Entecavir

The label describes entecavir for chronic hepatitis B virus infection in adults and children at least 2 years old.

It applies when there is active viral replication together with persistently raised liver enzymes (ALT or AST) or active liver disease on biopsy.

• Chronic hepatitis B infection
• Adults and children 2 years and older
• Active viral replication with liver inflammation

The label describes entecavir as an antiviral drug against the hepatitis B virus. It is a nucleoside analogue reverse transcriptase inhibitor.

The label we reviewed does not give more detail on how it works.

This page covers the US label for entecavir tablets taken by mouth, with the dosing the label gives for adults and, where the label says so, children.

This is label-level information, not personal advice. Indian pack labels may differ, and your prescriber's instruction always comes first.

The label says entecavir should be taken on an empty stomach, at least 2 hours after a meal and 2 hours before the next meal.

For adults and teens 16 and older, the label describes once-daily dosing. The amount differs if the person is new to treatment, has lamivudine resistance, or has decompensated liver disease.

For children 2 years and older, dosing is based on weight, and the oral solution is used up to a body weight of 30 kg. Dose adjustment is recommended when kidney function is reduced.

• Empty stomach
• Once daily
• Dose depends on treatment history and liver status
• Weight-based for children

The boxed warning says severe hepatitis B flares have been reported after stopping treatment. Liver function should be monitored closely for at least several months after stopping.

It also warns that treating HBV in people with untreated HIV may lead to HIV resistance, so it is not recommended unless they also receive effective HIV therapy.

The boxed warning mentions lactic acidosis and severe liver enlargement with fat, including fatal cases. The label lists no contraindications.

Pregnancy data in the registry are not enough to judge risk.

• Do not stop without medical advice
• Hepatitis flares after stopping
• HIV co-infection
• Lactic acidosis and liver enlargement
• Reduced kidney function

• Drugs that affect kidney function
• Drugs competing for kidney removal
• The label says entecavir is cleared mainly by the kidneys.
• Drugs that reduce kidney function or compete for removal may raise levels of either drug.
• Lamivudine, adefovir dipivoxil and tenofovir disoproxil fumarate showed no significant interactions.

No match in this label text. Ask your pharmacist about any medicine you take.

The label gives a storage range of 15 to 30 degrees C.

The label also says to protect it from light, keep the container tightly closed.

Follow the storage line on your own pack, and keep medicines out of the reach of children.

We did not find entecavir in the Drugs Rules 1945 Schedule H, H1, X or G rows we checked, so we cannot state its Indian prescription status from our lists. Ask your pharmacist or doctor.

We did not find entecavir on the National List of Essential Medicines 2022 in the list we checked.

NPPA lists ceiling prices for scheduled entecavir formulations. The table shows the rows we found. Check NPPA directly for the current list.

The Jan Aushadhi (PMBJP) list we checked has 1 product row that mention entecavir. We did not capture prices for them.

NPPA ceiling prices set the most a seller can charge per unit for the listed formulations, before local taxes. They are ceilings, not the price you will always pay.

Jan Aushadhi lists entecavir products including Entecavir Tablets IP 0.5 mg 0.5 mg. We have not shown a price for them. Check the pack and the seller for the actual price.