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Generic Name
Sofosbuvir
Brand Names
Epclusa, Harvoni, Ledipasvir, Sovaldi, Vosevi
FDA approval date: December 06, 2013
Classification: Hepatitis C Virus NS5A Inhibitor
Form: Pellet, Tablet
What is Epclusa (Sofosbuvir)?
EPCLUSA is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection [see Dosage and Administration.
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Related Clinical Trials
MINMON-J: An Effectiveness Implementation Pilot Study Evaluating a Low-barrier Hepatitis C Treatment Model in a Jail Setting
Summary: The goal of this clinical trial is to learn whether a low-barrier treatment program can help people with hepatitis C virus (HCV) who are in jail start and complete treatment more easily. This study focuses on adults at the Rhode Island Department of Corrections who have active HCV and are awaiting trial. The study asks: * Can a simplified, low-barrier HCV treatment program work in a jail setting? ...
Transplant of Redeemed Organs by Judicious Administration of New Direct-Acting Antivirals for Hepatitis-C Heart Recipients
Summary: This phase II, multi-center, open-label study will evaluate the safety and efficacy of utilizing HCV-positive donors for heart transplant in HCV-negative recipients treated with sofosbuvir 400 mg / velpatasvir 100 mg (Epclusa®).
Simplifying Hepatitis C Pathways for People Who Inject Drugs in Armenia, Georgia, and Tanzania (CUTTS HepC): a Non-randomised, Quasiexperimental, Prospective Comparative Trial
Summary: The goal of this non-randomised, quasi-experimental, prospective comparative trial is to trial simplified care pathways for hepatitis C testing and treatment for people who inject drugs in Armenia, Georgia, and Tanzania. The main questions it aims to answer are: 1. What is the feasibility of implementing a hepatitis C simplified care and same-day treatment care model in community and harm reductio...
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Brand Information
Epclusa (Velpatasvir and Sofosbuvir)
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV
Test 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 and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. 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
1INDICATIONS AND USAGE
EPCLUSA is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection
- without cirrhosis or with compensated cirrhosis
- with decompensated cirrhosis for use in combination with ribavirin.
2DOSAGE FORMS AND STRENGTHS
EPCLUSA is available as tablets or pellets for oral use. Each dosage form is available in two dose strengths:
- 400 mg/100 mg Tablets: pink, diamond-shaped, film-coated tablet debossed with "GSI" on one side and "7916" on the other side. Each tablet contains 400 mg of sofosbuvir and 100 mg of velpatasvir.
- 200 mg/50 mg Tablets: pink, oval-shaped, film-coated tablet debossed with "GSI" on one side and "S/V" on the other side. Each tablet contains 200 mg of sofosbuvir and 50 mg of velpatasvir.
- 200 mg/50 mg Oral Pellets: white to off-white, film-coated pellets in unit-dose packets. Each packet contains 200 mg of sofosbuvir and 50 mg of velpatasvir.
- 150 mg/37.5 mg Oral Pellets: white to off-white, film-coated pellets in unit-dose packets. Each packet contains 150 mg of sofosbuvir and 37.5 mg of velpatasvir.
3CONTRAINDICATIONS
EPCLUSA and ribavirin combination regimen is contraindicated in patients for whom ribavirin is contraindicated. Refer to the ribavirin prescribing information for a list of contraindications for ribavirin
4ADVERSE REACTIONS
The following serious adverse reactions are described below and elsewhere in labeling:
- Serious Symptomatic Bradycardia When Coadministered with Amiodarone
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
If EPCLUSA is administered with ribavirin, refer to the prescribing information for ribavirin for a description of ribavirin-associated adverse reactions.
4.2Postmarketing Experience
The following adverse reactions have been identified during post approval use of sofosbuvir. Because postmarketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
5OVERDOSAGE
No specific antidote is available for overdose with EPCLUSA. If overdose occurs the patient must be monitored for evidence of toxicity. Treatment of overdose with EPCLUSA consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient. Hemodialysis can efficiently remove the predominant circulating metabolite of sofosbuvir, GS-331007, with an extraction ratio of 53%. Hemodialysis is unlikely to result in significant removal of velpatasvir since velpatasvir is highly bound to plasma protein.
