Avodart

Name: Avodart

Side effects

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trial of another drug and may not reflect the rates observed in practice.

From clinical trials with AVODART as monotherapy or in combination with tamsulosin:

  • The most common adverse reactions reported in subjects receiving AVODART were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), and ejaculation disorders. The most common adverse reactions reported in subjects receiving combination therapy (AVODART plus tamsulosin) were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), ejaculation disorders, and dizziness. Ejaculation disorders occurred significantly more in subjects receiving combination therapy (11%) compared with those receiving AVODART (2%) or tamsulosin (4%) as monotherapy.
  • Trial withdrawal due to adverse reactions occurred in 4% of subjects receiving AVODART, and 3% of subjects receiving placebo in placebo-controlled trials with AVODART. The most common adverse reaction leading to trial withdrawal was impotence (1%).
  • In the clinical trial evaluating the combination therapy, trial withdrawal due to adverse reactions occurred in 6% of subjects receiving combination therapy (AVODART plus tamsulosin) and 4% of subjects receiving AVODART or tamsulosin as monotherapy. The most common adverse reaction in all treatment arms leading to trial withdrawal was erectile dysfunction (1% to 1.5%).

Monotherapy

Over 4,300 male subjects with BPH were randomly assigned to receive placebo or 0.5-mg daily doses of AVODART in 3 identical 2-year, placebo-controlled, double-blind, Phase 3 treatment trials, each followed by a 2-year open-label extension. During the double-blind treatment period, 2,167 male subjects were exposed to AVODART, including 1,772 exposed for 1 year and 1,510 exposed for 2 years. When including the open-label extensions, 1,009 male subjects were exposed to AVODART for 3 years and 812 were exposed for 4 years. The population was aged 47 to 94 years (mean age: 66 years) and greater than 90% were white. Table 1 summarizes clinical adverse reactions reported in at least 1% of subjects receiving AVODART and at a higher incidence than subjects receiving placebo.

Table 1. Adverse Reactions Reported in ≥1% of Subjects over a 24-Month Period and More Frequently in the Group Receiving AVODART than the Placebo Group (Randomized, Double- blind, Placebo-controlled Trials Pooled) by Time of Onset

Adverse Reaction AVODART (n) Placebo (n) Adverse Reaction Time of Onset
Months 0 6
(n = 2,167)
(n = 2,158)
Months 7 12
(n = 1,901)
(n = 1,922)
Months 13 18
(n = 1,725)
(n = 1,714)
Months 19 24
(n = 1,605)
(n = 1,555)
Impotencea
  AVODART 4.7% 1.4% 1.0% 0.8%
  Placebo 1.7% 1.5% 0.5% 0.9%
Decreased libidoa
  AVODART 3.0% 0.7% 0.3% 0.3%
  Placebo 1.4% 0.6% 0.2% 0.1%
Ejaculation disordersa
  AVODART 1.4% 0.5% 0.5% 0.1%
  Placebo 0.5% 0.3% 0.1% 0.0%
Breast disordersb
  AVODART 0.5% 0.8% 1.1% 0.6%
  Placebo 0.2% 0.3% 0.3% 0.1%
aThese sexual adverse reactions are associated with dutasteride treatment (including monotherapy and combination with tamsulosin). These adverse reactions may persist after treatment discontinuation. The role of dutasteride in this persistence is unknown.
bIncludes breast tenderness and breast enlargement.

Long-Term Treatment (Up To 4 Years)

High-grade Prostate Cancer

The REDUCE trial was a randomized, double-blind, placebo-controlled trial that enrolled 8,231 men aged 50 to 75 years with a serum PSA of 2.5 ng/mL to 10 ng/mL and a negative prostate biopsy within the previous 6 months. Subjects were randomized to receive placebo (n = 4,126) or 0.5-mg daily doses of AVODART (n = 4,105) for up to 4 years. The mean age was 63 years and 91% were white. Subjects underwent protocol-mandated scheduled prostate biopsies at 2 and 4 years of treatment or had “for-cause biopsies” at non-scheduled times if clinically indicated. There was a higher incidence of Gleason score 8-10 prostate cancer in men receiving AVODART (1.0%) compared with men on placebo (0.5%) [see INDICATIONS AND USAGE, WARNINGS AND PRECAUTIONS]. In a 7-year placebo-controlled clinical trial with another 5 alpha-reductase inhibitor (finasteride 5 mg, PROSCAR), similar results for Gleason score 8-10 prostate cancer were observed (finasteride 1.8% versus placebo 1.1%).

