Velpanat

Velpanat is an anti-hepatitis C viral medicine, containing active components known as Sofosbuvir and Velpatasvir available in the strength of 400mg & 100mg respectively. Velpatasvir is a class of anti-hepatitis C viral drug, called NS5A multiplication complex inhibitors. This may have combined with other anti-viral agent Sofosbuvir which expels its work by stopping the virus which may causes hepatitis C viral infection from spreading inside the body. Velpanat tablet is not a curable; it is only used to control the spreading of disease.

Sofosbuvir & Velpatasvir

Velpanat

400mg & 100mg

Natco




Velpanat indication and usage

Velpanat tablets are used only in adult’s patients with long lasting hepatitis C virus caused by genotypes I, II, III, IV, V or VI In two conditions Velpanat tablets are used;

Without cirrhosis or with compensated cirrhosis (child Pugh A or B) With decompensated cirrhosis by combining with ribavirin (child Pugh C)

Velpanat mechanism of action

Both the components in Velpanat tablets are involved in inhibiting nonstructural protein which is essential for viral multiplication. Sofosbuvir is a NS5B inhibitor, whereas Velpatasvir is considered as NS5Ainhibitor Velpanat is a directly acting anti-hepatitis C viral agent.

Sofosbuvir leads to produce pharmacologically active uridine analog triphosphate by intracellular metabolism. Sofosbuvir is inserted into viral HCV DNA by NS5B polymerase and act as a chain terminator. Velpatasvir inhibits NS5A protein which is responsible for viral assembly.



The peak plasma concentration time of Sofosbuvir and Velpatasvir is 0.5 to 1 hour and 3 hours respectively. The effect of food with Velpanat tablet determines as; With moderate meal: Sofosbuvir increases to 60%; increases to 34% With high fat meal: Sofosbuvir increases to 78%; increases to 21% The blood plasma ratio of Sofosbuvir & Velpatasvir is 0.7 & 0.52 to 0.67 respectively

The human plasma protein bound; Sofosbuvir & Velpatasvir is 61 to 65% &>99.5% respectively. The metabolism of Sovihep occurs; Sofosbuvir: cathepsin A, or carboxyl esterase Velpatasvir: CYP2B6, CYP2C8 or CYP3A4

The elimination of Velpanat occurs via; Sofosbuvir: Glomerular filtration, active tubular secretion Velpatasvir: biliary excretion The terminal half-life of Velpanat tablets; Sofosbuvir: 0.5 hours; GS331007: 25 hours & Velpatasvir 15 hours Elimination of Sofosbuvir in urine at 80%; feces at 14% Elimination of Velpatasvir in urine 0.4%; feces at 94%





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Velpanat
Brand Velpanat
Ingredients Sofosbuvir & Velpatasvir
Strength 400mg & 100mg
Manufactured Natco
Rating

Before initiation of therapy

Before starting the therapy, patient should be examined by counting hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) for confirmation of HBV infection. The usual recommended dosage of Velpanat tablet is one tablet should be administered as a single dose, by taking with or without food.

In new patients or experienced patients with or without cirrhosis

The prescribed dosage of Velpanat in this condition is one tablet should be taken as a single dose.

In new or already treated patients with decompensated cirrhosis

The prescribed dosage of Velpanat in this condition is one tablet to be taken as a single dose by combining with ribavirin.

The dosage of ribavirin

Based on body weight of the patients, the dosage of ribavirin should be recommended. Less than 75kg: 1000mg of ribavirin should be recommended At least 75kg: 1200mg of ribavirin should be recommended Ribavirin must be administered with food. Dosage adjustment should not be recommended in renal and hepatic impairment patients.

Over dosage

The over dosage of Velpanat tablets; If it occurs manage with supportive measures, and hemodialysis should be recommended for eliminating the components of Velpanat and its metabolite. Sofosbuvir is removed with the coefficient of 53%; Velpatasvir is highly bounds to human plasma protein and it is difficult to eliminate.

Velpanat causes undesirable effects

Headache, Fatigue, Nausea, Asthenia, Insomnia, Anemia, HBV reactivation, Elevation of lipase & amylase levels, Elevation of creatine kinase, Cardiac disorder like bradycardia while concomitant with amiodarone, Angioedema, Skin rashes

Velpanat precautions

Exposure of hepatitis B viral infection occurs in HBV/HCV co infections Serious symptomatic bradycardia while concomitant with amiodarone Risk of depletion of therapeutic effect occurs due to combination of Velpanat with P-gp inducers or CYP3A4 inducers.

Fetal adverse occurs while concomitant with ribavirin For all these conditions, withhold or discontinue the therapy with Velpanat tablets.

Velpanat drug interactions

  • P-gp or BCRP inducers combination with Velpanat causes depletion of plasma concentration of Velpanat leads to decreasing the therapeutic effect of Velpanat.
  • P-gp or BCRP inhibitors concurrent use with Velpanat tablets leads to increase the exposure of these drugs.
  • Variation in INR values occurs, while concomitant with warfarin.
  • Velpanat is concurrently used with gastric regulators, causes decreasing the plasma concentration of Velpatasvir.
  • Velpanat combined with amiodarone cause severe life threatening cardiac effects like bradycardia.
  • Velpanat combined with digoxin, causes increases effect of concentration of digoxin.
  • Velpanat tablets combined with anti-convulsants causes’ decrease in plasma concentration of Velpanat
  • Velpanat tablets with herbal product like st.Johns wort causes decreasing the effect of Velpatasvir.
  • Velpanat tablets combined with HMG CoA reductase inhibitors causes increasing the effedt of concentration of these drugs.


Velpanat contraindicated to


Velpanat is contraindicated to patients who are taking in combination with ribavirin.

Ribavirin is contraindicated to pregnancy condition.

Velpanat uses in specific condition

Pregnancy category of Velpanat : B Pregnancy category of Velpanat & ribavirin: X Ribavirin is not recommended for pregnancy condition. While concomitant with ribavirin, breast feeding should not be suggested.

The potency of Velpanat tablet has not been established in pediatric patients Renal & hepatic impairment patients: The safety of Velpanat tablets has not been established.

Velpanat tablet to be kept at the temperature below 30°C Protect the container away from moisture, heat and light.

If Velpanat dose is forgot to take, must consult with medical practitioner and follow the instruction. On the other hand, the missed dose should be skipped and follow the regular dosing schedule.




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