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Ambrisentan Viatris (Previously Ambrisentan Mylan) is a brand name for Ambrisentan. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ambrisentan Viatris is indicated for the treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment (see section 5.1). Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.
Verbatim from this product's EMA label. Tap a section to expand.
Treatment must be initiated by a physician experienced in the treatment of PAH. 3 Posology Ambrisentan monotherapy Ambrisentan Viatris is to be taken orally to begin at a dose of 5 mg once daily and may be increased to 10 mg daily depending upon clinical response and tolerability.
Ambrisentan in combination with tadalafil When used in combination with tadalafil, Ambrisentan Viatris should be titrated to 10 mg once daily. 1). When used in combination with tadalafil, patients were initiated with 5 mg ambrisentan and 20 mg tadalafil.
Dependent on tolerability the dose of tadalafil was increased to 40 mg after 4 weeks and the dose of ambrisentan was increased to 10 mg after 8 weeks. More than 90% of patients achieved this. Doses could also be decreased depending on tolerability.
Limited data suggest that the abrupt discontinuation of ambrisentan is not associated with rebound worsening of PAH. 2). 2). 2). There is limited experience with ambrisentan in individuals with severe renal impairment (creatinine clearance <30 ml/min); therapy should be initiated cautiously in this subgroup and particular care taken if the dose is increased to 10 mg ambrisentan.
Patients with hepatic impairment Ambrisentan has not been studied in individuals with hepatic impairment (with or without cirrhosis). Since the main routes of metabolism of ambrisentan are glucuronidation and oxidation with subsequent elimination in the bile, hepatic impairment might be expected to increase exposure (Cmax and AUC) to ambrisentan.
4). Paediatric population The safety and efficacy of Ambrisentan Viatris in children and adolescents aged below 18 years has not been established. 3 regarding data available in juvenile animals). Method of administration Ambrisentan Viatris is for oral use.
It is recommended that the tablet is swallowed whole and it can be taken with or without food. It is recommended that the tablet should not be split, crushed or chewed.
Summary of the safety profile Peripheral oedema (37%) and headache (28%) were the most common adverse reactions observed with ambrisentan. 4). Serious adverse reactions associated with ambrisentan use include anaemia (decreased haemoglobin, decreased haematocrit) and hepatotoxicity.
Reductions in haemoglobin concentrations and haematocrit (10%) have been associated with ERAs including ambrisentan. 4). 1). Tabulated list of adverse reactions Frequencies are defined as: 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 available data).
For dose-related adverse reactions the frequency category reflects the higher dose of ambrisentan. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. g. 4) Skin and subcutaneous tissue disorders Common Rash8 General disorders and administration site conditions Very common Peripheral oedema, fluid retention, chest pain/discomfort5, fatigue Common Asthenia 1 See section ‘Description of selected adverse reactions’.
2 The frequency of headache appeared higher with 10 mg ambrisentan. 3 Cases were only observed in a placebo-controlled clinical study of ambrisentan in combination with tadalafil. 4 Most of the reported cases of cardiac failure were associated with fluid retention.
5 Frequencies were observed in a placebo-controlled clinical study of ambrisentan in combination with tadalafil. Lower incidence was observed with ambrisentan monotherapy. 6 Cases of worsening dyspnoea of unclear aetiology have been reported shortly after starting ambrisentan therapy.
7 The incidence of nasal congestion was dose related during ambrisentan therapy. 8 Rash includes rash erythematous, rash generalised, rash papular and rash pruritic. 4). The frequency of decreased haemoglobin (anaemia) was higher with 10 mg ambrisentan.
Ambrisentan has not been studied in a sufficient number of patients to establish the benefit/risk balance in WHO functional class I PAH. The efficacy of ambrisentan as monotherapy has not been established in patients with WHO functional class IV PAH.
g. epoprostenol) should be considered if the clinical condition deteriorates. Liver function Liver function abnormalities have been associated with PAH. 1). 3). Patients should be monitored for signs of hepatic injury and monthly monitoring of ALT and AST is recommended.
g. jaundice), ambrisentan therapy should be discontinued. In patients without clinical symptoms of hepatic injury or of jaundice, re-initiation of ambrisentan may be considered following resolution of hepatic enzyme abnormalities. The advice of a hepatologist is recommended.
Haemoglobin concentration Reductions in haemoglobin concentrations and haematocrit have been associated with endothelin receptor antagonists (ERAs) including ambrisentan. Most of these decreases were detected during the first 4 weeks of treatment and haemoglobin generally stabilised thereafter.
2 g/dL) in haemoglobin concentrations persisted for up to 4 years of treatment with ambrisentan in the long-term open-label extension of the pivotal Phase 3 clinical studies. 8). Initiation of ambrisentan is not recommended for patients with clinically significant anaemia.
It is recommended that haemoglobin and/or haematocrit levels are measured during treatment with ambrisentan, for example at 1 month, 3 months and periodically thereafter in line with clinical practice. If a clinically significant decrease in haemoglobin or haematocrit is observed, and other causes have been excluded, dose reduction or discontinuation of treatment should be considered.
The incidence of anaemia was increased when ambrisentan was dosed in combination with tadalafil (15% 5 adverse event frequency), compared to the incidence of anaemia when ambrisentan and tadalafil were given as monotherapy (7% and 11%, respectively).
6). 6). 6). 2). 4). 1).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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83 g/dL); mean changes from baseline appeared to stabilise over the subsequent 8 weeks. 5%) in the ambrisentan treatment groups had decreases in haemoglobin of ≥15% from baseline and which fell below the lower limit of normal. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Fluid retention Peripheral oedema has been observed with ERAs including ambrisentan. Most cases of peripheral oedema in clinical studies with ambrisentan were mild to moderate in severity, although it may occur with greater frequency and severity in patients ≥65 years.
8). Post-marketing reports of fluid retention occurring within weeks after starting ambrisentan have been received and, in some cases, have required intervention with a diuretic or hospitalisation for fluid management or decompensated heart failure.
If patients have pre-existing fluid overload, this should be managed as clinically appropriate prior to starting ambrisentan. If clinically significant fluid retention develops during therapy with ambrisentan, with or without associated weight gain, further evaluation should be undertaken to determine the cause, such as ambrisentan or underlying heart failure, and the possible need for specific treatment or discontinuation of ambrisentan therapy.
The incidence of peripheral oedema was increased when ambrisentan was dosed in combination with tadalafil (45% adverse event frequency), compared to the incidence of peripheral oedema when ambrisentan and tadalafil were given as monotherapy (38% and 28%, respectively).
The occurrence of peripheral oedema was highest within the first month of treatment initiation. Women of child-bearing potential Ambrisentan Viatris treatment must not be initiated in women of child-bearing potential unless the result of a pre-treatment pregnancy test is negative and reliable contraception is practiced.
If there is any doubt on what contraceptive advice should be given to the individual patient, consultation with a gynaecologist should be considered. 6). Pulmonary veno-occlusive disease Cases of pulmonary oedema have been reported with vasodilating medicinal products, such as ERAs, when used in patients with pulmonary veno-occlusive disease.
Consequently, if PAH patients develop acute pulmonary oedema when treated with ambrisentan, the possibility of pulmonary veno-occlusive disease should be considered. 2). Excipients Lactose Ambrisentan Viatris contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Allura red AC aluminium lake Ambrisentan Viatris contains the azo-colouring agent Allura red AC Aluminium Lake (E129), which may cause allergic reactions. 6 Sodium Ambrisentan Viatris contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.