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Questions & Answers
Side Effects & Adverse Reactions
Viadur®, like other LH-RH agonists, causes a transient increase in serum concentrations of testosterone during the first week of treatment. Patients may experience worsening of symptoms or onset of new symptoms, including bone pain, neuropathy, hematuria, or ureteral or bladder outlet obstruction (see PRECAUTIONS).
Cases of ureteral obstruction and spinal cord compression, which may contribute to paralysis with or without fatal complications, have been reported with LH-RH agonists.
If spinal cord compression or renal impairment develops, standard treatment of these complications should be instituted.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Viadur® is indicated in the palliative treatment of advanced prostate cancer.
There is currently no drug history available for this drug.
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® 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-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt), with the following structural formula: