Hepcludex (Subcutaneous)
Bulevirtide is used to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis.
Bulevirtide may also be used for purposes not listed in this medication guide.
warnings
What is the most important information I should know about Hepcludex (Subcutaneous)?
You should not use bulevirtide if you are allergic to it.
It is not known if bulevirtide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Ask your doctor if it is safe to breastfeed while using this medicine.
Side Effects
What are the side effects of Hepcludex (Subcutaneous)?
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- new or worsening symptoms of hepatitis--right-sided upper stomach pain, vomiting, loss of appetite, yellowing of your skin or eyes, and not feeling well.
Common side effects may include:
- headache, stomach pain;
- itching;
- feeling very tired; or
- pain, bruising, swelling, or irritation where the medicine was injected.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Pregnancy & Breastfeeding
Can I take Hepcludex (Subcutaneous) if I’m pregnant or breastfeeding?
It is not known if bulevirtide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Ask your doctor if it is safe to breastfeed while using this medicine.
Interactions
What drugs and food should I avoid while taking Hepcludex (Subcutaneous)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Dosage Guidelines & Tips
How to take Hepcludex (Subcutaneous)?
Use Hepcludex (Subcutaneous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Bulevirtide is injected under the skin, usually once per day. A healthcare provider may give you this injection or may teach you or your caregiver how to properly use this medicine by yourself.
Read and carefully follow the Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand how to use an injection.
Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.
Use the medication right away after mixing.
Your healthcare provider will show you where to inject bulevirtide. Avoid injection within 1 inch of your navel (belly button) or into skin that is red, hard, tender, bruised, or injured, or into areas with moles, scars, or tattoos. Do not inject into the same place two times in a row.
Each needle, syringe, or vial is for one use only. Throw away after one use, even if there is still medicine left inside. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.
Your doctor will check your progress on a regular basis and will determine how long you should continue treatment.
Do not change your dose or stop using this medicine without your doctor's advice.
You will need regular blood tests for at least 6 months to check your liver function after stopping this medicine.
Store at room temperature away from moisture and heat.
Use the medicine as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use two doses at one time.
Get your prescription refilled before you run out of medicine completely.