Telbivudine Dosage

Applies to the following strengths: 600 mg

Usual Adult Dose for Chronic Hepatitis B

600 mg orally once a day
Duration of therapy: Optimum duration not established

Use: For the treatment of chronic HBV infection in patients with evidence of viral replication and either evidence of persistent serum aminotransferase (ALT or AST) elevations or histologically active disease

Usual Pediatric Dose for Chronic Hepatitis B

16 years or older: 600 mg orally once a day
Duration of therapy: Optimum duration not established

Use: For the treatment of chronic HBV infection in patients with evidence of viral replication and either evidence of persistent serum aminotransferase (ALT or AST) elevations or histologically active disease

Renal Dose Adjustments

CrCl at least 50 mL/min: No adjustment recommended.

CrCl 30 to 49 mL/min:

Oral solution: 400 mg orally once a day
Tablets: 600 mg orally every 48 hours

CrCl less than 30 mL/min (not requiring dialysis):

Oral solution: 200 mg orally once a day
Tablets: 600 mg orally every 72 hours

Liver Dose Adjustments

No adjustment recommended.

Precautions

US BOXED WARNINGS:

LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS: Lactic acidosis and severe hepatomegaly with steatosis (including fatalities) reported with use of nucleoside analogs alone or in combination with antiretrovirals.
POSTTREATMENT EXACERBATIONS OF HEPATITIS B: Severe acute exacerbations of hepatitis B reported in patients who discontinued antihepatitis B therapy (including this drug). Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue antihepatitis B therapy. If appropriate, resumption of antihepatitis B therapy may be necessary.

Safety and efficacy have not been established in patients younger than 16 years.

Consult WARNINGS section for additional precautions.

Dialysis

ESRD on hemodialysis:

Oral solution: 120 mg orally once a day
Tablets: 600 mg orally every 96 hours

Comments:

Dose should be administered after hemodialysis when given on hemodialysis days.

Other Comments

Administration advice:

Consult the manufacturer product information regarding aspects to consider when starting this drug.
Due to higher rates of resistance that may develop with longer-term therapy among patients with incomplete viral suppression, only start this drug (if pretreatment HBV DNA and ALT measurements are known) in the following patients:
Hepatitis B e antigen (HBeAg)-positive: HBV DNA less than 9 log10 copies/mL and ALT at least 2 times the upper limit of normal prior to therapy
HBeAg-negative: HBV DNA less than 7 log10 copies/mL prior to therapy
May administer without regard to food
May consider the oral solution for patients who have difficulty swallowing tablets
Discard the oral solution 2 months after opening the bottle.
Use on-treatment response to guide continued therapy.
Start alternate therapy for patients with incomplete viral suppression (HBV DNA at least 300 copies/mL)/detectable HBV DNA after 24 weeks of therapy or if patients test positive for HBV DNA at any time after their initial response.
Use resistance testing to guide optimal therapy.

Storage requirements:

Store in original container at 25C (77F); excursions permitted to 15C to 30C (59F to 86F).
Do not freeze oral solution.

General:

Indication based on histological, virological, biochemical, and serological responses in nucleoside therapy naive adults with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver function.
This drug has not been studied in the treatment of patients with confirmed nucleoside analog reverse transcriptase inhibitor-resistant HBV infection; cross-resistance to lamivudine expected.
This drug has not been evaluated in liver transplant recipients, in patients with decompensated liver disease, or in HBV-infected patients coinfected with HIV, HCV, or hepatitis D virus.
Safety and efficacy not established in Black/African American or Hispanic patients.
The correlation between initial therapy response and long-term outcomes (e.g., hepatocellular carcinoma, decompensated cirrhosis) has not been established.
The oral solution contains about 47 mg sodium per 600 mg dose (30 mL).

Monitoring:

General: HBV DNA (every 6 months [to assure continued response])
Hepatic: Hepatic function (periodically during therapy); hepatic function with clinical and laboratory follow-up (for at least several months after stopping therapy)
Renal: Renal function in elderly patients

Patient advice:

Read the US FDA-approved patient labeling (Medication Guide and Instructions for Use).
Promptly report unexplained muscle weakness, tenderness, or pain.
Promptly report any numbness, tingling, and/or burning sensations in the arms and/or legs, with or without difficulty walking.