Entecavir

What is Entecavir?

• Entecavir (BARACLUDE) is a hepatitis B virus nucleoside analogue reverse transcriptase inhibitor used in the treatment of hepatitis B virus (HBV) infection.

Entecavir

Entecavir ball-and-stick model

What are the uses of this medicine?

• BARACLUDE is a prescription medicine used to treat chronic hepatitis B virus (HBV) in adults and children 2 years of age and older who have active liver disease.

• BARACLUDE will not cure HBV.
• BARACLUDE may lower the amount of HBV in the body.
• BARACLUDE may lower the ability of HBV to multiply and infect new liver cells.
• BARACLUDE may improve the condition of your liver.
• It is not known whether BARACLUDE will reduce your chances of getting liver cancer or liver damage (cirrhosis), which may be caused by chronic HBV infection.
• It is not known if BARACLUDE is safe and effective for use in children less than 2 years of age.

How does this medicine work?

• Entecavir (en tek' a vir) is a guanosine analogue with potent activity against HBV and minimal activity against HIV.
• Entecavir is phosphorylated intracellularly where it acts by competing with guanosine for uptake by the HBV DNA polymerase and incorporation into the growing HBV DNA molecule, leading to inhibition of polymerase activity and chain termination.
• Entecavir lowers HBV DNA levels and leads to improvements in serum aminotransferase levels in the majority of patients.
• Long term therapy is well tolerated and antiviral resistance to entecavir is rare.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• coadministration of BARACLUDE with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
• Coadministration of entecavir with lamivudine, adefovir dipivoxil, or tenofovir disoproxil fumarate did not result in significant drug interactions.

Is this medicine FDA approved?

• Entecavir was approved by the FDA in 2005 and is currently widely used.

How should this medicine be used?

Recommended dosage: If Nucleoside-inhibitor-treatment-naïve with compensated liver disease (greater than or equal to 16 years old):

• 0.5 mg once daily.

If Nucleoside-inhibitor-treatment-naïve and lamivudine-experienced pediatric patients at least 2 years of age and weighing at least 10 kg:

• dosing is based on weight.

If Lamivudine-refractory or known lamivudine or telbivudine resistance substitutions (greater than or equal to 16 years old):

• 1 mg once daily.

In adults with decompensated liver disease :

• 1 mg once daily.

Renal impairment:

• Dosage adjustment is recommended if creatinine clearance is less than 50 mL/min.

Administration:

• Take BARACLUDE on an empty stomach, at least 2 hours after a meal and at least 2 hours before the next meal.
• BARACLUDE Oral Solution should be swallowed directly from the dosing spoon.
• BARACLUDE Oral Solution should not be mixed with water or any other liquid.
• After each use, rinse the dosing spoon with water and allow it to air dry.
• If you lose the dosing spoon, call your pharmacist or healthcare provider for instructions.
• Do not change your dose or stop taking BARACLUDE without talking to your healthcare provider.
• If you miss a dose of BARACLUDE, 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.
• When your supply of BARACLUDE starts to run low, call your healthcare provider or pharmacy for a refill. Do not run out of BARACLUDE.
• If you take too much BARACLUDE, call your healthcare provider or go to the nearest emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 0.5 mg and 1 mg
• Oral solution: 0.05 mg/mL

This medicine is available in fallowing brand namesː

• BARACLUDE

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• tiredness
• dizziness
• nausea

BARACLUDE may cause serious side effects include:

• hepatitis B virus (HBV) infection may get worse
• Lactic acidosis
• HIV virus may develop resistance
• Serious liver problems

What special precautions should I follow?

• Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. Inform patients that discontinuation of anti-hepatitis B therapy, including BARACLUDE, may result in severe acute exacerbations of hepatitis B. Advise the patient to not discontinue BARACLUDE without first informing their healthcare provider.
• BARACLUDE has not been evaluated in HIV/HBV co-infected patients who were not simultaneously receiving effective HIV treatment. Inform patients that if they have or develop HIV infection and are not receiving effective HIV treatment, BARACLUDE may increase the risk of development of resistance to HIV medication.
• Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogue inhibitors, including BARACLUDE, alone or in combination with antiretrovirals. Advise patients to contact their healthcare provider immediately and stop BARACLUDE if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity.
• Inform patients that it is important to take BARACLUDE on a regular dosing schedule on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal) and to avoid missing doses as it can result in development of resistance.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• There is limited experience of entecavir overdosage reported in patients.

