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Epclusa

(sofosbuvir - velpatasvir)

How does this medication work? What will it do for me?

Sofosbuvir - velpatasvir is used alone or with ribavirin to treat chronic (long-term) hepatitis C virus (HCV) infection.

This combination product contains 2 medications: sofosbuvir and velpatasvir. Both of these medications belong to the class of medications called antivirals. Sofosbuvir and velpatasvir work by blocking different steps in the reproduction of the virus, helping to stop the duplication of the virus and allowing the body to get rid of the virus.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The recommended dose of this medication 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 this medication, 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 this medication 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 this medication 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.

What form(s) does this medication come in?

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.

Who should NOT take this medication?

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

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • headache
  • tiredness
  • vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • muscle aches
  • rash
  • signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

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 this medication.

Hepatitis B co-infection: The safety and effectiveness of using this medication have not been established for people who also have hepatitis B infection. If you have hepatitis B infection, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Human immunodeficiency virus (HIV) co-infection: The safety and effectiveness of using this medication have not been established for people who also have HIV infection. If you have HIV infection, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Some of the medications used to treat HIV infection are affected by sofosbuvir or velpatasvir and may contribute to severe side effects.

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

Pregnancy and contraception: The use of this medication 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 this medication, 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 therapy. 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 this medication.

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

Children: The safety and effectiveness of using this medication have not been established for children less than 18 years of age.

What other drugs could interact with this medication?

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

  • abiraterone acetate
  • aliskiren
  • amiodarone
  • antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide)
  • anti-cancer medications (e.g., doxorubicin; etoposide, paclitaxel, vincristine)
  • asunaprevir
  • “azole” antifungals
  • barbiturates (e.g., phenobarbital, secobarbital)
  • bosentan
  • brentuximab
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • carbamazepine
  • carvedilol
  • cetirizine
  • ciprofloxacin
  • cobicistat
  • colchicine
  • corticosteroids (e.g., dexamethasone, hydrocortisone)
  • cyclosporine
  • dabigatran
  • deferasirox
  • digoxin
  • dipyridamole
  • dronedarone
  • enzalutamide
  • estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
  • “gliptin” diabetes medications (e.g., linagliptin, saxagliptin, sitagliptin)
  • grapefruit juice
  • grazoprevir
  • H2 antagonists (e.g., famotidine, ranitidine)
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delaviridine, efavirenz, etravirine, nevirapine)
  • HIV protease inhibitors (e.g., indinavir, nelfinavir, ritonavir, saquinavir, tipranavir)
  • lomitapide
  • loperamide
  • loratidine
  • lumacaftor
  • mefloquine
  • methotrexate
  • mirabegron
  • mitotane
  • modafinil
  • morphine
  • nadolol
  • naloxegol
  • nefazodone
  • ondansetron
  • paliperidone
  • phenobarbital
  • prazosin
  • progesterone
  • propranolol
  • proton pump inhibitors (e.g., lansoprazole, omeprazole)
  • prucalopride
  • quinidine
  • quinine
  • reserpine
  • rifabutin
  • rifampin
  • risperidone
  • romidepsin
  • seizure medications (e.g., carbamazepine, clobazam, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, valproic acid, zonisamide)
  • St. John's wort
  • silodosin
  • siltuximab
  • "statin" anti-cholesterol medications (e.g., atorvastatin, lovastatin, simvastatin)
  • tacrolimus
  • tamoxifen
  • ticagrelor
  • tocilizumab
  • tolvaptan
  • trabectedin
  • trazodone
  • tyrosine kinase inhibitors (e.g., bosutinib, crizotinib, imatinib, lapatinib)

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 this medication. 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.

All material copyright MediResource Inc. 1996 – 2017. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Epclusa

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