x+ribavirin for 24 weeks. See ribavirin SmPC for dosing instructions.
Special Populations: HIV-1 Co-infection: No dose adjustment required. For dosing with HIV antiviral agents refer to SmPC for additional information.
Liver Transplant recipients: Viekirax+Exviera+ribavirin for 24 weeks in liver transplant recipients with genotype 1 HCV infection. Viekirax + ribavirin in genotype 4 infected recipients. Elderly: No dose adjustment required. Renal impairment: No dose adjustment required. Hepatic impairment: No dose adjustment recommended in patients with mild hepatic impairment (Child-Pugh A).
No data for patients with moderate hepatic impairment (Child-Pugh B), however, no dose adjustment expected based on pharmacokinetic studies. Viekirax is contraindicated and Exviera should not be used in patients with severe hepatic impairment (Child-Pugh C).
Paediatric Population: No data available.
CONTRAINDICATIONS:
Hypersensitivity to any of the active substances or excipients. Ethinylestradiol-containing medicinal products such as those in most combined oral contraceptives or contraceptive vaginal rings.
Viekirax is contraindicated in patients with severe hepatic impairment (Child-Pugh C).
Viekirax in combination with CYP3A4 substrates: examples include; alfuzosin hydrochloride, amiodarone, astemizole, terfenadine, cisapride, colchicine in patients with renal or hepatic impairment, ergotamine, dihydroergotamine, ergonovine, methylergometrine, fusidic acid, lovastatin, simvastatin, atorvastatin, oral midazolam, triazolam, pimozide, quetiapine, quinidine, salmeterol, sildenafil (when used for the treatment of pulmonary arterial hypertension) and ticagrelor. Viekirax with or without Exviera in combination with enzyme inducers: examples include; carbamazepine, phenytoin, phenobarbital, efavirenz, nevirapine, etravirine, enzalutamide, mitotane, rifampicin, St. John’s Wort (Hypericum perforatum).
Viekirax with or without Exviera in combination with CYP3A4 inhibitors: examples include; cobicistat, indinavir, lopinavir/ritonavir, saquinavir, tipranavir, itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, telithromycin and conivaptan. Exviera is contraindicated in combination with CYP2C8 inhibitors: example includes; gemfibrozil.
SPECIAL WARNINGS AND PRECAUTIONS: Viekirax and Exviera are not recommended as monotherapies.
The efficacy of Viekirax has only been established in patients with Hepatitis C Virus (HCV) genotypes 1 and 4. The efficacy of Exviera has been only been established in patients with HCV genotype 1 only.
There are no data on the use of Viekirax and ribavirin in patients with genotype 4 infection with compensated cirrhosis, therefore optimal treatment duration has not been established. Co-administration of Viekirax with other antivirals other than Exviera and/or ribavirin has not been eva luated. When used in combination with ribavirin, women of childbearing potential or their male partners must use an effective form of contraception during the treatment and for 6 months after the treatment as recommended in the SmPC for ribavirin. Refer to the SmPC for ribavirin for additional information.
Although ALT elevations associated with Viekirax and Exviera have been asymptomatic, patients should be instructed to watch for early warning signs of liver inflammation, such as fatigue, weakness, lack of appetite, nausea and v |
