Indications And Dose
Pulmonary arterial hypertension (initiated under Cardiovascular system specialist supervision) ▶BY MOUTH ▶Adult: 10 mg daily
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Drug reference
Pulmonary arterial hypertension (initiated under Cardiovascular system specialist supervision) ▶BY MOUTH ▶Adult: 10 mg daily
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Severe anaemia
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Patients over 75 years. pulmonary veno- occlusive disease
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Scottish Medicines Consortium (SMC) decisions SMC No. 952/14 The Scottish Medicines Consortium has advised (April 2014) that macitentan (Opsumit ®) should be initiated and prescribed only by specialists in the Scottish Pulmonary Vascular Unit or other similar specialists.
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→Appendix 1: macitentan
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▶Common or very common Anaemia. headache. increased risk of infection. nasal congestion
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Manufacturer advises exclude pregnancy before treatment and ensure effective contraception during and for one month after stopping treatment. Monthly pregnancy tests advised.
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Toxicity in animal studies.
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Manufacturer advises avoid—present in milk in animal studies.
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Manufacturer advises avoid in severe impairment or if hepatic transaminases are greater than 3 times the upper limit of normal.
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Manufacturer advises caution in severe impairment and avoid in patients undergoing dialysis (no information available). Monitoring In renal impairment consider monitoring blood pressure (risk of hypotension).
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▶Monitor liver function before treatment, then monthly thereafter (discontinue if unexplained persistent raised serum transaminases or signs of hepatic injury—can restart on advice on hepatologist if liver function tests return to normal and no hepatic injury). ▶Monitor haemoglobin concentration before treatment and then as indicated.
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There can be variation in the licensing of different medicines containing the same drug. Tablet CAUTIONARY AND ADVISORY LABELS 25 ▶Opsumit (Actelion Pharmaceuticals UK Ltd) Macitentan 10 mg Opsumit 10mg tablets | 30 tablet P £2,306.00 GUANYLATE CYCLASE STIMULATORS
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Patients should be told how to recognise signs of liver disorder and advised to seek immediate medical attention if symptoms such as dark urine, nausea, vomiting, fatigue, abdominal pain, or pruritus develop. Patient card should be provided.
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10 mg daily
First-line fragment. Read the complete Indications and Dose section above.
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