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Clinical Studies.pdf

019732s045020517s043lbl.pdf
Preview of clinical studies
🔗 Source: accessdata.fda.gov
📊 Size: 334 KB
👤 Author: fda/cder
⬇️ Downloads: 163

Summary

LUPRON DEPOT (leuprolide acetate) is a gonadotropin-releasing hormone (GnRH) agonist indicated for the treatment of advanced prostatic cancer. It is available in 7.5 mg, 22.5 mg, 30 mg, and 45 mg injections for 1-month, 3-month, 4-month, and 6-month administration, respectively. The dosage strengths are not additive and must be selected based on the desired dosing schedule. LUPRON DEPOT must be administered under the supervision of a physician as a single intramuscular injection. Contraindications include hypersensitivity to GnRH, GnRH agonist, or any excipients in LUPRON DEPOT. Warnings and precautions include increased serum testosterone, hyperglycemia, diabetes, cardiovascular diseases, and embryo-fetal toxicity. Common adverse reactions (>10%) vary by dosage strength and include general pain, hot flashes, GI disorders, and urinary disorders.

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Description

LUPRON DEPOT (leuprolide acetate) is a gonadotropin-releasing hormone (GnRH) agonist indicated for the treatment of advanced prostatic cancer.

Technical Information

  • File Format: PDF
  • File Size: 334 KB
  • Pages: 28
  • Language: EN
  • Author: fda/cder
  • Total Downloads: 163
  • Last Updated: 5 days ago

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This PDF document about clinical studies provides comprehensive information and guidance. Whether you're a beginner or advanced user, this resource offers valuable insights into clinical studies.

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