No clinical benefit has been demonstrated in patients with prostate cancer treated with AVODART.

Reproductive And Breast Disorders

In the 3 pivotal placebo-controlled BPH trials with AVODART, each 4 years in duration, there was no evidence of increased sexual adverse reactions (impotence, decreased libido, and ejaculation disorder) or breast disorders with increased duration of treatment. Among these 3 trials, there was 1 case of breast cancer in the dutasteride group and 1 case in the placebo group. No cases of breast cancer were reported in any treatment group in the 4-year CombAT trial or the 4-year REDUCE trial.

The relationship between long-term use of dutasteride and male breast neoplasia is currently unknown.

Combination With Alpha-Blocker Therapy (CombAT)

Over 4,800 male subjects with BPH were randomly assigned to receive 0.5-mg AVODART, 0.4-mg tamsulosin, or combination therapy (0.5-mg AVODART plus 0.4-mg tamsulosin) administered once daily in a 4-year double-blind trial. Overall, 1,623 subjects received monotherapy with AVODART; 1,611 subjects received monotherapy with tamsulosin; and 1,610 subjects received combination therapy. The population was aged 49 to 88 years (mean age: 66 years) and 88% were white. Table 2 summarizes adverse reactions reported in at least 1% of subjects in the combination group and at a higher incidence than subjects receiving monotherapy with AVODART or tamsulosin.

Table 2. Adverse Reactions Reported over a 48-Month Period in ≥1% of Subjects and More Frequently in the Coadministration Therapy Group than the Groups Receiving Monotherapy with AVODART or Tamsulos in (CombAT) by Time of Onset

Adverse Reaction Adverse Reaction Time of Onset
Year 1Year 2 Year 3 Year 4
Months 0 6 Months 7 12
Combination3 (n = 1,610) (n = 1,527) (n = 1,428) (n = 1,283) (n = 1,200)
AVODART (n = 1,623) (n = 1,548) (n = 1,464) (n = 1,325) (n = 1,200)
Tamsulosin (n = 1,611) (n = 1,545) (n = 1,468) (n = 1,281) (n = 1,112)
Ejaculation disordersb,c          
Combination 7.8% 1.6% 1.0% 0.5% <0.1%
AVODART 1.0% 0.5% 0.5% 0.2% 0.3%
Tamsulosin 2.2% 0.5% 0.5% 0.2% 0.3%
Impotencec,d          
Combination 5.4% 1.1% 1.8% 0.9% 0.4%
AVODART 4.0% 1.1% 1.6% 0.6% 0.3%
Tamsulosin 2.6% 0.8% 1.0% 0.6% 1.1%
Decreased libidoc,e          
Combination 4.5% 0.9% 0.8% 0.2% 0.0%
AVODART 3.1% 0.7% 1.0% 0.2% 0.0%
Tamsulosin 2.0% 0.6% 0.7% 0.2% <0.1%
Breast disordersf          
Combination 1.1% 1.1% 0.8% 0.9% 0.6%
AVODART 0.9% 0.9% 1.2% 0.5% 0.7%
Tamsulosin 0.4% 0.4% 0.4% 0.2% 0.0%
Dizziness          
Combination 1.1% 0.4% 0.1% <0.1% 0.2%
AVODART 0.5% 0.3% 0.1% <0.1% <0.1%
Tamsulosin 0.9% 0.5% 0.4% <0.1% 0.0%
aCombination = AVODART 0.5 mg once daily plus tamsulosin 0.4 mg once daily.
bIncludes anorgasmia, retrograde ejaculation, semen volume decreased, orgasmic sensation decreased, orgasm abnormal, ejaculation delayed, ejaculation disorder, ejaculation failure, and premature ejaculation.
cThese sexual adverse reactions are associated with dutasteride treatment (including monotherapy and combination with tamsulosin). These adverse reactions may persist after treatment discontinuation. The role of dutasteride in this persistence is unknown.
dIncludes erectile dysfunction and disturbance in sexual arousal.
eIncludes libido decreased, libido disorder, loss of libido, sexual dysfunction, and male sexual dysfunction.
fIncludes breast enlargement, gynecomastia, breast swelling, breast pain, breast tenderness, nipple pain, and nipple swelling.

