Sofosbuvir/velpatasvir
Pronunciation: so-fos-boo-vear/vell-pat-is-vear
Generic name: sofosbuvir/
Brand name: Epclusa (ep-KLOO-suh)
Dosage form: oral tablet, oral pellets
Drug class: Antiviral combinations
What is sofosbuvir/velpatasvir?
Sofosbuvir/
- without cirrhosis or with compensated cirrhosis
- with decompensated cirrhosis when used in combination with ribavirin.
Your doctor will perform tests to find out which hepatitis genotype you have
The ingredients in sofosbuvir/
Sofosbuvir/
Warnings
If you've had hepatitis B (HBV), sofosbuvir/
A very slow heartbeat (bradycardia) may occur in those patients also administered amiodarone who also take beta-blockers, have underlying cardiovascular conditions, or advanced liver disease.
Sofosbuvir/
It is not known if sofosbuvir/
Related/similar drugs
Harvoni, Vosevi, Epclusa, Mavyret, ribavirin, Sovaldi
What are the side effects of sofosbuvir/velpatasvir?
Sofosbuvir/
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have new or worsening symptoms such as:
- right-sided upper stomach pain
- vomiting, loss of appetite, or not feeling well
- jaundice (yellowing of the skin or eyes).
Common side effects of sofosbuvir/
- Adults and children 6 years of age and older: headache and fatigue
- Children less than 6 years of age: vomiting and spitting up the drug
- When used together with ribavirin in adults with decompensated cirrhosis: fatigue, anemia, nausea, headache, insomnia, and diarrhea.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to Gilead Sciences, Inc. at 1-800-GILEAD-5FDA or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Before taking
Before taking sofosbuvir/
- have ever had a hepatitis B virus infection
- have liver problems other than hepatitis C infection
- have had a liver transplant
- have kidney problems or you are on dialysis
- have HIV-1 infection
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed.
Pregnancy
It is not known if sofosbuvir/
Males and females who take sofosbuvir/
Breastfeeding
It is not known if sofosbuvir/
How is sofosbuvir/velpatasvir administered?
Take sofosbuvir/
- Do not stop taking sofosbuvir/
velpatasvir without first talking with your healthcare provider.
Take the oral tablets or oral pellets by mouth
- May be taken with or without food.
- For adults, the usual dose of sofosbuvir/
velpatasvir is one 400/100 mg tablet each day. - For children 3 years of age and older your healthcare provider will prescribe the right dose of sofosbuvir/
velpatasvir oral pellets or tablets based on your child’s body weight. - The dose may change if the child gains or loses weight.
Tell your healthcare provider if your child has problems with swallowing tablets.
How should I give sofosbuvir/velpatasvir oral pellets to my child?
Administer sofosbuvir/
- The oral pellets can be taken with food or placed directly in the mouth.
- For children younger than 6 years, give them the oral pellets with food.
- The sofosbuvir/
velpatasvir oral pellets should be swallowed whole. Instruct your child not to chew them because they have a bitter aftertaste. - Do not open the packet of oral pellets until ready to use.
Read and follow the Epclusa Oral Pellets Dosage and Administration guide. Ask your doctor or pharmacist if you need help.
What happens if I miss a dose?
Do not miss a dose of sofosbuvir/
If you do happen to forget a dose, take the dose as soon as you remember. But if it is almost time for your next dose, skip that dose. Do not take 2 doses at once.
What happens if I overdose?
If you take too much sofosbuvir/
What should I avoid while taking sofosbuvir/velpatasvir?
Using this medicine will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HCV transmission during sex. Sharing drugs or medicine needles is never safe, even for a healthy person.
What other drugs will affect sofosbuvir/velpatasvir?
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take:
- omeprazole (Prilosec) or an antacid. Do not take them for at least 4 hours after you have taken your dose of sofosbuvir/
velpatasvir - amiodarone. Get medical help right away if you take this medicine and you have very slow heartbeats, chest pain, shortness of breath, confusion, memory problems, weakness, extreme tiredness, or a light-headed feeling (like you might pass out).
- P-gp inducers and/or moderate to strong CYP inducers (such as rifampin, St. John’s wort, and carbamazepine). May decrease concentrations of sofosbuvir/
velpatasvir. Use together is not recommended
Clearance of HCV infection with direct-acting antivirals may lead to changes in liver function, which may impact the safe and effective use of other medications. Frequent laboratory monitoring and dose adjustments may be necessary.
Keep a list of your medicines to show your healthcare provider and pharmacist. You can ask your healthcare provider or pharmacist for a list of medicines that interact with sofosbuvir/
Storage
Store Epclusa tablets or oral pellets below 86°F (30°C). Keep them in the original container. Do not use the oral pellets if the carton tamper-evident seal or the packet has been opened or damaged.
Throw away (dispose of) any unused portion. Do not store and reuse any leftover Epclusa oral pellets or mixture (oral pellets mixed with food).
Keep out of the reach of children.
Ingredients
Epclusa tablets
Active ingredients: sofosbuvir and velpatasvir
Inactive ingredients: copovidone, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose.
Film coating: iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.
Epclusa tablets are a fixed-dose tablet in two strengths:
- 400 mg of sofosbuvir and 100 mg of velpatasvir
- 200 mg of sofosbuvir and 50 mg of velpatasvir.
Epclusa oral pellets
Active ingredients: sofosbuvir and velpatasvir
Inactive ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.
Film-coating: amino methacrylate copolymer, colloidal silicon dioxide, hypromellose, L-tartaric acid, polyethylene glycol, stearic acid, talc, and titanium dioxide.
Epclusa oral pellets are available in two strengths:
- 200 mg of sofosbuvir and 50 mg of velpatasvir
- 150 mg of sofosbuvir and 37.5 mg of velpatasvir.
Manufacturer
Gilead Sciences, Inc.
Popular FAQ
The newest drugs for the treatment of hepatitis C include Mavyret (glecaprevir and pibrentasvir), Vosevi (sofosbuvir, velpatasvir, and voxilaprevir), and Epclusa (sofosbuvir and velpatasvir). All are FDA-approved for the treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A), as well as other uses. Continue reading
The cost of Epclusa (sofosbuvir and velpatasvir) tablets is roughly $US78,078 for a full 12-week course of treatment. Your cost might vary based on insurance or manufacturer-provided discounts. Epclusa is covered by most insurance plans. Epclusa oral pellets have also been approved to treat children unable to swallow tablets. Continue reading
Epclusa has a 98% overall cure rate in all 6 of the main types of hepatitis C in patients without cirrhosis (a serious liver disease) or with compensated cirrhosis (mild or no symptoms). Continue reading
More FAQ
- Can you drink alcohol while taking Epclusa?
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- How does Epclusa work in the body?
- What is the difference between Vosevi and Epclusa?
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