A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Uvadex Indications, Dosage, Storage, Stability - Methoxsalen
Uvadex Indications, Dosage, Storage, Stability - Methoxsalen
INDICATIONS
UVADEXÒ (methoxsalen)
Sterile Solution is indicated for extracorporeal
administration
with the UVAR 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
Each UVADEXÒ treatment
involves collection of leukocytes, photoactivation, and reinfusion
of photoactivated cells. UVADEXÒ
(methoxsalen) Sterile Solution is supplied in 10 mL vials containing
200 mcg of methoxsalen (concentration
of 20 mcg/mL). During each photopheresis treatment
performed with UVADEXÒ
, 10 mL (200mcg) of UVADEXÒ
is injected directly
into the photoactivation bag
during the first buffy coat
collection cycle. At the end
of six cycles, a total of 740 mL (240 mL of buffy coat, 300 mL of
plasma, and 200 mL of
normal saline
priming fluid) is collected and mixed with the 200 mcg
of UVADEXÒ present
in the photoactivation bag. After photoactivation the cells are
reinfused. The UVARÒ
Photopheresis System Operator’s Manual should be consulted before
using this product.
Frequency/Schedule of Treatment
Normal Treatment Schedule: UVADEXÒ
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
UVADEXÒ beyond six
months or using a different schedule
provides additional benefit. In study C.C.
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
UVADEXÒ (methoxsalen)
Sterile Solution 20 mcg/mL in 10 mL vials (NDC Methoxsalen-Methoxsalen-xx), and
cartons of 12 vials (NDC Methoxsalen-Methoxsalen-xx).
The drug product
must be stored between 59°F (15°C) and 86°F (30°C).
REFERENCES
- 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.
- AMA Council Report, Guidelines for Handling of
Parenteral Antineoplastics. JAMA, 1985; 2.53 (11): 1590-1592.
- 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.
- Clinical Oncological Society of Australia, Guidelines
and Recommendations for Safe Handling of Antineoplastic Agents.
Med J Australia, 1983; 1:426-428.
- 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.
- American Society of Hospital Pharmacists Technical
Assistance Bulletin of Handling Cytotoxic and Hazardous Drugs.
Am J. Hosp Pharm, 1990;47:1033-1049.
- Controlling Occupational Exposure to Hazardous
Drugs. (OSHA Work-Practice Guidelines), AM J. Health-Syst Pharm,
1996; 53: 1669-1685.
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