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
7INSTRUCTIONS FOR USE EPCLUSA®(ep-KLOO-suh) (sofosbuvir and velpatasvir) pellets, for oral use
Read the Patient Information that comes with EPCLUSA oral pellets for important information about EPCLUSA.
This Instructions for Use contains information on how to take EPCLUSA oral pellets. Be sure you understand and follow the instructions. If you have any questions, ask your healthcare provider or pharmacist.
Important Information You Need to Know Before Taking EPCLUSA oral pellets
- For oral use only (take by mouth with or without food).
- Pellets should be swallowed whole.
- Do not open the EPCLUSA oral pellet packet(s) until ready to use.
- For children younger than 6 years, take EPCLUSA oral pellets with food.
- EPCLUSA oral pellets are white to off-white pellets supplied as single-use packets in cartons. Each carton contains 28 packets.
- Do not use EPCLUSA oral pellets if the carton tamper-evident seal or the packet has been opened or damaged.
Gather Supplies:
Before you prepare a dose of EPCLUSA oral pellets, gather the following supplies:
- Daily EPCLUSA oral pellet packet(s), as prescribed by your healthcare provider
- Scissors (optional)
If taking EPCLUSA oral pellets with food, gather the following additional supplies:
- One or more spoonfuls of non-acidic soft food such as pudding, chocolate syrup, or ice cream
- Bowl
- Spoon
Prepare and Administer a Dose:
Step 5:
- If taking EPCLUSA oral pellets with food, carefully pour the entire contents of the prescribed number of EPCLUSA oral pellet packet(s) onto the food in the bowl and gently mix with a spoon (see Figure F). Take the EPCLUSA oral pellets and food mixture within 15 minutes without chewing to avoid a bitter taste.
- If taking EPCLUSA oral pellets by mouth, pour the entire contents of the prescribed number of EPCLUSA oral pellet packet(s) directly in the mouth and swallow without chewing to avoid a bitter taste (see Figure G). Water may be taken after swallowing the pellets, if needed.
Step 6: Make sure all of the EPCLUSA oral pellets are taken. Make sure that no EPCLUSA oral pellets remain in the packet(s) or in the food.
Storing EPCLUSA oral pellets
- Store EPCLUSA pellets below 86°F (30°C).
- Keep EPCLUSA oral pellets and all medicines out of the reach of children.
Disposing of EPCLUSA oral pellets
- Throw away (dispose of) any unused portion. Do not store and reuse any leftover EPCLUSA oral pellets or EPCLUSA mixture (oral pellets mixed with food).
For more information, call 1-800-445-3235 or go to www.EPCLUSA.com.
Manufactured for and distributed by: Gilead Sciences, Inc., Foster City, CA 94404
© 2022 Gilead Sciences, Inc. All rights reserved.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
8PRINCIPAL DISPLAY PANEL - 400 mg/100 mg Tablet Bottle Label
NDC 61958-2201-1
Epclusa
Take 1 tablet once daily
Note to pharmacist:
ALERT: Find out about medicines that
9PRINCIPAL DISPLAY PANEL - 200 mg/50 mg Tablet Bottle Label
NDC 61958-2203-1
Epclusa
200 mg/50 mg
Note to pharmacist:
ALERT: Find out about medicines that
10PRINCIPAL DISPLAY PANEL - 200 mg/50 mg Packet Carton
NDC 61958-2204-1
Rx only
Epclusa
200 mg/50 mg per packet
Pellets should be swallowed whole. Do not chew pellets.
Note to pharmacist: Do not cover ALERT box with pharmacy label.
ALERT: Find out about medicines that should NOT be taken with Epclusa
GILEAD
11PRINCIPAL DISPLAY PANEL - 150 mg/37.5 mg Packet Carton
NDC 61958-2205-1
Rx only
Epclusa
150 mg/37.5 mg per packet
Pellets should be swallowed whole. Do not chew pellets.
Note to pharmacist: Do not cover ALERT box with pharmacy label.
ALERT: Find out about medicines that should NOT be taken with Epclusa
GILEAD