Cardiac Failure

In CombAT, after 4 years of treatment, the incidence of the composite term cardiac failure in the combination therapy group (12/1,610; 0.7%) was higher than in either monotherapy group: AVODART, 2/1,623 (0.1%) and tamsulosin, 9/1,611 (0.6%). Composite cardiac failure was also examined in a separate 4-year placebo-controlled trial evaluating AVODART in men at risk for development of prostate cancer. The incidence of cardiac failure in subjects taking AVODART was 0.6% (26/4,105) compared with 0.4% (15/4,126) in subjects on placebo. A majority of subjects with cardiac failure in both trials had comorbidities associated with an increased risk of cardiac failure. Therefore, the clinical significance of the numerical imbalances in cardiac failure is unknown. No causal relationship between AVODART alone or in combination with tamsulosin and cardiac failure has been established. No imbalance was observed in the incidence of overall cardiovascular adverse events in either trial.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of AVODART. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to AVODART.

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.

Warnings

Included as part of the "PRECAUTIONS" Section

Manufacturer

  • GlaxoSmithKline LLC

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

What is the most important information I should know about dutasteride?

Dutasteride should never be taken by a woman or a child. Dutasteride can be absorbed through the skin, and women or children should not be permitted to handle dutasteride capsules.

Although dutasteride is not for use by women, this medication can cause birth defects if a woman is exposed to it during pregnancy. Dutasteride capsules should not be handled by a woman who is pregnant or who may become pregnant.

Do not chew, crush, or open a dutasteride capsule. Swallow the capsule whole. Dutasteride can irritate your lips, mouth, or throat if the capsule has been broken or opened before you swallow it.

If a woman accidentally comes into contact with this medication from a leaking capsule, wash the area with soap and water right away.

Before taking dutasteride, tell your doctor if you have ever had an allergic reaction to this medication, or to a similar medicine called finasteride (Propecia, Proscar).

Using dutasteride may increase your risk of developing prostate cancer. Your doctor will perform tests to make sure you do not have other conditions that would prevent you from safely using dutasteride.

Do not donate blood while taking dutasteride and for at least 6 months after your treatment ends. Dutasteride can be carried in the blood and could cause birth defects if a pregnant women receives a transfusion with blood that contains dutasteride.

What should I avoid while taking dutasteride?

Do not donate blood while taking dutasteride and for at least 6 months after your treatment ends. Dutasteride can be carried in the blood and could cause birth defects if a pregnant women receives a transfusion with blood that contains dutasteride.

Actions

  • Competitive inhibitor of both the type 1 and type 2 isoenzymes of steroid 5α-reductase.1 9 14 These enzymes convert testosterone to DHT.1 9

  • Reduces serum and prostatic DHT concentrations substantially.1 DHT appears to be the principal androgen responsible for initial development and subsequent enlargement of the prostate gland.1 9

  • Increases serum testosterone (generally remaining within the normal range) and prostatic testosterone concentrations.1 3 9

Uses of Avodart

  • In men, it is used to treat the signs of an enlarged prostate.
  • It may be given to you for other reasons. Talk with the doctor.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Avodart (dutasteride) or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Avodart. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Indications and Usage for Avodart

Monotherapy

Avodart® (dutasteride) soft gelatin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:

• improve symptoms, • reduce the risk of acute urinary retention (AUR), and • reduce the risk of the need for BPH-related surgery.

Combination with Alpha-adrenergic Antagonist

Avodart in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate.

Limitations of Use

Avodart is not approved for the prevention of prostate cancer.

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information).

PSA Monitoring

Inform patients that Avodart reduces serum PSA levels by approximately 50% within 3 to 6 months of therapy, although it may vary for each individual. For patients undergoing PSA screening, increases in PSA levels while on treatment with Avodart may signal the presence of prostate cancer and should be evaluated by a healthcare provider [see Warnings and Precautions (5.1)].

Increased Risk of High-grade Prostate Cancer

Inform patients that there was an increase in high-grade prostate cancer in men treated with 5 alpha-reductase inhibitors (which are indicated for BPH treatment), including Avodart, compared with those treated with placebo in trials looking at the use of these drugs to reduce the risk of prostate cancer [see Indications and Usage (1.3), Warnings and Precautions (5.2), Adverse Reactions (6.1)].

Exposure of WomenRisk to Male Fetus

Inform patients that Avodart capsules should not be handled by a woman who is pregnant or who could become pregnant because of the potential for absorption of dutasteride and the subsequent potential risk to a developing 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 [see Warnings and Precautions (5.4), Use in Specific Populations (8.1)].

Blood Donation

Inform men treated with Avodart that they should not donate blood until at least 6 months following their last dose to prevent pregnant women from receiving dutasteride through blood transfusion [see Warnings and Precautions (5.5)]. Serum levels of dutasteride are detectable for 4 to 6 months after treatment ends [see Clinical Pharmacology (12.3)].

