Trade name: Myhep All
Composition: Sofosbuvir & Velpatasvir
Strength of the components: 400mg & 100mg respectively
Manufacturer name: Mylan
Package: 28 tablets in a container
Classification: Anti-hepaciviral drug.
Drug Prescribing Information of Myhep All tablets:
Myhep All is used in following conditions like;
Patients suffered from compensated cirrhosis or without cirrhosis.
Patients with decompensated with long-lasting condition used in combination with ribavirin.
Myhep All tablets are used in the conditions like hepatitis C viral infection in adolescents; HCV infection is caused by various genotypes like I, II, III, IV, V or VI.
Mechanism of Action of Myhep All:
A Myhep All tablet containing directly acting anti-viral agents such as sofosbuvir & Velpatasvir which expels their actions by undergoing some mechanism includes;
Sofosbuvir is an inhibitor of HCV NS5B RNA dependent RNA polymerase, an enzyme essential for viral production. Hence this inhibition causes depletion in viral proliferation.
Velpatasvir is an inhibitor of HCV NS5A is a pan genotype, NS5A is a protein required for HCV viral replication thus the inhibition leads to reduce the production of HCV virus in the human body.
If gastric pH level increases lead to cause depletes insolubility of Velpatasvir.
The peak concentration time of both sofosbuvir and Velpatasvir occurs within 0.5 to 1 hour and 3 hours respectively.
The peak plasma concentration of sofosbuvir and Velpatasvir exist in 567ng/ml & 259ng/ml respectively.
The human plasma protein bound to sofosbuvir and Velpatasvir with the range of 61 to 65% and >99.5% respectively.
Sofosbuvir is metabolized hepatically, with the help of cathepsin A, CES1 & HINT1.
Sofosbuvir is a substrate of P-gp transporter and breast cancer resistance protein.
Velpatasvir is partially metabolized and it is excreted as an unchanged form.
The mean terminal half-life period of both sofosbuvir and Velpatasvir and the circulating metabolite called GS-331007 are reaching at 0.5 hours, 15 hours, & 27 hours respectively.
The main routes of excretion of all the components like;
Sofosbuvir by metabolism; Velpatasvir through bile in unchanged form & GS-331007 through glomerular filtration and active tubular secretion.
Sofosbuvir: 80%; Velpatasvir: 14%
Sofosbuvir: 0.4%; Velpatasvir: 94%
When to take the Tablet Myhep All:
Myhep All tablets should be taken with or without food.
To administer the Myhep All tablets frequently at the same time every day, as a single dose.
If concomitant with ribavirin, Myhep All must be taken with food.
Gastric pH increasing drugs causes depletion in effect of serum concentration of Velpatasvir, to avoid these complications consume the antacids, H2 antagonist and proton pump inhibitors before the dose of Myhep All.
Dosage Regimens of Myhep All tablets:
Before initiating the therapy, patients should be examined by counting the hepatitis B surface antigen and hepatitis B core antibody (HBsAg & Anti-HBc) to prevent the problem like reactivation of HBV infection.
The prescribed dosage of Myhep All tablets includes as;
Myhep All containing fixed-dose combination drugs like 400mg of sofosbuvir and 100mg of Velpatasvir.
Recommended Myhep All tablets in patients with chronic HCV infection related to genotypes like I, II, III, IV, V or VI.
Patients with child Pugh A: one tablet of Myhep All should be administered as a single dose.
Patients with chronic cirrhosis or decompensated (child B or C): Myhep All tablets should be combined with ribavirin.
The ribavirin dosage should be administered on the basis of the weight of the patients.
Less than 75kg: 1000mg per day; at least75kg: 1200mg per day.
No dosage adjustment is required for renal impaired patients.
Drug Called side effects:
Some effects may occur during the therapy of Myhep All tablets;
Elevate lipase level
Elevation of creatinine kinase
Life-threatening condition like severe symptomatic bradycardia occur while co-administration with amiodarone
Drug Interaction of Myhep All:
Myhep All tablet combining with HMG CoA reductase agents leads to increase the concentration of these agents.
Myhep All tablets are P-gp & BCRP drug transporters substrate while combining Myhep All with P-gp inducers causes depletion in plasma concentration of Myhep All tablet leads to reduce the curative effect.
Myhep All tablet concurrently used with anti-mycobacterials causes depletion of Myhep All tablet.
Myhep All with amiodarone causes serious bradycardia.
Myhep All tablet concomitant with acid-reducing agents, causes the decrease in the effect of concentration of Velpatasvir.
Myhep All tablet combined with digoxin causes increasing the serum concentration of digoxin.
Myhep All tablet with anticonvulsants causes depletion of the effect of concentration of Myhep All tablet.
Myhep All tablet combined with HIV anti-retroviral agents leads to cause decrease the serum concentration of Velpatasvir.
Food -Drug Interactions:
No food-drug interaction occurs, an herbal product like st. Johns wort combining with Myhep All causes decreasing the therapeutic effect of Myhep All.
The anaphylactic reaction occurs while patients have contraindicated to the components present in Myhep All tablet.
Myhep All tablets while using alone it is safe if it is combined with ribavirin which is contraindicated to pregnant women.
Ribavirin with Myhep All tablets in chronic condition causes ill to pregnant women cause fetal harm.
Care should be taken in renal and hepatic impaired patients.
After completion of therapy, reactivation of HBV infection occurs in the patients who are co-infected with HCV/HBV infections, to avoid these conditions investigate the patient by measuring HBsAg and anti-HBc.
Reduction in the therapeutic effect of Myhep All, while the concomitant use of Myhep All with P-gp inducers.
Serious bradycardia occurs while combining with amiodarone.
While taking Myhep All tablet some adverse effects occur, to avoid these conditions some precautions should be taken.
Pregnancy and Lactation:
Myhep All used alone then its pregnancy category comes under B1; safe to use.
If Myhep All combined with ribavirin, pregnancy category is X; causes fetal death.
Breastfeeding should not be recommended during therapy.
Storage and Handling:
Myhep All tablets container should be stored at room temperature below 30oC.
Keep the container away from moisture, heat, and light.
Myhep All is not a normal drug, it is prescription medicine used only by the patients who are all having a valid prescription.
If the patient fails to take the dose of Myhep All tablet, must get advice from a physician and take the medicine within the time because it is single dose therapy.
Otherwise, the missed dose should be skipped and follow the regular dosing schedule.
No distinct antidote is applicable for overdosing of Myhep All tablets; once the overdose occurs to confirm the presence of toxicity.
Check the crucial manifestations and give adjuvant measures.
The Hemodialysis is the alternative procedure used in the overdose of Myhep All tablets, can efficiently dispose of the dominant circulating metabolite of sofosbuvir, GS-331007 with eradicating ration of 53%.
Hence Velpatasvir is highly bound to the human plasma protein; it is not cleared by hemodialysis and gives incredible results.