Spedra (Avanafil)

Spedra (avanafil) is a PDE5-inhibitor for the treatment of erectile dysfunction, ED. It belongs to the second generation of a pharmaceutical group which brought major improvements for men suffering from ED when Viagra (sildenafil) was launched in 1998. Spedra was approved in the EU in 2014 and offers higher selectivity and different pharmacokinetics compared to the older PDE5-inhibitors which were launched about twenty years ago. Spedra was launched in 2016/2017 in Sweden and Norway and has gained much interest from urologists, sexologists and ED sufferers since then. Spedra is expected to contribute to future growth of Avia Pharma.

Spedra© (avanafil) tablets 100 mg and 200 mg. Rx, EF

ATC-code: G04BE10

Therapeutic indication: Treatment of erectile dysfunction in adult men. In order for Spedra to be effective, sexual stimulation is required.

Dosing: The recommended dose is 100 mg taken as needed approximately 15 to 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. Sexual stimulation is required for a response to treatment.

Contraindications: Hypersensitivity to the active substance or to any of the excipients. Patients who are using any form of organic nitrate or nitric oxide donors (such as amyl nitrite). The co-administration of type 5 phosphodiesterase (PDE5) inhibitors, including avanafil, with guanylate cyclase stimulators, such as riociguat is contraindicated as it may potentially lead to symptomatic hypotension. The use of avanafil is contraindicated in: – Patients who have suffered from a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months; – Patients with resting hypotension (blood pressure < 90/50 mmHg) or hypertension (blood pressure > 170/100 mmHg); – Patients with unstable angina, angina with sexual intercourse, or congestive heart failure categorised as New York Heart Association Class 2 or greater. Patients with severe hepatic impairment (Child-Pugh C). Patients with severe renal impairment (creatinine clearance < 30 mL/min). Patients who have loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure. Patients with known hereditary degenerative retinal disorders. Patients who are using potent CYP3A4 inhibitors. For full information see: www.fass.se

Warnings and precautions: A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered. For full information see: www.fass.se

Storage: Spedra does not require any special storage conditions.

Pack size: 4 and 12 tablets, blister.

For full information regarding prescription and SPC (April 2018) please see www.fass.se

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