Vemlidy (Tenofovir Alafenamide) - Oral

What Is Vemlidy?

Vemlidy (tenofovir alafenamide) is an orally administered prescription medication used to treat chronic (long-lasting) hepatitis B in adults and adolescents 12 and older with compensated liver disease (cirrhosis of the liver).

Vemlidy belongs to a group of drugs called nucleotide reverse transcriptase inhibitors, or NRTIs.

NRTIs work by inhibiting the virus that causes hepatitis B from replicating, which decreases levels of the virus in the blood.

Vemlidy contains the active ingredient tenofovir alafenamide. However, it should be noted that no generic, therapeutic equivalent of Vemlidy currently exists. No other brand-name, orally administered drug containing the active ingredient tenofovir alafenamide used for the treatment of hepatitis B is currently available either.

Vemlidy is not to be confused with Viread, an oral drug used for the treatment of human immunodeficiency virus (HIV) infections. Viread contains the active ingredient tenofovir disoproxil fumarate.

This article will highlight Vemlidy, a drug given in the form of an oral tablet.

What Is Vemlidy Used For?

The FDA has approved Vemlidy for the treatment of chronic hepatitis B in adults and children 12 and older with compensated liver disease (a damaged liver that is still somewhat operational).

Hepatitis B is a liver infection caused by the hepatitis B virus. Most adults who become infected with hepatitis B will develop an acute (short-term) infection and are able to recover from the illness without treatment.

Others, however, will develop a lifelong infection. Over time, the inflammation caused by chronic hepatitis B can lead to liver failure, cirrhosis, liver cancer, and death.

The risk of developing chronic hepatitis B is greater for people who become infected with the virus at a young age. For example, about 9 out of 10 infants who become infected during birth (from a parent with hepatitis B) go on to develop chronic, life-long infections. However, only less than 6% of people who become infected as adults will develop a chronic infection.

Hepatitis B is a vaccine-preventable illness. The best way to avoid getting hepatitis B is to get vaccinated.

Hepatitis B spreads through blood, semen, and other body fluids. Unvaccinated individuals can become infected with the virus from:

• Birth (from a parent with hepatitis B)
• Sex with a partner with hepatitis B
• Sharing needles, syringes, or other drug-related equipment
• Sharing items like toothbrushes, razors, and medical equipment with a person who has hepatitis B
• Coming into contact with blood or open sores of a person who has hepatitis B

Many people who develop an acute hepatitis B infection will not experience any symptoms. Others may have a fever, fatigue, loss of appetite, nausea, vomiting, stomach-area pain, and jaundice (yellowing of the eyes and skin).

For those who go on to develop chronic hepatitis B, most people will not have any symptoms for decades. When symptoms appear, they are often a sign of advanced liver disease.

The best way to know if you have hepatitis B is to get tested. Talk with your healthcare provider about your risk factors to determine if you should get screened for hepatitis B.

While treatment cannot cure chronic hepatitis B, antiviral therapies like Vemlidy can help decrease the amount of hepatitis B virus in your body and may improve the condition of your liver.

How to Take Vemlidy

Vemlidy is an oral tablet that is taken once daily with food. If you are on dialysis, take your daily dose of Vemlidy after dialysis on dialysis days.

Do not stop taking Vemlidy without talking to your healthcare provider first. Stopping Vemlidy can cause your hepatitis B to flare up and become worse. Be sure to refill your Vemlidy prescription before running out to ensure you don't miss any doses.

Storage

Store your Vemlidy prescription at room temperature (68 to 77 F).

Keep Vemlidy in its original container and make sure the bottle is tightly closed. Be sure to keep Vemlidy and all your medicines in a safe location, out of the reach of children and pets. Also, avoid storing it in an area susceptible to high levels of moisture, such as a bathroom.

Off-Label Uses

Healthcare providers may prescribe medicines for conditions not approved by the FDA. This is called off-label use.

Healthcare providers may prescribe Vemlidy off-label to:

• Prevent hepatitis B reactivation in people with a weakened immune system
• Prevent hepatitis B reinfection in people receiving a liver transplant

Tenofovir—the active ingredient in Vemlidy—is also used in combination with other medicines to treat human immunodeficiency virus (HIV). Vemlidy should never be used alone to treat HIV since this can make the HIV virus resistant and harder to treat.

What Are the Side Effects of Vemlidy?

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

You may experience side effects while taking Vemlidy. Be sure to let your healthcare provider know about any side effects that bother you or don't go away.

The most common side effect is headache.

Severe Side Effects

The FDA has issued a boxed warning for Vemlidy. See above for a detailed description of the boxed warning that outlines the potential risks associated with the use of Vemlidy.

Vemlidy may cause serious side effects. Contact your healthcare provider immediately if you develop any signs of a severe reaction. Call 911 if your symptoms feel life-threatening.

Serious side effects and their symptoms associated with the use of Vemlidy include:

• A flare-up or worsening of your hepatitis B infection if you stop taking Vemlidy: Do not stop taking Vemlidy without talking to your healthcare provider first.
• New or worse kidney problems, including kidney failure: Your healthcare provider will check your kidney function before starting Vemlidy and during treatment with blood and urine tests.
• Lactic acidosis, a severe and potentially deadly condition that causes lactic acid blood levels to become too high: Let your healthcare provider know if you develop weakness, unusual tiredness, unusual muscle pain, shortness of breath, fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, dizziness, light-headedness, or a fast or abnormal heartbeat.
• Decreased bone density
• Severe liver problems that can lead to death: Let your healthcare provider know if you develop any signs of liver problems, including yellowing of your skin or the white parts of your eyes, dark-colored urine, light-colored stools, loss of appetite, nausea, or stomach-area pain.

