pharmacopeia
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/api/v1/drug/methoxsalen

Boxed warning

UVADEX ® (methoxsalen) Sterile Solution should be used only by physicians who have special competence in the diagnosis and treatment of cutaneous T-cell lymphoma and who have special training and experience in the THERAKOS ® CELLEX ® Photopheresis System. Please consult the CELLEX ® Operator's Manual before using this product.

Mechanism of action

Sourced from openFDA

The exact mechanism of action of methoxsalen is not known. The best-known biochemical reaction of methoxsalen is with DNA.

Nucleic Acid Synthesis

Indications

Sourced from openFDA
  • UVADEX ® (methoxsalen) Sterile Solution is indicated for extracorporeal administration with the THERAKOS ® CELLEX ® Photopheresis System in the palliative treatment of the skin manifestations of Cutaneous T-Cell Lymphoma (CTCL) that is unresponsive to other forms of treatment.ICD-10: C85.90

Contraindications

Sourced from openFDA
  • UVADEX ® (methoxsalen) Sterile Solution is contraindicated in patients exhibiting idiosyncratic or hypersensitivity reactions to methoxsalen, other psoralen compounds or any of the excipients. Patients possessing a specific history of a light sensitive disease state should not initiate methoxsalen therapy.contraindicated

Dosage & administration

Sourced from openFDA

DRUG DOSAGE AND ADMINISTRATION Each UVADEX ® treatment involves collection of leukocytes, photoactivation, and reinfusion of photoactivated cells. UVADEX ® (methoxsalen) Sterile Solution is supplied in 10 mL vials containing 200 mcg of methoxsalen (concentration of 20 mcg/mL). The THERAKOS ® CELLEX ® Photopheresis System Operator's Manual should be consulted before using this product. UVADEX ® should not be diluted. The contents of the vial should be injected into the THERAKOS ® CELLEX ® Photopheresis System immediately after being drawn up into a syringe. Do not inject directly into patients. The UVADEX ® vial is for single use only. Any UVADEX ® that is not used during a procedure should be immediately discarded. UVADEX ® can adsorb onto PVC and plastics, therefore only THERAKOS ® CELLEX ® photopheresis procedural kits supplied for use with the instrument should be used to administer this medicinal product. Once UVADEX ® is drawn into a plastic syringe it should be immediately injected into the photoactivation bag. UVADEX ® exposed to a plastic syringe for more than one hour should be discarded. During treatment with the THERAKOS ® CELLEX ® Photopheresis System, the dosage of UVADEX ® for each treatment will be calculated according to the treatment volume.

Warnings & precautions

Sourced from openFDA

Concomitant Therapy 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, halogenated salicylanilides (bacteriostatic soaps), sulfonamides, tetracyclines, thiazides, and certain organic staining dyes such as methylene blue, toluidine blue, rose bengal and methyl orange may be at greater risk for photosensitivity reactions with UVADEX ® . Carcinogenicity, Mutagenesis, Impairment of Fertility Oral administration of methoxsalen followed by cutaneous UVA exposure (PUVA therapy) is carcinogenic. In a prospective study of 1380 patients given PUVA therapy for psoriasis, 237 patients developed 1422 cutaneous squamous cell cancers. This observed incidence of cutaneous carcinoma is 17.6 times that expected for the general population. Previous cutaneous exposure to tar and UVB treatment, ionizing radiation or arsenic increased the risk of developing skin carcinomas after PUVA therapy. Because the dose of methoxsalen with UVADEX ® therapy is about 200 times less than with PUVA and the skin is not exposed to high cumulative doses of UVA light, the risk of developing skin cancer following UVADEX ® therapy may be lower. Methoxsalen was carcinogenic in male rats that were given the drug by oral gavage five days per week for 103 weeks at doses of 37.5 and 75 mg/kg. The 37.5 mg/kg dose is about 1900 times greater than a single human methoxsalen dose during extracorporeal photopheresis treatment on a body surface area basis.

