UVADEX- methoxsalen injection, solution
Therakos, Inc.
Rx ONLY.
CAUTION: READ THE THERAKOS� UVAR XTS � or 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� UVAR XTS � or THERAKOS � CELLEX � Photopheresis System. Please consult the appropriate 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;
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.
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.
UVADEX Indications and Usage
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.
CONTRAINDICATIONS
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.
UVADEX Indications and Usage
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.
CONTRAINDICATIONS
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.
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� 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.
The prescribed amount of UVADEX � should be injected into the recirculation bag prior to the Photactivation Phase using the formula:
TREATMENT VOLUME X 0.017 = mL of UVADEX � for each treatment
Example: Treatment volume of 240 mL X 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.
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).
