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What is VEMLIDY?
INDICATION AND IMPORTANT SAFETY INFORMATION
VEMLIDY is a prescription medicine used to treat chronic (long-lasting) hepatitis B virus (HBV) in adults with stable (compensated) liver disease.
Studies in a broad range of patients have shown that VEMLIDY:
-
may reduce the amount of
hepatitis B in your body (viral load) -
may improve the
condition of the liver
Continued below
How VEMLIDY works
IMPORTANT SAFETY INFORMATION
It’s important for your medicine to work right where you need it. That’s why VEMLIDY has been designed to work right at the liver, where the hep B virus is.
How it works:
- VEMLIDY was
designed in a way
that allows it to
travel to the liver
before becoming active - Once at the liver,
most of the medicine
is activated within
the liver cells - VEMLIDY then works
in the liver cells,
right where the
hep B virus is
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Same dose every day with VEMLIDY
IMPORTANT SAFETY INFORMATION (continued)
Pill image not to scale.
(8 mm in diameter)
VEMLIDY is one small tablet that you take once a day with food.
You must take VEMLIDY exactly how your doctor tells you to. If you are on dialysis, on your dialysis days, take VEMLIDY after dialysis. It’s also important to take VEMLIDY on a regular dosing schedule to avoid missing doses.
Do not stop taking VEMLIDY unless your doctor tells you to. If you stop taking your medicine, your HBV infection could get worse (flare-up). A “flare-up” is when your HBV infection suddenly returns in a worse way than before.
It is very important that you refill your prescription on time, before you run out. When your VEMLIDY supply starts to run low, get more from your doctor or pharmacy. This will help make sure that you are not at risk for missing any doses and causing a flare-up.
If you take too much VEMLIDY, call your healthcare provider or go to the nearest hospital emergency room right away.
Tips to help you remember:
Make it a habit by taking
your medicine at the
same time every day
Set an alarm or
download a reminder
app on your phone
Get help from your
family or friends
Continued below
Understanding side effects
IMPORTANT SAFETY INFORMATION (continued)
WHAT ARE THE POSSIBLE SIDE EFFECTS OF VEMLIDY?
New or worse kidney problems, including kidney failure. Your healthcare provider may do blood and urine tests to check your kidneys when starting and during treatment with VEMLIDY. Your healthcare provider may tell you to stop taking VEMLIDY if you develop new or worse kidney problems.
Too much lactic acid in your blood (lactic acidosis), which is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feeling dizzy or lightheaded, or a fast or abnormal heartbeat.
Severe liver problems, which in rare cases can lead to death. Tell your healthcare provider right away if you get these symptoms: skin or the white part of your eyes turns yellow, dark “tea-colored” urine, light-colored stools, loss of appetite for several days or longer, nausea, or stomach-area pain.
The most common side effect of VEMLIDY is headache.
These are not all the possible side effects of VEMLIDY. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
What is the most important information I should know about VEMLIDY?
— — — — — — — — — — — — — — — — — — —
VEMLIDY can cause serious side effects, including:
- Worsening of hepatitis B virus (HBV) infection. Your HBV infection may get worse (flare-up) if you take VEMLIDY and then stop taking it. A “flare-up” is when your HBV infection suddenly returns in a worse way than before. Do not stop taking VEMLIDY without first talking to your healthcare provider, as they will need to monitor your health regularly to check your liver.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Continued below
INDICATION AND IMPORTANT SAFETY INFORMATION
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.
VEMLIDY may lower the amount of HBV in your body.
VEMLIDY may improve the condition of your liver.
What is the most important information I should know about VEMLIDY?
VEMLIDY can cause serious side effects, including:
Worsening of hepatitis B virus (HBV) infection. Your HBV infection may get worse (flare-up) if you take VEMLIDY and then stop taking it. A “flare-up” is when your HBV infection suddenly returns in a worse way than before. Do not stop taking VEMLIDY without first talking to your healthcare provider, as they will need to monitor your health regularly to check your liver.
What should I tell my healthcare provider before taking VEMLIDY?
All of your medical conditions, including if you have end stage renal disease (ESRD) or HIV-1 infection. Your healthcare provider may test you for HIV infection before starting VEMLIDY. If you have HIV and only take VEMLIDY, the HIV virus may develop resistance and become harder to treat.
If you are pregnant or plan to become pregnant. It is not known if VEMLIDY will harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with VEMLIDY.
If you are breastfeeding or plan to breastfeed. It is not known if VEMLIDY 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-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how VEMLIDY works. Keep a list of all your medicines and show it to your healthcare provider and pharmacist. Do not start a new medicine without telling your healthcare provider. Ask your healthcare provider if it is safe to take VEMLIDY with all of your other medicines.
What are the possible side effects of VEMLIDY?
New or worse kidney problems, including kidney failure. Your healthcare provider may do blood and urine tests to check your kidneys when starting and during treatment with VEMLIDY. Your healthcare provider may tell you to stop taking VEMLIDY if you develop new or worse kidney problems.
Too much lactic acid in your blood (lactic acidosis), which is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feeling dizzy or lightheaded, or a fast or abnormal heartbeat.
Severe liver problems, which in rare cases can lead to death. Tell your healthcare provider right away if you get these symptoms: skin or the white part of your eyes turns yellow, dark “tea-colored” urine, light-colored stools, loss of appetite for several days or longer, nausea, or stomach-area pain.
The most common side effect of VEMLIDY is headache.
These are not all the possible side effects of VEMLIDY. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Click here for Important Facts about VEMLIDY, including important warnings.