Approved Use & Safety Info
Approved Use
Important Safety Information
Approved Use
What is HIBSAGO?
HIBSAGO is a prescription medicine used with nucleos(t)ide analog reverse transcriptase inhibitors (NrtIs) to treat adults with chronic hepatitis B virus (HBV) infection who do not have cirrhosis (advanced liver disease), have taken an NrtI for at least 6 months, have undetectable HBV DNA, and have an HBV surface antigen (HBsAg) level of 3,000 IU/mL or less.
Important Safety Information
What is the most important information I should know about HIBSAGO?
HIBSAGO may cause serious side effects, including:
- flare-ups in liver enzyme levels during treatment measured using liver function blood tests. Tell your healthcare provider right away if you get any of these symptoms:
- upper right stomach pain
- dark or “tea-colored” urine
- yellowing of your skin or the white part of your eyes
- nausea or vomiting
- loss of appetite
- low platelet counts (thrombocytopenia), which can happen at any time during treatment, suddenly and without warning, and can be life-threatening. Stop using HIBSAGO and tell your healthcare provider right away if you get any of these symptoms:
- unusual bruising or a rash of tiny reddish-purple spots
- bleeding from skin cuts that does not stop or oozes
- bleeding from your gums or nose
- blood in your urine or stools
- abnormal or heavy periods (menstrual bleeding)
- sudden severe headaches or neck stiffness
- bleeding into the whites of your eyes
Your healthcare provider will check your liver and platelet count with blood tests before and during treatment, and for up to 24 weeks after you stop HIBSAGO if results are abnormal.
Who should not use HIBSAGO?
Do not use HIBSAGO if you have:
- a condition where your liver is currently not working as well as it should
- advanced liver disease (cirrhosis)
- low platelet counts.
Before using HIBSAGO, tell your healthcare provider about all of your medical conditions, including if you:
- have or had bleeding problems
- have kidney problems
- have received an organ transplant
- have an immune system problem (autoimmune disease) or a history of blood vessel inflammation (vasculitis)
- have hepatitis D. HIBSAGO is not recommended if you have hepatitis D because it may increase the chance of liver enzyme flare-ups.
- are pregnant or plan to become pregnant. It is not known if HIBSAGO will harm your unborn baby.
- are breastfeeding or plan to breastfeed. HIBSAGO may pass into your breast milk.
Tell your healthcare provider about all the medicines you take, especially:
- medicines that prevent blood clotting or lower your platelet count.
- medicines that may lower your kidney function.
- peginterferon alfa-2a.
What are the possible side effects of HIBSAGO?
HIBSAGO may cause these additional serious side effects, including:
- Worsening kidney function. Your healthcare provider will check your kidneys with blood tests before and during treatment, and for up to 12 weeks after you stop HIBSAGO if results are abnormal.
- Inflammatory or immune system problems. Tell your healthcare provider if you get flu-like symptoms; purple rashes or spots on legs; scaly, raised, or red patches; swelling and itchiness; or joint pain that does not go away.
- Serious side effects when HIBSAGO is not injected correctly. Rotate injection sites each week, keep the two weekly injections at least 2 inches (5 cm) apart, and do not inject into skin that is tender, bruised, red, or hard.
- The most common side effects of HIBSAGO include: injection site reactions, fever, tiredness, and headache.
These are not all the possible side effects of HIBSAGO. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Please see full Prescribing Information, including Boxed Warning and Medication Guide, for HIBSAGO.
