Sovir Plus

Sovir Plus Special Precautions

sofosbuvir + ledipasvir

Manufacturer:

Zifam Pinnacle

Distributor:

Pinnacle House
Full Prescribing Info
Special Precautions
Risk of Hepatitis B Virus Reactivation: Test all patients for evidence of current or prior HBV infection before initiation of HCV treatment. Monitor HCV/HBV coinfected patients for HBV reactivation and hepatitis flare during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
Bradycardia with amiodarone coadministration: Serious symptomatic bradycardia may occur in patients taking amiodarone, particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease.
Coadministration of amiodarone with ZIFAM SOVIR PLUS is not recommended. In patients without alternative, viable treatment options, cardiac monitoring is recommended.
Concomitant use of ZIFAM SOVIR PLUS and P-gp inducers (e.g., rifampin, St. John's wort) may significantly decrease ledipasvir and sofosbuvir plasma concentrations and may lead to a reduced therapeutic effect of ZIFAM SOVIR PLUS.
If ZIFAM SOVIR PLUS is administered with ribavirin regimen should be avoided in pregnancy.
Use in pregnancy: There are no adequate and well-controlled studies with ZIFAM SOVIR PLUS in pregnant women. Because animal reproduction studies are not always predictive of human response, ZIFAM SOVIR PLUS should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
If ZIFAM SOVIR PLUS is used in combination with ribavirin or peginterferon alfa/ribavirin, extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Women of childbearing potential and their male partners must use two forms of effective contraception during treatment and for a period of time after the treatment has concluded. As a precautionary measure, it is preferable to avoid the use of ZIFAM SOVIR PLUS during pregnancy.
Use in lactation: The development and health benefits of breastfeeding should be considered along with the mother's clinical need for ZIFAM SOVIR PLUS and any potential adverse effects on the breastfed child from ZIFAM SOVIR PLUS or from the underlying maternal condition.
Paediatric population: ZIFAM SOVIR PLUS is not recommended for use in paediatric patients aged < 12 years because the safety and efficacy have not been established in this population.
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