Yuvanci

Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH. Posology 3 The recommended dose of Yuvanci is one 10 mg/40 mg tablet taken orally once daily.  For patients who are currently treated with 10 mg macitentan and 40 mg tadalafil as separate tablets use Yuvanci 10 mg/40 mg tablet  For patients who are currently treated with 10 mg macitentan and 20 mg tadalafil as separate tablets use Yuvanci 10 mg/20 mg tablet.

The dose may be increased to 10 mg/40 mg once per day, based on tolerability. Yuvanci should be taken every day at about the same time. Missed dose If the patient misses a dose of Yuvanci, the patient should take it as soon as possible and then take the next dose at the regularly scheduled time.

The patient should not take two doses at the same time if a dose has been missed. 2). Renal impairment The use of Yuvanci is not recommended in patients undergoing dialysis or in patients with severe renal impairment (creatinine clearance <30 ml/min).

2). 3). 2). Paediatric population The safety and efficacy of Yuvanci in children and adolescents below 18 years have not been studied. No data are available. Method of administration For oral use. The film-coated tablets are not breakable and are to be swallowed whole with water, with or without food.

The impact of breaking or grinding was not investigated.

1%). 5%). Tabulated list of adverse reactions 10 The safety profile presented below is based on data for Yuvanci and the known safety profile of the individual components macitentan and tadalafil. The safety data for Yuvanci was obtained from a double-blind, active controlled, Phase 3 clinical study (A DUE) and an open-label extension in patients with PAH.

1 weeks. Known adverse reactions for macitentan and tadalafil which have not been observed in the A DUE study, are included in table 1 based on the prescribing information for the individual components macitentan and tadalafil. Adverse reactions are listed by MedDRA system organ class and by frequency.

Frequency categories are defined as follows: 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 (frequency cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. , macitentan, tadalafil, and Yuvanci), the category representing the highest frequency is presented. b Not observed with Yuvanci in double-blind study data, but reported with macitentan monotherapy c Includes anaemia, iron deficiency anaemia, anaemia of chronic disease, haemoglobin decreased, normochromic anaemia, pancytopenia, blood loss anaemia, and myelofibrosis.

d Pruritus was observed with macitentan with a frequency of uncommon. e Not observed with Yuvanci in double-blind study data, but reported with tadalafil monotherapy. f Events not reported in registration studies and cannot be estimated from the available data.

The adverse reactions have been included in the table as a result of postmarketing or clinical study data from the use of tadalafil in the treatment of erectile dysfunction. g Includes flushing and hot flush. h Includes heavy menstrual bleeding, intermenstrual bleeding, polymenorrhagia, and vaginal haemorrhage.

8). Yuvanci is contraindicated in patients with severe hepatic impairment, with or without cirrhosis (Child-Pugh Class C) or elevated hepatic aminotransferases greater than 3 times the upper limit of normal (> 3 × ULN). 3). Patients should be monitored for signs of hepatic injury and monthly monitoring of ALT and AST is recommended.

, jaundice), Yuvanci treatment should be discontinued. Reinitiation of Yuvanci may be considered following the return of hepatic enzyme levels to within the normal range in patients who have not experienced clinical symptoms of liver injury.

The advice of a hepatologist is recommended. 6). Women should not become pregnant for 1 month after discontinuation of Yuvanci. Monthly pregnancy tests during treatment with Yuvanci are recommended to allow the early detection of pregnancy.

8). In placebo-controlled studies, macitentan-related decreases in haemoglobin concentration were not progressive, stabilised after the first 4-12 weeks of treatment and remained stable during chronic treatment. Cases of anaemia requiring blood cell transfusion have been reported with macitentan and other ERAs.

Initiation of Yuvanci is not recommended in patients with severe anaemia. It is recommended that haemoglobin concentrations be measured prior to initiation of treatment with Yuvanci, and tests repeated during treatment as clinically indicated.

Pulmonary veno-occlusive disease Cases of pulmonary oedema have been reported with vasodilators (mainly prostacyclins) when used in patients with pulmonary veno-occlusive disease. Consequently, if signs of pulmonary oedema occur when Yuvanci is administered in patients with PAH, the possibility of pulmonary veno-occlusive disease should be considered.

Since there are no clinical data on administration of Yuvanci to patients with veno-occlusive disease, administration of Yuvanci to such patients 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.

1.  Acute myocardial infarction within the last 90 days. 6). 6). 6). 4). 4).  Severe hypotension (<90/50 mm Hg). 5).  Patients with a history of non-arteritic anterior ischaemic optic neuropathy (NAION).