Hepcludex® (bulevirtide-gmod)
Is it safe to use HEPCLUDEX when pregnant or breastfeeding?
Gilead Sciences, Inc. is providing this letter in response to your unsolicited request for medical information. It is not promotional. It is intended for a US audience 18 years or older.
Gilead Sciences, Inc. is providing this letter in response to your unsolicited request for medical information. It is not promotional. It is intended for a US audience 18 years or older.
Is it safe to use HEPCLUDEX when pregnant or breastfeeding?
This information is provided in response to your question. It is not treatment advice on how to use HEPCLUDEX. Please discuss this question and others you have about your medical condition or treatment with your healthcare provider.
Download the HEPCLUDEX Patient Information for more details, including approved use(s) and important warnings:
www.gilead.com/-/media/files/pdfs/medicines/hdv/hepcludex/hepcludex_pi
The short answer1
It is not known if HEPCLUDEX can harm your unborn baby.
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It is not known if HEPCLUDEX can pass into your breast milk. | |
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What is the most important information I should know about HEPCLUDEX?1
HEPCLUDEX has an important warning for: Worsening of HBV and HDV infection. Your HBV or HDV infection may get worse (flare-up) if you take HEPCLUDEX and then stop taking it, especially if you have cirrhosis. A “flare-up” is when your HDV or HBV infection suddenly returns in a worse way than before.
| Do not stop taking HEPCLUDEX without first talking to your healthcare provider. |
- Do not run out of HEPCLUDEX. Refill your prescription or talk to your healthcare provider before your HEPCLUDEX is all gone.
- If you stop taking HEPCLUDEX, your healthcare provider will need to check your health often and do blood tests regularly for at least 6 months to check your liver, and may give you medicine to treat your virus infection.
- Tell your healthcare provider about any new or unusual symptoms after you stop HEPCLUDEX.
- If your HBV or HDV flares up, it may need to be treated again.
Who is HEPCLUDEX for?1
HEPCLUDEX is a prescription medicine used to treat chronic (long-lasting) hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis.
It is not known if HEPCLUDEX is safe and effective in children less than 18 years of age.
Is it safe to use HEPCLUDEX when pregnant or breastfeeding?1
It is not known if HEPCLUDEX can harm your unborn baby.
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It is not known if HEPCLUDEX can pass into your breast milk. | |
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Glossary
Compensated cirrhosis: When some liver damage has occurred, but the non‑damaged part of the liver is still healthy enough to work.
HBV (hepatitis B virus) infection: a type of virus (HBV) that can cause serious liver infection.
HDV (hepatitis D virus) infection: a type of virus (HDV) that can cause serious liver infection. HDV only develops in patients with HBV.
Reference
1. Enclosed. Gilead Sciences Inc. HEPCLUDEX® (bulevirtide-gmod) injection, for subcutaneous use. US Prescribing Information. Foster City, CA.
More information about HEPCLUDEX
If you would like more detailed information about HEPCLUDEX, please visit:
www.gilead.com/-/media/files/pdfs/medicines/hdv/hepcludex/hepcludex_pi
This is the US FDA-approved Prescribing Information, including the Patient Labeling, for HEPCLUDEX. It will tell you about the uses, warnings, and other important safety information about HEPCLUDEX.
Important note
Gilead Sciences, Inc. is providing this letter in response to your unsolicited request for medical information. Some of the information included in this letter may not be covered in the US FDA- approved Prescribing Information for HEPCLUDEX. Gilead Sciences, Inc. does not intend this letter to be used as medical advice and does not promote use of HEPCLUDEX in a way that has not been approved by the FDA. Please discuss this question and others you may have about your medical condition or treatment with your healthcare provider.
Follow-Up
For any additional questions, please contact Gilead Medical Information at:
☎1‐866‐MEDI‐GSI (1‐866‐633‐4474) or https://www.patient.askgileadmedical.com/
Reporting side effects
Please report all adverse events to:
Gilead Global Patient Safety ☎ 1-800-445-3235, option 3 or
www.gilead.com/utility/contact/report-an-adverse-event
FDA MedWatch Program by ☎ 1-800-FDA-1088 or MedWatch, FDA, 5600 Fishers Ln, Rockville, MD 20852 or www.accessdata.fda.gov/scripts/medwatch
Data Privacy
The Medical Information service at Gilead Sciences may collect, store, and use your personal information to provide a response to your medical request. We may share your information with other Gilead Sciences colleagues to ensure that your request is addressed appropriately. If you report an adverse event or concern about the quality of a Gilead or Kite product, we will need to use the information you have given us in order to meet our regulatory requirements in relation to the safety of our medicines.
It may be necessary for us to share your information with Gilead’s affiliates, business partners, service providers, and regulatory authorities located in countries besides your own. Gilead Sciences has implemented measures to protect the personal information you provide. Please see the Gilead Privacy Statement (www.gilead.com/privacy-statements) for more information about how Gilead handles your personal information and your rights. If you have any further questions about the use of your personal information, please contact gilead.privacy@gilead.com.
HEPCLUDEX, GILEAD, and the GILEAD logo are registered trademarks of Gilead Sciences, Inc., or its related companies.
© 2026 Gilead Sciences, Inc.
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Do you want to report a side effect or other concern about a Gilead medicine?
Report side effects
To report a side effect or unexpected reaction (sometimes called an “adverse event”) please call 1-800-445-3235 (option #3), available 24 hours a day, 7 days a week.
Product complaints
To report issues with our products, like defects or package errors, please call 1-800-445-3235 (option #2) available Monday – Friday, 8am – 5pm PT, or email QualityComplaints@gilead.com.
FDA MedWatch
To report a side effect or product quality concern directly to the U.S. Food and Drug Administration (FDA), please call 1-800-FDA-1088 or email www.fda.gov/MedWatch.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch.