Epclusa Dosage, forms & strengths
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Get started todayEpclusa (sofosbuvir/velpatasvir) is a direct-acting antiviral (DAA) that is manufactured by Gilead Sciences, Inc. It is indicated by the U.S. Food and Drug Administration (FDA) to treat adults and pediatric patients 3 years of age and older with chronic HCV genotype 1 through 6 infections. Epclusa is used as monotherapy in patients or if they have compensated cirrhosis (Child-Pugh A). It is taken in combination with Rebetol (ribavirin) in those with decompensated cirrhosis (Child-Pugh B or C).
Epclusa has been very effective with an overall cure rate of 98% in clinical studies of chronic hepatitis C patients without cirrhosis or with compensated cirrhosis.
How does Epclusa work?
Hepatitis C is an infection caused by a virus that attacks your liver and causes inflammation. Most people with hepatitis C have no symptoms. Those that do can have fatigue, nausea, loss of appetite, and jaundice (yellowing of the eyes and skin). Without proper treatment, hepatitis C can have serious complications including liver damage, cirrhosis, liver cancer, or death.
Epclusa is a combination prescription medication that contains a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor (sofosbuvir) and an HCV NS5A inhibitor (velpatasvir). Sofosbuvir is a prodrug that blocks HCV replication by inhibiting HCV NS5B RNA polymerase activity. Velpatasvir blocks the NS5A protein that is necessary for viral replication.
Epclusa dosage forms and strengths
Epclusa is available as an oral tablet and pellets in the following strengths:
- 400 mg/100 mg tablets
- 200 mg/50 mg tablets
- 200 mg/50 mg oral pellets
- 150 mg/37.5 mg oral pellets
Epclusa dosage
The recommended dose of Epclusa in adults is 400mg of sofosbuvir and 100mg of velpatasvir (1 tablet) taken by mouth once daily with or without food.
The recommended dose of Epclusa in pediatric patients 3 years and older is based on the patient’s body weight.
Epclusa adult dosage chart
table
Indication
Starting dosage
Standard dosage
Maximum dosage
Epclusa adult dosage chart
Indication
Treatment Regimen and Duration
HCV without cirrhosis and with compensated cirrhosis
1 tablet (400 mg sofosbuvir/100 mg velpatasvir) once daily with or without food for 12 weeks.
HCV with decompensated cirrhosis
1 tablet (400 mg sofosbuvir/100 mg velpatasvir) once daily with or without food for 12 weeks + ribavirin.
Epclusa dosage chart for pediatric patients 3 years and older with HCV
Body weight (kg)
Daily dose of Epclusa
Epclusa oral pellets dose
Epclusa tablet dose
Less than 17
150 mg/37.5 mg per day.
One 150 mg/37.5 mg packet once a day.
N/A
17 to less than 30
200 mg/50 mg per day.
One 200 mg/50 mg packet once a day.
One 200 mg/50 mg tablet once daily.
30 and above
400 mg/100 mg per day.
Two 200 mg/50 mg packets once a day.
One 400 mg/100 mg once a day.
end table
***https://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/epclusa/epclusa_pi.pdf Look at Table 1 and Table 2 on page 4 for the format***
Epclusa dosage restrictions
- No dose adjustment of Epclusa is necessary for patients with any degree of renal impairment, including those with end-stage renal disease on dialysis.
How to take Epclusa
- Read the Full Prescribing Information, Instructions for Use, and Medication Guide that comes with Epclusa.
- Use Epclusa exactly as your healthcare provider prescribes it. Do not change your dose or stop taking Epclusa without talking to them first.
- Epclusa is taken once a day with or without food.
- Epclusa oral pellets should not be chewed. They should be swallowed whole, with or without food. For pediatric patients under the age of 6, Epclusa oral pellets should be taken with food. Sprinkle the oral pellets on at least 1 spoonful of soft non-acidic food at or below room temperature. Non-acidic foods include pudding, chocolate syrup, or ice cream. You should take the oral pellets within 15 minutes of mixing them with food.
- Epclusa tablets or oral pellets should be stored in the original container below 86°F (30°C). Discard Epclusa oral pellets if the carton tamper-evident seal or the packet has been damaged or opened.
Epclusa dosage FAQs
What are some common side effects of Epclusa?
