MyHep Special Precautions

General: Sofosbuvir is not recommended for administration as monotherapy and should be prescribed in combination with other medicinal products for the treatment of hepatitis C infection. If the other medicinal products used in combination with Sofosbuvir are permanently discontinued, Sofosbuvir should also be discontinued (see Dosage & Administration). Consult the Summary of Product Characteristics for co-prescribed medicinal products before starting therapy with Sofosbuvir.
Severe bradycardia and heart block: Cases of severe bradycardia and heart block have been observed when Sofosbuvir is used in combination with Daclatasvir and concomitant amiodarone with or without other drugs that lower heart rate. The mechanism is not established.
The concomitant use of amiodarone was limited through the clinical development of sofosbuvir plus direct-acting antivirals (DAAs). Cases are potentially life threatening, therefore amiodarone should only be used in patients on Sofosbuvir + Daclatasvir when other alternative anti­ arrhythmic treatments are not tolerated or are contraindicated.
Should concomitant use of amiodarone be considered necessary it is recommended that patients are closely monitored when initiating Sofosbuvir + Daclatasvir. Patients who are identified as being high risk of bradyarrhythmia should be continuously monitored for 48 hours in an appropriate clinical setting.
Due to the long half-life of amiodarone, appropriate monitoring should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated on Sofosbuvir in combination with Daclatasvir.
All patients receiving Sofosbuvir + Daclatasvir in combination with amiodarone with or without other drugs that lower heart rate should also be warned of the symptoms of bradycardia and heart block and should be advised to seek medical advice urgently should they experience them.
Treatment-experienced patients with genotype 1 HCV Infection: Sofosbuvir has not been studied in a Phase 3 study in treatment-experienced patients with genotype 1 HCV infection. Thus, the optimal treatment duration in this population has not been established.
Co-administration with other direct-acting antivirals against HCV: Sofosbuvir should only be co-administered with other direct-acting antiviral medicinal products if the benefit is considered to outweigh the risks based upon available data. There are no data to support the co-administration of Sofosbuvir and telaprevir or boceprevir. Such co-administration is not recommended (see also Interactions).
Risks associated with Combination Treatment: Because sofosbuvir is used in combination with other antiviral drugs for treatment of HCV infection, consult the prescribing information for these drugs used in combination with sofosbuvir. Warnings and Precautions related to these drugs also apply to their use in sofosbuvir combination treatment.
Pregnancy and concomitant use with ribavirin: When Sofosbuvir is used in combination with ribavirin or peginterferon alfa/ribavirin, women of childbearing potential or their male partners must use an effective form of contraception during the treatment and for a period of time after the treatment as recommended in the Summary of Product Characteristics for ribavirin. Refer to the Summary of Product Characteristics for ribavirin for additional information.  
Use with moderate P-gp inducers: Medicinal products that are moderate P-gp inducers in the intestine (e.g. oxcarbazepine and modafinil) may decrease sofosbuvir plasma concentration leading to reduced therapeutic effect of Sofosbuvir. Co-administration of such medicinal products is not recommended with Sofosbuvir (see Interactions).
Renal impairment: The safety of Sofosbuvir has not been assessed in subjects with severe renal impairment (eGFR <30 mL/min/1.73 m²) or ESRD requiring haemodialysis. Furthermore, the appropriate dose has not been established. When Sofosbuvir is used in combination with ribavirin or peginterferon alfa/ribavirin, refer also to the Summary of Product Characteristics for ribavirin for patients with creatinine clearance (CrCI) <50 mL/min (see also Pharmacology: Pharmacokinetics under Actions).
HCV/HBV (hepatitis B virus) co-infection: There are no data on the use of Sofosbuvir in patients with HCV/HBV co-infection.
Effects on ability to drive and use machines: Sofosbuvir has moderate influence on the ability to drive and use machines. Patients should be informed that fatigue and disturbance in attention, dizziness and blurred vision have been reported during treatment with sofosbuvir in combination with peginterferon alfa and ribavirin (see Adverse Reactions).
Paediatric population: Sofosbuvir is not recommended for use in children and adolescents under 18 years of age because the safety and efficacy have not been established in this population.