Hepcludex: Uses, Side Effects and Dosage

Serious warnings and precautions box

What HEPCLUDEX is used for:

HEPCLUDEX is used to treat adults with long-term HDV infection with a condition called compensated liver disease.

HEPCLUDEX is not approved for use in children and adolescents since it has not been studied in these patients.

How HEPCLUDEX works:

HEPCLUDEX blocks HDV from getting into liver cells. This reduces the spread of HDV in the liver and reduces inflammation.

The ingredients in HEPCLUDEX are:

Medicinal ingredient: bulevirtide (as bulevirtide acetate)

Non-medicinal ingredients: hydrochloric acid, mannitol, sodium carbonate anhydrous, sodium hydrogen carbonate, sodium hydroxide

HEPCLUDEX comes in the following dosage form:

Powder for solution: 2 mg / vial of bulevirtide (as bulevirtide acetate)

Do not use HEPCLUDEX if:

• you are allergic to bulevirtide

Your hepatitis may get worse after treatment with HEPCLUDEX is stopped:

Stopping treatment with HEPCLUDEX can make hepatitis delta virus (HDV) and hepatitis B virus (HBV) infections worse, especially if you have cirrhosis (scarring of the liver). Do not stop taking HEPCLUDEX unless your healthcare professional tells you to. Stopping treatment can reactivate the infection and make your disease worse. If your healthcare professional does stop your treatment with HEPCLUDEX they will closely monitor your liver for at least six months after. They may also resume your treatment.

HEPCLUDEX (bulevirtide)

• you are allergic to or any of the other ingredients in HEPCLUDEX or to any part of the container

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take HEPCLUDEX. Talk about any health conditions or problems you may have, including if you:

• have decompensated liver disease which is an advanced liver disease where your liver is not working properly.
• have moderate to severe liver problems.
• have kidney problems.
• have human immunodeficiency virus (HIV).
• have hepatitis C virus.

Other warnings you should know about:

Pregnancy

HEPCLUDEX should not be used during pregnancy unless necessary. This is because it is not known how it might affect an unborn baby. Before you are given this medicine, tell your healthcare professional if you are pregnant, think you may be pregnant or are planning to become pregnant. Your healthcare professional will decide if you will be given HEPCLUDEX.

Breastfeeding

Tell your healthcare professional if you are breastfeeding or planning to breastfeed. It is not known if HEPCLUDEX passes into breastmilk. Ask your healthcare professional for advice before breastfeeding your baby.

Driving and using machines

HEPCLUDEX can cause dizziness and tiredness. This might affect your ability to safely drive and use machines.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with HEPCLUDEX:

• Carbamazepine, phenytoin, fosphenytoin, oxcarbazepine, eslicarbazepine, used to treat seizures
• Cyclosporine, tacrolimus, sirolimus, and everolimus, used to treat immune system disorders
• Ezetimibe, simvastatin, rosuvastatin, used to treat high cholesterol
• Indomethacin, used to treat inflammation and pain
• Irbesartan, used to treat high blood pressure
• Methylprednisolone, used to treat inflammation, allergies, or asthma
• Midazolam, a medicine to treat insomnia (inability to sleep) and for anaesthesia (to avoid pain during surgery)
• Nifedipine, used to treat high blood pressure
• Prochlorperazine, used to treat nausea and vomiting and psychiatric conditions
• Ritonavir, used to treat HIV infection
• Rosiglitazone, used to treat diabetes

HEPCLUDEX (bulevirtide)

• Sulfasalazine, used to treat arthritis, ulcerative colitis, or Crohn’s disease
• Warfarin, used to prevent blood clotting

How to take HEPCLUDEX:

• HEPCLUDEX will be prescribed to you and your treatment monitored by a healthcare professional who has experience in managing liver problems caused by viruses.
• Always take this medicine exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.

• Your healthcare professional will show you how to prepare and to inject HEPCLUDEX. Within the HEPCLUDEX carton you will find “Instructions for Use”. These instructions are also found at the end of the Patient Medication Information. The “Instructions for Use” is a step-by-step injection guide for patients and caregivers. Read these before you use HEPCLUDEX. Refer to them as needed after that. Especially, please note the following:

  • You must store HEPCLUDEX in the refrigerator (2–8 °C) before you prepare it for injection.
  • You must mix HEPCLUDEX with Sterile Water for Injection before you inject it.
  • The Sterile Water for Injection, syringe and needles you will need to prepare and inject HEPCLUDEX are all provided separately.
  • HEPCLUDEX and the Sterile Water for Injection, syringes and needles are all Single Use Only. Throw away all components after use, including any unused Sterile Water for Injection.
  • HEPCLUDEX must only be injected subcutaneously, meaning under the skin. It must not be injected by any other route.

