omiting, as well as later signs such as jaundice and discoloured faeces, and to consult a doctor without delay if such symptoms occur. Use caution when administering Viekirax with fluticasone or other glucocorticoids that are metabolised by CYP3A4. Concomitant use of inhaled glucocorticoids metabolised with CYP3A can increase systemic exposures of the glucocorticoids, and cases of Cushing’s syndrome and subsequent adrenal suppression have been reported with ritonavir-containing regimens. The safety and efficacy of Viekirax and Exviera have not been established in Hepatitis C/Hepatitis B co-infection patients.
INTERACTIONS: See SmPCs for full details. Viekirax in combination with Exviera: Not Recommended: darunavir in patients with extensive PI resistance, fluvastatin and pitavastatin not recommended.
Use caution and dose decrease may be needed for repaglinide.
Use Caution: sulfasalazine, erythromycin, trazodone (lower dose of trazodone may be considered), fexofenadine, diltiazem, verapamil, rilpivirine once daily should only be used in patients without known QT prolongation, and without other QT prolongation co-medications.
Monitor Levels: digoxin, warfarin (INR), Adjust Dose: Monitoring and dose reduction recommended for valsartan. Monitoring and lower doses of imatinib recommended. Monitoring and dose adjustment may be needed for s-mephenytoin. Reduction in colchicine dose or interruption of colchicine treatment is recommended in patients with normal renal or hepatic function. Decrease amlodipine dose by 50% and monitor. Decrease nifedipine dose and monitor.
Furosemide decrease of up to 50% may be required upon monitoring. 300 mg dose of atazanavir recommended to be administered at the same time as Viekirax with Exviera, 800 mg darunavir once-daily without ritonavir recommended to be administered at the same time as Viekirax with Exviera in the absence of extensive PI resistance. Do not exceed 5 mg/day rosuvastatin. Reduce pravastatin dose by 50%. When starting co-administration, give one fifth of the total daily dose of ciclosporin once daily, monitor ciclosporin levels and adjust dose and/or dosing frequency as needed.
When starting co-dosing, administer 0.5 mg tacrolimus once every week, monitor and adjust dose and/or dosing frequency as needed. Use higher doses of omeprazole if clinically indicated. Higher doses of esomeprazole/lansoprazole may be needed if clinically indicated. A decrease in alprazolam dose can be considered based on clinical monitoring. Clinical monitoring and dose adjustment may be required for levothyroxine Viekirax without Exviera: As per combination with Exviera with following exceptions. Use Caution: dabigatran etexilate Not Recommended: Atazanavir and darunavir are not recommended with Viekirax without Exviera. Adjust Dose: Decrease digoxin dose by 30–50% and monitor. Do not exceed 10 mg/day rosuvastatin.
PREGNANCY AND LACTATION: When Viekirax and Exviera are taken in combination with ribavirin, the contraindications regarding the use of ribavirin in pregnancy apply.
See the ribavirin SmPC for information. Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when co-administered with ribavirin. There is only limited data on the use of Viekirax and Exviera in pregnant women. The potential risk to humans is unknown. Viekirax and Exviera should not be used in pregnancy.
It is not known whether Viekirax, Exviera and |
