UVADEX Methoxsalen 20 ug/mL Injection, Solution
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Psoralen class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Patient education
Supplement & herbal interactions
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Uvadex 20 ug/mLthis 64067-0216-01 | Therakos | 12 vials | — | — | Discontinued | — |
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⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 64067-0216-01 You're viewing this | 12 VIAL, GLASS in 1 CARTON (64067-216-01) / 10 mL in 1 VIAL, GLASS | 1999-02-25 | Inactivated by FDA |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🚨 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.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE 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.
⏱️ Dosage and Administration ▾
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.
The prescribed amount of UVADEX ® should be injected into the recirculation bag prior to the Photoactivation Phase using the formula: TREATMENT VOLUME × 0.017 = mL of UVADEX ® for each treatment Example: Treatment volume of 240 mL × 0.017 = 4.1 mL of UVADEX ® Frequency/Schedule of Treatment Normal Treatment Schedule Treatment is given on two consecutive days every four weeks for a minimum of seven treatment cycles (six months). Accelerated Treatment Schedule If the assessment of the patient during the fourth treatment cycle (approximately three months) reveals an increased skin score from the baseline score, the frequency of treatment may be increased to two consecutive treatments every two weeks.
If a 25% improvement in the skin score is attained after four consecutive weeks, the regular treatment schedule may resume. Patients who are maintained in the accelerated treatment schedule may receive a maximum of 20 cycles. There is no clinical evidence to show that treatment with UVADEX ® beyond six months or using a different schedule provides additional benefit.
In study CTCL 3, 15 of the 17 responses were seen within six months of treatment and only two patients responded to treatment after six months.
⛔ Contraindications ▾
CONTRAINDICATIONS 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. Diseases associated with photosensitivity include lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum and albinism.
UVADEX ® Sterile Solution is contraindicated in patients with aphakia, because of the significantly increased risk of retinal damage due to the absence of lenses. Patients should not receive UVADEX ® if they have any contraindications to the photopheresis procedure.
⚠️ Warnings ▾
WARNINGS 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.
The neoplastic lesions in rats included adenomas and adenocarcinomas of the tubular epithelium of the kidneys, carcinoma or squamous cell carcinoma of the Zymbal gland and alveolar or bronchiolar adenomas. Topical or intraperitoneal methoxsalen is a potent photo-carcinogen in albino mice and hairless mice. With S9 activation, methoxsalen is mutagenic in the Ames test.
In the absence of S9 activation and UV light, methoxsalen is clastogenic in vitro (sister chromatid exchange and chromosome aberrations in Chinese hamster ovary cells). Methoxsalen also causes DNA damage, interstrand cross-links and errors in DNA repair. 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. Photosensitivity Severe photosensitivity can occur in patients treated with UVADEX ® .
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. See Precautions section for additional information.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS 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.
🔄 Drug Interactions ▾
Drug Interactions See Warnings Section.
🤰 Pregnancy ▾
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.
🧒 Pediatric Use ▾
Pediatric Use Safety in children has not been established. Potential hazards of long-term therapy include the possibilities of carcinogenicity and cataractogenicity as described in the Warnings Section as well as the probability of actinic degeneration which is also described in the Warnings Section.
🆘 Overdosage ▾
OVERDOSAGE In the event of overdosage, the patient should be kept in a darkened room for at least 24 hours.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Mechanism of action The exact mechanism of action of methoxsalen is not known. The best-known biochemical reaction of methoxsalen is with DNA. Methoxsalen, upon photoactivation, conjugates and forms covalent bonds with DNA which leads to the formation of both monofunctional (addition to a single strand of DNA) and bifunctional adducts (crosslinking of psoralen to both strands of DNA).
Reactions with proteins have also been described. The formation of photoadducts results in inhibition of DNA synthesis, cell division and epidermal turnover. For the palliative treatment of Cutaneous T-Cell Lymphoma, Photopheresis consists of removing a portion of the patient's blood and separating the red blood cells from the white cell layer (buffy coat) by centrifugation.
The red cells are returned to the patient and the UVADEX ® Sterile Solution is then injected into the instrument and mixed with the buffy coat. The instrument then irradiates this drug-cell mixture with ultraviolet light (UVA light, 320–400 nm) and returns the treated cells to the patient. See the appropriate Operator's Manual for details of this process.
Although extracorporeal phototherapy exposes less than 10% of the total body burden of malignant cells to methoxsalen plus light, some patients achieve a complete response. Animal studies suggest that the photopheresis may activate an immune-mediated response against the malignant T-cells. Use of the THERAKOS ® UVAR and UVAR XTS ® Photopheresis Systems after oral administration of methoxsalen were previously approved for the treatment of Cutaneous T-Cell Lymphoma.
Interpatient variability in peak plasma concentration after an oral dose of methoxsalen ranges from 6 to 15 fold. UVADEX ® is injected directly into the separated buffy coat in the instrument in an attempt to diminish this interpatient variability and to improve the exposure of the cells to the drug. Methoxsalen is reversibly bound to serum albumin and is also preferentially taken up by epidermal cells.
Methoxsalen is rapidly metabolized in humans, with approximately 95% of the drug excreted as metabolites in the urine within 24 hours. Systemic administration of methoxsalen followed by UVA exposure leads to cell injury. The most obvious manifestation of this injury after skin exposure is delayed erythema, which may not begin for several hours and peaks at 48–72 hours.
