Sofosbuvir -Sovaldi-@-(Dec 2013)- Anti-Viral
Drug Name:Sofosbuvir -Sovaldi-@-(Dec 2013)- Anti-Viral
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Interaction with Food
Pregnancy and lactation
Drug Interaction:
Coadministration of amiodarone with SOVALDI in combination with another
DAA may result in serious symptomatic bradycardia.
Drugs that are intestinal P-gp inducers (e.g., rifampin, St. John’s wort)
may alter the concentrations of sofosbuvir.
Indication:
SOVALDI® (sofosbuvir) tablets, for oral use
Initial U.S. Approval: 2013
RECENT MAJOR CHANGES
Indications and Usage (1) 08/2015
Dosage and Administration (2.1, 2.2) 08/2015
Contraindications (4) 08/2015
Warnings and Precautions (5.1) 03/2015
Warnings and Precautions (5.2, 5.3, 5.4) 08/2015
Drug Name- Sovaldi
Active Ingredient - Sofosbuvir
To treat chronic hepatitis C virus (HCV) infection
Indication-
To treat Chronic Hepatitis C virus (HCV) Infection
Approved by FDA on 06-12--2013 (Ref- FDA approved List- 2013)
Indication-
With ribavirin (with or without peginterferon alfa) for the treatment of
Chronic Hepatitis C
LIST OF APPROVED DRUG FROM 01-01-2015 To 31-12-2015
ISSUED BY NEW DRUG DIVISION - DRUG CONTROLLER GENERAL- INDIA
Sr.No Name of Drug Indication Date of Issue
1. Sofasbuvir Tablet 400mg 13-01-2015
100/150mg
In combination woth other medicinal products for the
treatment of chronic Hepatitis C (CHC) in adults
Approved by DCG INDIA (Ref- DCGI approved List- 01-01-2015 To 31-12-3015)
Adverse Reaction:
The most common adverse events (incidence greater than or equal
to 20%, all grades) observed with SOVALDI in combination with ribavirin
were fatigue and headache. The most common adverse events observed
with SOVALDI in combination with peginterferon alfa and ribavirin were
fatigue, headache, nausea, insomnia and anemia.
Contra-Indications:
CONTRAINDICATIONS
When used in combination with peginterferon alfa/ribavirin or ribavirin alone,
all contraindications to peginterferon alfa and/or ribavirin also apply
to SOVALDI combination therapy.
WARNINGS AND PRECAUTIONS
Bradycardia with amiodarone coadministration: Serious symptomatic
bradycardia may occur in patients taking amiodarone and SOVALDI in
combination with another direct acting antiviral (DAA), particularly in patients
also receiving beta blockers, or those with underlying cardiac comorbidities
and/or advanced liver disease. Coadministration of amiodarone with
SOVALDI in combination with another DAA is not recommended. In patients
without alternative, viable treatment options, cardiac monitoring
is recommended.
Use with other drugs containing sofosbuvir is not recommended
Dosages/ Overdosage Etc:
Indication-
With ribavirin (with or without peginterferon alfa) for the treatment of
Chronic Hepatitis C
Dosage-
400mg once daily with food. Continue for upto 24 weeks
INDICATIONS AND USAGE
SOVALDI is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase
inhibitor indicated for the treatment of genotype 1, 2, 3 or 4 chronic
hepatitis C virus (HCV) infection as a component of a combination
antiviral treatment regimen.
DOSAGE AND ADMINISTRATION
One 400 mg tablet taken once daily with or without food. (2.1)
Should be used in combination with ribavirin or in combination with pegylated
interferon and ribavirin for the treatment of HCV.
Recommended combination therapy:
HCV/HIV-1 co-infection: For patients with HCV/HIV-1 co-infection,
follow the dosage recommendations in the table above.
SOVALDI in combination with ribavirin for 24 weeks can be considered for patients
with genotype 1 infection who are interferon ineligible.
Should be used in combination with ribavirin for treatment of HCV in patients
with hepatocellular carcinoma awaiting liver transplantation for up to 48 weeks
or until liver transplantation, whichever occurs first.
A dosage recommendation cannot be made for patients with severe renal
impairment or end stage renal disease.
DOSAGE FORMS AND STRENGTHS
Tablets: 400 mg.
Patient Information:
PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Serious Symptomatic Bradycardia
When Coadministered with Amiodarone and Another HCV Direct Acting Antiviral
Advise patients to seek medical evaluation immediately for symptoms of
bradycardia such as near-fainting or fainting, dizziness or lightheadedness,
malaise, weakness, excessive tiredness, shortness of breath, chest pain,
confusion or memory problems
Pregnancy
Advise patients to avoid pregnancy during combination treatment with SOVALDI
and ribavirin or SOVALDI and peginterferon and ribavirin. Inform patients
to notify their health care provider immediately in the event of a pregnancy
Drug Interactions
Advise patients that SOVALDI may interact with some drugs; therefore, patients
should be advised to report the use of any prescription, non-prescription
medication or herbal products to their healthcare provider
.
Hepatitis C Virus Transmission
Inform patients that the effect of treatment of hepatitis C infection on transmission
is not known, and that appropriate precautions to prevent transmission
of the hepatitis C virus during treatment or in the event of treatment failure
should be taken.
Important Information on Co-Administration with Ribavirin or Peginterferon and Ribavirin
Advise patients that the recommended regimen for patients with genotype 1 or 4 HCV
infection is SOVALDI administered in combination with peginterferon alfa and ribavirin
and the recommended regimen for patients with genotype 2 or 3 HCV infection is
SOVALDI administered in combination with ribavirin. If peginterferon and/or ribavirin are
permanently discontinued, SOVALDI should also be discontinued.
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
Sofosbuvir is a direct-acting antiviral agent against the hepatitis C virus
2. Pharmacokinetics
Absorption
The pharmacokinetic properties of sofosbuvir and the predominant circulating
metabolite GS-331007 have been evaluated in healthy adult subjects and in
subjects with chronic hepatitis C.
Relative to healthy subjects administered sofosbuvir alone (N=272), the sofosbuvir
AUC0-24 was 60% higher; and GS-331007 AUC0-24 was 39% lower, respectively,
in HCV-infected subjects. Sofosbuvir and GS-331007 AUCs are near dose
proportional over the dose range of 200 mg to 1200 mg
Interaction with Food:
To be taken with food
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1 Pregnancy
Pregnancy Category B:
There are no adequate and well-controlled studies with SOVALDI in pregnant women.
Because animal reproduction studies are not always predictive of human response,
SOVALDI should be used during pregnancy only if the potential for benefit justifies
the potential risk to the fetus
2. Nursing Mothers
It is not known whether SOVALDI and its metabolites are present in human breast milk.
If SOVALDI is administered in a regimen containing ribavirin, the information for ribavirin
with regard to nursing mothers also applies to this combination regimen.
Refer to the ribavirin prescribing information for more information on use in nursing
mothers.
3.Pediatric Use
Safety and effectiveness of SOVALDI in children less than 18 years of age have not
been established.
4. Geriatric Use
SOVALDI was administered to 90 subjects aged 65 and over. The response rates
observed for subjects over 65 years of age were similar to that of younger subjects
across treatment groups. No dosage adjustment of SOVALDI is warranted in geriatric
patients