Avodart is a registered trademark of the GSK group of companies.

The brands listed are trademarks of their respective owners and are not trademarks of the GSK group of companies. The makers of these brands are not affiliated with and do not endorse the GSK group of companies or its products.

Manufactured for:

GlaxoSmithKline
Research Triangle Park, NC 27709

©2014, the GSK group of companies. All rights reserved.

AVT:12PI

PHARMACIST-DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT

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PATIENT INFORMATION

Avodart® (av’ ō dart)

(dutasteride) capsules

Avodart is for use by men only.

Read this patient information before you start taking Avodart and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is Avodart?

Avodart is a prescription medicine that contains dutasteride. Avodart is used to treat the symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:

• improve symptoms, • reduce the risk of acute urinary retention (a complete blockage of urine flow), • reduce the risk of the need for BPH-related surgery.

Who should NOT take Avodart?

Do Not Take Avodart if you are:

• pregnant or could become pregnant. Avodart may harm your unborn baby. Pregnant women should not touch Avodart capsules. If a woman who is pregnant with a male baby gets enough Avodart in her body by swallowing or touching Avodart, the male baby may be born with sex organs that are not normal. 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. • a child or a teenager. • allergic to dutasteride or any of the ingredients in Avodart. See the end of this leaflet for a complete list of ingredients in Avodart. • allergic to other 5 alpha-reductase inhibitors, for example, PROSCAR® (finasteride) tablets.

What should I tell my healthcare provider before taking Avodart?

Before you take Avodart, tell your healthcare provider if you:

• have liver problems

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Avodart and other medicines may affect each other, causing side effects. Avodart may affect the way other medicines work, and other medicines may affect how Avodart works.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Avodart?

• Take 1 Avodart capsule once a day. • Swallow Avodart capsules whole. Do not crush, chew, or open Avodart capsules because the contents of the capsule may irritate your lips, mouth, or throat. • You can take Avodart with or without food. • If you miss a dose, you may take it later that day. Do not make up the missed dose by taking 2 doses the next day.

What should I avoid while taking Avodart?

• You should not donate blood while taking Avodart or for 6 months after you have stopped Avodart. This is important to prevent pregnant women from receiving Avodart through blood transfusions.

What are the possible side effects of Avodart?

Avodart may cause serious side effects, including:

• Rare and serious allergic reactions, including: • swelling of your face, tongue, or throat • serious skin reactions, such as skin peeling

Get medical help right away if you have these serious allergic reactions.

• Higher chance of a more serious form of prostate cancer.

The most common side effects of Avodart include:

• trouble getting or keeping an erection (impotence)* • a decrease in sex drive (libido)* • ejaculation problems* • enlarged or painful breasts. If you notice breast lumps or nipple discharge, you should talk to your healthcare provider.

*Some of these events may continue after you stop taking Avodart.

Depressed mood has been reported in patients receiving Avodart.

Avodart has been shown to reduce sperm count, semen volume, and sperm movement. However, the effect of Avodart on male fertility is not known.

Prostate-Specific Antigen (PSA) Test: Your healthcare provider may check you for other prostate problems, including prostate cancer before you start and while you take Avodart. A blood test called PSA (prostate-specific antigen) is sometimes used to see if you might have prostate cancer. Avodart will reduce the amount of PSA measured in your blood. Your healthcare provider is aware of this effect and can still use PSA to see if you might have prostate cancer. Increases in your PSA levels while on treatment with Avodart (even if the PSA levels are in the normal range) should be evaluated by your healthcare provider.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects with Avodart. For more information, ask you healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Avodart?

• Store Avodart capsules at room temperature (59°F to 86°F or 15°C to 30°C). • Avodart capsules may become deformed and/or discolored if kept at high temperatures. • Do not use Avodart if your capsules are deformed, discolored, or leaking. • Safely throw away medicine that is no longer needed.

Keep Avodart and all medicines out of the reach of children.

Medicines are sometimes prescribed for purposes other than those listed in a patient leaflet. Do not use Avodart for a condition for which it was not prescribed. Do not give Avodart to other people, even if they have the same symptoms that you have. It may harm them.

This patient information leaflet summarizes the most important information about Avodart. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Avodart that is written for health professionals.

For more information, go to www.Avodart.com or call 1-888-825-5249.

What are the ingredients in Avodart?

Active ingredient: dutasteride.

Inactive ingredients: butylated hydroxytoluene, ferric oxide (yellow), gelatin (from certified BSE-free bovine sources), glycerin, mono-di-glycerides of caprylic/capric acid, titanium dioxide, and edible red ink.

