IMPORTANT SAFETY INFORMATION
RAPAFLO® is contraindicated in:
Patients with severe renal impairment (Creatinine Clearance [CCr] <30 mL/min)
Patients with severe hepatic impairment (Child-Pugh score ≥10)
Concomitant administration of strong Cytochrome P450 3A4 (CYP3A4) inhibitors (eg, ketoconazole, clarithromycin,
Patients with a history of hypersensitivity to silodosin or any of the ingredients of RAPAFLO®
RAPAFLO® (silodosin), a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). RAPAFLO® is not indicated for the treatment of hypertension.
IMPORTANT SAFETY INFORMATION (cont’d)
Warnings and Precautions
Postural hypotension, with or without symptoms (eg, dizziness) may develop when beginning RAPAFLO® treatment. As with other alpha-blockers, there is potential for syncope. Patients should be cautioned about driving, operating machinery, or performing hazardous tasks when initiating therapy.
The dose of RAPAFLO® should be reduced
to 4 mg in patients with moderate renal impairment. Exercise caution and monitor
such patients for adverse events.
RAPAFLO® has not been tested in patients with severe hepatic impairment, and therefore should not be prescribed to such patients.
Pharmacokinetic Drug-Drug Interactions
Concomitant use of ketoconazole or other strong CYP3A4 inhibitors (eg, itraconazole, clarithromycin, ritonavir) is contraindicated. Exercise caution and monitor patients for adverse events when coadministering RAPAFLO® with moderate CYP3A4 inhibitors (eg, diltiazem, erythromycin, verapamil).
Pharmacodynamic Drug-Drug Interactions
RAPAFLO® should not be used in combination with other alpha-blockers. Interactions involving concomitant use have not been determined. However, interactions are expected and concomitant use is not recommended. Exercise caution during concomitant use with antihypertensives and monitor patients for possible adverse events. Caution is also advised when alpha-adrenergic blocking agents including RAPAFLO® are coadministered with PDE5 inhibitors. Alpha-adrenergic blockers and PDE5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these 2 drug classes can potentially cause symptomatic hypotension.
Carcinoma of the Prostate
Patients thought to have benign prostatic hyperplasia (BPH) should be examined prior to starting therapy with RAPAFLO® to rule out the presence of carcinoma of the prostate.
Intraoperative Floppy Iris Syndrome
Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients on or previously treated with alpha-1 blockers. Patients planning cataract surgery should be told to inform their ophthalmologist that they are taking RAPAFLO®.
In clinical studies, the most common treatment-emergent adverse reactions (incidence ≥2% and greater than placebo) were
retrograde ejaculation (28.1% vs 0.9%), dizziness (3.2% vs 1.1%), diarrhea (2.6% vs 1.3%), orthostatic hypotension (2.6% vs
1.5%), headache (2.4% vs 0.9%), nasopharyngitis (2.4% vs 2.2%), and nasal congestion (2.1% vs 0.2%) for RAPAFLO® vs
Strong P-glycoprotein (P-gp) Inhibitors
Coadministration may increase plasma silodosin concentration. RAPAFLO® is therefore not recommended in patients taking strong P-gp inhibitors such as cyclosporine.
Please see full Prescribing Information.
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US-RAP-220001 03/22 015717
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