UVADEX- methoxsalen injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Methoxsalen (UNII: U4VJ29L7BQ) (Methoxsalen - UNII:U4VJ29L7BQ)

Available from:

Therakos, Inc.

INN (International Name):

Methoxsalen

Composition:

Methoxsalen 20 ug in 1 mL

Administration route:

EXTRACORPOREAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. - 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 photop

Product summary:

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)

Authorization status:

New Drug Application

Summary of Product characteristics

UVADEX- METHOXSALEN INJECTION, SOLUTION
THERAKOS, INC.
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UVADEX
(METHOXSALEN)
STERILE SOLUTION, 20 MCG/ML
RX ONLY.
CAUTION: READ THE THERAKOS CELLEX PHOTOPHERESIS SYSTEM OPERATOR'S
MANUAL PRIOR TO PRESCRIBING OR DISPENSING THIS MEDICATION.
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.
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.
CLINICAL PHARMACOLOGY
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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