Usual adult dose:

The usual dose is 2 mg once a day injected under the skin. Your healthcare professional will decide how long you should keep using HEPCLUDEX for.

Overdose:

If you think you, or a person you are caring for, have taken too much HEPCLUDEX, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

If you miss a dose, take it as soon as possible on the same day. If you were not able to take the missed dose on the same day, then take your next dose at the usual time. Never take a double dose to make up for a missed dose.

Possible side effects from using HEPCLUDEX:

These are not all the possible side effects you may have when taking HEPCLUDEX. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• Headache

HEPCLUDEX (bulevirtide)

• Itching
• Reactions at the injection site that may include swelling, redness, irritation, bruising, itchiness, rash, or local pain
• Dizziness
• Nausea
• Tiredness
• An increase in the level of bile salts in the blood
• An increase in white blood cells (eosinophils)

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store in the original package to protect from light. Store in refrigerator between 2°C-8°C.

Once mixed with Sterile Water for Injection, HEPCLUDEX must be used immediately.

Keep out of reach and sight of children.

Do not reuse the vials, syringe, needles, or any remaining Sterile Water for Injection. HEPCLUDEX and ancillary supplies are for single use only. Throw away all components after use, including unused Sterile Water for Injection.

HEPCLUDEX (bulevirtide)

If you want more information about HEPCLUDEX:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website: (https://health-products.canada.ca/dpd-bdpp/); the manufacturer’s website [www.gilead.ca], or by calling 1-866-207-4267.

Date of Authorization: 2026-05-14

Gilead Sciences, Inc.

Foster City, CA 94404

USA

Gilead Sciences Canada, Inc.

Mississauga, ON L5N 7K2

HEPCLUDEX^® is a trademark of Gilead Sciences, Inc. or its related companies.

All other marks referenced herein are the property of their respective owners.

© 2026 Gilead Sciences, Inc. All rights reserved.

e259704-GS-001

HEPCLUDEX (bulevirtide)

Instructions for Use: Step-by-step injection guide for patients / caregivers

Read the Patient Medication Information before you use HEPCLUDEX.

Before you begin treatment at home, your healthcare professional will show you how to prepare and inject HEPCLUDEX. This guide shows how to prepare and inject HEPCLUDEX. Talk to your healthcare professional if you have questions, or if you need more information or help. Take your time to carefully prepare and inject HEPCLUDEX.

If you have been prescribed HEPCLUDEX, but are unable to administer it yourself, these instructions for use are for your caregiver. They will prepare and inject HEPCLUDEX for you.

You will need the following items which are obtained separately from HEPCLUDEX:

• Vials with Sterile Water for Injection (referred to below as “sterile water”)
• Disposable syringes
• Longer needles (for HEPCLUDEX preparation)
• Shorter needles (for HEPCLUDEX injection)

Note: The supplies (needles, syringes, Sterile Water for Injection) not included in the HEPCLUDEX carton may slightly differ in size, shape and color from the figures shown in this step-by-step injection guide. These instructions provide the steps to mix and inject HEPCLUDEX using an example set of supplies. If you have any questions, talk to your healthcare professional or pharmacist.

Important! Do not reuse the HEPCLUDEX vial, syringe, needles or any remaining Sterile Water for Injection. These are all Single Use Only and must be thrown away after use.

Injection sites

Abdomen

Upper thighs

The best places to inject are the abdomen and upper thighs, as shown in the pictures. If administered by a healthcare professional or caregiver only, it can also be injected in the back of the upper arm. In order to reduce injection site reactions, you should change the site of HEPCLUDEX injection daily.

Do not inject HEPCLUDEX into the following areas: knee, groin, the lower or inner buttocks, directly over a blood vessel, around the navel (belly button), on scar tissue, a bruise, a mole, a surgical scar, tattoo or burn site, or where there is an injection site reaction.

HEPCLUDEX (bulevirtide)

1. 1. Before you inject

1A

1B

1C

1D

Storage

Preparing doses

Wash hands

Clean vial

HEPCLUDEX vials must be stored in the original packaging in the refrigerator (2–8 °C) in order to protect HEPCLUDEX from light.

The following instructions are for dissolving a single dose.

Wash your hands well using soap and warm water and dry them with a clean towel.

Once your hands are clean, do not touch anything else other than the medicine, supplies and the area around the injection site.

Wipe the vial top with a new alcohol pad and let the top air-dry.

If you touch the rubber top after cleaning it, clean it again with a new alcohol pad.

HEPCLUDEX (bulevirtide)

2A

2B

2C

Draw up sterile water

Inject sterile water into the powder

Gently mix HEPCLUDEX solution

Pick up the syringe. Put the longer needle (with cap) on the syringe.

