etreatment of chronic hepatitis C (CHC) in adults.
EXVIERA is indicated in combination with other medicinal products for the treatment ofchronic hepatitis C (CHC) in adults.
Important EU Safety Information
Contraindications:VIEKIRAX+ EXVIERA are contraindicated in patients with severe hepaticimpairment (Child-Pugh C).
Patients taking ethinyl estradiol-containingmedicinal products must discontinue them and switch to an alternativemethod of contraception prior to initiating VIEKIRAX+EXVIERA.
Do notgive VIEKIRAX with certain drugs that are sensitive CYP3A substrates or
strong inhibitors of CYP3A. Do not give VIEKIRAX and EXVIERA with strong
or moderate enzyme inducers. Do not give EXVIERA with certain drugsthat are strong inhibitors of CYP2C8.
Special warnings and precautions for use:VIEKIRAXand EXVIERA are notrecommended as monotherapy and should be used incombination with other medicinal products for the treatment of hepatitisC infection.
Pregnancy and concomitant use with ribavirinWhenVIEKIRAX+EXVIERA are used in combination with ribavirin, women ofchildbearing potential or their male partners must use an effective formof contraception during the treatment and 6 months after the treatment.
Refer to the Summary of Product Characteristics for ribavirin foradditional information.
ALT elevationsTransientelevations of ALT to >5x ULN without concomitant elevations ofbilirubin occurred in clinical trials with VIEKIRAX + EXVIERA and weremore frequent in a subgroup who were using ethinyl estradiol-containing
contraceptives.
Use with concomitant medicinal productsUsecaution when administering VIEKIRAX with fluticasone or otherglucocorticoids that are metabolized by CYP3A4. A reduction incolchicine dosage or interruption in colchicine is recommended in
patients with normal renal or hepatic function.
VIEKIRAX with or withoutEXVIERA is expected to increase exposure of statins so certain statinsneed to be discontinued or dosages reduced. Low dose ritonavir, which ispart of VIEKIRAX, may select for PI resistance in HIV co-infected
patients without ongoing antiretroviral therapy.
HIV co-infectedpatients without suppressive antiretroviral therapy should not betreated with VIEKIRAX.
Adverse ReactionsMost common (>20 percent) adverse reactions for VIEKIRAX + EXVIERA with RBV were fatigue and nausea.
Full summary of product characteristics is available at www.ema.europa.eu
Globally, prescribing information varies; refer to the individual country product label for complete information. |
