STENDRA is a phosphodiesterase 5 (PDE5) inhibitor indicated for the
treatment of erectile dysfunction.
IMPORTANT SAFETY INFORMATION about STENDRA
- Administration of STENDRA with any form of organic nitrates, either
regularly and/or intermittently, is contraindicated. STENDRA has been shown
to potentiate the hypotensive effects of nitrates.
- STENDRA is contraindicated in patients with a known hypersensitivity to
any component of the tablet.
- Do not use STENDRA in patients who are using a Guanylate Cyclase
(GC) stimulator, such as riociguat. PDE 5 inhibitors, including STENDRA may
potentiate the hypotensive effects of GC stimulators
- There is a potential for cardiac risk during sexual activity in
patients with preexisting cardiovascular disease. Patients should therefore
not use STENDRA if sexual activity is inadvisable due to cardiovascular
status or any other reason.
- Patients with the following characteristics (recent serious
cardiovascular events, resting hypotension or uncontrolled hypertension,
unstable angina, angina with sexual intercourse, New York Heart Association
Class 2 or greater congestive heart failure, or hereditary degenerative
retinal disorders, including retinitis pigmentosa) were not included in the
clinical safety and efficacy trials. STENDRA is therefore not recommended
for those patients.
- As with other PDE5 inhibitors STENDRA has systemic vasodilatory
properties and may augment the blood pressure-lowering effect of other
antihypertensive medications. Physicians should carefully consider whether
patients with underlying cardiovascular disease could be affected adversely
by such vasodilatory effects, especially in combination with sexual
- STENDRA metabolism is principally mediated by the CYP450 isoform 3A4
(CYP3A4). Inhibitors of CYP3A4 may reduce STENDRA clearance and increase
plasma concentrations of avanafil. Do not use STENDRA in patients taking
concomitant strong CYP3A4 inhibitors. For patients taking concomitant
moderate CYP3A4 inhibitors, the maximum recommended dose of STENDRA is 50
mg, not to exceed once every 24 hours.
- Prolonged erections greater than 4 hours in duration and priapism
(painful erections greater than 6 hours in duration) have been reported
with other PDE5 inhibitors. Patients should seek emergency treatment for an
erection that lasts longer than 4 hours. If not treated immediately, penile
tissue damage and permanent loss of potency could result. Use with caution
in patients with anatomical deformation of the penis or in patients with
conditions that may predispose them to priapism.
- Physicians should advise patients to stop use of all PDE5 inhibitors,
including STENDRA, and seek medical attention in the event of a sudden loss
of vision in one or both eyes. This may be a sign of nonarteritic anterior
ischemic optic neuropathy (NAION), a cause of decreased vision including
permanent loss of vision. STENDRA should be used with caution, and only
when the anticipated benefits outweigh the risks, in patients with a
history of NAION.
- Use of PDE5 inhibitors has been associated with sudden decrease or loss
of hearing, which may be accompanied by tinnitus or dizziness. It is not
possible to determine whether these events are related directly to the use
of PDE5 inhibitors or to other factors. Patients experiencing these
symptoms should be advised to stop taking STENDRA and seek prompt medical
- Physicians should discuss with patients the potential for STENDRA to
augment the blood pressure-lowering effect of alpha-blockers and other
- Caution is advised when PDE5 inhibitors are coadministered with
alpha-blockers. Patients who demonstrate hemodynamic instability on
alpha-blocker therapy alone are at increased risk of symptomatic
hypotension with concomitant use of PDE5 inhibitors. Patients should be
stable on alpha-blocker therapy prior to initiating treatment with a PDE5
inhibitor. In those patients who are stable on alpha-blocker therapy, PDE5
inhibitors should be initiated at the lowest dose (STENDRA 50 mg). In those
patients already taking an optimized dose of a PDE5 inhibitor,
alpha-blocker therapy should be initiated at the lowest dose. Stepwise
increase in alpha-blocker dosage may be associated with further lowering of
blood pressure when taking a PDE5 inhibitor.
- Both alcohol and PDE5 inhibitors including STENDRA act as vasodilators.
When vasodilators are taken in combination, blood-pressure-lowering effects
of each individual compound may be increased. Physicians should therefore
inform patients that substantial consumption of alcohol (ie, greater than 3
units) in combination with STENDRA may increase the potential for
orthostatic signs and symptoms, including increase in heart rate, decrease
in standing blood pressure, dizziness, and headache.
- The safety and efficacy of combinations of STENDRA with other
treatments for ED have not been studied. The use of such combinations is
therefore not recommended.
- The safety of STENDRA is unknown in patients with bleeding disorders
and patients with active peptic ulceration. In vitro studies with
human platelets indicate that STENDRA potentiates the anti-aggregatory
effect of sodium nitroprusside (a nitric oxide [NO] donor).
- The use of STENDRA offers no protection against sexually transmitted
diseases. Counseling patients about the protective measures necessary to
guard against sexually transmitted diseases, including Human
Immunodeficiency Virus (HIV), should be considered.
- The most common adverse reactions (greater than or equal to 2%) include
headache, flushing, nasal congestion, nasopharyngitis, and back pain.
- Drug interactions: STENDRA can potentiate the hypotensive effect of
nitrates, alpha-blockers, antihypertensives, and alcohol. CYP3A4 inhibitors
(eg, ketoconazole, ritonavir, erythromycin) increase STENDRA exposure.
Please see full Prescribing Information.