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Overview: Hepcludex is used to treat hepatitis D, which is a liver infection. It works by blocking the hepatitis D virus from entering liver cells. Common side effects include irritation or discomfort at the injection site, headache, stomach pain, tiredness, and skin itchiness. Do not stop using Hepcludex without talking to your health care provider first.

Uses

What is Hepcludex used for?

Hepcludex (bulevirtide-gmod) is commonly used to treat chronic hepatitis delta virus (HDV) infection, or hepatitis D. Hepatitis D is a liver disease that can only happen in people who also have hepatitis B.

Learn more about treating hepatitis D with Hepcludex.

Hepcludex may also be used for other conditions as determined by your health care provider.

How does Hepcludex work (mechanism of action)?

Hepcludex works by blocking the hepatitis D virus (HDV) from entering liver cells. This makes it harder for the infection to spread through the liver. Over time, Hepcludex can lower the amount of virus in the body, sometimes to the point that blood tests cannot detect the virus. 

How is Hepcludex supplied (dosage forms)?

Brands and other names

  • Hepcludex

Dosage forms and strengths

  • 8.5 mg single-dose vials

How should I store Hepcludex?

Before mixing, store Hepcludex vials at room temperature, between 68 F and 77 F (20 C and 25 C). Hepcludex can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. 

After mixing, use Hepcludex right away. Throw away the vial after one use, even if some medicine remains.

Side Effects

What are the most common side effects of Hepcludex?

The most common side effects of Hepcludex are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Pain, itching, swelling, redness, bruising, or infection at the injection site
  • Headache
  • Stomach pain
  • Tiredness
  • Itchiness

There may be other side effects of Hepcludex that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Hepcludex?

While less common, the most serious side effects of Hepcludex are described below, along with what to do if they happen.

Severe Allergic Reactions. Hepcludex may cause allergic reactions, which can be serious. Stop using Hepcludex and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Warnings & Precautions

Who should not use Hepcludex?

Allergies to Ingredients. People who are allergic to any of the following should not use Hepcludex.

  • Bulevirtide
  • Hepcludex
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Hepcludex.

What should I know about Hepcludex before using it?

Do not use Hepcludex unless it has been prescribed to you by a health care provider. Use it as prescribed.

Do not share Hepcludex with other people, even if they have the same condition as you. It may harm them.

Keep Hepcludex out of the reach of children.

This medicine is injected under the skin. Read and follow the instructions and make sure that you or a caregiver understands how to properly prepare and use Hepcludex. If you have any questions, talk to your health care provider.

Stopping Hepcludex may cause a serious flare-up, or sudden worsening, of your hepatitis D or hepatitis B infection. Your risk may be higher if you have cirrhosis. Do not run out of Hepcludex or stop taking it without talking to your health care provider first. If you stop using Hepcludex, keep all appointments for blood tests and follow-up visits, and tell your health care provider if you have any new or worsening symptoms. Your health care provider will closely monitor your liver health and virus levels for at least 6 months after stopping Hepcludex. In some cases, they may restart treatment (antiviral medicine).

What should I tell my health care provider before using Hepcludex?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Hepcludex is right for you.

In particular, make sure that you discuss any of the following.

Pregnancy. It is not known if or how Hepcludex could affect pregnancy or harm a fetus. Tell your health care provider if you are pregnant or plan to become pregnant.

Breastfeeding. It is not known if Hepcludex passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should use Hepcludex while breastfeeding.

How can I get more information about Hepcludex?

For more information about Hepcludex, you can visit the drugmaker’s website at www.hepcludex.com or call them at 855-769-7284.

Interactions

Does Hepcludex interact with foods or drinks?

There are no known interactions between Hepcludex and foods or drinks. 

It is unknown if drinking alcohol will affect Hepcludex, but alcohol may cause further liver damage in people with hepatitis D. It is best to avoid alcohol or limit the amount you drink. 

Does Hepcludex interact with other medicines (drug interactions)?

There are no known interactions between Hepcludex and other medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Hepcludex?

If you or someone else has used too much Hepcludex, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Hepcludex?

If you miss a dose, use it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only use the next dose. Do not use double or extra doses. 

Missing doses of Hepcludex can cause it to not work as well over time. So it is important not to miss or skip doses.