UVADEX (Page 3 of 3)

POSTMARKETING

Adverse reactions reported from postmarketing experience include nausea, dysgeusia, photosensitivity reaction, pyrexia and hypersensitivity reactions including anaphylaxis and rash.

OVERDOSAGE

In the event of overdosage, the patient should be kept in a darkened room for at least 24 hours.

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.

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.

Manufactured by Patheon Manufacturing Services LLC, Greenville, NC 27834
For Therakos, Inc., Bedminster, NJ 07921

March 2021
NDA 20-969
1460544H_US

Trademarks are the property of a Mallinckrodt company. For a list of patents, see
https://www.mallinckrodt.com/patents/

PRINCIPAL DISPLAY PANEL — 10 mL Vial Carton

NDC 64067-216-01

UVADEX®
(Methoxsalen) Sterile Solution 10 mL

1460543F_US

PRINCIPAL DISPLAY PANEL -- 10 mL Vial Carton
(click image for full-size original)
UVADEX
methoxsalen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64067-216
Route of Administration EXTRACORPOREAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Methoxsalen (Methoxsalen) Methoxsalen 20 ug in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64067-216-01 12 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS
1 10 mL in 1 VIAL, GLASS This package is contained within the CARTON (64067-216-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020969 02/25/1999
Labeler — Therakos, Inc. (003083703)

Revised: 05/2021 Therakos, Inc.

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