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Uvadex

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Uvadex

Indications
Dosage
How Supplied

INDICATIONS

UVADEX™ (methoxsalen) Sterile Solution is indicated for extracorporeal administration with the 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.

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 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 UVAR XTS or 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 UVAR XTS or 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 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).

REFERENCES

1. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs, NIH Publication No. 83-2621. For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402.

2. AMA Council Report, Guidelines for Handling of Parenteral Antineoplastics. JAMA, 1985; 2.53 (11): 1590-1592.

3. National Study Commission on Cytotoxic Exposure-Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, ScD., Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115.

4. Clinical Oncological Society of Australia, Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia, 1983; 1:426-428.

5. Jones, RB, et al. Safe Handling of Chemotherapeutic Agents: A Report from The Mount Sinai Medical Center. CA-A Cancer Journal for Clinicians, 1983; (Sept/Oct) 258-263.

6. American Society of Hospital Pharmacists Technical Assistance Bulletin of Handling Cytotoxic and Hazardous Drugs. Am J. Hosp Pharm, 1990;47:1033-1049.

7. Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work-Practice Guidelines), AM J. Health-Syst Pharm, 1996; 53: 1669-1685.

November 2013. Manufactured by DSM Pharmaceuticals, Inc., Greenville, NC 27834 For Therakos, Inc., 1001 US Highway 202, Raritan, NJ 08869-0606

Last reviewed on RxList: 11/27/2013
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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