Vemlidy

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

Vemlidy belongs to a group of drugs called nucleoside reverse transcriptase inhibitors (NRTIs) which work by stopping the virus from replicating.

Vemlidy comes in tablet form. It is usually taken once daily, with food. 

Common side effects include headache, abdominal pain, fatigue, and cough. 

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

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information. 

• Gilead Sciences, Inc.

Serious side effects have been reported with Vemlidy. See the "Vemlidy Precautions" section. 

Common side effects of Vemlidy include the following: 

• Headache
• Abdominal pain
• Fatigue
• Cough
• Nausea
• Back pain 

This is not a complete list of Vemlidy side effects. Ask your doctor or pharmacist for more information. 

Tell a doctor if you have any side effect that bothers you or that does not go away. 

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Vemlidy may affect the way other medicines work, and other medicines may affect how Vemlidy works. 

Especially tell your healthcare provider if you take: 

• Any of the following anticonvulsant medications
  • carbamazepine (Tegretol, Equetro, Carbatrol)
  • phenytoin (Dilantin, Phenytek)
  • phenobarbital
  • oxcarbazepine (Trileptal)
  • primidone (Mysoline)
• Medications used to treat tuburculosis like rifampin (Rifadin) and rifapentine (Priftin)
• Rifabutin (Mycobutin)
• Tipranavir (Aptivus)
• Adefovir (Hepsera)
• St. John's Wort

This is not a complete list of Vemlidy drug interactions. Ask your doctor or pharmacist for more information. 

Vemlidy can cause serious side effects, including:

1.  Build-up of an acid in your blood (lactic acidosis). Lactic acidosis can happen in some people who take Vemlidy. 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 the following symptoms which could be signs of lactic acidosis:

• feeling very weak or tired
• have unusual (not normal) muscle pain
• have trouble breathing
• have stomach pain with
  • nausea (feel sick to your stomach)
  • vomiting
• feel cold, especially in your arms and legs
• feel dizzy or lightheaded
• have a fast or irregular heartbeat

 

2.  Severe liver problems. Severe liver problems can 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) when you take Vemlidy.

Call your healthcare provider right away if you have 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 for several days or longer
• nausea
• stomach pain

You may be more likely to get lactic acidosis or severe liver problems if you are female, very overweight (obese), or have been taking Vemlidy for a long time.
 

3.  Worsening of your Hepatitis B infection. Your hepatitis B Virus (HBV) infection may become worse (flare-up) if you take Viread and then stop it. A "flare-up" is when your HBV infection suddenly returns in a worse way than before.

• Do not let your Vemlidy run out. Refill your prescription or talk to your healthcare provider before your tenofovir is all gone.
• Do not stop taking Vemlidy without first talking to your healthcare provider.
• If you stop taking Vemlidy, your healthcare provider will need to check your health often and do blood tests regularly to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking Vemlidy. 
• Talk to your doctor about taking an HIV test before starting treatment with Vemlidy for chronic hepatitis B. You should also get a test for HBV if you are taking tenofovir for treatment of HIV.

Other serious side effects of Vemlidy that can occur include:

• New or worse kidney problems can happen in some people who take Vemlidy. If you have had kidney problems in the past or need to take another medicine that can cause kidney problems, your healthcare provider may need to do blood tests to check your kidneys during your treatment with Vemlidy.
• Bone problems can happen in some people who take Vemlidy. Bone problems include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do additional tests to check your bones.
• Changes in body fat can happen in some people who take antiviral medicines. These changes may include increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these conditions are not known.
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having new symptoms after starting your HIV medicine. 

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Vemlidy, there are no specific foods that you must exclude from your diet when receiving this medication. 

Before taking Vemlidy, tell your healthcare provider about all of your medical conditions.

Especially tell your healthcare provider if you: 

• Are allergic to Vemlidy or any of its ingredients 
• Have liver problems, including hepatitis B infection (HBV)
• Have kidney problems
• Have bone problems
• Have any other medical conditions, including HIV infection
• Are pregnant or plan to become pregnant. It is not known whether Vemlidy will harm your unborn baby. 
• Are breastfeeding or plan to breastfeed

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

Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether Vemlidy will harm your unborn baby. 

Talk to your healthcare provider about how you can take part in the pregnancy exposure registry, which monitors pregnancy outcomes in women exposed to Vemlidy during pregnancy.

Tell your doctor if you are breastfeeding or plan to breastfeed. 

It is not known if Vemlidy crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Vemlidy. 

Take Vemlidy exactly as prescribed.

Take Vemlidy at the same time every day.

Vemlidy comes in a 25mg tablet that is usually taken once daily with food. If you have kidney problems, your healthcare provider may tell you take Vemlidy less often. If you are taking certain medications that interact with Vemlidy, your dose may be adjusted. 

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Vemlidy at the same time. 

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• Other medical conditions you have
• Other medications you are taking
• How you respond to this medication

For adults, the recommended dose of Vemlidy for the treatment of hepatitis B is one 25mg tablet every day with food. 

If you take too much Vemlidy, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away. 

• Store Vemlidy at a temperature below 86°F (30°C).
• Keep Vemlidy in the original container. 
• Do not use if the seal over the bottle is broken or missing.
• Keep the bottle tightly closed.
• Keep this and all medicines out of the reach of children.

WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including Vemlidy.

Discontinuation of anti-hepatitis B therapy may result in severe acute exacerbations of hepatitis B. Hepatic function should be monitored closely in patients who discontinue Vemlidy. If appropriate, resumption of anti-hepatitis B therapy may be warranted.