سعر ناشيليف 10مجم 20 قرص 2023

• Primary biliary cholangitis with UDCA (inadequate UDCA response) or as monotherapy (UDCA intolerance)Population: AdultsEuropean Medicines Agency (EMA)

• Most common: pruritus (63%) and fatigue (22%). Common: abdominal pain/discomfort, constipation, dizziness, palpitations, oropharyngeal pain, thyroid function abnormality, eczema, rash, arthralgia, peripheral oedema, pyrexia. Frequency not known: hepatic failure, raised bilirubin, jaundice, hepatic cirrhosis.International label, equivalent formulation · European Medicines Agency (EMA)

• Hypersensitivity to the active substance or excipients; decompensated cirrhosis (e.g. Child-Pugh B or C) or a prior decompensation event; complete biliary obstruction.International label, equivalent formulation · European Medicines Agency (EMA)

• Hepatic failure, sometimes fatal or requiring transplant, has been reported in PBC patients with compensated or decompensated cirrhosis; ALT/AST rises and hepatic decompensation can occur within the first month. Permanently discontinue on evidence of decompensation; interrupt during severe intercurrent illness.International label, equivalent formulation · European Medicines Agency (EMA)
• Severe pruritus (23% on 10 mg vs 7% placebo); manage with resins, antihistamines, dose reduction or interruption.International label, equivalent formulation · European Medicines Agency (EMA)
• The EU marketing authorisation of Ocaliva was revoked by Commission Implementing Decision of 30 August 2024.International label, equivalent formulation · European Medicines Agency (EMA)

• Bile acid binding resins (cholestyramine, colestipol, colesevelam)Reduce absorption; take obeticholic acid at least 4-6 hours before or after the resin.European Medicines Agency (EMA)
• WarfarinINR decreases; monitor INR and adjust warfarin dose.European Medicines Agency (EMA)
• CYP1A2 substrates with narrow therapeutic index (e.g. theophylline, tizanidine)Exposure may increase; therapeutic monitoring recommended.European Medicines Agency (EMA)

• No data in pregnant women; animal studies do not indicate harm; as a precaution avoid use during pregnancy.International label, equivalent formulation · European Medicines Agency (EMA)
• Unknown whether excreted in human milk; not expected to affect the breastfed child; decide whether to stop breastfeeding or therapy.International label, equivalent formulation · European Medicines Agency (EMA)

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