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Adcirca (Previously Tadalafil Lilly) is a brand name for Tadalafil. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adults Treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity (see section 5.1). Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease. Paediatric population Treatment of paediatric patients aged 2 years…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH. Posology Adults The recommended dose is 40 mg (two x 20 mg film-coated tablets) taken once daily. Paediatric population (age 2 years to 17 years) The recommended once daily doses based on age and weight categories in paediatric patients are shown below.
3 Paediatric patient’s age and/or weight Recommended daily dose and dosing regimen Age ≥ 2 years old Body weight ≥ 40 kg Body weight < 40 kg 40 mg (two 20 mg tablets) once daily 20 mg (one 20 mg tablet or 10 mL of oral suspension (OS), 2 mg/mL tadalafil*) once daily * Oral suspension is available for administration to paediatric patients who require 20 mg and are not able to swallow tablets.
For patients < 2 years old no PK or efficacy data are available from clinical trials. The most appropriate dose of ADCIRCA in children aged between 6 months to < 2 years has not been established. Therefore, ADCIRCA is not recommended in this age subset.
Delayed dose, missed dose, or vomiting If there is a delay in the administration of ADCIRCA, but yet within the same day, the dose should be taken with no changes to the subsequent dose schedules. Patients should not take an extra dose if a dose is missed.
Patients should not take an extra dose if vomiting occurs. Special populations Elderly patients Dose adjustments are not required in elderly patients. Renal impairment Adults and paediatric population (2 to 17 years, weighing at least 40 kg) In patients with mild to moderate renal impairment a starting dose of 20 mg once per day is recommended.
The dose may be increased to 40 mg once per day, based on individual efficacy and tolerability. 2). Paediatric population (2 to 17 years, weighing less than 40 kg) In patients < 40 kg and with mild to moderate renal impairment a starting dose of 10 mg once per day is recommended.
The dose may be increased to 20 mg once per day, based on individual efficacy and tolerability. 2). Hepatic impairment Adults and paediatric population (2 to 17 years, weighing at least 40 kg) Due to limited clinical experience 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.
Paediatric population (2 to 17 years, weighing less than 40 kg) In patients < 40 kg and with mild to moderate hepatic impairment, a starting dose of 10 mg once per day may be considered. For patients of all ages, if tadalafil is prescribed, a careful individual benefit/risk assessment should be undertaken by the prescribing physician.
Summary of the safety profile The most commonly reported adverse reactions, occurring in ≥ 10 % of patients in the tadalafil 40 mg treatment arm, were headache, nausea, back pain, dyspepsia, flushing, myalgia, nasopharingitis and pain in extremity.
The adverse reactions reported were transient, and generally mild or moderate. Adverse reaction data are limited in patients over 75 years of age. 5 mg to 40 mg once daily and 82 patients were treated with placebo. The duration of treatment was 16 weeks.
The overall frequency of discontinuation due to adverse events was low (ADCIRCA 11 %, placebo 16 %). Three hundred and fifty-seven (357) patients who completed the pivotal study entered a long-term extension study. Doses studied were 20 mg and 40 mg once daily.
Tabulated list of adverse reactions The table below lists the adverse reactions reported during the placebo-controlled clinical trial in patients with PAH treated with ADCIRCA. Also included in the table are some adverse reactions which have been reported in clinical trials and/or post-marketing with tadalafil in the treatment of male erectile dysfunction.
These events have either been assigned a frequency of “Not known,” as the frequency in PAH patients cannot be estimated from the available data or assigned a frequency based on the clinical trial data from the pivotal placebo-controlled study of ADCIRCA.
Frequency estimate:
Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000) and not known (cannot be estimated from the available data). System Organ Class Very common Common Uncommon Rare Not known1 Immune system disorders Hypersensitivity reactions5 Angioedema Nervous system disorders Headache6 Syncope, Migraine5 Seizures5, Transient amnesia5 Stroke2 (including haemorrhagic events) Eye disorders Blurred vision Non-arteritic anterior ischemic optic neuropathy (NAION), Retinal vascular occlusion, Visual field defect, Central serous chorioretinopathy Ear and labyrinth disorders Tinnitus Sudden hearing loss Cardiac disorders Palpitations2, 5 Sudden cardiac death2, 5, Tachycardia2, 5 Unstable angina pectoris, Ventricular arrhythmia, Myocardial Infarction2 Vascular disorders Flushing Hypotension Hypertension Respiratory, thoracic and mediastinal disorders Nasopharyngitis (including nasal congestion, sinus congestion and rhinitis) Epistaxis 10 Gastrointestinal disorders Nausea, Dyspepsia (including abdominal pain/discomfort3 ) Vomiting, Gastroesophage al reflux Skin and subcutaneous tissue disorders Rash Urticaria5, Hyperhydrosis (sweating)5 Stevens-Johnson Syndrome, Exfoliative dermatitis Musculoskeletal , connective tissue and bone disorders Myalgia, Back pain Pain in extremity (including limb discomfort) Renal and urinary disorders Haematuria Reproductive system and breast disorders Increased uterine bleeding4 Priapism5, Penile haemorrhage, Haematospermia Prolonged erections General disorders and administration site conditions Facial oedema, Chest pain2 (1) Events not reported in registration trials and cannot be estimated from the available data.
