What is Adcirca?
Adcirca is a medicine that contains the active substance tadalafil. It is available as orange almond shaped tablets (20 mg).
What is Adcirca used for?
Adcirca is used to treat adults with pulmonary arterial hypertension (PAH) in order to improve their exercise capacity (ie the possibility of exercising). PAH refers to an elevated blood pressure above the norm in the arteries of the lungs. Adcirca is used in patients with PAH class II or III. The "class" indicates the severity of the illness: "class II" means a slight limitation of physical activity, while for "class III" a marked limitation of physical activity. Adcirca has been shown to be effective in cases of PAH without a recognized cause and in cases of PAH caused by collagen vascular diseases.
The medicine can only be obtained with a prescription.
How is Adcirca used?
Adcirca therapy should only be started and monitored by a physician experienced in the treatment of PAH.
Adcirca should be taken at a dose of two tablets (40 mg) once a day, with or without food. Patients with mild or moderate kidney or liver problems should start with a lower dose which, if necessary, can be increased based on the patient's response. Adcirca is not recommended for patients with severe kidney or liver problems.
How does Adcirca work?
PAH is a debilitating disease in which there is a strong constriction (narrowing) of the blood vessels of the lungs. It causes a very high pressure in the vessels that carry blood from the heart to the lungs. This pressure reduces the amount of oxygen that the blood can receive in the lungs, making physical activity more problematic. The active substance in Adcirca, tadalafil, belongs to a group of medicines called "phosphodiesterase type 5 inhibitors (PDE5)" that block the PDE5 enzyme. This enzyme is found in the blood vessels of the lungs and when blocked, a substance called cyclic "guanosine monophosphate" (cGMP) cannot be degraded and remains in blood vessels causing relaxation and enlargement. In patients with PAH, Adcirca widens the blood vessels of the lungs, which causes a drop in blood pressure and an improvement in symptoms.
How has Adcirca been studied?
Four doses of Adcirca (2.5, 10, 20 and 40 mg once a day) were compared with placebo (a dummy treatment) in one main study involving 406 patients with PAH, mostly class II or III, of unknown cause or attributable to vascular collagen diseases. The main measure of effectiveness was the change in distance that patients could walk for six minutes after 16 weeks of treatment. It is a method to measure the variation in exercise capacity.
What benefit has Adcirca shown during the studies?
Adcirca was more effective than placebo at improving exercise capacity. Before the therapy, patients could travel an average of 343 meters in six minutes. After 16 weeks, this distance was increased by 26 meters more in patients taking 40 mg of Adcirca than in patients taking placebo.
What is the risk associated with Adcirca?
The most common side effects with Adcirca (seen in more than 1 patient in 10) are headache, redness of the skin, nasopharyngitis (inflammation of the nose and throat), including stuffy or runny nose and closed paranasal sinuses, nausea, dyspepsia ( heartburn) including stomach pain, myalgia (muscle pain), back pain and pain in the limbs (arms, hands, legs and feet). For the full list of all side effects reported with Adcirca, see the Package Leaflet.
Adcirca should not be used in people who may be hypersensitive (allergic) to tadalafil or any of the other substances. Adcirca should not be used in patients who have had an acute myocardial infarction (sudden infarction) in the last three months or who suffer from severe hypotension (low blood pressure). Adcirca should not be taken with nitrates (a group of medicines used to treat angina). It must not be taken by patients who have had a loss of vision in the past due to a problem of non-arteritic anterior ischemic optic neuropathy (NAION) that compromises blood flow to the optic nerve.
Why has Adcirca been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Adcirca's benefits are greater than its risks and recommended that it be given marketing authorization.
More information about Adcirca
On 1 October 2008, the European Commission granted a marketing authorization for Tadalafil Lilly to Eli Lilly Nederland BV. This authorization was based on the authorization granted to Cialis in 2002 ("informed consent"). On October 21, 2009 the name of the medicine was changed to Adcirca. The marketing authorization is valid for five years and can be renewed after this period.
For the full EPAR for Adcirca, click here.
Last update of this summary: 01-2010.
