methoxsalen, griseofulvin. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive photosensitizing effects.

              • hydrochlorothiazide

                methoxsalen, hydrochlorothiazide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive photosensitizing effects.

              • indapamide

                methoxsalen, indapamide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive photosensitizing effects.

              • ivacaftor

                methoxsalen increases levels of ivacaftor by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor when coadministered with weak CYP3A4 inhibitors .

              • lemborexant

                methoxsalen will increase the level or effect of lemborexant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Lower nightly dose of lemborexant recommended if coadministered with weak CYP3A4 inhibitors. See drug monograph for specific dosage modification.

              • lomitapide

                methoxsalen increases levels of lomitapide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Lomitapide dose should not exceed 30 mg/day.

              • methyclothiazide

                methoxsalen, methyclothiazide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive photosensitizing effects.

              • methylene blue

                methoxsalen, methylene blue. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive photosensitizing effects.

              • metolazone

                methoxsalen, metolazone. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive photosensitizing effects.

              • midazolam intranasal

                methoxsalen will increase the level or effect of midazolam intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of mild CYP3A4 inhibitors with midazolam intranasal may cause higher midazolam systemic exposure, which may prolong sedation.

              • minocycline

                methoxsalen, minocycline. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive photosensitizing effects.

              • oxytetracycline

                methoxsalen, oxytetracycline. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive photosensitizing effects.

              • pentoxifylline

                methoxsalen will increase the level or effect of pentoxifylline by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              • perphenazine

                methoxsalen, perphenazine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive photosensitizing effects.

              • prochlorperazine

                methoxsalen, prochlorperazine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive photosensitizing effects.

              • promazine

                methoxsalen, promazine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive photosensitizing effects.

              • promethazine

                methoxsalen, promethazine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive photosensitizing effects.

              • sulfadiazine

                methoxsalen, sulfadiazine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive photosensitizing effects.

              • sulfamethoxazole

                methoxsalen, sulfamethoxazole. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive photosensitizing effects.

              • sulfisoxazole

                methoxsalen, sulfisoxazole. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive photosensitizing effects.

              • tasimelteon

                methoxsalen will increase the level or effect of tasimelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Avoid coadministration; potentially large increase in tasimelteon exposure and greater risk of adverse reactions with strong CYP1A2 inhibitors

              • tazemetostat

                methoxsalen will increase the level or effect of tazemetostat by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • terbinafine

                methoxsalen will increase the level or effect of terbinafine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              • tetracycline

                methoxsalen, tetracycline. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive photosensitizing effects.

              • thioridazine

                methoxsalen, thioridazine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive photosensitizing effects.

              • tinidazole

                methoxsalen will increase the level or effect of tinidazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • trifluoperazine

                methoxsalen, trifluoperazine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive photosensitizing effects.

              Minor (2)

              • food

                food increases levels of methoxsalen by enhancing GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown. Admin. each oral dose of methoxsalen at same time w/respect to food.

              • ruxolitinib

                methoxsalen will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

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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 treatment 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 treatment

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

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

              Avoid sun exposure 8 hr post-treatment

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

              Severe photosensitivity can occur; advise patients to wear UVA absorbing, wrap-around sunglasses and cover exposed skin or use a sunblock (SP 15 or higher), and avoid all exposure to sunlight for twenty-four (24) hours following photopheresis treatment

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

              Thromboembolic events, such as pulmonary embolism and deep vein thrombosis, reported with administration through photopheresis systems for treatment of patients with graft-versus-host disease, a disease for which methoxsalen is not approved

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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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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              methoxsalen oral
              -
              10 mg capsule

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

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              Patient Education
              methoxsalen injection

              METHOXSALEN - INJECTION

              (meth-OX-a-len)

              COMMON BRAND NAME(S): Uvadex

              USES: This medication is used to treat cutaneous T-cell lymphoma (CTCL), a type of cancer that affects the skin and blood and sometimes the lymph nodes and other organs. CTCL is caused by the uncontrolled growth of abnormal white blood cells in the skin. This drug is used in a procedure called photopheresis. Some of your blood is removed from your body through a vein and goes into a special machine that separates the white blood cells. The machine adds methoxsalen to these white blood cells, then shines ultraviolet (UV) light on them. Then the machine returns the treated cells (and the rest of your blood) to your body through the same vein. Your immune system is thought to react to the treated cells and other similar untreated T-cells that are not working properly. This effect helps to restore your immune balance and lessens the skin problems (e.g., rash, plaques, tumors) of CTCL. Methoxsalen is known as a psoralen photosensitizer. It works by making the treated white blood cells more sensitive to UV light.

              HOW TO USE: See Uses section.This medication is injected into your collected white blood cells during photopheresis by a health care professional. This medication is usually used once a day for 2 days in a row or as directed by your doctor. Photopheresis is usually repeated every 4 weeks depending on your response to treatment.Dosage is based on your medical condition, the amount of white blood cells collected, and response to treatment.

              SIDE EFFECTS: See also Precautions section.Dizziness, headache, weakness, leg cramps, or bitter/sour taste in the mouth may occur. Skin freckling, dry skin, and skin aging may also occur. If these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: depression, swollen ankles/feet, new/unusual skin sores, irregular heartbeat.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Before using methoxsalen, tell your doctor or pharmacist if you are allergic to it; or to sunlight; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you: have had an unusual or bad reaction to other psoralen products in the past, have conditions that make you sensitive to light (such as lupus, certain porphyrias, xeroderma pigmentosum, albinism), or have no natural lens in the eye.Before using this medication, tell your doctor or pharmacist your medical history, especially of: coal tar/UVA treatment, radiation treatment, arsenic treatments, other skin cancer (melanoma, basal cell or squamous cell carcinomas), cataracts, liver problems, kidney problems, heart problems.For 24 hours after treatment with this medication, your eyes and skin will be more sensitive to the sun, including sunlight through a glass window. Limit your time in the sun. Avoid tanning booths and sunlamps. To protect your skin during this time, use sunscreen and wear protective clothing when outdoors. To protect your eyes, wear dark wrap-around UV-absorbing sunglasses. Get medical help right away if you have vision changes, skin blisters/redness/swelling/peeling, or if you get sunburned. Ask your doctor for details.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss the use of reliable forms of birth control (such as condoms, birth control pills) during treatment with this medication. If you become pregnant or think you may be pregnant, tell your doctor right away.It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: anthralin, bacteriostatic soaps, coal tar, certain dyes (methylene blue, toluidine blue, rose bengal, methyl orange), griseofulvin, nalidixic acid, sulfa antibiotics (e.g., sulfamethoxazole, sulfisoxazole), tetracycline antibiotics (e.g., doxycycline, tetracycline), certain "water pills" (thiazide diuretics such as hydrochlorothiazide).

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: serious burning/blistering of skin.

              NOTES: Laboratory and/or medical tests (e.g., blood counts) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

              MISSED DOSE: It is important to get each scheduled treatment with this medication as directed. If you miss a treatment, ask your doctor for a new treatment schedule.

              STORAGE: Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

              Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.