Cardiovascular diseases The following groups of patients with cardiovascular disease were not included in PAH clinical trials: - Patients with clinically significant aortic and mitral valve disease - Patients with pericardial constriction - Patients with restrictive or congestive cardiomyopathy - Patients with significant left ventricular dysfunction - Patients with life-threatening arrhythmias - Patients with symptomatic coronary artery disease - Patients with uncontrolled hypertension.
Since there are no clinical data on the safety of tadalafil in these patients, the use of tadalafil is not recommended. Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD).
Since there are no clinical data on administration of tadalafil to patients with veno-occlusive disease, administration of tadalafil to such patients is not recommended. Should signs of pulmonary oedema occur when tadalafil is administered, the possibility of associated PVOD should be considered.
Tadalafil has systemic vasodilatory properties that may result in transient decreases in blood pressure. Physicians should carefully consider whether their patients with certain underlying conditions, such as severe left ventricular outflow obstruction, fluid depletion, autonomic hypotension or patients with resting hypotension, could be adversely affected by such vasodilatory effects.
5). Therefore, the combination of tadalafil and doxazosin is not recommended. Vision Visual defects, including Central Serous Chorioretinopathy (CSCR), and cases of NAION have been reported in connection with the intake of tadalafil and other PDE5 inhibitors.
Most cases of CSCR resolved spontaneously after stopping tadalafil. Regarding NAION, analyses of observational data suggest an increased risk of acute NAION in men with erectile dysfunction following exposure to tadalafil or other PDE5 inhibitors.
1. Acute myocardial infarction within the last 90 days. Severe hypotension (< 90/50 mm Hg). In clinical trials, tadalafil was shown to augment the hypotensive effects of nitrates. This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway.
5). 5). 4).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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2). Paediatric population (age < 2 years) Dosing and efficacy of ADCIRCA has not been established for children aged < 2 years. 1. 4 Method of administration ADCIRCA is for oral use. The film-coated tablets should be swallowed whole with water, with or without food.
The adverse reactions have been included in the table as a result of post-marketing or clinical trial data from the use of tadalafil in the treatment of erectile dysfunction. (2) Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors.
(3) Actual MedDRA terms included are abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, and stomach discomfort. (4) Clinical non-MedDRA term to include reports of abnormal/excessive menstrual bleeding conditions such as menorrhagia, metrorrhagia, menometrorrhagia, or vaginal haemorrhage.
(5) The adverse reactions have been included in the table as a result of post-marketing or clinical trial data from the use of tadalafil in the treatment of erectile dysfunction; and in addition, the frequency estimates are based on only 1 or 2 patients experiencing the adverse reaction in the pivotal placebo- controlled study of ADCIRCA.
(6) Headache was the most commonly reported adverse reaction. Headache may occur at the beginning of therapy; and decreases over time even if treatment is continued. 5 to 17 years with PAH were treated with tadalafil in clinical trials (H6D-MC-LVHV, H6D-MC-LVIG).
A total of 391 paediatric patients with PAH, from new-born to < 18 years, were treated with tadalafil in an observational post-marketing study (H6D-JE- TD01). Following tadalafil administration, the frequency, type and severity of adverse reactions in children and adolescents were similar to that seen for adults.
Due to differences in study design, sample size, gender, age range, and doses, safety findings from these trials are detailed separately below. 2 years) with PAH, a total of 17 patients were treated once daily with ADCIRCA 20 mg (middle-weight cohort, ≥ 25 kg to < 40 kg) or 40 mg (heavy-weight cohort, ≥ 40 kg), and 18 patients 11 were treated with placebo, for 24 weeks.
8 % each). No deaths or SAEs were reported. Of the 35 paediatric patients treated in the short-term, placebo-controlled study, 32 entered the 24 month long-term open-label extension and 26 patients completed the follow-up. No new safety signals were observed.
Uncontrolled pharmacokinetic study in paediatric patients (H6D-MC-LVIG) In a paediatric multiple ascending dose study, 19 […]
3). Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in the clinical trials, and use in these patients is not recommended. Decreased or sudden hearing loss Cases of sudden hearing loss have been reported after the use of tadalafil.
Although other risk factors were present in some cases (such as age, diabetes, hypertension, previous hearing loss history and associated connective tissue diseases) patients should be advised to seek prompt medical attention in the event of sudden decrease or loss of hearing.
Renal and hepatic impairment Due to increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis, tadalafil is not recommended in patients with severe renal impairment.
Patients with severe hepatic cirrhosis (Child-Pugh Class C) have not been studied and, therefore, dosing of tadalafil is not recommended. Priapism and anatomical deformation of the penis Priapism has been reported in men treated with PDE5 inhibitors.
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 should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
5). 5). Treatments for erectile dysfunction The safety and efficacy of combinations of tadalafil and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied. Patients should be informed not to take ADCIRCA with these medicinal products.
6 Prostacyclin and its analogues The efficacy and safety of tadalafil co-administered with prostacyclin or its analogues has not been studied in controlled clinical trials. Therefore, caution is recommended in case of co-administration.
1). Lactose ADCIRCA contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.