Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- fezolinetant
methoxsalen will increase the level or effect of fezolinetant by affecting hepatic enzyme CYP1A2 metabolism. Contraindicated. Fezolinetant AUC and peak plasma concentration are increased if coadministered with drugs that are weak, moderate, or strong CYP1A2 inhibitors
Serious - Use Alternative (5)
- 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.
- melatonin
methoxsalen will increase the level or effect of melatonin by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of melatonin with strong CYP1A2 inhibitors
- 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 (44)
- atogepant
methoxsalen will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- 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.
- isavuconazonium sulfate
methoxsalen will increase the level or effect of isavuconazonium sulfate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- 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.
- mavacamten
methoxsalen will increase the level or effect of mavacamten by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely. Inititiation of weak CYP2C19 inhibitors may require decreased mavacamten dose.
- 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.
- warfarin
methoxsalen will increase the level or effect of warfarin by Other (see comment). Use Caution/Monitor. Warfarin's less potent R-enantiomer is metabolized in part by CYP3A4 (and also CYP1A2 and CYP2C19). Monitor INR more frequently if coadministered with inhibitors of these isoenzymes and adjust warfarin dose if needed.
Minor (3)
- 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.
- ruxolitinib topical
methoxsalen will increase the level or effect of ruxolitinib topical by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
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
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
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.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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| methoxsalen oral - | 10 mg capsule |  | |
| methoxsalen oral - | 10 mg capsule |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
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 (such as 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 used as directed by your doctor, usually once a day for 2 days in a row. 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 last or get worse, 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.Before using this medication, tell your doctor or pharmacist your medical history, especially of: unusual or bad reactions to other psoralen products, conditions that make you sensitive to light (such as lupus, certain porphyrias, xeroderma pigmentosum, albinism), removal of natural lens in the eye, 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).Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using methoxsalen. Methoxsalen may harm an unborn baby. Consult your doctor for more details and ask about reliable forms of birth control (such as condoms, birth control pills) while using this medication. If you become pregnant or think you may be pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if 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), fezolinetant, griseofulvin, sulfa antibiotics (such as sulfamethoxazole, sulfisoxazole), tetracycline antibiotics (such as 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: Lab and/or medical tests (such as blood counts) should be done while you are using this medication. Keep all medical and lab appointments. 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 May 2023. Copyright(c) 2023 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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