ABOUT RAPAFLO®
(silodosin)

HOW RAPAFLO® WORKS

RAPAFLO® is a highly selective alpha-blocker1

  • The efficacy of alpha-blockers is driven by their affinity for the
    adrenoceptor subtype α1A.1,13
  • α1A is the predominant receptor subtype in BPH tissue.17
  • α1B is the primary receptor expressed in the vasculature.17-19
  • RAPAFLO® has a higher affinity for the α1A-adrenoceptor subtype and
    prostatic tissue than for the α1B receptor and vascular tissue.18,20*

*Aortic tissue.

Results based on in vitro studies. In vitro results may not correlate with actual
clinical outcomes.

SUSTAINED IMPROVEMENTS IN BPH SYMPTOMS

IPSS reductions sustained over 12 weeks1,21

  • RAPAFLO® produced significant improvement in both
    obstructive and irritative BPH symptoms, as measured by
    reductions in the total IPSS, over 12 weeks (P<0.0001).1,21

Mean IPSS at baseline=21.3

Pooled results from two 12-week, identically designed, parallel group, multicenter, randomized, double-blind, placebo-controlled trials. Patients were randomized to receive RAPAFLO® 8 mg (n=466) or placebo (n=457) once daily. The primary efficacy endpoint was the mean change from baseline to week 12 in total IPSS. Last observation carried forward (LOCF) analysis shown.21

IPSS=International Prostate Symptom Score.

PROVEN SAFETY PROFILE

Treatment-emergent adverse reactions1

  • The α1A receptors not only regulate contraction of smooth muscle of the prostate, bladder base and neck, and urethra, but also the smooth muscle of the seminal vesicles and vas deferens.1,13,14
  • Retrograde ejaculation (RE) is a common, expected effect of highly selective α1A-blockers such as RAPAFLO®, and is reversible upon discontinuation.1,22
  • RE was the most common treatment-related adverse event (28.1%).1- 2.8% of patients discontinued due to retrograde
    ejaculation.1
  • Other treatment-emergent adverse reactions occurred at a rate of ≤3.2%.1

EXPERIENCE WITH CONCOMITANT THERAPIES

Studied with antihypertensive agents or
PDE5 inhibitors1,20*†‡

  • Approximately one-third of patients studied in clinical trials were taking RAPAFLO® concomitantly with other antihypertensive agents including ACE inhibitors, calcium channel blockers, ARBs, and beta-blockers. (The use of other alpha-blockers was not permitted in the study protocol.)1,20,21
  • In RAPAFLO® clinical trials, about 45% of the enrolled patients had a history of erectile dysfunction.20

    Among the RAPAFLO® safety population, which includes all US controlled and uncontrolled studies, 11.5% of patients were taking PDE5 inhibitors.20
  • Patients taking concomitant antihypertensive agents or PDE5 inhibitors with RAPAFLO® did not experience a significant increase in the incidence of retrograde ejaculation, dizziness, orthostatic hypotension, or syncope.1,20†‡

DOSING AND ADMINISTRATION

RAPAFLO® has once-daily dosing1

  • The recommended dose of RAPAFLO® is 8 mg orally once daily with a meal.1
  • No dosage adjustment is required in patients with mild renal impairment (creatinine clearance [CCr] 50-80 mL/min) or mild (Child-Pugh score 5-6) or moderate (Child-Pugh score 7-9) hepatic impairment.1
  • In patients with moderate renal impairment (CCr 30-50 mL/min), the dose should be reduced to 4 mg once daily with a meal.1
  • Eligible commercially insured patients save money with a 90-day prescription and RAPAFLO® Savings Card.
REFERENCES

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healthcare professionals in the United States only. It is
not intended for the general public.

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