Dosing & Uses
Dosage Forms & Strengths
Benign Prostatic Hyperplasia
0.5 mg PO qDay
Renal impairment: Dose adjustment not necessary
Hepatic impairment: Dose adjustment not necessary
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Adverse reactions decrease with duration of treatment, except for gynecomastia
Frequency Not Defined
Prostate cancer (high grade)
Immune system disorders: Hypersensitivity reactions, including rash, pruritus, urticaria, localized edema, serious skin reactions, and angioedema
Neoplasms: Male breast cancer
Psychiatric disorders: Depressed mood
Reproductive system and breast disorders: Testicular pain and testicular swelling
Prior to initiating treatment, rule out other urologic conditions
Pregnant women should avoid handling capsules due to risk of absorption through skin
Obstructive uropathy, liver disease
Patient should not donate blood until 6 months after last dose of dutasteride
Dutasteride lowers serum PSA 40-50%; establish new baseline PSA after 3-6 months of treatment
Monitor for cardiac changes or cardiac failure
5-ARIs and prostate cancer risk
- June 9, 2011: Recent data from 2 large, randomized, controlled trials observed an increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer) in trial participants taking 5-alpha reductase inhibitors (5-ARIs)
- The 2 trials are the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial
- The revised prescribing information recommends that prior to initiating therapy with 5-ARIs, appropriate evaluation should be performed to rule out other urologic conditions, including prostate cancer, that might mimic benign prostatic hyperplasia
Pregnancy & Lactation
Pregnancy category: X
Lactation: Excretion in milk unknown/contraindicated
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Selective inhibitor of type 1 and type 2 isoforms of 5-alpha-reductase; suppresses serum dihydrotestosterone levels by inhibiting the conversion of testosterone to dihydrotestosterone
Onset: 1-2 weeks
Peak plasma time: 2-3 hours
Protein bound: 99%
Vd: 300-500 L
Hepatic P450 enzyme CYP3A4 & CYP3A5
Metabolites, major: 4'-hydroxydutasteride, 6-hydroxydutasteride (as active as parent), 1,2'-dihydrodutasteride
Half-life: 5 weeks (at steady state)
Excretion: Feces (40%), urine (<1%)
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
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- Compare formulary status to other drugs in the same class.
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|5||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|6||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.