Posology : מינונים

4.2      Posology and method of administration
Therapy must be initiated by a physician experienced in the management of chronic hepatitis B infection in adults over 16 years of age.
Adults
The recommended dose of Sebivo for the treatment of chronic hepatitis B is 600 mg once daily.
Due to risk of higher rates of resistance that may develop with longer term treatment among patients with incomplete viral suppression, treatment should only be initiated after baseline HBV DNA criteria are met (see section 4.1 Therapeutic indication).

Monitoring and duration of treatment
On-treatment response at week 24 has been shown to be predictive of longer-term response (see section 5.1 Pharmacodynamic properties). HBV DNA levels should be monitored at 24 weeks of treatment to assure complete viral suppression (HBV DNA less than 300 copies/mL). Alternate therapy should be initiated for patients who have detectable HBV DNA after 24 weeks of treatment.
HBV DNA should be monitored every 6 months to assure continued response. If patients are tested positive for HBV DNA at any time after their initial response, alternate treatment should be instituted. Optimal treatment should be guided by resistance testing.
The optimal treatment duration has not been established.



SEB API AUG17 CL V7                                         REF EMA SmPC 23Jun2017 Renal impairment/insufficiency
Sebivo may be used for the treatment of chronic hepatitis B in patients with impaired renal function. No adjustment of the recommended dose of telbivudine is necessary in patients whose creatinine clearance is 50 mL/min. Dose adjustment is required in patients with creatinine clearance <50 mL/min including those with end stage renal disease (ESRD) on haemodialysis. Dose adjustment may be achieved by changing of the tablet dose interval as shown below:

Table 1               Dose adjustment of Sebivo in patients with renal impairment 
Creatinine clearance (mL/min)                    Tablet Dose
(1 tablet = 600 mg)
50                                              600 mg once daily
30 – 49                                          600 mg once every 48 hours <30 (not requiring dialysis)                     600 mg once every 72 hours ESRD*                                            600 mg once every 96 hours * End stage renal disease
The proposed dose modification is based on extrapolation and may not be optimal. The safety and effectiveness of these dosing interval adjustment guidelines have not been clinically evaluated. Therefore, close clinical monitoring is recommended in these patients.
End Stage Renal Disease (ESRD) patients
For patients with ESRD, Sebivo should be administered after haemodialysis (see section 5.2 Pharmacokinetic properties).
Hepatic impairment
No adjustment of the recommended dose of Sebivo is necessary in patients with hepatic impairment (see section 5.2 Pharmacokinetic properties).
Paediatric patients (age below 16 years)
No studies have been performed in children under the age of 16 years. Therefore, until more information is available, Sebivo is not recommended for use in children.
Elderly patients (age above 65 years)
No data are available to support a specific dose recommendation for patients over the age of 65 years (see section 4.4 Special warnings and precautions for use).

Missed Doses
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.


SEB API AUG17 CL V7                                          REF EMA SmPC 23Jun2017 Method of Administration
Sebivo is to be taken orally, with or without food.
The tablet should not be crushed, split or crushed.