VELASOF
Drug profile:
Trade name: Velasof
Composition: Sofosbuvir & Velpatasvir
Strength of the components: 400mg & 100mg
respectively
Manufacturer name: Hetero healthcare
Package: 28 tablets in a container
Classification: Anti-hepaciviral drug.
Drug Prescribing Information of Velasof tablets:
Patients suffered from compensated cirrhosis
or without cirrhosis.
Patients with decompensated with long-lasting
condition used in combination with ribavirin.
velasof 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
Velasof:
- A Velasof tablet containing
directly acting anti-viral agents such as sofosbuvir & Velpatasvir which
expels their actions by undergoing some mechanism includes;
- Sofosbuvir
(Velasof ) 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(Velasof tablet) 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.
Absorption:
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.
Distribution:
The human plasma protein bound to sofosbuvir(Velasof tablet) and Velpatasvir
(Velasof ) with
the range of 61 to 65% and >99.5% respectively.
Metabolism:
Sofosbuvir is
a substrate of P-gp transporter and breast cancer resistance protein.
Elimination:
The Velasof tablet 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.
Urine:
Sofosbuvir:
80%; Velpatasvir: 14%
Feces:
Sofosbuvir:
0.4%; Velpatasvir: 94%
When to take the Tablet Velasof:
To administer the Velasof frequently at the same time
every day, as a single dose.
If concomitant with ribavirin, Velasof tablet 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 Velasof .
Dosage Regimens of Velasof 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 Velasof tablet includes as;
Velasof tablet containing
fixed-dose combination drugs like 400mg of sofosbuvir and
100mg of Velpatasvir.
Recommended Velasof tablet 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 Velasof should
be administered as a single dose.
Patients with chronic cirrhosis or
decompensated (child B or C): Velasof tablet 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 Velasof tablet;
Nausea
Insomnia
Asthenia
Elevate lipase level
Depression
Headache
Fatigue
Anemia
Rash
Elevation of creatinine kinase
Life-threatening condition like severe
symptomatic bradycardia occurs while co-administration with amiodarone.
Drug Interaction of Velasof:
Velasof tablet combining
with HMG CoA reductase agents leads to increase the concentration of these
agents.
Velasof tablet concomitant
with acid-reducing agents causes the decrease in the effect of concentration
of Velpatasvir.
Velasof are
P-gp & BCRP drug transporters substrate while combining Velasof with
P-gp inducers causes depletion in plasma concentration of Velasof tablet leads to reduce the
curative effect.
Velasof 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 Velasof causes decreasing the
therapeutic effect of Velasof.
Possible Contraindications:
The anaphylactic reaction occurs while
patients are contraindicated to the components present in Velasof tablet.
Velasof while using
alone it is safe if it is combined with ribavirin which is contraindicated in
pregnant women.
Safety Measures:
Ribavirin with Velasof tablet in chronic condition
causes ill to pregnant women cause fetal harm.
Serious bradycardia occurs while combining
with amiodarone.
While taking Velasof some adverse effects occur,
to avoid these conditions some precautions should be taken.
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 Velasof tablet, while the
concomitant use of Velasof with
P-gp inducers.
Pregnancy and Lactation:
If Velasof tablet combined with
ribavirin, pregnancy category is X; causes fetal death.
Breastfeeding should not be recommended during
therapy.
Storage and Handling:
Keep the container away from moisture, heat,
and light.
Missed dose:
Velasof 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 Velasof tablet,
must get advice from the 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.
Overdosage:
No distinct antidote is applicable for
overdosing of Velasof tablet;
once the overdose occurs to confirm the presence of toxicity.
Treatment:
Check the crucial manifestations and give
adjuvant measures.
The Hemodialysis is another method used in an
overdose of Velasof tablet,
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.
CONTACT US
EMAIL ID : millionhealthpharmaceuticals@gmail.com
PHONE NO : +91-9940472902
PHONE NO : +91-9940472902
Comments
Post a Comment