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Epclusa (Generic Sofosbuvir and Velpatasvir)

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WARNING

You might already have hepatitis B (a virus that affects the liver and can result in serious liver damage), but you might not be aware of it. In this instance, taking sofosbuvir and velpatasvir together may raise your risk of developing symptoms and a more serious or life-threatening illness. If you have or have previously had a hepatitis B virus infection, let your doctor know. To determine whether you currently have or have previously had hepatitis B infection, your doctor will conduct a blood test. Throughout and for a few months after your treatment, your doctor will continue to keep an eye out for any symptoms of hepatitis B infection. Before and during your treatment with the sofosbuvir and velpatasvir combination, if necessary, your doctor may give you medication to treat this infection. Call your doctor right away if you notice any of the following symptoms during or after your treatment: extreme fatigue, yellowing of the skin or eyes, appetite loss, nausea, or vomiting, pale stools, stomach pain, or dark urine.

Keep all of your appointments with your physician and the lab. To monitor your body’s reaction to the sofosbuvir and velpatasvir combination, your doctor may prescribe specific tests prior to, during, and after your therapy.

Discuss the potential risks of taking sofosbuvir with velpatasvir with your doctor.

Why is this medication prescribed?

Adults and kids aged 6 and older or who weigh at least 37 lbs (17 kg) who have chronic hepatitis C are treated with the combination of sofosbuvir and velpatasvir either alone or in conjunction with ribavirin (Copegus, Rebetol, Ribasphere). The antiviral drug sofosbuvir belongs to the group of drugs known as nucleotide hepatitis C virus (HCV) NS5B polymerase inhibitors. A group of antiviral drugs known as HCV NS5A replication complex inhibitors includes velpatasvir. The interaction of sofosbuvir and velpatasvir prevents the hepatitis C virus from proliferating within the body.

How should this medicine be used?

The oral tablet containing sofosbuvir and velpatasvir is available. It is typically taken once daily for 12 weeks with or without food. Every day, take sofosbuvir and velpatasvir about the same time. Ask your doctor or chemist to explain any instructions on your prescription label that you are unsure about following. As prescribed, use velpatasvir and sofosbuvir together. Never take it in larger or less amounts or more frequently than directed by your doctor.

Even if you feel well, keep taking sofosbuvir and velpatasvir. Without consulting your doctor, never stop taking sofosbuvir and velpatasvir.

For a copy of the manufacturer’s information for the patient, ask your chemist or doctor.

Other uses for this medicine

Ask your doctor or chemist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking sofosbuvir and velpatasvir,

  • If you have any allergies, including to sofosbuvir, velpatasvir, other medicines, or any of the substances in sofosbuvir and velpatasvir tablets, inform your doctor right away. Request a list of the ingredients from your chemist.
  • Inform your doctor and chemist about any vitamins, nutritional supplements, prescription and non-prescription drugs, and herbal preparations you are taking or intend to use. Any of the following should be mentioned: atorvastatin (Lipitor, in Caduet), amiodarone (Nexterone, Pacerone), efavirenz (Sustiva, in Atripla); digoxin (Lanoxin); carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril); phenobarbital, phenytoin (Dilantin, Phenytek), oxcarbazepine (Oxtellar, Trileptal); proton-pump inhibitors such esomeprazole (Nexium, in Vimovo), dexlansoprazole (Dexilant), pantoprazole (Protonix), rabeprazole (AcipHex), lansoprazole (Prevacid, in Prevpac), and omeprazole (Prilosec, Zegerid): rifabutin (Mycobutin); rosuvastatin (Crestor); rifampin (Rifadin, Rimactane, in Rifamate, Rifater); rifapentine (Priftin); tipranavir (Aptivus) administered with ritonavir (Norvir); Tenofovir DF (Viread, in Atripla, Complera, Stribild, Truvada, and other medications); warfarin (Coumadin, Jantoven), topotecan (Hycamtin), and others. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects. Tell your doctor about all of the drugs you are taking, including any not on this list, as many other drugs may also interact with sofosbuvir and velpatasvir.
  • Take antacids 4 hours before or 4 hours after taking sofosbuvir and velpatasvir if you take them.
  • Inform your doctor if you are using any H2 blockers, such as cimetidine, ranitidine (Zantac), famotidine (Pepcid, in Duexis), or nizatidine, for indigestion, heartburn, or ulcers. Your doctor may advise you to take this drug at the same time as sofosbuvir and velpatasvir, or you may be instructed to take it 12 hours before or after sofosbuvir and velpatasvir.
  • Please let your doctor know if you are taking any herbal supplements, especially St. John’s wort.
  • Inform your doctor if you have human immunodeficiency virus (HIV), any liver conditions other than hepatitis C, or if you ever did.
  • Inform your physician if you are nursing a baby, intend to get pregnant, or are already pregnant. Call your doctor if you become pregnant while taking sofosbuvir and velpatasvir.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Velpatasvir with sofosbuvir may have adverse effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Rash
  • Not enough energy
  • Feeling agitated
  • Feeling melancholy

Velpatasvir and sofosbuvir may also have other adverse effects. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online at http://www.fda.gov/Safety/MedWatch or by phone at 1-800-332-1088 if you have a serious side event.

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Keep it at room temperature and out of the bathroom and other places with excessive heat and moisture.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilizing a medicine take-back program is the easiest approach to get rid of your medication. To find out about take-back programs in your area, speak with your chemist or the garbage/recycling agency in your city. If you do not have access to a take-back program, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

What other information should I know?

No one else should take your medication. Any queries you may have regarding prescription refills should be directed to your chemist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Epclusa®
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