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UVADEX
Overview
What is UVADEX?
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 UVAR XTS and THERAKOS CELLEX Photopheresis System to extracorporeally treat leukocyte enriched buffy coat.
What does UVADEX look like?
What are the available doses of UVADEX?
Sorry No records found.
What should I talk to my health care provider before I take UVADEX?
Sorry No records found
How should I use UVADEX?
UVADEX (methoxsalen) Sterile Solution is indicated for extracorporeal administration with the THERAKOS UVAR XTS or 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.
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 UVAR XTS or 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 UVAR XTS or 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 UVAR XTS or 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 UVAR XTS or THERAKOS CELLEX Photopheresis System, the dosage of UVADEX for each treatment will be calculated according to the treatment volume.
What interacts with UVADEX?
PHOTOSENSITIVITY
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.
What are the warnings of UVADEX?
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/m2 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.
What are the precautions of UVADEX?
General
ACTINIC DEGENERATION
After methoxsalen administration, exposure to sunlight and/or ultraviolet radiation may result in "premature aging" of the skin.
BASAL CELL CARCINOMAS
Since oral psoralens may increase the risk of skin cancers, monitor closely those patients who exhibit multiple basal cell carcinomas or who have a history of basal cell carcinomas.
SERIOUS SKIN BURNS
Serious burns from either UVA or sunlight (even through window glass) can result if the recommended dosage of methoxsalen is exceeded or precautions are not followed. Advise patients to avoid all exposure to sunlight during the 24 hours following photopheresis treatment.
CATARACT FORMATION
Exposure to large doses of UVA light causes cataracts in animals. Oral methoxsalen exacerbates this toxicity. The concentration of methoxsalen in the human lens is proportional to the concentration in serum. Serum methoxsalen concentrations are substantially lower after extracorporeal UVADEX treatment than after oral methoxsalen treatment. Nevertheless, if the lens is exposed to UVA light while methoxsalen is present, photoactivation of the drug may cause adducts to bind to biomolecules within the lens. If the lens is shielded from UVA light, the methoxsalen will diffuse out of the lens in about 24 hours.
Patients who use proper eye protection after PUVA therapy (oral methoxsalen) appear to have no increased risk of developing cataracts. The incidence of cataracts in these patients five years after their first treatment is about the same as that in the general population. Instruct patients emphatically to wear UVA absorbing, wrap-around sunglasses for twenty-four (24) hours after UVADEX treatment. They should wear these glasses any time they are exposed to direct or indirect sunlight, whether they are outdoors or exposed through a window.
VENOUS AND ARTERIAL THROMBOEMBOLISM
Thromboembolic events, such as pulmonary embolism and deep vein thrombosis, have been reported with UVADEX administration through photopheresis systems for treatment of patients with graft-versus-host disease, a disease for which UVADEX is not approved.
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.
Drug Interactions
See Section.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
See Section.
Pregnancy
See Section.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when methoxsalen is administered to a nursing woman.
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.
UVADEX has not been evaluated in patients with renal or hepatic impairment.
What are the side effects of UVADEX?
Side effects of photopheresis (UVADEX used with the THERAKOS Photopheresis System) 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
An analysis of postmarketing data shows the following events occurred with an incidence of <0.01%: rash, allergic reaction, pyrexia, nausea, dysgeusia.
What should I look out for while using UVADEX?
What might happen if I take too much UVADEX?
There are no known reports of overdosage with extracorporeal administration of methoxsalen. However, in the event of overdosage, the patient should be kept in a darkened room for at least 24 hours.
How should I store and handle UVADEX?
JEVTANA is a cytotoxic anticancer drug. Follow applicable special handling and disposable procedures Pentoxifylline extended-release tablets, USP are available for oral administration as 400 mg white, oval, unscored, film coated tablets, imprinted “APO 033” on one side and plain on the other side; supplied in Cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-5448-61Store at 20° to 25°C (68° to 77°F) [see Controlled Room Temperature].Dispense in a tight, light-resistant container [see USP]. APOTEX INC.PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400mgManufactured by Manufactured forDistributed By:MAJOR® PHARMACEUTICALS31778 Enterprise DriveLivonia, MI 48150Revised: May 2016 Rev. 7Pentoxifylline extended-release tablets, USP are available for oral administration as 400 mg white, oval, unscored, film coated tablets, imprinted “APO 033” on one side and plain on the other side; supplied in Cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-5448-61Store at 20° to 25°C (68° to 77°F) [see Controlled Room Temperature].Dispense in a tight, light-resistant container [see USP]. APOTEX INC.PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400mgManufactured by Manufactured forDistributed By:MAJOR® PHARMACEUTICALS31778 Enterprise DriveLivonia, MI 48150Revised: May 2016 Rev. 7Pentoxifylline extended-release tablets, USP are available for oral administration as 400 mg white, oval, unscored, film coated tablets, imprinted “APO 033” on one side and plain on the other side; supplied in Cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-5448-61Store at 20° to 25°C (68° to 77°F) [see Controlled Room Temperature].Dispense in a tight, light-resistant container [see USP]. APOTEX INC.PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400mgManufactured by Manufactured forDistributed By:MAJOR® PHARMACEUTICALS31778 Enterprise DriveLivonia, MI 48150Revised: May 2016 Rev. 7Pentoxifylline extended-release tablets, USP are available for oral administration as 400 mg white, oval, unscored, film coated tablets, imprinted “APO 033” on one side and plain on the other side; supplied in Cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-5448-61Store