What is Viadur?

Viadur is a leuprolide acetate implant that is placed under the skin of the patient’s upper arm. The implant releases leuprolide acetate, which reduces the amount of testosterone produced by the testicles and circulated in the body. (Reduction of testosterone production usually leads to the cancer shrinking or the prevention of further growth.) Viadur releases leuprolide acetate for 12 months. After 12 months, the implant must be removed and may be replaced with a new implant.

What is DUROS^® implant technology and how does it work?

The DUROS^® technology used for Viadur is an osmotically driven, leuprolide acetate-filled, miniature titanium implant — a technology developed by ALZA Corporation that enables Viadur's continuous, steady-state drug delivery.

Following surgical implantation of the Viadur implant, water from surrounding tissue enters one end of the cylinder through a semipermeable membrane. This causes the osmotic engine to swell, which in turn pushes the piston toward the drug compartment, causing a release rate equal to the inflow of water. The drug is delivered from an exit port opposite the semipermeable membrane. This controlled release process takes place at rates less than 1/100th of a drop of water over 24 hours.

Where can I find complete prescribing information for Viadur?

Click here for prescribing information.

What are the reported adverse effects with Viadur?

In clinical trials, the most common systemic side effects reported with Viadur were vasodilatation (hot flashes, 67.9 %), loss of strength (7.6 %), gynecomastia (6.9 %), depression (5.3 %), and sweating (5.3 %). The most common local side effects were bruising (34.6 %) and burning (5.6 %).

Viadur is contraindicated in patients with hypersensitivity to GnRH, GnRH agonist analogs, or any of the components in Viadur. Viadur is contraindicated in women and pediatric patients and was not studied in women or children. 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 including bone pain, neuropathy, hematuria, or ureteral or bladder outlet obstruction.For complete product details, please review the Viadur prescribing information.

How complicated is insertion and removal?

In the pivotal studies, the mean duration of the insertion procedure was 4 minutes from incision to close (range 1 to 15 minutes) not including patient prep and recovery. Preparation time includes identifying the insertion site, preparing the sterile field, loading the implanter, and anesthetizing the area. The mean duration for removal of the used Viadur implant and insertion of a new implant was just under 7 minutes (range 1 to 28 minutes). This does not include patient preparation or recovery time.

To view information regarding the studies discussed please visit the clinical trial information page.

How common and severe are local side effects related to the procedure?

Based on pooled data from the pivotal studies, the majority of local reactions associated with initial insertion, or removal and insertion of a new implant, began and resolved within the first 2 weeks.

Local reactions after the initial insertion included bruising (34.6%) and burning (5.6%). Other less frequently reported reactions included pulling, pressure, itching, erythema, pain, edema, and bleeding.

Local reactions persisted in 9.3% of patients; 10.3% of patients developed local reactions 2 weeks after insertion.

Of the 107 patients who received 1 implant, only 4 experienced application site infection/inflammation following initial insertion or insertion of a new implant. These were treated with oral antibiotics and resolved.

To view information regarding the studies discuss please visit the clinical trial information page.

How does Viadur compare with other LHRH agonist therapies, such as Lupron Depot^® (TAP Pharmaceuticals) and Zoladex^® (AstraZeneca)?

There have been no head-to-head clinical trials comparing the three therapies. All three therapies for the palliative treatment of advanced prostate cancer have similar modes of action – they are analogs of luteinizing hormone-releasing hormone (LHRH).

The three drugs are administered differently. Viadur is an implant administered subcutaneously into the inner part of the upper arm. Both Zoladex and Lupron Depot are administered by injection. Zoladex is administered subcutaneously into the upper abdominal wall and Lupron Depot is administered by intramuscular injection.

A single Viadur implant achieves steady serum leuprolide concentrations consistently throughout the 12-month dosing period. Lupron Depot is dosed either every one, three, four or six months. Zoladex is dosed either every one or three months.

What supplies can I expect to receive in the Viadur implant kit?

The Viadur sterile procedure kit provides everything required for the procedure except the sterile gloves. This includes: a povidone swab, needles, a syringe, a scalpel, gauze, a closure strip, a bandage, alcohol prep, a marking pen/ruler, forceps, skin protectant, and lidocaine, as well as the implanter device and Viadur implant.

What are the terms of the agreement between ALZA Corporation and Bayer regarding Viadur?

ALZA Corporation manufactures and supplies Viadur to Bayer. Bayer markets, distributes, and promotes Viadur in the U.S.