Description of Velpanat
Velpanat is a combination medicine, contains an active ingredients like Sofosbuvir and Velpatasvir, both having anti-viral properties.
Velpanat is active against virus which is responsible for chronic hepatitis C viral infection.
Velpanat is a prescription medicine; it is used by the patient under the supervision of medical practitioner.
Sofosbuvir: HCV NS5B polymerase inhibitor
Velpatasvir: HCV NS5A inhibitor
Trade name: Velpanat
Active ingredients: Sofosbuvir and Velpatasvir
Strength of the drug: 400mg and 100mg respectively
Package: 28 tablets in a container
Pharmacology of Velpanat
Velpanat Mechanism of action:
Velpanat containing two ingredients which exhibits antiviral activity,
Sofosbuvir: a nonstructural protein 5B polymerase inhibitor, essential for viral multiplication.
Sofosbuvir is a prodrug (nucleotide analog), metabolized into active form called uridine analogue triphosphate (GS-461203)
The metabolite GS-461203 is integrated into hepatitis C virus RNA by NS5B polymerase and performed as a chain terminator.
Velpatasvir: NS5A protein is responsible for RNA replication and aggregation of HCV virions.
Velpatasvir is a NS5A inhibitor which interfere with the enzyme activity and eradicates the viral multiply
After oral administration of Velpanat tablet, absorption occurs very quickly.
The peak plasma concentration of the Sofosbuvir, Velpatasvir and GS-461203 (active metabolite) occurs within 1 hour, 3 hours and 3 hours respectively.
Effect of food:
The response rate of both Sofosbuvir and Velpatasvir are similar to each other while taking with or without food.
Sofosbuvir is bound to human plasma protein in the range of 61-65%
Velpatasvir is highly bound to plasma protein around >99.5%
The active metabolite GS-461203 has poor protein binding property
Sofosbuvir is largely metabolized in liver, converted to active analogue triphosphate GS-461203
Velpatasvir is eliminated greatly in unchanged form
80%, 14%, and 2.5% of the drug is eliminated through urine, faeces and exhaled air respectively.
The terminal half life of Tablet Velpanat is 15 hours.
Indication of Velpanat
Velpanat is primarily indicated for the patients who are suffered with chronic hepatitis C viral infection associated genotype I, II, III, IV, V or VI infection
There are two conditions like;
Without cirrhosis or with compensated cirrhosis
With decompensated cirrhosis with use of ribavirin
Dose & Dosage's of Velpanat
Velpanat Dosage and administration:
Velpanat is mainly recommended for adults, safety and efficacy of the drug has not been established for children.
Chronic hepatitis C virus (HCV) infection genotypes I, II, III, IV, V or VI
One tablet to be taken as a single dose
Velpanat should be taken with or without food
If patient without cirrhosis or compensated cirrhosis (child Pugh A) should take Velpanat for 12 weeks
If patient with decompensated cirrhosis (child Pugh B or C) should take Velpanat with ribavirin for 12 weeks
The dose of ribavirin recommended on the basis of weight of patient;
<75 kg: 1000mg/day twice daily
≥75 kg: 1200mg/day twice daily
The dosage of ribavirin should be decreased on the basis of hemoglobin and creatine clearance levels.
If patient missed the dose of Velpanat tablet, should be skipped and follow the next dose schedule
Do not take double dose
Side Effects of Velpanat
Velpanat Side effects:
Headache, fatigue, shortness of breath, chest pain
With decompensated cirrhosis
Fatigue, anemia, decreased hemoglobulin levels, nausea, headache, insomnia
1-10% of patients attain;
Lipase increase, rash, depression, increased creatine kinase, insomnia, asthenia
With decompensated cirrhosis;
Diarrhea, hemoglobin levels get depleted, rash, increased creatine kinase
Contraindication of Velpanat
Velpanat is contraindicated to the pregnant women or become pregnant and children
While taking Velpanat with ribavirin causes some defects to the unborn babies
Drug Interaction of Velpanat
Velpanat Drug interaction:
The potentially significant drug interaction occurs while concomitant with some medicines;
Acid reducing agents like Aluminium and magnesium hydroxide, H2 receptor antagonist like famotidine, proton pump inhibitors like Omeprazole these drugs are reduce the effect of concentration of Velpatasvir
Antiarrhythmic drug like amiodarone when co administered with Velpanat leads to life threatening condition like symptomatic bradycardia
While concomitant with digoxin, the effect of concentration of digoxin will get elevated
Anticancer drug like topotecan, co administration is not recommended because of elevation of effect of concentration of topotecan
Some list of medicines causes drug interactions like;
Carbamazepine, phenytoin, Phenobarbital, oxcarbazepine, rifampin, rifabutin, rifapentine, efavirenz, st. John’s wort, rosuvastatin and Atorvastatin.
Precaution of Velpanat
Care should be taking while using Velpanat with ribavirin, amiodarone causes;
Serious effects to unborn baby
Patient with liver and kidney disorders
Usage & Safety profile of Velpanat Pregnancy & Lactation
Pregnancy and lactation:
Generally, Velpanat is not prescribed for pregnant women and who become pregnant and children
Velpanat with ribavirin is contraindicated to pregnant women it may cause fetal death
In lactation, some metabolites are excreted in human milk it also cause some ill effects
Storage of Velpanat
Storage of Velpanat tablets:
Velpanat should be stored at room temperature.
Velpanat container should be keep away from moisture, heat, and light