Epclusa

The active ingredients in Epclusa are sofosbuvir and velpatasvir. Both of these medications are antivirals and work against the Hepatitis C virus (HCV). They are direct-acting antivirals that are specific for HCV genotypes 1, 2, 3, 4, 5, or 6.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Epclusa. However, the following is a synopsis of the general guidelines for the use of Epclusa:

• Epclusa should be used exactly as prescribed. Typically, for adults, the dose is standard. But for pediatric patients, it will depend on the weight.
• It is typically taken once daily with or without food. Do not stop taking without consulting your prescriber first. Do not miss doses. Each missed dose makes the infection more difficult to treat. If you miss a dose, call your healthcare provider immediately.
• Oral pellets may be taken without regard to meals, but for children younger than 6, it is recommended to take them with food. Pellets should be swallowed and not chewed. Do not open the packet until you are ready to use it.
• Patients should be advised to avoid becoming pregnant during therapy and for 6 months after completion.

The most common side effects of Epclusa seen in clinical trials include:

• Headache
• Fatigue
• Nausea
• Vomiting

Some individuals may experience serious side effects while using Epclusa. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Reactivation of a latent Hepatitis B infection. Watch for signs of upper right abdominal pain, loss of appetite, jaundice or yellowing of eyes and skin, and dark urine.
• Signs of bradycardia or slow heart rate, such as fainting, dizziness, lightheadedness, weakness, extreme fatigue, shortness of breath, chest pain, confusion, or memory problems.

These are not all of the possible side effects of Epclusa. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Epclusa, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• History of Hepatitis B
• Liver disease
• Liver transplant
• Kidney problems
• On dialysis
• HIV-1 infection
• Are pregnant or planning to become pregnant
• Are breastfeeding or planning to breastfeed

Boxed Warning

• In some cases, Epclusa can reactivate the Hepatitis B virus (HBV) that is latent in the body and cause hepatitis, liver failure, or death.
• All patients should be tested for HBV before treatment initiation. Co-infected patients should be monitored for HBV reactivation during treatment of HCV infection and at follow-up after completing treatment.

Do not use this medication if you are using Epclusa and ribavirin combination, but have an allergy to ribavirin.

Epclusa begins to work against the infection right after the first dose. However, it is typically taken for 12 weeks to ensure complete treatment of the infection.

When Epclusa is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Amiodarone
• Antacids with aluminum or magnesium
• H2-Receptor Antagonists such as famotidine or ranitidine
• Atorvastatin
• Carbamazepine
• Digoxin
• HIV Antiretrovirals such as efavirenz, tenofovir DF, tipranavir, and ritonavir
• Phenytoin
• Phenobarbital
• Proton-pump inhibitors such as pantoprazole, omeprazole, lansoprazole, rabeprazole, and dexlansoprazole
• Rifabutin
• Rifampin
• Rifapentine
• Rosuvastatin
• St. John’s Wort
• Topotecan
• Warfarin

Epclusa tablets are available in the following strengths:

• 200 mg sofosbuvir/50 mg velpatasvir
• 400 mg sofosbuvir/100 mg velpatasvir

Epclusa is also available as oral pellets that come in the following strengths:

• 150 mg sofosbuvir/37.5 mg velpatasvir
• 200 mg sofosbuvir/50 mg velpatasvir

Epclusa should be stored at room temperature in its original container, away from light and heat, and out of reach of children.

Epclusa is manufactured by the pharmaceutical company Gilead Sciences.

Currently, there is no generic available for Epclusa.

It is important you take Epclusa for the full duration to appropriately treat the infection. Consult your doctor or pharmacist before starting, stopping, or changing medications while taking Epclusa.

It is unknown if Epclusa is safe in pregnancy. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is unknown if Epclusa passes into the breast milk. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.