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velasof

PRODUCT DETAILS

Brand Name : Velasof
Active components : Sofosbuvir & Velpatasvir
Strength of the components : 400mg & 100mg respectively
Package : 28 tablets in a container
Manufactured by: Hetero Drugs Ltd
Classified as: Anti-viral drugs

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Velasof is the fixed dose combination of these two most widely used anti-viral agents. Sofosbuvir & Velpatasvir are directly acting anti-viral agents which are involved in the treatment of chronic hepatitis C viral infection. Sofosbuvir is usually combined with other anti-viral agent for exhibiting the prominent effects. Velasof is the FDA approved product, which is used in chronic HCV condition. Velasof should be used in genotype I, II, III, IV, V or VI associated hepatitis C viral infections.

DOSAGE BEFORE THE TREATMENT

Examine the patients thoroughly, before initiating the treatment with HCV anti-viral agents. Care should be taken while using HCV medication in patients with HCV/HIV-1co infections, in this case HBV reactivation occurs. Velasof tablets are recommended for chronic condition of hepatitis C viral infection related to genotype 1, 2, 3, 4, 5 or 6. The dosing of Velasof; The usual recommended dose of Velasof is, one tablet should be administered orally as a single dose. Velasof tablet consist of 100mg of Velpatasvir & 400mg of Sofosbuvir

WORKS

Sofosbuvir is a NS5B protein inhibitor, protein is essential for viral production. Sofosbuvir is a prodrug form, which get converted into active uridine triphosphate form which is required for anti-viral activity. This dynamic active moiety is get inserted into HCV RNA with the help of NS5B polymerase and leads as chain eliminator. Velpatasvir is pharmacologically acts as NS5A inhibitor; this protein is required for HCV viral production. Velpatasvir is involved its action in viral production process.

PHARMACOKINETICS

The maximum plasma concentration of Velasof is; Sofosbuvir at 0.5 to 1 hour & Velpatasvir at 3 hours Food does not affect the absorption of Velasof The Velasof tablet is highly bound to human plasma protein is; Sofosbuvir 61 to 65% & Velpatasvir by >99.5%
The blood plasma ratio of;
Sofosbuvir 0.7 & Velpatasvir 0.52 to 0.67. The Velasof metabolism is majorly occurs in liver; sofosbuvir by cathepsin A or carboxyl esterase 1 & Velpatasvir by CYP2B6, CYP2C8 or CYP3A4.
Velasof excretion occurs via;
Sofosbuvir by urine (80%), feces (14%) & exhaled air (2.5%) & Velpatasvir by urine (88%) & feces (6.6%)
The half lives of Velasof;
Sofosbuvir 0.4 hour; GS-331007 27 hours & Velpatasvir 15 hours

Severe bradycardia

This adverse occurs by combination of Velasof with amiodarone, causes increased concentration of amiodarone leads to severe bradycardia. To overcome the problem by; Stop the combinational treatment ECG monitoring Start alternative medication for reducing the cardiac issues

Loss of activity occurs during concomitant use of Velasof with P-gp inducers

The concurrent use of Velasof with P-gp inducers causes loss of therapeutic activity of Velasof.

Embryo fetal damage due to combination of Velasof with ribavirin

Fetal damage condition is due to the concomitant use of Velasof with ribavirin during pregnancy period.

THERAPY DURATION

Patients suffered with compensated cirrhosis or without cirrhosis; One tablet of Velasof should be administered orally as once daily over period of 12 weeks. Patients suffered with decompensated cirrhosis; One Velasof tablet should be combined with weight based ribavirin by administering with food for 12 hours. The dose of ribavirin should be calculated for the patients; Patient with <75kg of body weight, the recommended dose of ribavirin is 1000mg administered as twice daily. Patient with at least 75kg of body weight, recommended dose of ribavirin is 1200mg administered as twice daily. For both renal & hepatic impaired patients; Velasof tablets dosage adjustment should not be recommended.

DRUG INTERACTION

Velasof tablets are combined with P-gp inducers either potent or moderate, causes loss of activity of Velasof by decreasing the sofosbuvir plasma concentration. Velasof tablets co administered with P-gp or BCRP inhibitors, leads to increase the exposure of adverse effects of these substrates. Velasof combined with warfarin causes variation in both prothrombin time & INR values. Velasof co administered with acid reducing agents causes decreasing the effect of concentration of sofosbuvir & Velpatasvir leads to loss of activity of Velasof. Velasof tablets combined with amiodarone leads to cause bradycardia. Velasof tablets co administered with anti-convulsants, or anti-mycobacterials, causes decreasing concentration of sofosbuvir & Velpatasvir. Velasof with st Johns wort causes losing the anti-viral activity of Velasof by decreasing the concentration of either sofosbuvir or Velpatasvir. Velasof combined with HMG CoA reductase inhibitors causes increasing the concentration of these drugs.

Warning should be provided to the patients receiving Velasof

The reoccurrence of HBV infection happens in patients who are co infected with HBV/HCV. This may prevented by; Examine the patients HBsAg & anti-HBc levels before initiating the therapy. Liver function test should be examine frequently The health management related to HBV infection should be started.

CONTRAINDICATION

Velasof is contraindicated to pregnancy condition due to concomitant use with ribavirin. Some anaphylactic reactions are acquired during the therapy, while the patients are contraindicated to the component of Velasof.

LACTATION

Breast feeding should not be suggested

PEDIATRIC

The safety & effectiveness of Velasof should not be evaluated for pediatric patients.

GERIATRIC

In geriatric patients, no dosage adjustment of Velasof should be recommended.

SIDE EFFECTS

Serious bradycardia occurs due to concomitant use of Velasof with amiodarone:
Fatigue, Nausea, Asthenia, Insomnia, Irritability, Headache.

Lab abnormalities

Lipase elevation, Increased creatine kinase, Increased bilirubin levels.

Post marketing effects

Cardiac disorders, Rashes, Angioedema.

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