EPCLUSA (sofosbuvir 400 mg/velpatasvir 100 mg, sofosbuvir 200 mg/velpatasvir 50 mg tablets) is indicated for the treatment of patients 6 years of age and older or weighing at least 17 kg with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis and in combination with ribavirin for those with decompensated cirrhosis.
Please see below for Important Safety Information for EPCLUSA.
BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV/HBV COINFECTED
PATIENTSTest all patients for evidence of current or prior hepatitis B
virus (HBV) infection before
initiating treatment with EPCLUSA. HBV reactivation has been reported in HCV/HBV coinfected patients
who were undergoing or had completed treatment with HCV direct-acting antivirals (DAAs) and were not
receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure,
and death. Cases have been reported in patients who are HBsAg positive, in patients with serologic
evidence of resolved HBV, and also in patients receiving certain immunosuppressant or
chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV DAAs may be
increased in patients taking these other agents. Monitor HCV/HBV coinfected patients for hepatitis
flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate
patient management for HBV infection as clinically indicated.
INDICATION
EPCLUSA (sofosbuvir 400 mg/velpatasvir 100 mg, 200 mg/50 mg tablets; 200 mg/50 mg, 150 mg/37.5 mg oral
pellets) is indicated for the treatment of patients 3 years of age and older with chronic hepatitis C
virus (HCV) genotype 1-6 infection without cirrhosis or with compensated cirrhosis and in combination with
ribavirin for those with decompensated cirrhosis.
Contraindications
If EPCLUSA is used in combination
with ribavirin (RBV), all
contraindications, warnings and
precautions, in particular pregnancy
avoidance, and adverse reactions to
RBV also apply. Refer to RBV
prescribing information.
Warnings and Precautions
Serious Symptomatic Bradycardia
When Coadministered with
Amiodarone: Amiodarone is not
recommended for use with EPCLUSA
due to the risk of symptomatic
bradycardia, particularly in patients
also taking beta blockers or with
underlying cardiac comorbidities and/or with advanced liver disease. A fatal
cardiac arrest was reported in a patient
taking amiodarone who was
coadministered a sofosbuvir-containing regimen. In patients without
alternative viable treatment options,
cardiac monitoring is recommended.
Patients should seek immediate
medical evaluation if they develop
signs or symptoms of bradycardia.
Risk of Reduced Therapeutic Effect
Due to Concomitant Use of EPCLUSA
with P-gp Inducers and/or Moderate
to Strong Inducers of CYP2B6,
CYP2C8 or CYP3A4: Rifampin, St.
John’s wort, and carbamazepine are
not recommended for use with
EPCLUSA as they may significantly
decrease sofosbuvir and/or velpatasvir
plasma concentrations.
Adverse Reactions
The most common adverse reactions (≥10%, all grades) with EPCLUSA in adults and pediatric patients 6
years of age and older were headache and fatigue; and when used with RBV in adults with decompensated
cirrhosis were fatigue, anemia, nausea, headache, insomnia, and diarrhea. The most common adverse
reactions (≥10%, grade 1 or 2) in pediatric patients less than 6 years of age were vomiting and spitting
up the drug.
Drug Interactions
Coadministration of EPCLUSA is not
recommended with topotecan due to
increased concentrations of topotecan.
Coadministration of EPCLUSA is not recommended with proton-pump
inhibitors, phenobarbital, phenytoin,
rifabutin, rifapentine, efavirenz, and
tipranavir/ritonavir due to decreased
concentrations of sofosbuvir and/or
velpatasvir.
Consult the full Prescribing Information for EPCLUSA for more information on potentially significant
drug interactions, including clinical comments.
BOXED WARNING: RISK OF HEPATITIS B VIRUS
REACTIVATION:IN
HCV/HBV COINFECTED PATIENTSTest all patients for evidence of current or prior hepatitis B virus
(HBV)...
infection before
initiating treatment with EPCLUSA. HBV reactivation has been reported in HCV/HBV coinfected patients
who were undergoing or had completed treatment with HCV direct-acting antivirals (DAAs) and were not
receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure,
and death. Cases have been reported in patients who are HBsAg positive, in patients with serologic
evidence of resolved HBV, and also in patients receiving certain immunosuppressant or
chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV DAAs may be
increased in patients taking these other agents. Monitor HCV/HBV coinfected patients for hepatitis
flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate
patient management for HBV infection as clinically indicated.
INDICATION
EPCLUSA (sofosbuvir 400 mg/velpatasvir 100 mg, 200 mg/50 mg tablets; 200 mg/50 mg, 150 mg/37.5 mg oral
pellets) is indicated for the treatment of patients 3 years of age and older with chronic hepatitis C
virus (HCV) genotype 1-6 infection without cirrhosis or with compensated cirrhosis and in combination with
ribavirin for those with decompensated cirrhosis.