Genix Pharma Private Limited
Velso 100Mg/400Mg Tablets
Velso 100Mg/400Mg Tablets
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SPECIFICATION
Requires Prescription (YES/NO)
Yes
Generics
Sofosbuvir + Velpatasvir
Used For
Hepatitis
How it works
Sofosbuvir: Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication. Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator. Velpatasvir: Velpatasvir is a HCV inhibitor targeting the HCV NS5A protein, which is essential for both RNA replication and the assembly of HCV virions. Resistance selection in cell culture and cross-resistance studies indicate velpatasvir targets NS5A as its mode of action.
USAGE AND SAFETY
Dosage
Sofosbuvir + Velpatasvir
Side Effects
The most common adverse reactions (incidence greater than or equal to 10%, all grades) observed with treatment with sofosbuvir + velpatasvir for 12 weeks are headache, fatigue, nausea, nasopharyngitis, insomnia, diarrhea, asthenia, cough, back pain and arthralgia.
Drug Interactions
Antacids (e.g., aluminum and magnesium hydroxide) , H2 - receptor antagonists (e.g., famotidine) , Proton-pump inhibitors (e.g., omeprazole) , amiodarone , Digoxin , topotecan , carbamazepine , phenytoin , phenobarbital , oxcarbazepine , rifabutin rifampin , rifapentine , Efavirenz , Tipranavir / ritonavir , St. John’s wort (Hypericum perforatum) , rosuvastatin , atorvastatin.
Indication
Sofosbuvir + Velpatasvir is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6: - Without cirrhosis or with compensated cirrhosis. - With decompensated cirrhosis for use in combination with ribavirin .
When not to Use
Sofosbuvir + velpatasvir is contraindicated in patients with known hypersensitivity to sofosbuvir or to velpatasvir or to any excipient of the product. - Sofosbuvir + velpatasvir and ribavirin combination regimen is contraindicated in patients for whom ribavirin is contraindicated. - Sofosbuvir + velpatasvir should not be administered concurrently with other medicinal products containing any of the same active components.
PRECAUTIONS
Precaution
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. Co-administration of amiodarone with sofosbuvir + velpatasvir is not recommended. In patients without alternative viable treatment options, cardiac monitoring is recommended.
WARNINGS
Warning 1
Test all patients for evidence of current or prior HBV infection by measuring HBsAg and anti-HBc before initiating HCV treatment with sofosbuvir + velpatasvir. In patients with serologic evidence of HBV infection, monitor for clinical and laboratory signs of hepatitis flare or HBV reactivation during HCV treatment with sofosbuvir + velpatasvir and during post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
Warning 2
If sofosbuvir + velpatasvir is administered with ribavirin, the warnings and precautions for ribavirin apply to this combination regimen.
Warning 3
Direct acting anti-viral have been associated with hepatitis B virus (HBV) reactivation in patients who have a current or previous infection with HBV and are treated with certain Direct-Acting Antiviral (DAA) medicines for hepatitis C virus. Health Care Professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with DAAs and monitor patients through blood tests for HBV flare-ups or reactivation during treatment and post-treatment follow-up .
ADDITIONAL INFORMATION
Pregnancy category
Always consult your physician before using any medicine.
Storage (YES/NO)
Store this medicine at room temperature, away from direct light and heat.
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