AVODART

AbsorptionFollowing administration of a single 0.5-mg dose of a soft gelatin capsule, time to peak serum concentrations (T max ) of dutasteride occurs within 2 to 3 hours. Absolute bioavailability in 5 healthy subjects is approximately 60% (range: 40% to 94%). When the drug is administered with food, the maximum serum concentrations were reduced by 10% to 15%. This reduction is of no clinical significance.

DistributionPharmacokinetic data following single and repeat oral doses show that dutast...

14.1 Monotherapy AVODART 0.5 mg/day (n = 2,167) or placebo (n = 2,158) was evaluated in male subjects with BPH in three 2‑year multicenter, placebo‑controlled, double‑blind trials, each with 2‑year open‑label extensions (n = 2,340). More than 90% of the trial population was white. Subjects were aged at least 50 years with a serum PSA ≥1.5 ng/mL and <10 ng/mL and BPH diagnosed by medical history and physical examination, including enlarged prostate (≥30 cc) and BPH symptoms that were moderate to severe according to the American Urological Association Symptom Index (AUA‑SI). Most of the 4,325 su...

The most common adverse reactions, reported in ≥1% of subjects treated with AVODART and more commonly than in subjects treated with placebo, are impotence, decreased libido, ejaculation disorders, and breast disorders. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Waylis Therapeutics LLC at 888-514-4727 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed i...

AVODART is contraindicated for use in:

• Pregnancy. Dutasteride use is contraindicated in women who are pregnant. 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 [see Warnings and Precautions ( 5.4 ), Use in Specific Populations ( 8.1 )] .
• P...

• AVODART reduces serum prostate-specific antigen (PSA) concentration by approximately 50%. However, any confirmed increase in PSA while on AVODART may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for untreated men. ( 5.1 )
• AVODART may increase the risk of high-grade prostate cancer. ( 5.2 , 6.1 )
• Prior to initiating treatment with AVODART, consideration should be given to other urological conditions that may cause sim...

7 DRUG INTERACTIONS Use with caution in patients taking potent, chronic cytochrome P450 (CYP)3A4 enzyme inhibitors (e.g., ritonavir). ( 7 ) 7.1 Cytochrome P450 3A Inhibitors Dutasteride is extensively metabolized in humans by the cytochrome P450 (CYP)3A4 and CYP3A5 isoenzymes. The effect of potent CYP3A4 inhibitors on dutasteride has not been studied. Because of the potential for drug‑drug interac...