| Active ingredient | FinasterideType II 5-alpha reductase inhibitor | DutasterideType I and type II 5-alpha reductase inhibitor |
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| Supply | Prescription | Prescription |
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| Boxed warning | None | None |
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| What the FDA approved it for | - PROPECIA ® is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY.
- Efficacy in bitemporal recession has not been established.
- PROPECIA is not indicated for use in women.
- PROPECIA is a 5α-reductase inhibitor indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY.
| - AVODART is a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:
- reduce the risk of the need for BPH-related surgery. 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.
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| Forms and strengths | - PROPECIA tablets (1 mg) are tan, octagonal, film-coated convex tablets with "stylized P" logo on one side and PROPECIA on the other. 1 mg tablets.
| - 0.5-mg, opaque, dull yellow, gelatin capsules imprinted with "GX CE2" in red ink on one side. 0.5-mg soft gelatin capsules
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| How the label says it is taken | - PROPECIA may be administered with or without meals.
- The recommended dose of PROPECIA is one tablet (1 mg) taken once daily.
- In general, daily use for three months or more is necessary before benefit is observed.
- Continued use is recommended to sustain benefit, which should be re-evaluated periodically.
| - Monotherapy: 0.5 mg once daily.
- Combination with tamsulosin: 0.5 mg once daily and tamsulosin 0.4 mg once daily.
- Dosing considerations: Swallow whole. May take with or without food. Monotherapy The recommended dose of AVODART is 1 capsule (0.5 mg) taken once daily. Combination with Alpha-adrenergic Antagonist The recommended dose of AVODART is 1 capsule (0.5 mg) taken once daily and tamsulosin 0.4 mg taken once daily.
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| Most common adverse reactions | - most common adverse reactions, reported in ≥1% of patients treated with PROPECIA and greater than in patients treated with placebo are: decreased libido, erectile dysfunction and ejaculation disorder.
- the most frequently reported adverse reactions. Table 2 presents the only clinical adverse reactions considered possibly, probably or definitely drug related by the investigator, for which the incidence on PROSCAR was ≥1% and greater than placebo over the 4 years of the study.
| - 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. To report SUSPECTED ADVERSE REACTIONS, contact Waylis Therapeutics LLC at 888-514-4727 or FDA at 1-800-FDA-1088 or www.
- 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...
- 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.
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| Warnings and precautions | - PROPECIA is not indicated for use in women or pediatric patients.
- Women should not handle crushed or broken PROPECIA tablets when they are pregnant or may potentially be pregnant due to potential risk to a male fetus.
- PROPECIA causes a decrease in serum PSA levels.
- Any confirmed increase in PSA while on PROPECIA may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for men not taking a 5α-reductase inhibitor. 5α-reductase inhibitors may increase the risk of high-grade prostate cancer.
| - 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.
- AVODART may increase the risk of high-grade prostate cancer.
- Prior to initiating treatment with AVODART, consideration should be given to other urological conditions that may cause similar symptoms.
- Women who are pregnant or may be pregnant should not handle AVODART capsules due to potential risk to a male fetus.
- Patients should not donate blood until 6 months after their last dose of AVODART. Effects on Prostate-Specific Antigen (PSA) and the Use of PSA in Prostate Cancer Detection In clinical trials, AVODART reduced serum PSA concentration by approximately 50% within 3 to 6 months of treatment.
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| Contraindications | - PROPECIA is contraindicated in the following: Pregnancy.
- Finasteride use is contraindicated in women when they are or may potentially be pregnant.
- Because of the ability of Type II 5α-reductase inhibitors to inhibit the conversion of testosterone to 5α-dihydrotestosterone (DHT), finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant woman who receives finasteride.
- If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the pregnant woman should be apprised of the potential hazard to the male fetus. In female rats, low doses of finasteride administered during pregnancy have produced abnormalities of the external genitalia in male offspring.
| - Pregnancy. Dutasteride use is contraindicated in women who are pregnant.
- Patients with previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angioedema) to AVODART or other 5 alpha-reductase inhibitors.
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| Drug interactions | - Cytochrome P450-Linked Drug Metabolizing Enzyme System No drug interactions of clinical importance have been identified.
- Finasteride does not appear to affect the cytochrome P450-linked drug-metabolizing enzyme system.
- Compounds that have been tested in man include antipyrine, digoxin, propranolol, theophylline, and warfarin and no clinically meaningful interactions were found. Other Concomitant Therapy Although specific interaction studies were not performed, finasteride doses of 1 mg or more were concomitantly used in clinical studies with acetaminophen, acetylsalicylic acid, α-blockers, analgesics,...
| - Use with caution in patients taking potent, chronic cytochrome P450 (CYP)3A4 enzyme inhibitors (e.g., ritonavir).
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| Label version | 14 October 2024 | 12 March 2025 |
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