Patient Medication Information: uses, side effects, how to take - Entecavir
ABOUT THIS MEDICATION
What the medication is used for:
ENTECAVIR is a prescription medicine used for chronic infection with hepatitis B virus (HBV) in adults who also have active liver damage.
What it does:
- ENTECAVIR may lower the amount of HBV in the body
ENTECAVIR may lower the ability of HBV to multiply and
infect new liver cells
- ENTECAVIR may reduce the damage to the liver by HBV
ENTECAVIR will not cure HBV infection.
It is important to stay under your healthcare provider’s care while taking ENTECAVIR. Your healthcare provider will test the level of the hepatitis B virus in your blood regularly.
When it should not be used:
Do not take ENTECAVIR if you are allergic to any of its ingredients. The active ingredient in ENTECAVIR is entecavir. See “What the nonmedicinal ingredients are” for a complete list of ingredients in ENTECAVIR.
Tell your healthcare provider if you think you have had an allergic reaction to any of these ingredients.
ENTECAVIR has not been studied in children and is not recommended for anyone less than 16 years old.
What the medicinal ingredient is:
Entecavir
What the nonmedicinal ingredients are:
Crospovidone, Ethyl Alcohol (present in trace amounts), Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol (part. hydrolyzed), Talc, Titanium Dioxide, and the following:
1 mg tablet also contains: Red Iron Oxide
What dosage forms it comes in:
Film-Coated Tablets: 0.5 mg and 1 mg
Does ENTECAVIR lower the risk of passing HBV to others? ENTECAVIR does not stop you from spreading HBV to others by sex, sharing needles, or being exposed to your blood. Talk to your healthcare provider about safe sexual practices that protect your 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.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
Severe worsening of hepatitis (liver inflammation) has occurred in patients who have stopped taking anti- hepatitis B therapy (including ENTECAVIR). Your doctor will monitor your 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 ENTECAVIR, either alone or in combination. Reports of lactic acidosis with 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. Call your healthcare provider right away if you get any of the signs of lactic acidosis (see table Serious Side Effects and What to do About them).
Your hepatitis B infection may get worse or become very serious if you stop ENTECAVIR.
- take ENTECAVIR exactly as prescribed
- do not run out of ENTECAVIR
- do not stop ENTECAVIR without talking to your healthcare provider
Your healthcare provider will need to monitor your health and do regular blood tests to check your liver if you stop ENTECAVIR. Tell your healthcare provider right away about any new or unusual symptoms that you notice after you stop taking ENTECAVIR.
If you have or get HIV (human immunodeficiency virus) infection be sure to discuss your treatment with your doctor. If you are taking ENTECAVIR to treat chronic hepatitis B and are not taking medicines for your HIV at the same time, some HIV treatments that you take in the future may be less likely to work. You are advised to get an HIV test before you start taking ENTECAVIR and anytime after that when there is a chance you were exposed to HIV. ENTECAVIR will not help your HIV infection.
BEFORE you use ENTECAVIR talk to your doctor or pharmacist about all of your medical conditions, including if you:
- have had a liver transplant.
- have kidney problems. Your doctor may need to adjust your ENTECAVIR dose or dose schedule.
- have diabetes.
are pregnant or planning to become pregnant. I t is not known
if ENTECAVIR is safe to use during pregnancy. It is not known whether ENTECAVIR helps prevent a pregnant mother from passing HBV to her baby. You and your healthcare provider will need to decide if ENTECAVIR is right for you. If you use ENTECAVIR while you are pregnant, talk to your healthcare provider about the antiretroviral Pregnancy Registry.
are breast-feeding. It is not known if ENTECAVIR can pass into
your breast milk or if it can harm your baby. Do not breast-feed if you are taking ENTECAVIR.
are lactose intolerant. ENTECAVIR tablets contain lactose. If you have been told that you have intolerance to some sugars, contact your doctor before taking this medicine.
Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. ENTECAVIR may interact with other medicines that leave the body through the kidneys.
Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist.
INTERACTIONS WITH THIS MEDICATION
ENTECAVIR may interact with other medicines that leave the body through the kidneys.
PROPER USE OF THIS MEDICATION
Take ENTECAVIR exactly as prescribed. Your healthcare provider will tell you how much ENTECAVIR to take. Your dose will depend on whether you have been treated for HBV infection before and what medicine you took.
Usual dose:
The usual dose of ENTECAVIR tablets in adults and children over 16 years of age is 0.5 mg to 1 mg once daily by mouth. Your dose may be lower or you may take ENTECAVIR less often than once a day, if you have kidney problems.
Take ENTECAVIR once a day on an empty stomach to help it
work better. Empty stomach means at least 2 hours after a meal and at least 2 hours before the next meal. To help you remember to take your ENTECAVIR, try to take it at the same time each day.
Do not change your dose or stop taking ENTECAVIR without
talking to your healthcare provider. Your hepatitis B symptoms may get worse or become serious if you stop taking ENTECAVIR. After you stop taking ENTECAVIR, it is important to stay under your healthcare provider’s care. Your healthcare provider will need to do regular blood tests to check your liver.
When your supply of ENTECAVIR starts to run low, get more
from your healthcare provider or pharmacy. Do not run out of ENTECAVIR.
Overdose:
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose:
If you forget to take ENTECAVIR, take it as soon as you remember and then take your next dose at its regular time. If it is almost time for your next dose, skip the missed dose. Do not take two doses at the same time. Call your healthcare provider or pharmacist if you are not sure what to do.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
The most common side effects of ENTECAVIR are headache, tiredness, dizziness, and nausea. Rash has also been reported. Less common side effects include diarrhea, indigestion, vomiting, sleepiness, and trouble sleeping. In some patients, the results of blood tests that measure how the liver or pancreas is working may worsen.
SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM
| Symptom / effect | Talk with your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Lactic acidosis (high level of lactic acid in the blood) Symptoms: | |||
| Feeling very weak or tired | √ | ||
| Unusual (not normal) muscle pain | √ | ||
| Trouble breathing | √ | ||
| Stomach pain with nausea and vomiting | √ | ||
| Feeling cold especially in arms and legs | √ | ||
| Feeling dizzy or lightheaded | √ | ||
| Fast or irregular heartbeat | √ | ||
Worsening hepatitis (inflamed liver), liver enlargement (hepatomegaly) or fatty liver Symptoms: | |||
| Skin or the white part of eyes turn yellow (jaundice) | √ | ||
SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM
| Symptom / effect | Talk with your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Dark urine | √ | ||
| Bowel movements (stools) turn light in colour | √ | ||
| Nausea | √ | ||
| Lower stomach pain | √ | ||
| Loss of appetite for several days or longer | √ | ||
This is not a complete list of side effects. For any unexpected effects while taking ENTECAVIR, contact your doctor or pharmacist.
HOW TO STORE IT
ENTECAVIR Tablets should be stored between 15°C and 30°C.
Do not store ENTECAVIR Tablets in a damp place such as a bathroom medicine cabinet or near the kitchen sink.
Keep the container tightly closed.
Discard ENTECAVIR when it is outdated or no longer needed by returning the unused portion to your pharmacist for proper disposal.
Keep ENTECAVIR and all medicines out of the reach and sight of children and pets.
General Information
Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use ENTECAVIR for a condition for which it was not prescribed. Do not give ENTECAVIR to other people, even if they have the same symptoms you have. It may harm them. The leaflet summarizes the most important information about ENTECAVIR. If you would like more information, talk with your healthcare provider.
REPORTING SIDE EFFECTS
You can report any suspected side effects associated with the use of health products to Health Canada by:
Visiting the Web page on Adverse Reaction Reporting
(https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
If you want more information about ENTECAVIR:
- Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website:
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; or by calling the manufacturer, Sanis Health Inc. at 1-866-236-4076 or by emailing quality@sanis.com.
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
www.sanis.com