dutasteride (Rx)

Brand and Other Names:Avodart
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 0.5mg

Benign Prostatic Hyperplasia

0.5 mg PO qDay

Dosing Modifications

Renal impairment: Dose adjustment not necessary

Hepatic impairment: Dose adjustment not necessary

Safety and efficacy not established

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Interactions

Interaction Checker

and dutasteride

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Adverse reactions decrease with duration of treatment, except for gynecomastia

            1-10%

            Impotence

            Decreased libido

            Ejaculation disorder

            Breast disorders

            <1%

            Dizziness

            Frequency Not Defined

            Cardiac failure

            Prostate cancer (high grade)

            Postmarketing Reports

            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

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            Warnings

            Contraindications

            Hypersensitivity

            Women

            Children

            Cautions

            Prior to initiating treatment, rule out other urologic conditions

            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

            Capsules should not be handled by women who are pregnant or may be pregnant; drug can be absorbed through skin and could result in unintended fetal exposure and potential risk to a male fetus; if a pregnant woman comes in contact with leaking dutasteride capsules, the contact area should be washed immediately with soap and water; drug can be absorbed through skin based on animal studies

            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
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            Pregnancy & Lactation

            Pregnancy

            Contraindicated for use in pregnancy because it may cause harm to male fetus; not indicated for use in women

            Drug is a 5 alpha-reductase inhibitor that prevents conversion of testosterone to dihydrotestosterone (DHT), a hormone necessary for normal development of male genitalia; abnormalities in genitalia of male fetuses is an expected physiological consequence of inhibition of this conversion; these results are similar to observations in male infants with genetic 5 alpha-reductase deficiency

            In animal reproduction studies, drug inhibited normal development of external genitalia in male offspring when given to rats or rabbits during organogenesis at less than maximum recommended human dose (MRHD) of 0.5 mg daily, in absence of maternal toxicity; at 15 times the MRHD, prolonged pregnancy, decreased reproductive organ weights, and delayed puberty in male offspring were observed in rats, with no-effect levels less than the MRHD of 0.5 mg daily; increased placental weights in rabbits were also observed, with no-effect levels < MRHD of 0.5 mg daily

            Although dutasteride is secreted into human semen, drug concentration in human female partner is approximately 100 times less than concentrations producing abnormalities of male genitalia in animal studies; in monkeys dosed during organogenesis at blood concentrations comparable to or above levels to which a human female partner is estimated to be exposed, male offspring external genitalia was not adversely affected; no feminization occurred in male offspring of untreated female rats mated to treated male rats even though detectable blood levels of dutasteride were observed in the female rats

            Reproductive Potential

            • The effects of 0.5 mg/day on semen characteristics were evaluated in normal volunteers at 52 weeks, the mean percent reductions from baseline in total sperm count, semen volume, and sperm motility were 23%, 26%, and 18%, respectively, in the dutasteride group when adjusted for changes from baseline in placebo group; sperm concentration and sperm morphology were unaffected; after 24 weeks of follow-up, the mean percent change in total sperm count in dutasteride group remained 23% lower than baseline
            • While mean values for all semen parameters at all timepoints remained within normal ranges and did not meet predefined criteria for a clinically significant change (30%), 2 subjects in the dutasteride group had decreases in sperm count of greater than 90% from baseline at 52 weeks, with partial recovery at 24-week follow-up; clinical significance of dutasteride’s effect on semen characteristics for an individual patient’s fertility not known

            Lactation

            Not indicated for use in women; there is no information available on presence of drug in human milk, effects on breastfed child, or on milk production

            Pregnancy Categories

            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.

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            Pharmacology

            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

            Absorption

            Bioavailability: 60%

            Onset: 1-2 weeks

            Peak plasma time: 2-3 hours

            Distribution

            Protein bound: 99%

            Vd: 300-500 L

            Metabolism

            Hepatic P450 enzyme CYP3A4 & CYP3A5

            Metabolites, major: 4'-hydroxydutasteride, 6-hydroxydutasteride (as active as parent), 1,2'-dihydrodutasteride

            Elimination

            Half-life: 5 weeks (at steady state)

            Excretion: Feces (40%), urine (<1%)

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            Formulary

            FormularyPatient Discounts

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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.

            Tier Description
            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.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.