Viadur (Leuprolide Acetate) - Drug Interactions, Contraindications, Overdosage, etc

DRUG INTERACTIONS

Drug Interactions

See PHARMACOKINETICS.

OVERDOSAGE

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^® implants.

CONTRAINDICATIONS

1. Viadur^® is contraindicated in patients with hypersensitivity to GnRH, GnRH agonist analogs, or any of the components in Viadur^®. Anaphylactic reactions to synthetic GnRH or GnRH agonist analogs have been reported in the literature.²
2. Viadur^® 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

1. Sennello LT et al. Single-dose pharmacokinetics of leuprolide in humans following intravenous and subcutaneous administration. J Pharm Sci 1986; 75(2): 158-160.
2. MacLeod TL et al. Anaphylactic reaction to synthetic luteinizing hormone-releasing hormone. Fertil Steril 1987; 48(3): 500-502.

Manufactured by:
ALZA Corporation
Mountain View, CA 94043 U.S.A.

Distributed by:
Bayer Pharmaceuticals Corporation
400 Morgan Lane, West Haven, CT 06516 USA

Viadur^® and DUROS^® are registered trademarks of ALZA Corporation under license to Bayer Pharmaceuticals Corporation. For further information about the product contact Bayer Pharmaceuticals Corporation.

An ALZA DUROS^® Technology Product

Edition Date: November 2005