Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Sebivo is indicated for the treatment of chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.
Initiation of Sebivo treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate.
See section 5.1 for details of the study and specific patient characteristics on which this indication is based.
Therapy must be initiated by a physician experienced in the management of chronic hepatitis B infection.
The recommended dose of Sebivo is 600 mg (one tablet) once daily.
Sebivo oral solution may be considered for patients who have difficulties swallowing tablets.
On-treatment response at week 24 has been shown to be predictive of longer-term response (see Table 7 in section 5.1). HBV DNA levels should be monitored at 24 weeks of treatment to assure complete viral suppression (HBV DNA less than 300 copies/ml). For patients with detectable HBV DNA after 24 weeks of therapy, treatment modification should be considered.
HBV DNA should be monitored every 6 months to assure continued response. If patients test positive for HBV DNA at any time after their initial response, treatment modification should be considered. Optimal therapy should be guided by resistance testing.
The optimal treatment duration is unknown. Treatment discontinuation should be considered as follows:
If a dose is missed, the patient may take the missed dose only up to 4 hours prior to the next scheduled dose. The next dose should be taken at the usual time.
No data are available to support a specific dose recommendation for patients over the age of 65 years (see section 4.4).
No adjustment of the recommended dose of telbivudine is necessary in patients whose creatinine clearance is ≥50 ml/min. Adjustment of the dose is required in patients with creatinine clearance <50 ml/min, including those with end-stage renal disease (ESRD) on haemodialysis. A reduction of the daily dose using Sebivo oral solution, as detailed in Table 1 below, is recommended. If use of the oral solution is not possible, Sebivo film-coated tablets could be used as an alternative and dosing should be adjusted by increasing the time interval between doses, as detailed in Table 1.
Table 1. Dosing regimen adjustment of Sebivo in patients with renal impairment:
| Creatinine clearance (ml/min) | Τelbivudine 20 mg/ml oral solution | Τelbivudine 600 mg film-coated tablet |
|---|---|---|
| Daily dose adjustment | Alternative** dose adjustment with increased dose intervals | |
| ≥50 | 600 mg (30 ml) once daily | 600 mg once daily |
| 30-49 | 400 mg (20 ml) once daily | 600 mg once every 48 hours |
| <30 (not requiring dialysis) | 200 mg (10 ml) once daily | 600 mg once every 72 hours |
| ESRD* | 120 mg (6 ml)once daily | 600 mg μία φορά κάθε 96 hours |
* End stage renal disease
** In case use of the oral solution is not possible
The proposed dose modifications are based on extrapolation and may not be optimal. The safety and effectiveness of these dosing adjustment guidelines have not been clinically evaluated. Therefore, close clinical monitoring is recommended in these patients.
For patients with ESRD, Sebivo should be administered after haemodialysis (see section 5.2).
No adjustment to the recommended dose of Sebivo is necessary in patients with hepatic impairment (see section 5.2).
The safety and efficacy of Sebivo in the paediatric population have not yet been established. No data are available.
Sebivo is to be taken orally, with or without food. The tablet should not be chewed, split or crushed.
There is no information on intentional overdose of telbivudine, but one subject was given an unintentional overdose which was asymptomatic. Tested doses up to 1,800 mg/day, three times greater than the recommended daily dose, have been well tolerated. A maximum tolerated dose of telbivudine has not been determined. In the event of an overdose, Sebivo should be discontinued and appropriate general supportive treatment applied as necessary.
Shelf life: 3 years.
This medicinal product does not require any special storage conditions.
PVC/aluminium blisters.
Pack sizes: 28 or 98 film-coated tablets.
Not all pack sizes may be marketed.
No special requirements for disposal.
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