دواعي استعمال ريفوليد 25مجم 14 قرص

Eltrombopag 25 mg film-coated tablets (Revolade), oral thrombopoietin receptor agonist used for thrombocytopenia.

• Primary immune thrombocytopenia (ITP) refractory to other treatments (e.g. corticosteroids, immunoglobulins).الفئة: AdultsEuropean Medicines Agency (EMA)
• Primary ITP lasting 6 months or longer from diagnosis and refractory to other treatments.الفئة: Children aged 1 year and aboveEuropean Medicines Agency (EMA)
• Thrombocytopenia in chronic hepatitis C where thrombocytopenia prevents initiation or limits optimal interferon-based therapy.الفئة: AdultsEuropean Medicines Agency (EMA)
• Acquired severe aplastic anaemia refractory to prior immunosuppressive therapy or heavily pretreated and unsuitable for haematopoietic stem cell transplantation.الفئة: AdultsEuropean Medicines Agency (EMA)

• In adult ITP the most important serious adverse reactions were hepatotoxicity and thrombotic/thromboembolic events; the most common (>= 10%) were nausea, diarrhoea, increased ALT and back pain.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)

• Hypersensitivity to eltrombopag or any excipient.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)

• Can cause abnormal liver function and severe, potentially life-threatening hepatotoxicity; measure ALT, AST and bilirubin before starting, every 2 weeks during dose adjustment and monthly once stable; discontinue for specified persistent/progressive ALT elevations.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
• Boxed warning: risk of hepatic decompensation in chronic hepatitis C patients when combined with interferon and ribavirin, and risk of hepatotoxicity.نشرة دولية لنفس التركيبة · DailyMed (U.S. National Library of Medicine)

• Polyvalent cations (antacids, dairy products, mineral supplements with iron, calcium, magnesium, aluminium, selenium, zinc)Eltrombopag chelates polyvalent cations, markedly reducing its absorption; separate administration (at least 2 h before or 4 h after).European Medicines Agency (EMA)
• Rosuvastatin and other HMG-CoA reductase inhibitors (statins)Eltrombopag (OATP1B1/BCRP inhibition) increased rosuvastatin Cmax by 103%; consider reduced statin dose and monitor for statin adverse reactions.European Medicines Agency (EMA)

• Limited human data; animal studies showed reproductive toxicity. Revolade is not recommended during pregnancy or in women of childbearing potential not using contraception.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
• Unknown whether excreted in human milk; animal data suggest secretion into milk, so a risk to the suckling child cannot be excluded; decide whether to discontinue breast-feeding or therapy.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)

• Liver function tests (ALT, AST, bilirubin) at baseline, every 2 weeks during dose adjustment and monthly after a stable dose; platelet counts to guide dosing.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)

• Small-molecule thrombopoietin receptor agonist that stimulates megakaryocyte proliferation and differentiation, increasing platelet production.