Direct healthcare professional communication on the new safety information related to the hepatic safety of Viekirax (ombitasvir, paritaprevir, ritonavir) with or without Exviera (dasubuvir)
04.01.2016
AbbVie d.o.o., in agreement with the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) and the European Medicines Agency (EMA), has informed healthcare professionals of important new safety information related to the hepatic safety of Viekirax (ombitasvir, paritaprevir, ritonavir) with or without Exviera (dasubuvir).
Summary and recommendations
- Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, have been reported postmarketing in patients treated with Viekirax with Exviera.
- Most patients with these severe outcomes had evidence of advanced or decompensated cirrhosis prior to initiating therapy.
- Therefore, Viekirax with or without Exviera is not recommended in patients with moderate hepatic impairment (Child-Pugh B) and remains contraindicated in patients with severe hepatic impairment (Child-Pugh C).
- Patients with cirrhosis should be monitored
- for clinical signs and symptoms of hepatic decompensation
- and with hepatic laboratory testing including direct bilirubin levels at baseline, during the first 4 weeks of starting treatment and as clinically indicated thereafter. - Patients receiving Viekirax and Exviera should be informed to watch for early symptoms of liver inflammation, liver failure or hepatic decompensation and to consult their healthcare provider without delay if such symptoms occur.
- Patients with moderate hepatic impairment (Child-Pugh B) currently on treatment with Viekirax with and without Exviera may be continued on treatment after a discussion of the benefits and risks of continued treatment. Patients who continue on treatment should be monitored for evidence of hepatic decompensation as stated above.
- The Product Information for these products will be updated with the new recommendations.
- Patients who develop evidence of clinically relevant hepatic decompensation should discontinue treatment.
Further information
Viekirax is indicated in combination with other medicinal products for the treatment of chronic hepatitis C in adults.
Exviera is indicated in combination with other medicinal products for the treatment of chronic hepatitis C in adults.
With this direct healthcare professional communication (DHPC), the healthcare professionals are being informed of new recommendations relating to treatment of patients with moderate hepatic impairment with these medicinal products and are being provided with additional information regarding this safety concern.
Here you may view the direct healthcare professional communication.
The healthcare professionals are being reminded that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED. HALMED recommends the patients to contact their doctor or pharmacist regarding any adverse reaction they notice.
