Entecavir

Entecavir Tablet

Entecavir is an antiviral medication used for the treatment of chronic hepatitis B virus (HBV) infection. It belongs to the class of nucleoside analog reverse transcriptase inhibitors (NRTIs) and helps lower the amount of HBV in the body, improving liver function and reducing the risk of complications such as cirrhosis or liver cancer.

Description

• Generic Name: Entecavir

• Available Strengths: 0.5 mg, 1 mg tablets

• Therapeutic Class: Antiviral (NRTI)

• Manufacturer: Multiple pharmaceutical companies

Indications

• Chronic hepatitis B virus (HBV) infection in adults and children (≥2 years old) with:

  • Active viral replication

  • Evidence of liver inflammation or damage

• Used in both treatment-naïve patients and those with resistance to other HBV therapies.

Mechanism of Action

• Entecavir is a guanosine nucleoside analog.

• It inhibits all three functions of the HBV polymerase:

  1. Base priming

  2. Reverse transcription of the negative strand

  3. Synthesis of the positive strand HBV DNA

• This prevents viral replication and reduces HBV DNA levels in the body.

Dosage & Administration

• Adults:

  • 0.5 mg once daily (treatment-naïve patients)

  • 1 mg once daily (patients with lamivudine-resistant HBV or decompensated liver disease)

• Children (≥2 years): Dose is based on body weight.

• Should be taken on an empty stomach (at least 2 hours before or after a meal).

Side Effects

Common:

• Headache

• Fatigue

• Dizziness

• Nausea

• Indigestion

Serious (rare):

• Lactic acidosis

• Severe hepatomegaly (enlarged liver)

• Exacerbation of hepatitis after stopping therapy

Precautions

• Regular monitoring of liver function and HBV DNA levels is required.

• Use with caution in patients with kidney problems (dose adjustment needed).

• Stopping treatment abruptly may lead to severe worsening of hepatitis B.

• Not recommended during pregnancy unless prescribed by a doctor.

Storage

• Store at 20°C – 25°C (room temperature).

• Protect from moisture and light.

• Keep out of reach of children.

FAQs

Q1. What is Entecavir used for?
A: Entecavir is used to treat chronic hepatitis B infection and helps lower HBV levels in the body.

Q2. How long should I take Entecavir?
A: Treatment duration varies; some patients may need long-term or even lifelong therapy. Always follow your doctor’s advice.

Q3. Can Entecavir cure hepatitis B?
A: No, Entecavir does not cure hepatitis B, but it helps control the infection and prevents liver complications.

Q4. Can I stop taking Entecavir if I feel better?
A: No. Stopping treatment suddenly may worsen your hepatitis B. Consult your doctor before making any changes.

Q5. Is Entecavir safe during pregnancy?
A: It should be used only if clearly needed. Discuss risks and benefits with your doctor.

TRUSTED Anti Cancer  MEDICINE PROVIDER – UNNATI PHARMAX

References:-

• European Medicines Agency (EMA) – Entecavir Accord (Generic enTecavir)
  https://www.ema.europa.eu/en/medicines/human/EPAR/entecavir-accord European Medicines Agency (EMA)

• European Medicines Agency (EMA) – Baraclude (Reference Brand Entecavir)
  https://www.ema.europa.eu/en/medicines/human/EPAR/baraclude European Medicines Agency (EMA)

• European Medicines Agency (EMA) – Entecavir Viatris (formerly Mylan)
  https://www.ema.europa.eu/en/medicines/human/EPAR/entecavir-viatris European Medicines Agency (EMA)

• DailyMed (U.S. National Library of Medicine) – Entecavir Tablet Prescribing Information
  https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b7919013-1511-44f0-a759-3fa78a9fa178 Drugs.com

• European Medicines Agency (EMA) – Entecavir Product-Specific Bioequivalence Guidance
  https://www.ema.europa.eu/en/entecavir-product-specific-bioequivalence-guidance