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FDA Approval: Velmidy for Hepatitis B

by The GoodRx Pharmacist on December 15, 2016 at 4:50 pm

As you may have noticed, there have been many new hepatitis medications released recently, and we have another to add to the list! Gilead Sciences is a popular manufacturer for many hepatitis medications, and as of November 10th, they have recently gained approval for Vemlidy for hepatitis B.

Your liver is a key organ in your body that is important for removing toxins from your body and blood, aiding in digestion, and producing energy. So, it’s important to take care of it and treat it well. That is where Vemlidy comes in!

What is Vemlidy for? 

Vemlidy is indicated for the treatment of chronic hepatitis B, a viral infection that can lead to irreversible liver damage or even liver cancer. Hepatitis B is caused by contact with infected bodily fluids (from medical procedures like a blood transfusion) or through risky behaviors (like intravenous drug use or unprotected sex).

Vemlidy is specifically for adults with compensated liver disease, which means that the liver has become heavily scarred. Although the liver may still function properly, it will get worse and should be treated sooner rather than later.

Is there anything unique about Vemlidy?

Actually, yes. Vemlidy has a boxed warning, which is the FDA’s strongest warning aimed at informing patients and health care providers of a drug’s adverse effects. For Vemlidy, these serious adverse effects include:

  • Lactic Acidosis: a serious condition that can result in unusual muscle pain, trouble breathing, nausea, vomiting, dizziness, or irregular heartbeat.
  • Severe hepatomegaly with steatosis: the swelling of the liver beyond its normal size, with an increased build-up of fat in the liver.
  • Post-treatment severe acute hepatitis B exacerbation: a “flare-up” or return of the hepatitis B virus worse than it initially was.

Is there an advantage to Vemlidy?

Despite the boxed warning, there is a big advantage. Vemlidy is similar to another Gilead product Viread, also used to treat Hepatitis B. However, Vemlidy is to be given at one tenth of the dose of Viread. This makes it better for important organs like the kidneys and the bones!

How is Vemlidy to be taken?

Vemlidy is a once-daily treatment, so patients are instructed to take one 25mg tablet daily, with food.

What are the most common side effects?

The most common side effects associated with Vemlidy are as follows:

  • Headache
  • Stomach Pain
  • Tiredness
  • Cough
  • Nausea
  • Back Pain

For more information, see the press announcement from Gilead Pharmaceuticals here.

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