Important! Be sure the capped needle is tight by pushing it down slightly while twisting it clockwise.

Pull off the plastic cap.

Open the vial of Sterile Water for Injection. Insert the needle in the vial and gently turn the water vial upside down. Make sure the tip of the needle is always below the surface of the water to help keep air bubbles from entering the syringe.

Slowly pull the plunger back to get 1 mL of sterile water into the syringe. Carefully remove the needle and syringe from the vial.

Gently tap the HEPCLUDEX vial to loosen the powder.

Insert the needle with sterile water all the way into the HEPCLUDEX vial by pushing it straight through the centre of the rubber stopper at a 90° angle.

Inject all the sterile water slowly.

Remove the needle from the vial and put the syringe and needle somewhere safe.

Gently tap the HEPCLUDEX vial with your fingertip for 10 seconds to start dissolving the powder.

Then gently swirl or roll the vial between your hands to ensure thorough mixing. Make sure no powder is stuck to the vial wall.

Important! Do not shake the vial. Shaking will make the medicine foam, and it will take much longer to dissolve.

1. 2. Mix the injection

HEPCLUDEX (bulevirtide)

2D

2E

2F

Wait for HEPCLUDEX to fully dissolve

HEPCLUDEX ready for injection

Clean vial

Once the powder starts to dissolve, set it aside and it will completely dissolve.

After tapping, it could take up to 3 minutes to dissolve.

When mixed completely, the HEPCLUDEX solution should be clear.

Important! Completely dissolved HEPCLUDEX should be clear and without foam.

If the solution appears foamy or yellowish, allow more time for it to dissolve.

If you see bubbles, gently tap the vial until they disappear.

If you see any particles in the solution once it is completely dissolved, do not use that vial. Contact your healthcare professional that provided it.

Dissolved HEPCLUDEX must be used right away.

Clean the HEPCLUDEX vial top again, using a new alcohol pad.

Allow it to air dry.

HEPCLUDEX (bulevirtide)

3A

Insert needle into vial

3B

Draw up HEPCLUDEX

3C

Finishing preparation

3D

Change and discard the needle

Pick up the syringe with the long needle attached.

Re-insert the needle all the way into the HEPCLUDEX vial by pushing it straight through the centre of the rubber stopper at a 90° angle.

Gently turn the vial upside down.

Make sure the tip of the needle is always below the surface of the HEPCLUDEX solution to help keep air bubbles from entering the syringe. Slowly pull the plunger to get 1 mL of HEPCLUDEX.

To be sure you end up with 1 mL of HEPCLUDEX in the syringe, you may need to pull the plunger past the 1 mL mark on the syringe.

Gently tap or flick the syringe and push / pull the plunger to remove extra air and bubbles.

Carefully remove the needle and syringe from the vial.

Important! Discard the vial after use, including any unused excess liquid.

Remove the longer needle from the syringe and dispose of it properly into a sharps disposal container so that nobody can be injured.

Important! Do not put the plastic cap back on the needle.

1. 3. Inject a dose

HEPCLUDEX (bulevirtide)

3E

3F

3G

3H

Attach needle for injection

Choose the injection site

Fold back safety shield (if applicable)

Remove needle cap

Place the shorter needle with cap on the syringe.

Important! Be sure the capped needle is tightly attached to the syringe by pushing it down slightly while twisting it clockwise.

Note: The shorter needle may or may not have a safety shield on the side.

Choose a site different from the one you used for your last injection.

Clean the injection site with a new alcohol pad.

Start in the centre, apply pressure and clean in a circular motion, working outward.

Important! Allow site to air-dry.

Note: If there is no safety shield on the injection needle, go directly to Step 3H.

Hold the syringe with one hand and fold the safety shield back towards the syringe.

Do not remove the needle safety shield from the injection needle.

Carefully pull off the injection needle plastic cap.

Do not touch the needle or allow it to touch any other surface.

HEPCLUDEX (bulevirtide)

3I

3J

3K

3L

Prepare injection site

Inject HEPCLUDEX

After injecting, cover needle with safety shield (if applicable)

Dispose of the needle properly

Pinch and hold a fold of cleaned skin around the injection site.

Pierce the skin at a 45° angle. The needle should be inserted all the way in.

Slowly push the plunger all the way to inject HEPCLUDEX.

Remove the needle from the skin.

Note: If there is no safety shield on the injection needle, go directly to Step 3L.

Place the injection needle safety shield on the work surface.

Press the needle toward the safety shield to cover the needle and lock the safety shield.

Do not touch the needle.

Do not remove the needle from the syringe.

Throw away (dispose of) the used syringe and injection needle into the sharps disposal container so that nobody can be injured.