ENTADFI EFFICACY
ENTADFI provides better relief of BPH symptoms, including LUTS, faster than finasteride alone1,2
Results from an international, randomized, double-blind, parallel-design trial that measured the efficacy and safety of tadalafil 5 mg once daily combined with finasteride 5 mg for 26 weeks compared to placebo combined with finasteride 5 mg in men with BPH-LUTS and prostatic enlargement. Results were derived from least squares mean changes from baseline in the International Prostate Symptom Score after 4, 12, and 26 weeks between tadalafil/finasteride and placebo/finasteride.
Rapid and statistically significant symptom improvement seen as early as 4 weeks
Sustained improvement demonstrated throughout the 26-week study period
Statistical significance achieved across all primary and secondary endpoints by end of study
IPSS
What is the International Prostate Symptom Score (IPSS)?
The International Prostate Symptom Score (IPSS) is an eight-question, self-administered survey used to screen for, diagnose, track, and manage the symptoms of BPH.3
LS: least squares; SE: standard endpoint
* Secondary endpoint
† LS mean: a statistical methodology that computed the mean from a model such as SAS or ANOVA. The methodology allows for adjustment across multiple variables (age, sex, race, previous/existing urologic conditions, etc).2
‡ Primary endpoint
The dual components of ENTADFI significantly improved voiding scores through the full duration of the study2
DUAL MOA
Target the symptoms and the progression of BPH in a single, dual MOA, once-daily pill1,2
Some men with BPH experience frustrating sexual side effects with finasteride alone1,2
With a dual MOA, ENTADFI1,2:
Tadalafil helps provide quick relief from BPH2
Finasteride reduces the size of the prostate1
SAFETY INFORMATION
Drug-related adverse reactions with tadalafil and finasteride1
§N=581 and 576, tadalafil vs placebo, respectively.
‖ N=1524 and 1516, finasteride vs placebo, respectively.
ENTADFI contains tadalifil which is an ED medication and therefore it should not be prescribed with other ED medications
The dual components of ENTADFI significantly improved voiding scores through the full duration of the study2
ENTADFI DOSING
Dosing and administration with ENTADFI1
One capsule. Once daily.
At approximately the same time every day.
Efficacy was maintained through 26 weeks
To be taken orally without food
ACCESS FOR HCPs
How to prescribe ENTADFI for your patients
ENTADFI is available at pharmacies nationwide
Most patients will pay reasonable out-of-pocket costs, which vary based on the patient's individual insurance plan.
To ensure ENTADFI is dispensed for your patients, be sure to specify no substitution when ordering the prescription.
ACCESS FOR PHARMACISTS
How to stock your pharmacy with ENTADFI
NDC
NDC 83449-125-30:
30-count per bottle
(finasteride 5 mg/tadalafil 5 mg)
ICD-110 Code
N40.1 — BPH with lower urinary tract symptoms
Medical info
PHONE: 855-ENTADFI
Wholesale
ENTADFI is available wholesale from these suppliers
- Cardinal Health
- AmerisourceBergen
FAQs
Find answers to the most important questions about ENTADFI
What are the components of ENTADFI?
ENTADFI is a combination of finasteride, a 5α-reductase inhibitor, and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor.1
How is ENTADFI taken?
ENTADFI is taken once daily without food—approximately the same time every day for up to 26 weeks.1
What is the dose form and strength of ENTADFI?
ENTADFI includes finasteride 5 mg and tadalafil 5 mg, in a size-3 capsule with an opaque white cap and body with a black two-lined bar printed on
the cap and body.1
How was the study that compared ENTADFI therapy to finasteride designed?
The study was an international, randomized, double-blind, parallel-design trial that measured the efficacy and safety of tadalafil 5 mg once daily
combined with finasteride 5 mg for 26 weeks compared to placebo combined with finasteride 5 mg in men with BPH-LUTS and prostatic enlargement.1
What makes ENTADFI unique?
Faster and better relief of BPH with fewer sexual side effects1,2
References: 1. ENTADFI. Prescribing information. Veru Inc.; 2022. 2. Casabé A, Roehrborn CG, Da Pozzo LF, et al. Efficacy and safety of the coadministration of tadalafil once daily with finasteride for 6 months in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia. J Urol. 2014;191(3):727-733. doi:10.1016/j.juro.2013.09.059 3. D’Silva KA, Dahm P, Wong CL. Does this man with lower urinary tract symptoms have bladder outlet obstruction?: The Rational Clinical Examination: a systematic review. JAMA. 2014;312(5):535-542. doi:10.1001/jama.2014.5555
Indications and Usage
ENTADFI is a combination of finasteride, a 5α-reductase inhibitor, and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor, and, indicated to initiate treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate for up to 26 weeks.
Important Safety Information
Dosage and Administration
One capsule orally once daily at approximately the same time every day for up to 26 weeks. Take without food.
Dosage Forms and Strengths
Capsules: fixed dose combination containing finasteride 5 mg and tadalafil 5 mg.
Contraindications
- Concomitant use with any form of organic nitrate, either regularly and/or intermittently. ENTADFI can potentiate the hypotensive effect of nitrates.
- Known hypersensitivity to ENTADFI or any of its components.
- Pregnancy.
- Concomitant use with guanylate cyclase (GC) stimulators. ENTADFI may potentiate the hypotensive effects of GC stimulators.
Warnings and Precautions
- Cardiovascular Risk: Administer nitrates concomitantly only in life-threatening situations under close medical supervision.
- Potential for Drug Interactions when taking ENTADFI: Use alpha-blockers, antihypertensives, strong CYP3A4 inhibitors and alcohol with caution due to the potential for symptomatic hypotension.
- Consideration of Other Urological Conditions Prior to Initiation of Treatment for BPH: Carefully monitor patients with large residual urinary volume and/or severely diminished urinary flow for obstructive uropathy. Prostate cancer and BPH may coexist.
- Effects of PSA and the Use of PSA in Prostate Cancer Detection: PSA reduction by approximately 50% within six months of treatment can be seen which can affect interpretation of serial and isolated PSA values. Evaluate any confirmed increase in PSA as it may signal the presence of prostate cancer.
- Increased Risk of High-Grade Prostate Cancer: Increased incidence of high-grade prostate cancer has been observed.
- Risk to Male Fetus from Topical ENTADFI Exposure to Pregnant Females: Pregnant women should not handle crushed or open ENTADFI capsules.
- Hypersensitivity Reactions: Immediately discontinue if a hypersensitivity reaction occurs.
- Prolonged Erection and Priapism: Use with caution in patients predisposed to priapism. Advise patients to seek emergency treatment if an erection lasts more than 4 hours.
- Ocular Adverse Reactions: Stop use in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). Use with caution in patients at increased risk of NAION.
- Sudden Hearing Loss: Stop use and seek prompt medical attention.
Adverse Reactions
Most common adverse reactions associated with finasteride monotherapy (≥1%) in a 4-year study were impotence, decreased libido, decreased volume of ejaculate, breast enlargement, breast tenderness, and rash. Most common adverse reactions (≥2%) associated with tadalafil were headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in limb.
To report SUSPECTED ADVERSE REACTIONS, contact Blue Water Biotech, Inc. at 1-855-ENTADFI or here or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
CYP3A4 inducers: Concomitant use may increase tadalafil exposure. Use is not recommended.
Use in Specific Populations
Hepatic Impairment:
- Child’s Pugh Class A and B: Use with caution.
- Child’s Pugh Class C: Use is not recommended.
Renal Impairment:
- Creatinine clearance less than 50 mL/min or hemodialysis: Use is not recommended.
Please see full Prescribing Information.