- 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.
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
Available formulations
No information is present at this moment.
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
Dosages
| Chronic HBV infection in nucleoside-naive patients |
|---|
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
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.
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
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]
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
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]
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
| 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 | ||
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
References
- BRISTOL-MYERS SQUIBB PHARMA EEIG, SmpC Baraclude (EU/1/06/343/001-005) Rev 27, 11-02-2022, www.ema.europa.eu
- Glenmark, SmPC Entecavir 1mg Filmtabletten (98010.00.00), 06/2017
- Glenmark, SmPC Entecavir Glenmark 0,5mg Filmtabletten (98009.00.00), 07/2017
- Klinge, SmPC Entecavir 0,5mg/1mg Filmtabletten (98007.00.00), 04/2017
- Bristol-Myers Squibb, SmPC Baraclude 0,5mg/1mg Filmtabletten (EU/1/06/343/003), 04/2016
- Bristol-Myers Squibb, SmPC Baraclude 0,05mg/ml Lösung zum Einnehmen (EU/1/06/343/005), 04/2016
- Online GL. Gelbe Liste Online, https://www.gelbe-liste.de/, Accessed July 4, 2018
- AVOXA, ABDA-Datenbank Wirkstoffdossier Entecavir, Letzte Bearbeitung 04/2019, aufgerufen am 08.04.2019
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
Changes
Changes
