Entecavir

Generic name
Entecavir
Brand name
ATC Code
J05AF10
Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The steady-state pharmacokinetics of entecavir were evaluated (study 028) in 24 nucleoside naïve HBeAg-positive paediatric subjects from 2 to < 18 years of age with compensated liver disease. Entecavir exposure among nucleoside naïve subjects receiving once daily doses of entecavir 0.015 mg/kg up to a maximum dose of 0.5 mg was similar to the exposure achieved in adults receiving once daily doses of 0.5 mg. The Cmax, AUC(0-24), and Cmin for these subjects was 6.31 ng/ml, 18.33 ng h/ml, and 0.28 ng/ml, respectively.

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Chronic HBV infection in nucleoside-naive patients
  • Oral

Renal impaiment in children > 3 months

In reduced renal function in adults:

creatinine clearance 30-50 ml/min: 50% of the standard dose;

creatinine clearance 10-30 ml/min: 30% of the standard dose;

creatinine clearance less than 10 ml/min: the manufacturer recommends 0.05 mg once daily or 0.5 mg once per 5-7 days for nucleoside-naive patients.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

The side effects observed in paediatric patients who were treated with entecavir were in line with those observed in the clinical trials of entecavir in adults

neutropenia in adolescents ≥10 % [SmPC Baraclude® Dilution]

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

  • A lower virological response (HBV-DNA < 50 I.U./ml) was observed in children and adolescents with initial HBV-DNA ≥ 8.0 log10 I.U./ml. Entecavir should only be used in these patients if the potential benefit justifies the potential risk to the child (e.g. resistance).[SmPC Baraclude® Dilution]

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

DIRECT ACTING ANTIVIRALS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05AB01
J05AB04
J05AB11
J05AB14
Protease inhibitors
J05AE10
J05AE03
Nucleoside and nucleotide reverse transcriptase inhibitors
J05AF05
J05AF01
Non-nucleoside reverse transcriptase inhibitors
J05AG01
Neuraminidase inhibitors
J05AH02
Antivirals for treatment of HIV infections, combinations
J05AR02
J05AR10
Other antivirals
J05AX12
J05AX08
ANTIVIRALS FOR TREATMENT OF HIV INFECTIONS, COMBINATIONS
J05AR02
J05AR10
Antivirals for treatment of HCV infections
J05AP57
J05AP08
J05AP55

References

  1. BRISTOL-MYERS SQUIBB PHARMA EEIG, SmpC Baraclude (EU/1/06/343/001-005) Rev 27, 11-02-2022, www.ema.europa.eu
  2. Glenmark, SmPC Entecavir 1mg Filmtabletten (98010.00.00), 06/2017
  3. Glenmark, SmPC Entecavir Glenmark 0,5mg Filmtabletten (98009.00.00), 07/2017
  4. Klinge, SmPC Entecavir 0,5mg/1mg Filmtabletten (98007.00.00), 04/2017
  5. Bristol-Myers Squibb, SmPC Baraclude 0,5mg/1mg Filmtabletten (EU/1/06/343/003), 04/2016
  6. Bristol-Myers Squibb, SmPC Baraclude 0,05mg/ml Lösung zum Einnehmen (EU/1/06/343/005), 04/2016
  7. Online GL. Gelbe Liste Online, https://www.gelbe-liste.de/, Accessed July 4, 2018
  8. AVOXA, ABDA-Datenbank Wirkstoffdossier Entecavir, Letzte Bearbeitung 04/2019, aufgerufen am 08.04.2019

Changes

Therapeutic Drug Monitoring


Overdose