FDA Approves Combination Treatment for BPH Symptoms

By Jessica Pyhtila, PharmD, BCGP, BCPS

The FDA recently approved the combination medication Entadfi for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men. The medication, which combines the 5α-reductase inhibitor finasteride and the phosphodiesterase 5 (PDE5) inhibitor tadalafil, was approved in December 2021.

The prostate gland enlarges due to the effect of the androgen 5αdihydrotestosterone (DHT), a product of testosterone. Finasteride works by blocking the conversion of testosterone to DHT, thereby preventing prostate enlargement. In contrast, it is unclear how tadalafil reduces BPH symptoms.

Entadfi combines finasteride 5 mg and tadalafil 5 mg into a single tablet. Of note, both medications are independently FDA-approved and available by prescription. Finasteride (Proscar) is available as a 5 mg tablet and is often prescribed for BPH symptoms. Tadalafil (Cialis) is also available as a 5 mg tablet and is prescribed at varying doses for conditions including BPH and erectile dysfunction.

Entadfi comes as a capsule and should be taken at the same time once daily without food. Women of childbearing age should not handle open or crushed Entadfi capsules due to the potential for finasteride absorption and subsequent abnormal development of external genitalia in a male fetus.

Adverse effects for Entadfi as a combination medication were not studied in clinical trials. Instead, the adverse effect data for finasteride and tadalafil separately were reviewed. Finasteride’s most common side effects include impotence, decreased libido, decreased ejaculatory volume, breast enlargement or breast tenderness, and rash. Tadalafil’s most common adverse reactions include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and limb pain. If a person experiences sudden vision or hearing loss, Entadfi should be discontinued.

Entadfi is contraindicated in those who are prescribed nitrates including PRN nitroglycerin. For this reason, those who experience angina after taking Entadfi should seek immediate medical attention, as any nitrate administration requires close medical monitoring to avoid hypotension.

It also should be noted that combining Entadfi and alpha-blockers like tamsulosin has not been adequately studied. Due to the potential for vasodilatory hypotension if the agents are combined, mixing them should be avoided. The medication should also be avoided in those predisposed to priapism.

References:

Food and Drug Administration. “Entadfi.” December 2021. Retrieved from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215423s000lbl.pdf