"The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for"...
(leuprolide acetate) Implant
Viadur® (leuprolide acetate implant) is a sterile nonbiodegradable, osmotically driven miniaturized implant designed to deliver leuprolide acetate for 12 months at a controlled rate (Figure A). Viadur® (leuprolide acetate implant) incorporates DUROS® technology. The system contains 65 mg of leuprolide (free base). Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The implant is inserted subcutaneously in the inner aspect of the upper arm. After 12 months, the implant must be removed. At the time an implant is removed, another implant may be inserted to continue therapy.
Viadur® contains 72 mg of leuprolide acetate (equivalent to 65 mg leuprolide free base) dissolved in 104 mg dimethyl sulfoxide. The 4 mm by 45 mm titanium alloy reservoir houses a polyurethane rate-controlling membrane, an elastomeric piston, and a polyethylene diffusion moderator. The reservoir also contains the osmotic tablets, which are not released with the drug formulation. The osmotic tablets are composed of sodium chloride, sodium carboxymethyl cellulose, povidone, magnesium stearate, and sterile water for injection. Polyethylene glycol fills the space between the osmotic tablets and the reservoir. A minute amount of silicone medical fluid is used during manufacture as a lubricant. The weight of the implant is approximately 1.1g.
Figure A : Viadur® (leuprolide acetate implant) (diagram
not to scale)
The chemical name is 5-Oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-Lleucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt), with the following structural formula:
Last reviewed on RxList: 3/8/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Viadur Information
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