What is the most important information I should know about HEPCLUDEX?

HEPCLUDEX may cause serious side effects, including:

Worsening of hepatitis delta virus (HDV) and hepatitis B virus (HBV) infection. Your HDV or HBV infection may get worse (flare-up) if you stop taking HEPCLUDEX, 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, as they will need to monitor health regularly to check your liver.

Severe allergic reactions (anaphylaxis). Stop taking HEPCLUDEX and call your healthcare provider or emergency medical help right away if you develop any of the following signs or symptoms: trouble swallowing or breathing, swelling of the mouth, lips, tongue or face, throat tightness, dizziness or fainting, severe rash, hives or itching, stomach area pain, nausea, diarrhea, or vomiting.

What are the other possible side effects of HEPCLUDEX?

The most common side effects of HEPCLUDEX are injection site reactions (including infection, redness, itching, swelling, bruising, rash, and pain at the injection site), headache, stomach area pain, feeling tired, and itchy skin. These are not all the possible side effects of HEPCLUDEX. Tell your healthcare provider if you have any side effects that bother you or don’t go away.

What should I tell my healthcare provider before taking HEPCLUDEX?

All your medical conditions, including:

If you are pregnant or plan to become pregnant. It is not known if HEPCLUDEX can harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with HEPCLUDEX.

If you are breastfeeding or plan to breastfeed. It is not known if HEPCLUDEX can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with HEPCLUDEX.

All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not start a new medicine without telling your healthcare provider.

How should I take HEPCLUDEX?

See the detailed Instructions for Use that is provided with HEPCLUDEX for information on how to prepare and inject HEPCLUDEX.

• HEPCLUDEX is given as an injection under your skin (subcutaneous) by you or a caregiver.
• Make sure you or your caregiver are trained by your healthcare provider on how to prepare and inject HEPCLUDEX before you take it for the first time.
• Do not reuse the vials, syringe, needles, or any remaining Sterile Water for Injection.
• Take HEPCLUDEX exactly as your healthcare provider tells you to take it.
• Take HEPCLUDEX 1 time each day.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see Patient Prescribing Information for HEPCLUDEX, including Important Warnings and Instructions for Use.