HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
SOVALDI safely and effectively. See full prescribing information
for SOVALDI.
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
-------------------------------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. (1)
------------------------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: (2.1)
Patient Population Treatment Duration
Genotype 1 or 4
SOVALDI + peg-
interferon alfa + ribavirin
12 weeks
Genotype 2 SOVALDI + ribavirin 12 weeks
Genotype 3 SOVALDI + ribavirin 24 weeks
• HCV/HIV-1 co-infection: For patients with HCV/HIV-1 co-infection,
follow the dosage recommendations in the table above. (2.1)
• SOVALDI in combination with ribavirin for 24 weeks can be
considered for patients with genotype 1 infection who are
interferon ineligible. (2.1)
• 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. (2.1)
• A dosage recommendation cannot be made for patients with
severe renal impairment or end stage renal disease. (2.4, 8.6)
-----------------------DOSAGE FORMS AND STRENGTHS--------------------
Tablets: 400 mg. (3)
--------------------------------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. (4)
-------------------------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. (5.1, 6.2,7.1)
• Use with other drugs containing sofosbuvir is not recommended
(5.4)
--------------------------------ADVERSE REACTIONS-----------------------------
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. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Gilead
Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
---------------------------------DRUG INTERACTIONS-----------------------------
• Coadministration of amiodarone with SOVALDI in combination
with another DAA may result in serious symptomatic bradycardia.
(5.1, 6.2, 7.1)
• Drugs that are intestinal P-gp inducers (e.g., rifampin, St. John’s
wort) may alter the concentrations of sofosbuvir. (5.2, 7, 12.3)
• Consult the full prescribing information prior to use for potential
drug-drug interactions. (5.1, 5.2, 7, 12.3)
---------------------------USE IN SPECIFIC POPULATIONS--------------------
• Patients with HCV/HIV-1 co-infection: Safety and efficacy have
been studied. (14.4)
• Patients with hepatocellular carcinoma awaiting liver
transplantation: Safety and efficacy have been studied. (8.8)
See 17 for PATIENT COUNSELING INFORMATION and
FDA-approved patient labeling.
Revised: 08/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
2.2 Dosage Modification
2.3 Discontinuation of Dosing
2.4 Severe Renal Impairment and End Stage Renal Disease
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Serious Symptomatic Bradycardia When Coadministered
with Amiodarone and Another HCV Direct Acting Antiviral
5.2 Risk of Reduced Therapeutic Effect Due to Use with P-gp
Inducers
5.3 Risks Associated with Combination Treatment
5.4 Related Products Not Recommended
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Potentially Significant Drug Interactions
7.2 Drugs without Clinically Significant Interactions with
SOVALDI
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
8.8 Patients with Hepatocellular Carcinoma Awaiting Liver
Transplantation
8.9 Post-Liver Transplant Patients
8.10 Patients with Genotype 5 or 6 HCV Infection
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.4 Microbiology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
Reference ID: 3808716
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