دواعي استعمال كيوريفو 12.5/75/50مجم 56 اقراص

Qurevo: fixed-dose ombitasvir 12.5 mg / paritaprevir 75 mg / ritonavir 50 mg film-coated tablets (AbbVie) for chronic hepatitis C; Egyptian pack of 56 for Ministry of Health hospitals only.

• Chronic hepatitis C in combination with other medicinal products (dasabuvir and/or ribavirin depending on genotype)الفئة: AdultsEuropean Medicines Agency (EMA)

• With dasabuvir and ribavirin the most common adverse reactions (>20%) were fatigue and nausea.نشرة دولية لنفس التركيبة · European Medicines Agency (EMA)

• Hypersensitivity to the active substances or excipients; moderate to severe hepatic impairment (Child-Pugh B/C); ethinylestradiol-containing products; drugs highly dependent on CYP3A for clearance (e.g. alfuzosin, amiodarone, colchicine in renal/hepatic impairment, ergot derivatives, lovastatin/simvastatin/atorvastatin, oral midazolam, triazolam, pimozide, quetiapine, salmeterol, ticagrelor) and strong CYP3A/CYP2C8 inducers.نشرة دولية لنفس التركيبة · European Medicines Agency (EMA)

• Hepatic decompensation and hepatic failure, including fatal outcomes, reported mainly in patients with advanced cirrhosis; monitor cirrhotic patients and perform hepatic laboratory tests at baseline and during the first 4 weeks.نشرة دولية لنفس التركيبة · European Medicines Agency (EMA)
• Hepatitis B virus reactivation, some fatal, reported with direct-acting antivirals; screen all patients for HBV before treatment.نشرة دولية لنفس التركيبة · European Medicines Agency (EMA)
• Transient ALT elevations >5x ULN occurred in clinical trials, notably in women using ethinylestradiol-containing contraceptives.نشرة دولية لنفس التركيبة · European Medicines Agency (EMA)

• CYP3A substrates with narrow margin (e.g. quetiapine, simvastatin, oral midazolam)Co-administration contraindicated because ritonavir/paritaprevir markedly raise their levels.European Medicines Agency (EMA)
• Ethinylestradiol-containing contraceptivesContraindicated (ALT elevations).European Medicines Agency (EMA)

• Very limited human data; animal studies with ombitasvir and paritaprevir/ritonavir showed malformations. Do not use in pregnancy or in women of childbearing potential not using effective contraception; ribavirin contraindications apply when co-administered.نشرة دولية لنفس التركيبة · European Medicines Agency (EMA)

• In cirrhosis: monitor for hepatic decompensation and test liver function including direct bilirubin at baseline, during the first 4 weeks and as indicated.نشرة دولية لنفس التركيبة · European Medicines Agency (EMA)