Viadur (Leuprolide Acetate Implant) Drug Information: Overdosage and Contraindications

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May 27, 2012

Viadur

Prostate Cancer »

What is the prostate gland?

The prostate gland is an organ that is located at the base or outlet (neck) of the urinary bladder. (See the diagram that follows.) The gland surrounds the first part of the urethra. The urethra is the passage through which urine drains from the bladder to exit from the penis. One function of the prostate gland is to help control urination by pressing directly against the part of the urethra that it surrounds. The main function of the prostate gland is to produce some of the substances that are found in normal semen, such as minerals and sugar. Semen is the fluid that transports the sperm to assist with reproduction. A man can manage quite well, however, without his prostate gland. (See the section on surgical treatment for prostate cancer.)

In a young man, the normal prostate gland is the size of a walnut (<30g). During normal aging, however, the gland usually grows larger. This hormone-related enlargement with aging is called b...

Read the Prostate Cancer article »

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OVERDOSE

In clinical trials using daily subcutaneous leuprolide acetate in patients with prostate cancer, doses as high as 20 mg/day for up to 2 years caused no adverse effects differing from those observed with the 1 mg/day dose. The adverse event profiles were similar in patients receiving one or two Viadur® (leuprolide acetate implant) implants.

CONTRAINDICATIONS

Viadur® (leuprolide acetate implant) is contraindicated in patients with hypersensitivity to GnRH, GnRH agonist analogs, or any of the components in Viadur® (leuprolide acetate implant) . Anaphylactic reactions to synthetic GnRH or GnRH agonist analogs have been reported in the literature.²
Viadur® (leuprolide acetate implant) is contraindicated in women and in pediatric patients and was not studied in women or children. Moreover, leuprolide acetate can cause fetal harm when administered to a pregnant woman. Major fetal abnormalities were observed in rabbits but not in rats after administration of leuprolide acetate throughout gestation. There were increased fetal mortality and decreased fetal weights in rats and rabbits. The effects on fetal mortality are expected consequences of the alterations in hormonal levels brought about by this drug. The possibility exists that spontaneous abortion may occur.

REFERENCES

2. MacLeod TL et al. Anaphylactic reaction to synthetic luteinizing hormone-releasing hormone. Fertil Steril 1987; 48(3): 500-502.

Last reviewed on RxList: 3/8/2011
This monograph has been modified to include the generic and brand name in many instances.