Benign prostatic hyperplasia:
Note: For use in patients with a significantly enlarged prostate (eg, prostate volume >30 mL, prostate-specific antigen >1.5 ng/dL, or palpable prostate enlargement on digital rectal exam) (AUA [Lerner 2021]). Discontinue alpha-blockers (eg, alfuzosin, tamsulosin) at least 1 day prior to therapy initiation.
Oral: Finasteride 5 mg/tadalafil 5 mg once daily for up to 26 weeks.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
CrCl ≥50 mL/minute: No dosage adjustment necessary.
CrCl <50 mL/minute: Use is not recommended.
Hemodialysis: Use is not recommended.
There are no dosage adjustments provided in the manufacturer’s labeling. Use is not recommended in patients with severe hepatic impairment (Child-Pugh class C); use with caution in patients with mild to moderate hepatic impairment (Child-Pugh Class A or B).
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral:
Entadfi: Finasteride 5 mg and tadalafil 5 mg [contains carrageenan]
No
Oral: Administer on an empty stomach at approximately the same time each day.
Finasteride is a hazardous agent (NIOSH 2016 [group 3]).
Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2016; USP-NF 2020).
Note: Facilities may perform risk assessment of some hazardous drugs to determine if appropriate for alternative handling and containment strategies (USP-NF 2020). Refer to institution-specific handling policies/procedures.
Benign prostatic hyperplasia: Treatment of the signs and symptoms of benign prostatic hyperplasia in men with an enlarged prostate for up to 26 weeks.
Limitations of use: Use not recommended for >26 weeks because the incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and the incremental benefit beyond 26 weeks is unknown.
Entadfi may be confused with entecavir, erdafitinib.
See individual agents.
Hypersensitivity to finasteride, tadalafil, or any component of the formulation; pregnancy; concomitant use of organic nitrate (regularly and/or intermittently) or guanylate cyclase stimulators (eg, riociguat).
Concerns related to adverse effects:
• Anginal chest pain: Patients experiencing anginal chest pain after tadalafil administration should seek immediate medical attention.
• Hearing loss: Sudden decrease or loss of hearing has been reported rarely; hearing changes may be accompanied by tinnitus and dizziness. Instruct patients to seek medical assistance for sudden decrease in hearing or loss of hearing. A direct relationship between therapy and hearing loss has not been determined.
• Hypotension: Decreases in BP may occur due to vasodilator effects of tadalafil; use with caution in patients with left ventricular outflow obstruction (eg, aortic stenosis, idiopathic hypertrophic subaortic stenosis); may be more sensitive to hypotensive actions. Concurrent use with alpha-adrenergic antagonist therapy may cause symptomatic hypotension; patients should be hemodynamically stable prior to initiating therapy at the lowest possible dose. Instruct patients to avoid concurrent substantial ethanol consumption as this may increase the risk of symptomatic hypotension.
• Priapism: Painful erections lasting >6 hours in duration have been rarely reported with tadalafil use. Instruct patient to seek medical assistance for an erection lasting >4 hours, regardless of the presence of associated pain. Use with caution in patients who have conditions that may predispose them to priapism (eg, sickle cell anemia, multiple myeloma, leukemia, anatomical penis deformation).
• Vision loss: Vision loss (rare) may be a sign of nonarteritic anterior ischemic optic neuropathy (NAION); a causal relationship to phosphodiesterase-5 inhibitors (including tadalafil) has not been established. Instruct patients to discontinue therapy and seek medical assistance for sudden loss of vision in 1 or both eyes. Patients who have already experienced NAION are at an increased risk of recurrence. Patients with low cup-to-disc ratio (“crowded disc”) may also be at increased risk for NAION; use with caution in these patients and only when the benefits outweigh the risks. Safety has not been evaluated in patients with known hereditary degenerative retinal disorders (eg, retinitis pigmentosa); use is not recommended.
Disease-related concerns:
• Anatomical penis deformation: Use with caution in patients with anatomical deformation of the penis (eg, angulation, cavernosal fibrosis, Peyronie disease); may increase the risk of priapism.
• Bleeding disorders: Use with caution in patients with bleeding disorders; safety and efficacy have not been established.
