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Overview: Hibsago is used to treat chronic hepatitis B. It works by lowering the levels of hepatitis B viral proteins. Common side effects may include fever, tiredness, headache, and pain, itching, swelling, or redness near the injection site. Tell your health care provider right away if you have symptoms of a serious side effect, such as unusual bruising or bleeding, sudden severe headache, neck stiffness, dark-colored pee, or yellowing of the skin or whites of your eyes. It is important to keep all appointments for blood work before starting this medicine, while you are using it, and after you stop. Hibsago is an injection that is given under the skin.

Uses

What is Hibsago used for?

Hibsago (bepirovirsen) is commonly used to treat certain people with long-term (chronic) hepatitis B.

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

How does Hibsago work (mechanism of action)?

Hibsago is an antiviral medicine that works against the hepatitis B virus (HBV). It attaches to the virus’s mRNA, the genetic instructions liver cells use to make viral proteins, and causes it to break down. This leads to lower levels of hepatitis B viral proteins, including hepatitis B surface antigen (HBsAg). Hibsago may also help activate parts of your immune system.

How is Hibsago supplied (dosage forms)?

Brands and other names

  • Hibsago

Dosage forms and strengths

  • 150 mg/mL solution, single-dose prefilled syringe

How should I store Hibsago?

Store Hibsago at room temperature, up to 86 F (30 C), for up to 12 weeks. Do not freeze it or shake it. Keep it in its original carton to protect it from light. Throw it away 12 weeks after you get the medicine from your pharmacy or if the expiration date has passed. 

After removing Hibsago from the carton, you should use it within 6 hours. Throw it away if you do not use it within 6 hours.

Side Effects

What are the most common side effects of Hibsago?

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

  • Pain, itching, swelling, or redness near the injection site
  • Fever
  • Tiredness
  • Headache

There may be other side effects of Hibsago 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 Hibsago?

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

Severe Allergic Reactions. Hibsago may cause allergic reactions, which can be serious. Stop using Hibsago 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

Liver Flare-Ups. Hibsago may cause a liver flare-up, leading to liver inflammation and a spike in certain liver enzymes. It is important to keep all appointments with your health care provider to make sure this medicine is safe for you and that you are on the right dose. Call your health care provider right away if you have any of the following symptoms of a liver flare-up.

  • Stomach discomfort or pain in your upper right stomach area
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
  • Nausea, vomiting, or loss of appetite
  • Dark-colored pee
  • Unusual tiredness
  • Fever or chills
  • Stool (poop) that is clay-colored   

Severely Low Platelet Levels. Hibsago can cause you to have a severely low number of platelets in your blood, also called thrombocytopenia, which can be life-threatening. Platelets help to form blood clots. Having a low level of platelets may increase your risk of bleeding. Keep all appointments for blood work. Stop using Hisbago and tell your health care provider right away if you have any of the following symptoms of low platelet levels.

  • Easy or unusual bruising or bleeding
  • Bleeding that does not stop
  • Nosebleeds, bleeding of the gums, or bloodshot eyes
  • Tiny red, flat spots on your skin (petechiae)
  • Coughing up or throwing up blood
  • Heavy or irregular menstrual periods
  • Pink, red, or brown urine (pee)
  • Red or black stools (looks like tar)
  • Stiff neck
  • Severe or unusual headache

Kidney Problems. Your kidneys may not work as well when you are using Hibsago. Keep all appointments with your health care provider for lab tests to check the health of your kidneys. 

Immune System Reactions. Hibsago can cause serious inflammation and immune system reactions. These reactions include immune thrombocytopenia or autoimmune hemolytic anemia. Call your health care provider right away if you have any of the following symptoms.

  • Fever, chills, or other flu-like symptoms
  • Red or purple skin discoloration, patches, or rashes
  • Itching or swelling
  • Pain in multiple joints

Warnings & Precautions

Who should not use Hibsago?

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

  • Bepirovirsen
  • Hibsago
  • Any of the ingredients in the specific product dispensed

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

Current Liver Problems or Cirrhosis. You should not use Hibsago if you are having sudden or acute liver problems or if you have liver problems due to cirrhosis.  

Low Platelet Levels. You should not use Hibsago if you have low platelet levels. Your health care provider can check your levels and make sure it is safe for you to use this medicine.

What should I know about Hibsago before using it?

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

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

Keep Hibsago out of the reach of children. 

This medicine is injected under the skin. Your first dose of Hibsago will be given with your health care provider, who will show you how to inject it correctly. They will then decide whether you or a caregiver can give your later doses. Read and follow the “Instructions for Use” that comes with the medicine. Make sure that you or a caregiver understands how to properly prepare and use Hibsago. 

Serious side effects may happen if Hibsago is not injected correctly. Use a new injection site each week. Make sure that you give the two injections at least 2 inches (5 centimeters) apart from each other. Do not inject into areas that are tender, hard, bruised, or red. If you have any questions, talk to your health care provider.

It is very important to keep all appointments with your health care provider, including for lab tests, before you start Hibsago, during treatment, and after stopping it. You will likely need to have blood work done at least every week while using this medicine. These check-ups are needed to make sure the medicine is safe for you and that you are on the right dose. 

Stopping hepatitis B antiviral medicines can cause a serious flare-up, or worsening, of your hepatitis B. Do not run out of this medicine or stop using it or other hepatitis B antiviral medicines without talking to your health care provider first. Keep all appointments for blood work so your health care provider can check the health of your liver after stopping any hepatitis B medicines. 

If you are using medicine for both HIV and hepatitis B, do not stop using it unless your health provider tells you to. 

It is not known if Hibsago helps prevent the spread of hepatitis B. You should continue to take steps to prevent spreading hepatitis B to other people. Talk with your health care provider about ways to lower this risk, such as using condoms and not sharing needles.

People who are age 65 and older may be at greater risk of some side effects from Hibsago. Talk to your health care provider about your risks if you are in this age group.

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

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 Hibsago is right for you.

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

Current and Past Health Conditions. Tell your health care provider if you have or have had any of the following.

Other Medicines and Supplements. Hibsago may interact with other medicines and supplements. Before using Hibsago, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

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

Breastfeeding. Hibsago may pass 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 Hibsago while breastfeeding.

How can I get more information about Hibsago?

For more information about Hibsago, you can visit the drugmaker’s website at www.contactus.gsk.com or call them at 888-825-5249.

Interactions

Does Hibsago interact with foods or drinks?

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

It is unknown if drinking alcohol will affect Hibsago, but alcohol can affect your liver and may increase your risk of bleeding. Talk to your health care provider before drinking alcohol during treatment.

Does Hibsago interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before using Hibsago.

  • A blood thinner, which is a medicine used to treat or prevent blood clots
  • An antiplatelet medicine, such as clopidogrel (Plavix), ticagrelor (Brilinta), aspirin/dipyridamole, or cilostazol, which is a medicine used to prevent blood clots
  • Aspirin, which is in many prescription and OTC products, including those for pain, swelling, and fever
  • A medicine that may harm the kidneys, such as certain antibiotics, water pills, or nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Peginterferon alfa-2a (Pegasys), which is a medicine used to treat hepatitis B and hepatitis C

This may not be a complete list of medicines that can interact with Hibsago. Always check with your health care provider.

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 Hibsago?

If you or someone else has used too much Hibsago, 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 Hibsago?

If you miss a dose, use it as soon as you remember, unless your next dose is due in less than 3 days. If your next dose is due in less than 3 days, skip the missed dose and just use your next dose as scheduled. Do not use double or extra doses.

It is important to complete your prescribed course of Hibsago. Do not stop using it without talking to your health care provider first.