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Is there a generic for Vemlidy?

Is there a generic for Vemlidy?

Vemlidy is an oral antiviral drug manufactured by Gilead Sciences, Inc. It was approved by the U.S. Food and Drug Administration (FDA) in 2015 for the treatment of chronic hepatitis B virus (HBV) in adults and children aged 12 years and older. It helps stop or slow the growth of the HBV infection and can reduce the risk of serious complications such as cirrhosis and liver cancer. Currently, there is no generic version of Vemlidy available in the United States. However, in September 2022, Gilead reached a deal with several generic drug manufacturers that will allow them to roll out Vemlidy generics starting Halloween of 2031. Keep reading to learn more about Vemlidy and options to save money on this medication.

Vemlidy FAQs

What is Vemlidy?

Vemlidy (tenofovir alafenamide fumarate or TAF) is a brand-name medication that is considered a nucleoside analog reverse transcriptase inhibitor. It is FDA-approved to treat chronic hep B virus infection in adults and pediatric patients 12 years of age and older with compensated liver disease. It is a prodrug that is activated in the liver to slow or stop the growth of HBV. The active ingredient, TAF, is also used in combination medications such as Biktarvy to treat HIV-1 infections.

What dosage forms and strengths are available for Vemlidy?

Vemlidy is available as an oral 25 mg tablet.

How do you take Vemlidy?

The recommended dose of Vemlidy is 25 mg (1 tablet) taken by mouth once a day with food. Taking Vemlidy with food helps your body absorb it properly and makes it work more effectively.

Vemlidy carries a boxed warning from the FDA concerning severe hepatomegaly with steatosis and post-treatment severe acute exacerbation of hepatitis B. This means that you should not stop taking Vemlidy without discussing it with your doctor first or it may cause a severe flare-up of your HBV infection. This can lead to serious liver damage and cirrhosis.

What should you tell your doctor before starting Vemlidy?

Talk with your healthcare provider about the possible drug interactions with any other prescription drugs, over-the-counter products, vitamins, and supplements you are taking.

You should not take this medication if you have a known hypersensitivity to tenofovir alafenamide or any of the inactive ingredients in Vemlidy.

You should also be sure your healthcare provider is aware of your medical conditions, including:

  • HIV-1 infection

  • End-stage renal disease

  • Liver problems (cirrhosis or hepatitis C)

  • Pancreatitis

  • Are pregnant or plan on becoming pregnant

  • Are breastfeeding or plan to breastfeed

What are the side effects of Vemildy?

The most common side effects of Vemlidy seen in clinical trials include:

  • Headache

  • Cough

  • Abdominal pain

  • Fatigue

  • Nausea

  • Diarrhea

  • Back pain

Vemlidy can sometimes cause serious side effects such as:

  • Serious allergic reactions including life-threatening anaphylaxis (hives, swelling of the throat or tongue, and trouble breathing)

  • Lactic acidosis (build-up of lactic acid in your blood)

  • Inflammation of the pancreas (pancreatitis)

  • New or worsening kidney disease

  • Severe liver problems including jaundice (yellowing of your skin or eyes)

These are not all of the possible side effects of Vemlidy. You should always seek medical advice for any questions or concerns relating to your medical condition or treatment. You can report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

How long does it take Vemlidy to be effective?

It is not known exactly how long it takes Vemlidy to start working. Studies have shown that Vemlidy lowers the levels of hepatitis B virus in most patients. In one clinical study, 94% of people taking Vemlidy had very low levels of viral DNA after 48 weeks of treatment. In another study with patients whose HBV was multiplying more rapidly, 64% of people taking Vemlidy had very low levels of viral DNA after 48 weeks.

What is the difference between Vemlidy and Viread?

Vemlidy (tenofovir alafenamide) and Viread (tenofovir disoproxil fumarate) are both antiviral drugs manufactured by Gilead Sciences, Inc. They are also both prodrugs that are converted to tenofovir by the body.

Vemlidy is used to treat chronic HBV in patients 12 years and older. Viread can be used to treat chronic HBV and HIV-1 infections in patients that are 2 years and older as long as they weigh at least 22 lbs (10 kg).

They both have some of the same side effects such as headache, stomach pain, and nausea. Vemlidy may also cause fatigue and cough while Viread may cause depression and rash.

In clinical studies comparing them, Vemlidy and Viread were similar in terms of effectiveness. They both were generally well-tolerated and discontinuations due to adverse reactions were similar. However because the dose of Vemlidy (25 mg a day) is much lower than Viread (300 mg a day), it had less effect on bone density and kidney function.

One of the biggest differences is price. Viread is available as a generic and can be less than $100 for a month's supply without insurance. There is no generic available for Vemlidy in the United States so it can be really expensive. The average retail cost for a month’s supply is around $1800 without insurance.

What is the average monthly cost of Vemlidy?

The estimated cost for #30 (30-day supply) tablets of Vemlidy 25 mg is almost $1800. This is without any insurance or coupon card. If your insurance plan covers Vemlidy, your co-pay should be cheaper. Check with your plan to see if they cover it and what your cost will be. Another option is Universal Drug Store. We work with a number of Canadian and international pharmacy partners, all licensed by their qualified governmental regulatory bodies. With a valid prescription, we can save you up to 80% off the retail cost of a wide range of medications. For example, a one-month supply of brand-name Vemlidy 25mg from UDS is $679. We also have access to a generic that is even cheaper. A 3-month supply of tenofovir alafenamide 25 mg is only $345.

Is there a cheaper alternative to Vemlidy?

There are several other prescription medications you can take to treat HBV if you cannot take Vemlidy. Some examples include Viread (tenofovir disoproxil fumarate), Baraclude (entecavir), and Epivir HBV (lamivudine). You will need to talk to your healthcare provider to see if any of these alternatives may be right for you.

When will generic Vemlidy become available?

The exact date when a generic of Vemlidy will be released is not known. Based on the deal reached by the drug manufacturer in September 2022, you can expect a generic version of Vemlidy around the end of October 2031.

 

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