• Cardiovascular disease: Use is not recommended in patients with hypotension (<90/50 mm Hg), uncontrolled hypertension (>170/100 mm Hg), New York Heart Association class II to IV heart failure within the last 6 months, uncontrolled arrhythmias, stroke within the last 6 months, myocardial infarction within the last 3 months, unstable angina, or angina during sexual intercourse; safety and efficacy have not been evaluated in these patients. Use caution in patients with left ventricular outflow obstruction (eg, aortic stenosis, idiopathic hypertrophic subaortic stenosis); may be more sensitive to vasodilator effects.
• Hepatic impairment: Use is not recommended in patients with severe hepatic impairment (Child-Pugh class C); use with caution in patients with mild to moderate hepatic impairment (Child-Pugh class A or B).
• Peptic ulcer disease: Use with caution in patients with active peptic ulcer disease because of possible effect of tadalafil on platelets (bleeding); safety and efficacy have not been established.
• Prostate cancer: Use of 5-alpha-reductase inhibitors (including finasteride) has been associated with an increase in the incidence of high-grade prostate cancers; use is not approved in the United States or Canada for the prevention of prostate cancer.
• Renal impairment: Use with caution in patients with renal impairment.
Concurrent drug therapy issues:
• Nitrates: Tadalafil may potentiate the hypotensive effect of nitrates. When nitrate administration is medically necessary following the use of finasteride/tadalafil, at least 48 hours should elapse after the finasteride/tadalafil dose and before nitrate administration; close medical supervision is recommended.
Special handling:
• Females: Active ingredient of crushed or open capsules can be absorbed through the skin. Pregnant individuals should not touch or handle crushed or open capsules; if a pregnant person contacts a crushed or open capsule, immediately wash the contact area with soap and water.
Other warnings/precautions:
• Appropriate use: Use is not recommended for >26 weeks because the incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and the incremental benefit beyond 26 weeks is unknown. In patients with benign prostatic hyperplasia, rule out other urological diseases (including prostate cancer) before initiating finasteride/tadalafil. Not indicated for use in pediatric patients.
• Prostate specific antigen monitoring: Finasteride reduces prostate specific antigen (PSA) concentration by ~50% within 6 months of treatment. Reestablish new PSA baseline after initiation. A confirmed PSA increase while on this medication, even if within normal limits, may be associated with an increased risk for prostate cancer and should be evaluated. Finasteride does not interfere with free PSA levels.
Maximal serum concentrations of finasteride and tadalafil were decreased by 29% and 23%, respectively, following consumption of a high-fat, high-calorie meal; extent of absorption was not affected by food. Management: Administer on an empty stomach.
Patients who could potentially be pregnant should not touch or handle crushed or broken tablets.
Refer to individual monographs for additional information.
Based on the mechanism of action and data from animal reproduction studies, in utero exposure to finasteride may lead to abnormal development of the male genital tract. Use is contraindicated in patients who could become pregnant.
Pregnant patients should avoid contact with crushed or broken tablets and immediately wash the contact area with soap and water if exposure occurs.
Refer to individual monographs for additional information.
It is not known if finasteride or tadalafil are present in breast milk.
Refer to individual monographs for additional information.
Monitor International Prostate Symptom Score (baseline and 4 to 12 weeks after treatment initiation) (AUA [Lerner 2021]); objective and subjective signs of relief of benign prostatic hyperplasia (eg, improvement in urinary flow, reduction in symptoms of urgency, relief of difficulty in micturition); BP; chest pain; hearing or vision loss; renal function; hepatic function.
Obstructive uropathy: Carefully monitor patients with large residual urinary volume and/or severely diminished urinary flow for obstructive uropathy; may require therapy discontinuation if obstructive uropathy present.
Prostate specific antigen: To interpret serial prostate specific antigens (PSAs), establish a new PSA baseline ≥6 months after treatment initiation and monitor PSA periodically thereafter.
Finasteride: Finasteride competitively inhibits type II 5-alpha reductase, resulting in inhibition of the conversion of testosterone to dihydrotestosterone and markedly suppresses serum dihydrotestosterone levels.
Tadalafil: The exact mechanism for treating benign prostatic hyperplasia is unknown; effects are likely due to phosphodiesterase-5-mediated reduction in smooth muscle and endothelial cell proliferation, decreased nerve activity, and increased smooth muscle relaxation and tissue perfusion of the prostate and bladder.
Refer to individual agents.
Capsules (Entadfi Oral)
5-5 mg (per each): $3.80
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
