Epclusa

The recommended dose of Epclusa for adults and children aged 12 years and older who weigh 30 kg or more is 1 tablet taken by mouth, once daily. It is generally taken for 12 weeks.

Sofosbuvir - velpatasvir can be taken with food or on an empty stomach.

If you vomit within 3 hours of taking the medication, take another dose of the medication. If it is longer than 3 hours since you have taken the medication, do not take another tablet. Continue with your normal dose schedule.

Finish all Epclusa, even if you have started to feel better.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Epclusa exactly as prescribed by your doctor. If you miss a dose, and it is within 18 hours of the missed dose, take it as soon as possible and continue with your regular schedule. If it is more than 18 hours since the missed dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Epclusa in the original packaging, at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause a general feeling of weakness; it may cause unusual tiredness; it may cause sleep disturbances or insomnia; it may cause nausea or, rarely, vomiting; it may affect your mood. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Each pink, diamond-shaped, film-coated tablet debossed with "GSI" on one side and "7916" on the other contains 400 mg of sofosbuvir and 100 mg of velpatasvir. Nonmedicinal ingredients: copovidone, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose; film coating: iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

Do not take Epclusa if you are allergic to sofosbuvir, velpatasvir, or any ingredients of the medication.

There may be an interaction between sofosbuvir - velpatasvir and any of the following:

• Aliskiren
• Amiodarone
• antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide)
• anticancer medications (e.g., Doxorubicin, Etoposide, Paclitaxel, Vincristine)
• Apalutamide
• bilastine
• Bosentan
• Colchicine
• Cyclosporine
• dabigatran
• Deferasirox
• Diabetes medications (e.g., Canagliflozin, Glyburide, insulin, Linagliptin, Liraglutide, Metformin, Rosiglitazone)
• Digoxin
• Edoxaban
• Elagolix
• Eliglustat
• Enzalutamide
• Everolimus
• H2 antagonists (e.g., Famotidine, Ranitidine)
• hepatitis C antivirals (e.g., glecaprevir and pibrentasvir, grazoprevir, ledipasvir, voxilaprevir)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., ritonavir, tipranavir)
• lumacaftor and Ivacaftor
• Modafinil
• Morphine
• Nadolol
• Naloxegol
• proton pump inhibitors (e.g., Lansoprazole, Omeprazole)
• rifabutin
• rifampin
• rifaximin
• Risperidone
• Romidepsin
• Sarilumab
• seizure medications (e.g., Carbamazepine, Clobazam, Levetiracetam, Phenobarbital, Phenytoin, primidone, Topiramate, Valproic acid, zonisamide)
• St. John's wort
• Silodosin
• siltuximab
• Sirolimus
• "statin" anti-cholesterol medications (e.g., Atorvastatin, Lovastatin, Rosuvastatin, Simvastatin)
• Tacrolimus
• Tocilizumab
• Tolvaptan
• tyrosine kinase inhibitors (e.g., Bosutinib, Crizotinib, Dabrafenib, imatinib, Lapatinib, Nilotinib)
• Warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Epclusa. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Epclusa.

Hepatitis B co-infection: Talk to your doctor before taking Epclusa if you have or have had hepatitis B. People with hepatitis B infection that is dormant may experience a recurrence of the hepatitis B while they are taking sofosbuvir – velpatasvir or after they stop taking Epclusa. This can result in severe liver damage and possibly life-threatening liver failure. If you experience symptoms of worsening liver function, such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Human immunodeficiency virus (HIV) co-infection: Sofosbuvir - velpatasvir has been found to be a safe and effective treatment for hepatitis C, for people who also have HIV infection. Some of the medications used to treat HIV infection may affect sofosbuvir or velpatasvir and change how these medications work in the body. If you have HIV infection, discuss with your doctor how Epclusa may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Epclusa, and whether any special monitoring is needed.

Liver transplant: The safety and effectiveness of using sofosbuvir - velpatasvir after having a liver transplant have not been determined. Epclusa is not recommended for anyone who has had a liver transplant.

Pregnancy and contraception: The use of Epclusa is not recommended for pregnant women or women who may become pregnant, as it is not known if sofosbuvir - velpatasvir will harm an unborn child. If you become pregnant while taking Epclusa, contact your doctor immediately.

If you are using ribavirin along with sofosbuvir - velpatasvir, you must use 2 forms of effective birth control (one for each partner) during treatment and for 6 months after stopping the medication. During this time, women will have monthly pregnancy tests to ensure they are not pregnant. Tell your doctor immediately if you become pregnant while using Epclusa.

Breast-feeding: It is not known if sofosbuvir or velpatasvir pass into breast milk. If you are breast-feeding and are taking Epclusa, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Epclusa have not been established for children less than 12 years of age or who weigh less than 30kg. Epclusa has not been studied for children with moderate or severe liver impairment.

This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. It must be used regularly and continuously to maintain its beneficial effects. Be sure to keep an adequate supply on hand. If you remember missing a dose within 18 hours of the time it is usually taken, take it as soon as you remember, then take the next dose at the regularly scheduled time. If the dose is missed by more than 18 hours, skip the missed dose. Do not double the next dose to catch up. If you vomit within three (3) hours after taking the medication, contact your health care professional, an additional dose may be prescribed. This medication may be taken with or without food. To ensure effectiveness, avoid taking an antacid at the same time.