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U.S. Department of Health and Human Services

Safety

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Avodart (dutasteride) Soft Gelatin Capsules June 2008


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

CONTRAINDICATIONS

  • Pregnancy

WARNINGS AND PRECAUTIONS

  • Evaluation for Other Urological Diseases
  • Effects on Prostate-Specific Antigen (PSA) and the Use of PSA in Prostate Cancer Detection

ADVERSE REACTIONS

  • Clinical Trials Experience
    • Combination with Alpha-Blocker Therapy (CombAT)
    • Table 2

DRUG INTERACTIONS

  • Alpha-Adrenergic Blocking Agents
    • ...The effect of administration of tamsulosin or terazosin on dutasteride pharmacokinetic parameters has not been evaluated.

USE IN SPECIFIC POPULATIONS

  • Pregnancy
  • Hepatic Impairment
    • ...in a clinical study where 60 subjects received 5 mg (10 times the therapeutic dose) daily for 24 weeks, no additional adverse events were observed compared with those observed at the therapeutic dose of 0.5 mg...

PATIENT COUNSELING INFORMATION

  • Exposure of Women - Risk to Male Fetus
    • ...Dutasteride is absorbed through the skin and could result in unintended fetal exposure. If a pregnant woman or woman of childbearing potential comes in contact with leaking Avodart Capsules, the contact area should be washed immediately with soap and water...
  • Blood Donation
    • ...Serum levels of dutasteride are detectable for 4 to 6 months after treatment ends...

CONTRAINDICATIONS

Pregnancy - Dutasteride inhibits the activity of 5α-reductase, which prevents conversion of testosterone to dihydrotesterone, a hormone necessary for normal development of male genitalia. In animal reproduction and developmental toxicity studies, dutasteride inhibited development of male fetus external genitalia. Therefore, Avodart may cause fetal harm when administered to a pregnant woman. If Avodart is used during pregnancy or if the patient becomes pregnant while taking Avodart, the patient should be apprised of the potential hazard to the fetus...

WARNINGS AND PRECAUTIONS

Evaluation for Other Urological Diseases

...Patients should be assessed to rule out prostate cancer and other urological diseases prior to treatment with Avodart and periodically thereafter...

Effects on Prostate-Specific Antigen (PSA) and the Use of PSA in Prostate Cancer Detection

Coadministration of tamsulosin with dutasteride resulted in similar changes to total PSA as dutasteride monotherapy.