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Generic Name: tenofovir alafenamide
Date of Approval: November 10, 2016
Company: Gilead Sciences, Inc.

Treatment for: Chronic Hepatitis B Virus Infection

FDA Approves Vemlidy

The U.S. Food and Drug Administration (FDA) has approved Vemlidy (tenofovir alafenamide, TAF) 25mg, a once-daily hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor indicated for the treatment of adults with chronic HBV infection with compensated liver disease. Vemlidy is a novel, targeted prodrug of tenofovir that has demonstrated similar antiviral efficacy and improved renal and bone laboratory safety parameters compared to Viread (tenofovir disoproxil fumarate, TDF) 300mg.

Patient Information

Read this Patient Information before you start taking treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

Important information

Vemlidy can cause serious side effects, including:

  • Build-up of lactic acid in your blood (lactic acidosis). Lactic acidosis may happen in some people who take this medicine, or similar medicines. Lactic acidosis is a serious medical emergency that can lead to death.
    Lactic acidosis can be hard to identify early, because the symptoms could seem like symptoms of other health problems. Call your healthcare provider right away if you get any of the following symptoms which could be signs of lactic acidosis:
    • feel very weak or tired
    • have unusual (not normal) muscle pain
    • have trouble breathing
    • have stomach pain with nausea or vomiting
    • feel cold, especially in your arms and legs
    • feel dizzy or lightheaded
    • have a fast or irregular heartbeat
  • Severe liver problems. Severe liver problems may happen in people who take Vemlidy. In some cases, these liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Call your healthcare provider right away if you get any of the following symptoms of liver problems:
    • your skin or the white part of your eyes turns yellow (jaundice)
    • dark “tea-colored” urine
    • light-colored bowel movements (stools)
    • loss of appetite
    • nausea
    • pain, aching, or tenderness in the right side of your stomach area
    You may be more likely to get lactic acidosis or severe liver problems if you are female, very overweight (obese), or have been taking this medicine or a similar medicine for a long time.
  • Worsening of hepatitis B infection. Your hepatitis B (HBV) infection may become worse (flare-up) if you start treatment, and then stop. A “flare-up” is when your HBV infection suddenly returns in a worse way than before.
    • Do not run out of this medicine. Refill your prescription or talk to your healthcare provider before your pills are all gone.
    • Do not stop taking this medicine without first talking to your healthcare provider.
    • If you stop taking this medicine, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop treatment.

For more information about side effects, see Vemlidy side effects

What is Vemlidy?

Vemlidy is a prescription medicine used to treat chronic (long-lasting) hepatitis B virus (HBV) in adults with stable (compensated) liver disease.

  • It may lower the amount of HBV in your body.
  • It may also improve the condition of your liver.

It is not known if this medicine is safe and effective in children under 18 years of age.

Before taking Vemlidy

Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:

  • have HIV-1 infection. Your healthcare provider may test you for HIV infection before starting treatment. If you have HIV and take Vemlidy, the HIV virus may develop resistance and become harder to treat.
  • have end stage renal disease (ESRD).
  • are pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment.

    Pregnancy Registry: There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.

  • are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-thecounter medicines, vitamins, and herbal supplements.

Some medicines may affect how Vemlidy works.

  • Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. You can ask your healthcare provider or pharmacist for a list of medicines that interact with Vemlidy.
  • Do not start a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take Vemlidy with other medicines.

How should I take Vemlidy?

  • Take this medicine exactly as your healthcare provider tells you to take it.
  • Take Vemlidy one time each day with food.
  • Do not change your dose or stop taking this medicine without first talking with your healthcare provider. Stay under a healthcare provider’s care during treatment.
  • Do not miss a dose. If you take too much Vemlidy, call your healthcare provider or go to the nearest hospital emergency room right away.
  • When your supply of this medicine starts to run low, get more from your healthcare provider or pharmacy. This is very important because your HBV infection may get worse (flare-up) if you stop treatment.

Vemlidy side effects

Vemlidy may cause serious side effects, including:

  • See Important information
  • New or worse kidney problems, including kidney failure. Your healthcare provider may do blood and urine tests to check your kidneys before you start and during treatment. Your healthcare provider may tell you to stop taking Vemlidy if you develop new or worse kidney problems.

The most common side effects are:

  • headache
  • stomach pain
  • tiredness
  • cough
  • nausea
  • back pain

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA- 1088.

How should I store Vemlidy?

  • Store Vemlidy below 86 °F (30 °C).
  • Keep tablets in the original container.
  • Keep the container tightly closed.

Keep all medicines out of reach of children and pets.

General information about the safe and effective use of Vemlidy.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information that is written for health professionals.

What are the ingredients?

Active ingredients: tenofovir alafenamide

Inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets are film-coated with a coating material containing: iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

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