Dosage: How Much Vemlidy Should I Take?

Modifications

The following modifications (changes) should be kept in mind when using Vemlidy:

Severe allergic reaction: Avoid using Vemlidy if you have a known allergy to it or its ingredients. Ask your healthcare provider for a complete list of the ingredients if you're unsure.

Pregnancy: In animal studies, Vemlidy was not found to have harmful effects on the fetus. However, not enough is known about the safety and effectiveness of Vemlidy in pregnant humans and their unborn fetuses.

Let your healthcare provider know if you're pregnant or plan to become pregnant, and discuss the benefits and risks of taking Vemlidy during your pregnancy.

Breastfeeding: In animal studies, a different form of tenofovir (the active ingredient in Vemlidy) was present in breast milk. Not enough is known about the safety of Vemlidy in human breast milk and its risk to nursing babies.

Talk with your healthcare provider if you plan to breastfeed. Discuss the benefits and risks of taking Vemlidy while nursing and the different ways to feed your baby.

Adults over age 65: Clinical studies did not show any differences in the safety or effectiveness of using Vemlidy in older adults compared to younger adults.

Adolescents: Vemlidy is not approved by the FDA to treat people under 12 with hepatitis B.

Kidney and liver problems: Individuals with kidney or liver problems may not be able to clear the medication from their bodies as quickly as people with healthy organs. This means the medicine stays in the body longer and can have increased side effects.

For this reason, if you have kidney failure and are not receiving dialysis or have unstable liver disease, your healthcare provider will likely not prescribe Vemlidy.

Missed Dose

It is important not to miss any doses of Vemlidy. Skipping doses can cause your hepatitis B infection to flare up and become worse. Be sure to refill your Vemlidy prescription before you run out to avoid missing doses.

If you accidentally forget your Vemlidy dose, take it as soon as you remember.

Try to find ways to help yourself remember to routinely keep your appointments and take your medication. If you miss too many doses, Vemlidy might be less effective at treating your condition.

Overdose: What Happens If I Take Too Much Vemlidy?

There is limited information available about the effects of a Vemlidy overdose.

If you think that you're experiencing an overdose or life-threatening symptoms, however, seek immediate medical attention.

Precautions

What Are Reasons I Shouldn’t Take Vemlidy?

Do not take Vemlidy if you're allergic to it or any of its ingredients. Ask your healthcare provider for a full list of the ingredients if you're unsure.

What Other Medications Interact With Vemlidy?

Avoid taking Vemlidy with the following medications:

• Other products containing tenofovir, such as Viread and Genvoya (elvitegravir, cobicistat, emtricitabine, tenofovir AF)
  
• Dilantin (phenytoin)
• Trileptal (oxcarbazepine)
• Donnatal (belladonna/phenobarbital)
  
• Mycobutin (rifabutin)
• Rifadin (rifampin)
• Saint-John's-wort
• Hepsera (adefovir)
• Aptivus (tipranavir)

Use caution when taking Vemlidy with the following medications:

• Mysoline (primidone)
• Tegretol (carbamazepine)
• Nonsteroidal anti-inflammatory drugs (NSAIDs), such as Motrin or Advil (ibuprofen) and Aleve (naproxen)
• Zovirax (acyclovir)
• Valtrex (valacyclovir)

Other medications may interact with Vemlidy.

Be sure to let your healthcare provider and pharmacist know about all the medicines you take, including over-the-counter (OTC), nonprescription products, vitamins, and herbal supplements.

What Medications Are Similar?

Vemlidy is an antiviral medication that belongs to a group of drugs called NRTIs.

Other antiviral medicines that work similarly to Vemlidy and are used to treat chronic hepatitis B include:

• Baraclude (entecavir)
• Viread (tenofovir disoproxil fumarate)
• Epivir (lamivudine)

In most cases, healthcare providers prefer to use Baraclude or tenofovir-containing products like Vemlidy to treat chronic hepatitis B since they are well-tolerated and effective.

However, choosing a product will depend on several factors, including other therapies you may have tried previously, your other medical conditions, and cost.

How Can I Stay Healthy While Taking Vemlidy?

If you're taking Vemlidy, chances are you're looking to get better control over your chronic hepatitis B.

While living with hepatitis B does have its challenges, there are ways to help support your liver health. Refer below for some general tips:

Talk with your healthcare provider about vaccinations. If you've recently been diagnosed with hepatitis B, your healthcare provider will likely recommend getting vaccinated against hepatitis A and tested for hepatitis C.

Follow up with all lab work and blood tests to monitor your liver function and check for medication side effects.

Avoid alcohol. Even small amounts of alcohol can cause liver complications in people with hepatitis B. Also, don't smoke. Aside from being bad for your overall health, some studies have found that smoking increases the risk of liver cancer in people with hepatitis B.

Finally, always check with your healthcare provider before starting any new medications. Even OTC products, such as NSAIDs (e.g., Advil or Aleve), may need to be avoided or taken at a lower dose, depending on your liver function. Also, many herbal products may also potentially damage the liver.