ADCIRCA

What it is

ADCIRCA contains tadalafil 20 mg. ADCIRCA 20 mg tablets are orange, almond shaped tablets for oral administration. Tadalafil is a reversible inhibitor of cyclic guanosine monophosphate (cGMP)–specific phosphodiesterase type 5 (PDE5).

Approved indications —

Pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity in adults. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.

Dosing overview

Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH. The recommended dose is 40 mg (2 × 20 mg) taken once daily with or without food. In patients with mild to moderate renal impairment a starting dose of 20 mg once per day is recommended. Although clinical pharmacology studies in patients with renal impairment have not been performed with 40 mg the dose may be increased to 40 mg once per day, based on individual efficacy and tolerability. In patients with severe renal impairment the use of ADCIRCA is not recommended due to limited clinical experience in these patients. Based on data obtained in a clinical pharmacology study performed using single doses of 10 mg in patients with mild to moderate hepatic cirrhosis (Child-Pugh Class A and B), a starting dose of 20 mg once per day may be considered. Patients with severe hepatic cirrhosis (Child-Pugh Class C) have not been studied and therefore dosing of tadalafil is not recommended. ADCIRCA should not be used in individuals below 18 years of age.

Key safety warnings

Nitrates and tadalafil must not be used concomitantly. Co-administration of tadalafil with nitric oxide donors, organic nitrates or organic nitrites in any form either regularly or intermittently is contraindicated. Drugs which must not be used concomitantly include, but are not limited to, glyceryl trinitrate (injection, tablets, sprays or patches), isosorbide salts, sodium nitroprusside, amyl nitrite, nicorandil or organic nitrates in any form. Tadalafil is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure. Physicians should advise patients to stop taking PDE5 inhibitors, including ADCIRCA, and seek prompt medical attention in the event of sudden decrease or loss of hearing. This may be accompanied by tinnitus, which has been reported in association with the use of PDE5 inhibitors, including ADCIRCA. Priapism has been reported with PDE5 inhibitors, including tadalafil. Patients who experience erections lasting 4 hours or more should be instructed to seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result. Tadalafil has systemic vasodilatory properties that may result in mild and transient decreases in blood pressure. Prior to prescribing ADCIRCA, physicians should carefully consider whether their patients with underlying conditions, such as severe left ventricular outflow obstruction, fluid depletion, autonomic hypotension or patients with resting hypotension, could be adversely affected by vasodilatory effects.

Contraindications

The following groups of patients with cardiovascular disease were not included in clinical trials and the use of tadalafil is therefore contraindicated: patients with a myocardial infarction within the last 90 days; patients with severe hypotension (<90/50 mm Hg); patients with unstable angina; patients with uncontrolled arrhythmias; patients with uncontrolled hypertension; patients with a stroke within the last 6 months. Tadalafil should not be used in patients with a known hypersensitivity to tadalafil or to any ingredient of the tablet. The combination of tadalafil and guanylate cyclase stimulators, such as riociguat, is contraindicated because it may lead to symptomatic hypotension.

PBS listing

Information regarding PBS listing status, strength, item count, restriction type, and pricing for this medicine is not available in the provided documents.

Regulatory history

ADCIRCA tadalafil 20 mg tablet was first listed on the ARTG on 10 August 2011. An AusPAR was approved on 2011-08-05. The TGA approved the application for ADCIRCA (tadalafil) for the treatment of pulmonary arterial hypertension (PAH). This decision represents an extension of indications and the inclusion of an additional trade name for tadalafil.