Some common adverse effects of Epclusa include:
- Headache
- Extreme tiredness
- Anemia
- Nausea
- Vomiting
- Insomnia
- Diarrhea
- Rash
Epclusa can cause serious adverse reactions, including:
- Hepatitis B virus, or HBV reactivation
- Slow heart rate, chest pain, or shortness of breath when taken with Pacerone (amiodarone)
Contact your doctor for medical advice about any side effects you experience while taking Epclusa. You can report your side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What are some drug interactions with Epclusa?
When Epclusa is taken with other medicines, they may interact and change how they work. They can also change the plasma concentrations of these medications. Make sure your healthcare provider is aware of all prescription drugs, over-the-counter medications, vitamins, and herbal supplements you take. Some major drug interactions with Epclusa include:
- Antiepileptic medications including Tegretol (carbamazepine), Trileptal (oxcarbazepine), Luminal (phenobarbital), and Dilantin (phenytoin)
- HIV medications such as Sustiva (efavirenz), Aptivus (tipranavir), Viread (tenofovir), and Norvir (ritonavir)
- Antacids, H2-blockers such as Pepcid (famotidine), and proton-pump inhibitors such as Prilosec (omeprazole)
- Antibiotics such as Priftin (rifapentine), Rifadin (rifampin), and Mycobutin (rifabutin)
- Cholesterol medications (statins) such as Crestor (rosuvastatin) and Lipitor (atorvastatin)
- St. John’s wort
- Hycamtin (topotecan)
- Pacerone (amiodarone)
- Lanoxin (digoxin)
Are there any contraindications or precautions with Epclusa?
You should not take Epclusa if you have had a hypersensitivity reaction to sofosbuvir, velpatasvir, or any of its inactive ingredients.
If you use Epclusa with P-gp Inducers and/or Moderate to Strong Inducers of liver enzymes CYP2B6, CYP2C8, or CYP3A4 (rifampin, St. John’s wort, carbamazepine) it may not work as well. Your healthcare provider may switch you to an alternative HCV treatment.
Epclusa can cause some serious complications. Be sure your doctor is aware if you have any of the following medical conditions:
- Current or prior HBV infection
- Are taking Pacerone (amiodarone) as it can cause symptomatic bradycardia
- Have had a liver transplant
- Are on dialysis
- Human immunodeficiency virus (HIV)
- Diabetes
How long does it take for Epclusa to start working?
To get the full benefit of Epclusa, treatment-naïve and treatment-experienced patients will take it once daily for 12 weeks. If you have decompensated cirrhosis, you will take Epclusa along with ribavirin for the 12-week regimen. After finishing 12 weeks of Epclusa treatment, clinical trials showed a cure rate of up to 98%.
Can I take Epclusa if I was not cured with a previous HCV treatment?
Even if your previous treatment for an HCV infection was not successful, Epclusa may work for you. Epclusa has been proven effective for treating chronic HCV in patients who were not cured by peginterferon alfa and ribavirin, with or without a protease inhibitor.
Can Epclusa be used to treat HCV in people who inject drugs?
Yes, Epclusa can be used to treat chronic hepatitis C virus in people who inject drugs even if they are an active user.
How do I store Epclusa?
Epclusa tablets or oral pellets should be stored in the original container below 86°F (30°C). Discard Epclusa oral pellets if the carton tamper-evident seal or the packet has been damaged or opened.
Is it safe to use Epclusa while pregnant or breastfeeding?
It is not known whether the use of Epclusa during pregnancy causes any harm to your fetus. Epclusa should not be taken if it is administered with Rebetol (ribavirin) in pregnant women or in men whose female partners are pregnant.
It is not known whether Epclusa is found in breast milk or the effects it may have on the infant or milk production. You should always discuss the risks and benefits of any medication with your healthcare provider if you are pregnant, plan on becoming pregnant, or are breastfeeding.
Is there a generic for Epclusa?
Currently, there is no generic for Epclusa available on the market. However, you can still save on brand-name drugs like Epclusa through NiceRx if eligible for assistance.
Related resources for Epclusa dosage
- https://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/epclusa/epclusa_pi.pdf
- https://www.medicalnewstoday.com/articles/326248#about
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6135833/
- https://hcp.epclusa.com/
- https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-epclusa
- https://www.pdr.net/drug-summary/Epclusa-sofosbuvir-velpatasvir-3922#15