SPEDRA

What it is

SPEDRA contains avanafil. SPEDRA tablets are available in strengths of 50 mg, 100 mg and 200 mg. Avanafil is a reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).

Approved indications

— Treatment of erectile dysfunction in adult males.

Dosing overview

The recommended dose is 100 mg taken as needed approximately 15–30 minutes before sexual activity. Based on individual efficacy and tolerability, the dose may be increased to a maximum dose of 200 mg or decreased to 50 mg. The maximum recommended dosing frequency is once per day. SPEDRA may be taken with or without food; if taken with food, the onset of activity may be delayed compared to the fasted state. In those patients who are stable on alpha-blocker therapy, SPEDRA should be initiated at the lowest dose of 50 mg. In patients receiving concomitant treatment with moderate CYP3A4 inhibitors, the maximum recommended dose of SPEDRA should not exceed 100 mg, with an interval of at least 48 hours between doses.

Key safety warnings

There is a potential for cardiac risk during sexual activity in patients with pre-existing cardiovascular disease; treatments for erectile dysfunction, including SPEDRA, should not be used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status. SPEDRA has vasodilator properties, resulting in mild and transient decreases in blood pressure and may augment the blood pressure-lowering effect of other anti-hypertensive medications. SPEDRA potentiates the hypotensive effect of nitrates; therefore co-administration of SPEDRA and nitrates, nitric oxide donors, or organic nitrites is contraindicated. Physicians should discuss with patients the potential for SPEDRA to augment the blood-pressure lowering effect of alpha blockers and other antihypertensive medications; caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. Patients should be advised to stop taking PDE5 inhibitors, including SPEDRA, and seek prompt medical attention in the event of sudden decrease or loss of hearing; these events, which may be accompanied by tinnitus and dizziness, have been reported in association with the intake of PDE5 inhibitors. Visual defects including central serous chorioretinopathy and cases of non-arteritic anterior ischaemic optic neuropathy have been reported in connection with PDE5 inhibitor intake; physicians should advise patients to stop use of all PDE5 inhibitors, including SPEDRA, and seek medical attention in the event of sudden visual defect, and such an event may be a sign of non-arteritic anterior ischemic optic neuropathy, a cause of decreased vision including permanent loss of vision. Prolonged erection lasting 4 hours or more (priapism) has been reported with other PDE5 inhibitors; in the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance, as if priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.

Contraindications

Co-administration with nitrates, nitric oxide donors, or organic nitrites in any form either regularly or intermittently is contraindicated; drugs which must not be used concomitantly include glyceryl trinitrate (injection, tablets, sprays or patches), isosorbide salts, sodium nitroprusside, amyl nitrite, nicorandil or organic nitrates in any form. Patients in whom sexual intercourse is inadvisable due to cardiovascular risk factors are contraindicated. Co-administration with guanylate cyclase stimulators such as riociguat is contraindicated as it may lead to potentially life-threatening symptomatic hypotension. Patients with unstable angina, angina with sexual intercourse, or congestive heart failure categorised as New York Heart Association Class 2 or greater, or who in the last 6 months have suffered from a myocardial infarction, stroke, or life-threatening arrhythmia or coronary revascularisation, or who have resting hypotension (blood pressure < 90/50 mmHg) or hypertension (blood pressure > 170/100 mmHg) are contraindicated. Patients with severe hepatic impairment (Child–Pugh C) are contraindicated. Patients with severe renal impairment (creatinine clearance < 30 mL/min) or end stage renal failure are contraindicated. Patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy, regardless of whether this episode was in connection with previous exposure to a PDE5 inhibitor, are contraindicated. Patients with known hereditary degenerative retinal disorders are contraindicated. Patients who are using potent CYP3A4 inhibitors (including ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin) are contraindicated. Patients with a known hypersensitivity to avanafil or to any ingredient of the tablet are contraindicated.

PBS listing

SPEDRA is listed on the PBS in three strengths. The 50 mg tablet is listed with authority required restriction at an ex-manufacturer price of A$36.00. The 100 mg tablet is listed with authority required restriction at an ex-manufacturer price of A$38.00. The 200 mg tablet is listed with authority required restriction at an ex-manufacturer price of A$40.00.

Regulatory history

SPEDRA avanafil tablets in strengths of 50 mg, 100 mg and 200 mg were first registered on the ARTG on 6 April 2016. The AusPAR approval date was 10 November 2015, with indication for treatment of erectile dysfunction in adult males.