Sofosbuvir + ledipasvir

Generic Medicine Info
Hypersensitivity. Lactation. Concomitant use of potent P-glycoprotein (P-gp) inducers and rosuvastatin.
Special Precautions
Patient with hepatitis B virus (HBV) co-infection; decompensated cirrhosis and/or who are awaiting liver transplant or post-liver transplant, and those at high risk of bradyarrhythmia. Children. Pregnancy. Patient Counselling This drug may cause fatigue, if affected, do not drive or operate machinery. Monitoring Parameters Screen for current or previous hepatitis B infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis core antibody (anti-HBc) prior to initiation. Monitor bilirubin, liver enzymes, and serum creatinine at baseline and periodically; serum HCV-RNA at baseline, during and after treatment, and when clinically indicated. Monitor for signs of hepatitis flare or HBV reactivation.
Adverse Reactions
Gastrointestinal disorders: Nausea, diarrhoea. General disorders and administration site conditions: Fatigue, weakness, irritability. Immune system disorders: Rarely, angioedema. Investigations: Increased serum lipase, bilirubin, creatine phosphokinase. Nervous system disorders: Headache, dizziness. Psychiatric disorders: Insomnia, depression. Respiratory, thoracic and mediastinal disorders: Cough, dyspnoea. Skin and subcutaneous tissue disorders: Rash.
Potentially Fatal: Hepatitis B virus reactivation, resulting in fulminant hepatitis or hepatic failure (in patients with HBV co-infection).
Drug Interactions
Reduced plasma concentration with moderate P-gp inducers (e.g. oxcarbazepine). May increase tenofovir exposure. Reduced efficacy with antacids (Al and Mg hydroxide). May increase the serum concentration of digoxin. Reduced anticoagulant effect of vitamin K antagonists.
CIMS Class
ATC Classification
J05AP08 - sofosbuvir ; Belongs to the class of antivirals for treatment of HCV infections. Used in the treatment of hepatitis C viral infections.
Disclaimer: This information is independently developed by CIMS based on sofosbuvir + ledipasvir from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by
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