at 20° to 25°C (68° to 77°F) [see Controlled Room Temperature].Dispense in a tight, light-resistant container [see USP]. APOTEX INC.PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400mgManufactured by Manufactured forDistributed By:MAJOR® PHARMACEUTICALS31778 Enterprise DriveLivonia, MI 48150Revised: May 2016 Rev. 7Pentoxifylline extended-release tablets, USP are available for oral administration as 400 mg white, oval, unscored, film coated tablets, imprinted “APO 033” on one side and plain on the other side; supplied in Cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-5448-61Store at 20° to 25°C (68° to 77°F) [see Controlled Room Temperature].Dispense in a tight, light-resistant container [see USP]. APOTEX INC.PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400mgManufactured by Manufactured forDistributed By:MAJOR® PHARMACEUTICALS31778 Enterprise DriveLivonia, MI 48150Revised: May 2016 Rev. 7Pentoxifylline extended-release tablets, USP are available for oral administration as 400 mg white, oval, unscored, film coated tablets, imprinted “APO 033” on one side and plain on the other side; supplied in Cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-5448-61Store at 20° to 25°C (68° to 77°F) [see Controlled Room Temperature].Dispense in a tight, light-resistant container [see USP]. APOTEX INC.PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400mgManufactured by Manufactured forDistributed By:MAJOR® PHARMACEUTICALS31778 Enterprise DriveLivonia, MI 48150Revised: May 2016 Rev. 7Pentoxifylline extended-release tablets, USP are available for oral administration as 400 mg white, oval, unscored, film coated tablets, imprinted “APO 033” on one side and plain on the other side; supplied in Cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-5448-61Store at 20° to 25°C (68° to 77°F) [see Controlled Room Temperature].Dispense in a tight, light-resistant container [see USP]. APOTEX INC.PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400mgManufactured by Manufactured forDistributed By:MAJOR® PHARMACEUTICALS31778 Enterprise DriveLivonia, MI 48150Revised: May 2016 Rev. 7Pentoxifylline extended-release tablets, USP are available for oral administration as 400 mg white, oval, unscored, film coated tablets, imprinted “APO 033” on one side and plain on the other side; supplied in Cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-5448-61Store at 20° to 25°C (68° to 77°F) [see Controlled Room Temperature].Dispense in a tight, light-resistant container [see USP]. APOTEX INC.PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400mgManufactured by Manufactured forDistributed By:MAJOR® PHARMACEUTICALS31778 Enterprise DriveLivonia, MI 48150Revised: May 2016 Rev. 7Pentoxifylline extended-release tablets, USP are available for oral administration as 400 mg white, oval, unscored, film coated tablets, imprinted “APO 033” on one side and plain on the other side; supplied in Cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-5448-61Store at 20° to 25°C (68° to 77°F) [see Controlled Room Temperature].Dispense in a tight, light-resistant container [see USP]. APOTEX INC.PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400mgManufactured by Manufactured forDistributed By:MAJOR® PHARMACEUTICALS31778 Enterprise DriveLivonia, MI 48150Revised: May 2016 Rev. 7Pentoxifylline extended-release tablets, USP are available for oral administration as 400 mg white, oval, unscored, film coated tablets, imprinted “APO 033” on one side and plain on the other side; supplied in Cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-5448-61Store at 20° to 25°C (68° to 77°F) [see Controlled Room Temperature].Dispense in a tight, light-resistant container [see USP]. APOTEX INC.PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400mgManufactured by Manufactured forDistributed By:MAJOR® PHARMACEUTICALS31778 Enterprise DriveLivonia, MI 48150Revised: May 2016 Rev. 7Pentoxifylline extended-release tablets, USP are available for oral administration as 400 mg white, oval, unscored, film coated tablets, imprinted “APO 033” on one side and plain on the other side; supplied in Cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-5448-61Store at 20° to 25°C (68° to 77°F) [see Controlled Room Temperature].Dispense in a tight, light-resistant container [see USP]. APOTEX INC.PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400mgManufactured by Manufactured forDistributed By:MAJOR® PHARMACEUTICALS31778 Enterprise DriveLivonia, MI 48150Revised: May 2016 Rev. 7Pentoxifylline extended-release tablets, USP are available for oral administration as 400 mg white, oval, unscored, film coated tablets, imprinted “APO 033” on one side and plain on the other side; supplied in Cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-5448-61Store at 20° to 25°C (68° to 77°F) [see Controlled Room Temperature].Dispense in a tight, light-resistant container [see USP]. APOTEX INC.PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400mgManufactured by Manufactured forDistributed By:MAJOR® PHARMACEUTICALS31778 Enterprise DriveLivonia, MI 48150Revised: May 2016 Rev. 7Pentoxifylline extended-release tablets, USP are available for oral administration as 400 mg white, oval, unscored, film coated tablets, imprinted “APO 033” on one side and plain on the other side; supplied in Cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-5448-61Store at 20° to 25°C (68° to 77°F) [see Controlled Room Temperature].Dispense in a tight, light-resistant container [see USP]. APOTEX INC.PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400mgManufactured by Manufactured forDistributed By:MAJOR® PHARMACEUTICALS31778 Enterprise DriveLivonia, MI 48150Revised: May 2016 Rev. 7Pentoxifylline extended-release tablets, USP are available for oral administration as 400 mg white, oval, unscored, film coated tablets, imprinted “APO 033” on one side and plain on the other side; supplied in Cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-5448-61Store at 20° to 25°C (68° to 77°F) [see Controlled Room Temperature].Dispense in a tight, light-resistant container [see USP]. APOTEX INC.PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400mgManufactured by Manufactured forDistributed By:MAJOR® PHARMACEUTICALS31778 Enterprise DriveLivonia, MI 48150Revised: May 2016 Rev. 7
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Non-Clinical Toxicology
See Section.Side effects of photopheresis (UVADEX used with the THERAKOS Photopheresis System) 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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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