Management of overdosage:

• If overdose occurs, the patient must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary.
• Following a single 1 mg dose of entecavir, a 4-hour hemodialysis session removed approximately 13% of the entecavir dose.

Can this medicine be used in pregnancy?

• It is not known if BARACLUDE will harm your unborn baby.
• If you take BARACLUDE while you are pregnant, talk to your healthcare provider about how you can take part in the BARACLUDE Antiretroviral Pregnancy Registry. The purpose of the pregnancy registry is to collect information about the health of you and your baby.

Can this medicine be used in children?

• It is not known if BARACLUDE is safe and effective for use in children less than 2 years of age.

What are the active and inactive ingredients in this medicine?

• Active ingredient: entecavir
• Inactive ingredients in BARACLUDE Tablets: lactose monohydrate, microcrystalline cellulose, crospovidone, povidone, magnesium stearate.
• Tablet film-coat: titanium dioxide, hypromellose, polyethylene glycol 400, polysorbate 80 (0.5 mg tablet only), and iron oxide red (1 mg tablet only).
• Inactive ingredients in BARACLUDE Oral Solution: maltitol, sodium citrate, citric acid, methylparaben, propylparaben, and orange flavor.

Who manufactures and distributes this medicine?

Distributed by:

• Bristol-Myers Squibb Company
• Princeton, NJ

What should I know about storage and disposal of this medication?

• Store BARACLUDE Tablets or Oral Solution at room temperature, between 68°F and 77°F (20°C and 25°C).
• Keep BARACLUDE Tablets in a tightly closed container.
• Store BARACLUDE Tablets or BARACLUDE Oral Solution in the original carton, and keep the carton out of the light.
• Safely throw away BARACLUDE that is out of date or no longer needed. Dispose of unused medicines through community take-back disposal programs when available or place BARACLUDE in an unrecognizable closed container in the household trash.

Antiviral agents

Drugs for HIV Infection, in the Subclass Antiretroviral Agents

• Fusion Inhibitors (HIV)
  • Enfuvirtide, Maraviroc

• Integrase Inhibitors (HIV)
  • Dolutegravir, Elvitegravir, Raltegravir

• Monoclonal Antibodies
  • Ibalizumab

• Nonnucleoside Reverse Transcriptase Inhibitors (HIV)
  • Delavirdine, Efavirenz, Etravirine, Nevirapine, Rilpivirine

• Nucleoside Analogues (HIV)
  • Abacavir, Didanosine, Emtricitabine, Lamivudine, Stavudine, Tenofovir, Zidovudine

• Protease Inhibitors (HIV)
  • Amprenavir, Atazanavir, Darunavir, Fosamprenavir, Indinavir, Lopinavir, Nelfinavir,Ritonavir, Saquinavir, Tipranavir

Drugs for Hepatitis B

• • Alpha Interferon, Adefovir, Emtricitabine, Entecavir, Lamivudine, Telbivudine, Tenofovir

Drugs for Hepatitis C

• Interferon Based Therapies
  • Alpha Interferon and Peginterferon, Ribavirin

HCV NS5A Inhibitors

• Daclatasvir, Elbasvir, Ledipasvir, Ombitasvir, Pibrentasvir, Velpatasvir

HCV NS5B (Polymerase) Inhibitors

• Dasabuvir, Sofosbuvir

HCV Protease Inhibitors

• Asunaprevir, Boceprevir, Glecaprevir, Grazoprevir, Paritaprevir, Simeprevir, Telaprevir, Voxilaprevir

Combination Therapies

• Epclusa, Harvoni, Mavyret, Technive, Viekira Pak, Vosevi, Zepatier

Drugs for Herpes Virus Infections (HSV, CMV, others)

• Acyclovir, Cidofovir, Famciclovir, Foscarnet, Ganciclovir, Valacyclovir, Valganciclovir

Drugs for Influenza

• Amantadine, Oseltamivir, Peramivir, Rimantadine, Zanamivir

• Dailymed label info on Entecavir
• FDA Entecavir

Entecavir Resources
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