Adverse reactions

Sourced from openFDA

Side effects of photopheresis (UVADEX ® used with THERAKOS ® Photopheresis Systems) were primarily related to hypotension secondary to changes in extracorporeal volume (>1%). In study CTCL 3 (UVADEX ® ), six serious cardiovascular adverse experiences were reported in five patients (5/51, 10%). Five of these six events were not related to photopheresis and did not interfere with the scheduled photopheresis treatments. One patient (1/51, 2%) with ischemic heart disease had an arrhythmia after the first day of photopheresis that was resolved the next day. Six infections were also reported in five patients. Two of the six events were Hickman catheter infections in one patient, which did not interrupt the scheduled photopheresis. The other four infections were not related to photopheresis and did not interfere with scheduled treatments. POSTMARKETING Adverse reactions reported from postmarketing experience include nausea, dysgeusia, photosensitivity reaction, pyrexia and hypersensitivity reactions including anaphylaxis and rash.

Use in specific populations

Sourced from openFDA

Pregnancy Methoxsalen may cause fetal harm when given to a pregnant woman. Doses of 80 to 160 mg/kg/day given during organogenesis caused significant fetal toxicity in rats. The lowest of these doses, 80 mg/kg/day, is over 4000 times greater than a single dose of UVADEX ® on a mg/m 2 basis. Fetal toxicity was associated with significant maternal weight loss, anorexia and increased relative liver weight. Signs of fetal toxicity included increased fetal mortality, increased resorptions, late fetal death, fewer fetuses per litter, and decreased fetal weight. Methoxsalen caused an increase in skeletal malformation and variations at doses of 80 mg/kg/day and above. There are no adequate and well-controlled studies of methoxsalen in pregnant women. If UVADEX ® is used during pregnancy, or if the patient becomes pregnant while receiving UVADEX ® , the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.

Overdosage

Sourced from openFDA

In the event of overdosage, the patient should be kept in a darkened room for at least 24 hours.

Approval history

Sourced from openFDA
  • Feb 25, 1999NDANDA020969Therakos Development
  • Jun 5, 2014ANDAANDA202687Onesource Specialty

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
748 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Product Use In Unapproved Indication33645%
  2. 2Off Label Use577.6%
  3. 3Condition Aggravated415.5%
  4. 4Pulmonary Embolism374.9%
  5. 5Death364.8%
  6. 6Disease Progression354.7%
  7. 7Infection334.4%
  8. 8Hypotension304.0%
  9. 9Pyrexia273.6%
  10. 10Vomiting253.3%
  11. 11Dyspnoea243.2%
  12. 12Chronic Graft Versus Host Disease233.1%
  13. 13Nausea222.9%
  14. 14Fatigue202.7%
  15. 15Graft Versus Host Disease202.7%

Literature

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Recent PubMed references pinned to Methoxsalen as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 61 ClinicalTrials.gov registrations naming Methoxsalen as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Methoxsalen work?
The exact mechanism of action of methoxsalen is not known. The best-known biochemical reaction of methoxsalen is with DNA.
What is Methoxsalen used for?
According to FDA labeling, Methoxsalen carries indications including: UVADEX ® (methoxsalen) Sterile Solution is indicated for extracorporeal administration with the THERAKOS ® CELLEX ® Photopheresis System in the palliative treatment of the skin manifestations of Cutaneous T-Cell Lymphoma (CTCL) that is unresponsive to other forms of treatment.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Methoxsalen?
Methoxsalen is classified as Psoralens for systemic use, Psoralens for topical use, Photoactivated Radical Generator, Psoralen, Nucleic Acid Synthesis Inhibitors, Photoabsorption, Decreased DNA Integrity, Photosensitizing Activity.
What are the brand names for Methoxsalen?
Methoxsalen is marketed under brand names including Uvadex.
What are the contraindications for Methoxsalen?
Methoxsalen labeling lists contraindications including: UVADEX ® (methoxsalen) Sterile Solution is contraindicated in patients exhibiting idiosyncratic or hypersensitivity reactions to methoxsalen, other psoralen compounds or any of the excipients. Patients possessing a specific history of a light sensitive disease state should not initiate methoxsalen therapy.. Always consult the full prescribing information and a clinician.
Note. Data for methoxsalen is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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