Sofosbuvir/Velpatasvir, Oral

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KEY POINTS

• This medicine is taken by mouth to treat chronic hepatitis C. It may be taken alone or along with another medicine. Take it exactly as directed.
• This medicine may be taken along with ribavirin. Ribavirin can cause severe birth defects. It must not be used by women who are pregnant or by the male partners of women who are pregnant.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• This medicine may cause life-threatening problems if you take this medicine with certain other medicines. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: HCV nucleotide analog NS5B polymerase inhibitor/HCV NS5A inhibitor; antiviral

Generic and brand names: sofosbuvir/velpatasvir, oral; Epclusa

What is this medicine used for?

This medicine is a combination of 2 medicines taken by mouth to treat continuing (chronic) hepatitis C virus infections in adults. It may be taken alone or along with ribavirin.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Heart problems
• Kidney problems
• Liver disease other than hepatitis C

Taking this medicine with amiodarone (Cordarone, Pacerone) may cause a life-threatening slow heartbeat. Other medicines may also affect how this medicine works. Tell your provider about ALL of the medicines and natural remedies you take.

This medicine may be taken along with ribavirin. Ribavirin can cause severe birth defects. It must not be used by women who are pregnant or by the male partners of women who are pregnant.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if this medicine will harm an unborn baby. However, ribavirin can cause birth defects. Read the information that comes in the medicine package. Your healthcare provider will check that you are not pregnant before starting treatment, and every month while taking ribavirin, and for 6 months after stopping it. Use an effective birth control method while you are taking this medicine with ribavirin and for 6 months after stopping it. Talk with your healthcare provider about effective birth control. Stop taking this medicine with ribavirin at the first sign that you may be pregnant and contact your healthcare provider right away. Do not breast-feed while taking this medicine.

Males: Do not use this medicine with ribavirin if your female partner is pregnant. If your partner becomes pregnant while you are taking this medicine with ribavirin or within 6 months after you stop taking it, tell your healthcare provider right away.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval. Your symptoms may get worse if you stop taking this medicine too soon. Do not run out of this medicine.

Check with your healthcare provider before using this medicine in children under age 18.

You may take this medicine with or without food.

What if I miss a dose?

Do not skip or miss doses of this medicine. If you miss a dose, take the missed dose as soon as you remember the same day. Take your next dose at your regular time the next day. Do not take more than 1 tablet in a day. If you are not sure of what to do if you miss a dose or you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments.

This medicine does not cure hepatitis C or keep you from spreading it to other people. Do not share needles, toothbrushes, or razor blades with others.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. Carry an ID card or a Medic Alert bracelet. If you become unconscious, the ID tells emergency healthcare providers that you may need special care.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Unusual tiredness or weakness, shortness of breath, pale skin, chest pain, slow heartbeat, confusion, memory problems, severe dizziness or fainting.

Other: Nausea, mild tiredness, headache, trouble sleeping, diarrhea, mild rash or itching.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antacids that contain aluminum or magnesium, such as Gaviscon, Maalox, and Mylanta (Take antacids 4 hours before or 4 hours after you take this medicine.)
• Antibiotics such as azithromycin (Zithromax, Zmax), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), nafcillin, rifabutin (Mycobutin), rifampin (Rifadin), and rifapentine (Priftin)
• Antifungal medicines such as itraconazole (Sporanox), and ketoconazole (Nizoral)
• Antipsychotic medicines such as paliperidone (Invega) and risperidone (Risperdal)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), eslicarbazepine (Aptiom), fosphenytoin (Cerebyx), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Antiviral medicines such as elbasvir/grazoprevir (Zepatier), ledipasvir/sofosbuvir (Harvoni), ombitasvir/paritaprevir/ritonavir (Technivie), and simeprevir (Olysio)
• Cancer medicines such as abiraterone (Zytiga), bexarotene (Targretin), ceritinib (Zykadia), crizotinib (Xalkori), dabrafenib (Tafinlar), enzalutamide (Xtandi), imatinib (Gleevec), lapatinib (Tykerb), mitotane (Lysodren), nilotinib (Tasigna), pazopanib (Votrient), sunitinib (Sutent), tamoxifen, topotecan (Hycamtin), vandetanib (Caprelsa), vemurafenib (Zelboraf), venetoclax (Venclexta), and vinblastine
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), lomitapide (Juxtapid), lovastatin (Altoprev), and rosuvastatin (Crestor)
• Colchicine (Colcrys)
• Corticosteroids such as dexamethasone and hydrocortisone (A-Hydrocort, Cortef)
• Eliglustat (Cerdelga)
• Everolimus (Afinitor, Zortress)
• Flibanserin (Addyi)
• Heart medicines such as aliskiren (Tekturna), amiodarone (Cordarone, Pacerone), carvedilol (Coreg), diltiazem (Cardizem, Cartia, Tiazac), digoxin (Lanoxin), dronedarone (Multaq), nicardipine (Cardene), propafenone (Rythmol), quinidine, ranolazine (Ranexa), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as darunavir (Prezista), efavirenz (Sustiva), efavirenz/emtricitabine/tenofovir (Atripla), etravirine (Intelence), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), emtricitabine/tenofovir (Truvada), emtricitabine/rilpivirine/tenofovir (Complera), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), saquinavir (Invirase), tenofovir (Viread), and tipranavir (Aptivus)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Lumacaftor/ivacaftor (Orkambi)
• Malaria medicines such as mefloquine and quinine
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet), famotidine (Pepcid), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), and ranitidine (Zantac)
• Medicines to treat or prevent blood clots such as dabigatran (Pradaxa), dipyridamole (Persantine), edoxaban (Savaysa), and ticagrelor (Brilinta)
• Mirabegron (Myrbetriq)
• Modafinil (Provigil)
• Morphine (Kadian, MS Contin)
• Natural remedies such as red yeast rice and St. John’s wort Propranolol (Hemangeol, Inderal, InnoPran)
• Secobarbital (Seconal)
• Silodosin (Rapaflo)
• Tolvaptan (Samsca)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature in its original container. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.