The inflammation is followed over several days to weeks, by repair which is manifested by increased melanization of the epidermis and thickening of the stratum corneum. The total dose of methoxsalen delivered in UVADEX ® is substantially lower (approximately 200 times) than that used with oral administration. More than 80% of blood samples collected 30 minutes after reinfusion of the photoactivated buffy coat had methoxsalen levels below detection limits of the assay (<10 ng/ml), and the mean plasma methoxsalen concentration was approximately 25 ng/ml.
🧬 Mechanism of Action ▾
Mechanism of action The exact mechanism of action of methoxsalen is not known. The best-known biochemical reaction of methoxsalen is with DNA. Methoxsalen, upon photoactivation, conjugates and forms covalent bonds with DNA which leads to the formation of both monofunctional (addition to a single strand of DNA) and bifunctional adducts (crosslinking of psoralen to both strands of DNA).
Reactions with proteins have also been described. The formation of photoadducts results in inhibition of DNA synthesis, cell division and epidermal turnover. For the palliative treatment of Cutaneous T-Cell Lymphoma, Photopheresis consists of removing a portion of the patient's blood and separating the red blood cells from the white cell layer (buffy coat) by centrifugation.
The red cells are returned to the patient and the UVADEX ® Sterile Solution is then injected into the instrument and mixed with the buffy coat. The instrument then irradiates this drug-cell mixture with ultraviolet light (UVA light, 320–400 nm) and returns the treated cells to the patient. See the appropriate Operator's Manual for details of this process.
Although extracorporeal phototherapy exposes less than 10% of the total body burden of malignant cells to methoxsalen plus light, some patients achieve a complete response. Animal studies suggest that the photopheresis may activate an immune-mediated response against the malignant T-cells. Use of the THERAKOS ® UVAR and UVAR XTS ® Photopheresis Systems after oral administration of methoxsalen were previously approved for the treatment of Cutaneous T-Cell Lymphoma.
Interpatient variability in peak plasma concentration after an oral dose of methoxsalen ranges from 6 to 15 fold. UVADEX ® is injected directly into the separated buffy coat in the instrument in an attempt to diminish this interpatient variability and to improve the exposure of the cells to the drug. Methoxsalen is reversibly bound to serum albumin and is also preferentially taken up by epidermal cells.
Methoxsalen is rapidly metabolized in humans, with approximately 95% of the drug excreted as metabolites in the urine within 24 hours. Systemic administration of methoxsalen followed by UVA exposure leads to cell injury. The most obvious manifestation of this injury after skin exposure is delayed erythema, which may not begin for several hours and peaks at 48–72 hours.
The inflammation is followed over several days to weeks, by repair which is manifested by increased melanization of the epidermis and thickening of the stratum corneum. The total dose of methoxsalen delivered in UVADEX ® is substantially lower (approximately 200 times) than that used with oral administration. More than 80% of blood samples collected 30 minutes after reinfusion of the photoactivated buffy coat had methoxsalen levels below detection limits of the assay (<10 ng/ml), and the mean plasma methoxsalen concentration was approximately 25 ng/ml.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED UVADEX ® (methoxsalen) Sterile Solution 20 mcg/mL in 10 mL amber glass vials (NDC 64067-216-01), and cartons of 12 vials (NDC 64067-216-01). One vial of 10 mL contains 200 micrograms methoxsalen. The drug product must be stored between 59°F (15°C) and 86°F (30°C)
📦 Storage and Handling ▾
UVADEX ® (methoxsalen) Sterile Solution 20 mcg/mL in 10 mL amber glass vials (NDC 64067-216-01), and cartons of 12 vials (NDC 64067-216-01). One vial of 10 mL contains 200 micrograms methoxsalen. The drug product must be stored between 59°F (15°C) and 86°F (30°C)
📋 Description ▾
DESCRIPTION Methoxsalen is a naturally occurring photoactive substance found in the seeds of the Ammi majus (Umbelliferae) plant. It belongs to a group of compounds known as psoralens or furocoumarins. The chemical name of methoxsalen is 9-methoxy-7H-furo[3,2-g][1]-benzopyran-7-one; it has the following structure: Each mL of UVADEX ® (methoxsalen, 8-methoxypsoralen) Sterile Solution contains methoxsalen 20 mcg, propylene glycol 50 mg, sodium chloride 8 mg, sodium acetate 1.75 mg, ethanol 40.550 mg, glacial acetic acid 1.260 mg, and Water for Injection q.s. to 1.0 mL.
Glacial acetic acid and sodium hydroxide are used to adjust the pH of the solution if necessary. UVADEX ® is a clear, colorless to pale yellow liquid. UVADEX ® is used in combination with the THERAKOS ® CELLEX ® Photopheresis System to extracorporeally treat leukocyte enriched buffy coat.
Chemical Structure
💬 Information for Patients ▾
Information for Patients Patients should be told emphatically to wear UVA-absorbing, wrap-around sunglasses and cover exposed skin or use a sunblock (SP 15 or higher) for the twenty-four (24) hour period following treatment with methoxsalen, whether exposed to direct or indirect sunlight in the open or through a window glass.