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Serious Warnings and Precautions: Severe worsening of hepatitis (liver inflammation) has occurred in patients who have stopped taking anti-hepatitis B therapy (including pms-ENTECAVIR). The doctor will monitor the patient's condition in this case and may resume therapy.
Lactic acidosis (increase in acid level of blood) and severe hepatomegaly with steatosis (enlarged fatty liver), including fatal cases have been reported in patients using nucleoside analogue medicines, including pms-ENTECAVIR, either alone or in combination. Reports of lactic acidosis with pms-ENTECAVIR often involved patients who were seriously ill due to their liver disease or other medical condition. Lactic acidosis is a medical emergency and must be treated in the hospital.
Hepatitis B infection may get worse or become very serious if pms-ENTECAVIR is stopped.
Take pms-ENTECAVIR exactly as prescribed.
Do not run out of pms-ENTECAVIR.
Do not stop pms-ENTECAVIR without talking to the healthcare provider.
The healthcare provider will need to monitor the patient's health and do regular blood tests to check the liver if he/she stops pms-ENTECAVIR. Tell the healthcare provider right away about any new or unusual symptoms noticed after stopping taking pms-ENTECAVIR.
If the patient has or gets HIV (human immunodeficiency virus) infection be sure to discuss the treatment with the doctor. If he/she is taking pms-ENTECAVIR to treat chronic hepatitis B and is not taking medicines for HIV at the same time, some HIV treatments that he/she takes in the future may be less likely to work. The patient is advised to get an HIV test before starting pms-ENTECAVIR and anytime after that when there is a chance he/she was exposed to HIV. pms-ENTECAVIR will not help the HIV infection.
BEFORE using pms-ENTECAVIR talk to the doctor or pharmacist about all of the medical conditions, including if the patient: Has had a liver transplant;
Has kidney problems. The doctor may need to adjust the pms-ENTECAVIR dose or dose schedule.
Has diabetes;
Is pregnant or planning to become pregnant. It is not known if pms-ENTECAVIR is safe to use during pregnancy. It is not known whether pms-ENTECAVIR helps prevent a pregnant mother from passing HBV to her baby. The patient and healthcare provider will need to decide if pms-ENTECAVIR is right for the patient. If the patient uses pms-ENTECAVIR while pregnant, talk to the healthcare provider about the pms-ENTECAVIR Pregnancy Registry.
Is breast-feeding. It is not known if pms-ENTECAVIR can pass into the breast milk or if it can harm the baby. Do not breast-feed if taking pms-ENTECAVIR.
Is lactose intolerant. pms-ENTECAVIR tablets contain lactose. If the patient has been told that he/she has intolerance to some sugars, contact the doctor before taking this medicine.
Tell the healthcare provider about all the medicines being taken including prescription and non-prescription medicines, vitamins, and herbal supplements. pms-ENTECAVIR may interact with other medicines that leave the body through the kidneys.
Know the medicines the patient is taking. Keep a list of medicines with the patient to show his/her healthcare provider and pharmacist.
Does pms-ENTECAVIR lower the risk of passing HBV to others? pms-ENTECAVIR does not stop the patient from spreading HBV to others by sex, sharing needles, or being exposed to blood. Talk to the healthcare provider about safe sexual practices that protect the partner. Never share needles. Do not share personal items that can have blood or body fluids on them, like toothbrushes or razor blades. A shot (vaccine) is available to protect people at risk from becoming infected with HBV.
