AVODART (Page 6 of 6)
14.2 Combination with Alpha-blocker Therapy (CombAT)
The efficacy of combination therapy (AVODART 0.5 mg/day plus tamsulosin 0.4 mg/day, n = 1,610) was compared with AVODART alone (n = 1,623) or tamsulosin alone (n = 1,611) in a 4‑year multicenter, randomized, double‑blind trial. Trial entry criteria were similar to the double‑blind, placebo‑controlled monotherapy efficacy trials described in Section 14.1. Eighty‑eight percent (88%) of the enrolled trial population was white. Approximately 52% of subjects had previous exposure to 5 alpha‑reductase–inhibitor or alpha-adrenergic–antagonist treatment. Of the 4,844 subjects randomly assigned to receive treatment, 69% of subjects in the combination group, 67% in the group receiving AVODART, and 61% in the tamsulosin group completed 4 years of double‑blind treatment.
Effect on Symptom Score
Symptoms were quantified using the first 7 questions of the International Prostate Symptom Score (IPSS) (identical to the AUA‑SI). The baseline score was approximately 16.4 units for each treatment group. Combination therapy was statistically superior to each of the monotherapy treatments in decreasing symptom score at Month 24, the primary time point for this endpoint. At Month 24 the mean changes from baseline (±SD) in IPSS total symptom scores were -6.2 (±7.14) for combination, -4.9 (±6.81) for AVODART, and -4.3 (±7.01) for tamsulosin, with a mean difference between combination and AVODART of ‑1.3 units (P <0.001; [95% CI: ‑1.69, ‑0.86]), and between combination and tamsulosin of ‑1.8 units (P <0.001; [95% CI: ‑2.23, ‑1.40]). A significant difference was seen by Month 9 and continued through Month 48. At Month 48 the mean changes from baseline (±SD) in IPSS total symptom scores were -6.3 (±7.40) for combination, -5.3 (±7.14) for AVODART, and -3.8 (±7.74) for tamsulosin, with a mean difference between combination and AVODART of ‑0.96 units (P <0.001; [95% CI: ‑1.40, ‑0.52]), and between combination and tamsulosin of ‑2.5 units (P <0.001; [95% CI: ‑2.96, ‑2.07]). See Figure 6.
Figure 6. International Prostate Symptom Score Change from Baseline over a 48-Month Period (Randomized, Double-blind, Parallel –Group Trial [CombAT Trial])
Effect on Acute Urinary Retention or the Need for BPH-Related Surgery
After 4 years of treatment, combination therapy with AVODART and tamsulosin did not provide benefit over monotherapy with AVODART in reducing the incidence of AUR or BPH-related surgery.
Effect on Maximum Urine Flow Rate
The baseline Qmax was approximately 10.7 mL/sec for each treatment group. Combination therapy was statistically superior to each of the monotherapy treatments in increasing Qmax at Month 24, the primary time point for this endpoint. At Month 24, the mean increases from baseline (±SD) in Qmax were 2.4 (±5.26) mL/sec for combination, 1.9 (±5.10) mL/sec for AVODART, and 0.9 (±4.57) mL/sec for tamsulosin, with a mean difference between combination and AVODART of 0.5 mL/sec (P = 0.003; [95% CI: 0.17, 0.84]), and between combination and tamsulosin of 1.5 mL/sec (P <0.001; [95% CI: 1.19, 1.86]). This difference was seen by Month 6 and continued through Month 24. See Figure 7.
The additional improvement in Qmax of combination therapy over monotherapy with AVODART was no longer statistically significant at Month 48.
Figure 7. Qmax Change from Baseline over a 24-Month Period (Randomized, Double-blind, Parallel–Group Trial [CombAT Trial])
![Figure 7. Q-max Change Ffrom Baseline Over a 24-Month Period (Randomized, Double-Blind, Parallel Group Study [CombAT Study])](http://medlibrary.org/lib/images-rx/avodart-2/avodart-spl-image-08.jpg)
Effect on Prostate Volume
The mean prostate volume at trial entry was approximately 55 cc. At Month 24, the primary time point for this endpoint, the mean percent changes from baseline (±SD) in prostate volume were -26.9% (±22.57) for combination therapy, -28.0% (±24.88) for AVODART, and 0% (±31.14) for tamsulosin, with a mean difference between combination and AVODART of 1.1% (P = NS; [95% CI: -0.6, 2.8]), and between combination and tamsulosin of -26.9% (P <0.001; [95% CI: -28.9, -24.9]). Similar changes were seen at Month 48: -27.3% (±24.91) for combination therapy, -28.0% (±25.74) for AVODART, and +4.6% (±35.45) for tamsulosin.
16 HOW SUPPLIED/STORAGE AND HANDLING
AVODART soft gelatin capsules 0.5 mg are oblong, opaque, dull yellow, gelatin capsules imprinted with “GX CE2” with red edible ink on one side, packaged in bottles of 30 (NDC 69784-712-15) and 90 (NDC 69784-712-04) with child-resistant closures.
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Dutasteride is absorbed through the skin. AVODART capsules should not be handled by women who are pregnant or who could become pregnant because of the potential for absorption of dutasteride and the subsequent potential risk to a developing male fetus [see Warnings and Precautions (5.4)].
17 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)].
Transdermal Exposure of AVODART in Pregnant or Potentially Pregnant Women—Risk to Male Fetus
Inform patients that AVODART capsules should not be handled by women who are pregnant or may potentially be pregnant because of the potential for absorption of dutasteride and the subsequent potential risk to a developing male fetus. Dutasteride can be absorbed through the skin and could result in unintended fetal exposure. If a pregnant or potentially pregnant woman 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)].
Effects on Semen Parameters
Advise men that AVODART may affect sperm characteristics but the effect on fertility is unknown [see Warnings and Precautions (5.6), Use in Specific Populations (8.3)].
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 trademark by Woodward Pharma Services LLC.
The other brands listed are trademarks owned by or licensed to their respective owners and are not owned by or licensed to Woodward Pharma Services LLC. The makers of these brands are not affiliated with and do not endorse Woodward Pharma Services LLC or its products.
Manufactured for:
Woodward Pharma Services LLC
Wixom, MI 48393
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. | |
| 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:
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. | |
| Do not take AVODART if you are:
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| Before you take AVODART, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter 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?
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| What should I avoid while taking AVODART?
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| What are the possible side effects of AVODART? AVODART may cause serious side effects, including:
The most common side effects of AVODART include:
*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. These are not all the possible side effects of AVODART. 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?
Keep AVODART and all medicines out of the reach of children. | |
| General information about the safe and effective use of AVODART. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information 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. You can ask your healthcare provider or pharmacist for information about AVODART that is written for health professionals. For more information call 1-888-514-4727. | |
| 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. | |
| Manufactured for: AVODART is a trademark owned by or licensed to Woodward Pharma Services LLC. The other brand listed is a trademark owned by or licensed to its respective owner and is not a trademark owned by or licensed to Woodward Pharma Services LLC. The maker of this brand is not affiliated with and does not endorse Woodward Pharma Services LLC or its products. | |
| This Patient Information has been approved by the U.S. Food and Drug Administration. | Revised: 08/2022 |
PRINCIPAL DISPLAY PANEL
NDC 69784-712-04
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 25o C (77o F); excursions permitted to 15-30o C (59-86o F) [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:
Woodward Pharma Services LLC
Wixom, MI 48393
Rev. 05/22
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| Labeler — Woodward Pharma Services LLC (080406260) |
Revised: 12/2022 Woodward Pharma Services LLC
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