How does Avodart work?

Prostate growth is caused by a hormone in the blood called dihydrotestosterone (DHT). Avodart lowers DHT production in the body, leading to shrinkage of the enlarged prostate in most men. While some men have fewer problems and symptoms after 3 months of treatment with Avodart, a treatment period of at least 6 months is usually necessary to see if Avodart will work for you.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Avodart is a registered trademark of the GSK group of companies.

The brands listed are trademarks of their respective owners and are not trademarks of the GSK group of companies. The makers of these brands are not affiliated with and do not endorse the GSK group of companies or its products.

Manufactured for:

GlaxoSmithKline
Research Triangle Park, NC 27709

©2014, the GSK group of companies. All rights reserved.

September 2014
AVT:9PIL

PRINCIPAL DISPLAY PANEL

NDC 0173-0712-04

Avodart®

(dutasteride)

Soft Gelatin Capsules

0.5 mg

RX only

GX CE2

90 Capsules

WARNING: Avodart should not be used by women or children. Women who are or may potentially be pregnant should not use or handle Avodart Soft Gelatin Capsules (see prescribing information). If contact is made with leaking capsule, wash immediately with soap and water.

Each capsule contains 0.5 mg dutasteride.

Usual Dosage: 0.5 mg once a day.

Capsules should be swallowed whole and not chewed or opened. See prescribing information for further dosing information.

Store at 25oC (77oF); excursions permitted to 15-30oC (59-86oF) [see USP Controlled Room Temperature].

Dispense in a well-closed container as defined in the USP.

Do not use if printed safety seal under cap is broken or missing.

Manufactured for: GlaxoSmithKline

Research Triangle Park, NC 27709

Made in Ireland

  10000000143749 Rev. 11/16
Avodart 
dutasteride capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0173-0712
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DUTASTERIDE (DUTASTERIDE) DUTASTERIDE 0.5 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE  
FERRIC OXIDE YELLOW  
GELATIN  
GLYCERIN  
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES  
Product Characteristics
Color YELLOW (dull yellow) Score no score
Shape OVAL (soft gelatin capsule) Size 19mm
Flavor Imprint Code GX;CE2
Contains     
Packaging
# Item Code Package Description
1 NDC:0173-0712-04 90 CAPSULE, LIQUID FILLED in 1 BOTTLE
2 NDC:0173-0712-15 30 CAPSULE, LIQUID FILLED in 1 BOTTLE
3 NDC:0173-0712-02 7 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021319 12/10/2002
Labeler - GlaxoSmithKline LLC (167380711)
Revised: 09/2014   GlaxoSmithKline LLC

What is dutasteride (avodart)?

Dutasteride prevents the conversion of testosterone to dihydrotestosterone (DHT) in the body. DHT is involved in the development of benign prostatic hyperplasia (BPH).

Dutasteride is used to treat benign prostatic hyperplasia (BPH) in men with an enlarged prostate. Dutasteride helps improve urinary flow and may also reduce your need for prostate surgery later on.

Dutasteride is sometimes given with another medication called tamsulosin (Flomax). Be sure to read the medication guide or patient instructions provided with each of your medications.

Dutasteride may also be used for purposes not listed in this medication guide.

Avodart side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Avodart: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

  • decreased libido (sex drive);

  • decreased amount of semen released during sex;

  • impotence (trouble getting or keeping an erection); or

  • breast tenderness or enlargement.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For the Consumer

Applies to dutasteride: oral capsule liquid filled

Along with its needed effects, dutasteride (the active ingredient contained in Avodart) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking dutasteride:

Rare
  • Chest pain or discomfort
  • dilated neck veins
  • extreme fatigue
  • irregular breathing
  • irregular heartbeat
  • shortness of breath
  • swelling of the face, fingers, feet, or lower legs
  • weight gain
  • wheezing
Incidence not known
  • Blistering, flaking, or peeling of the skin
  • cough
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • hives or welts
  • itching skin
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness of the skin
  • skin rash
  • tightness in the chest
  • unusual tiredness or weakness
  • wheezing

Some side effects of dutasteride may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Abnormal ejaculation
  • decreased interest in sexual intercourse
  • decreased sexual performance or desire
  • impotence
  • inability to have or keep an erection
  • loss in sexual ability, desire, drive, or performance
  • pain, soreness, swelling, or discharge from the breast or breasts

Dutasteride Breastfeeding Warnings

Use is contraindicated. Excreted into human milk: Unknown Excreted into animal milk: Unknown Comments: The effects in the nursing infant are unknown.

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