Chronic Hepatitis B

Tyzeka is indicated for the treatment of chronic hepatitis B in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

The following points should be considered when initiating therapy with Tyzeka:

• This indication is based on virologic, serologic, biochemical and histologic responses in nucleoside treatment naïve adult patients with HBeAg positive and HBeAg negative chronic hepatitis B with compensated liver disease [see Clinical Studies].
• For HBeAg-positive patients, Tyzeka should only be initiated in patients with HBV DNA less than 9 log₁₀ copies per mL and ALT greater than or equal to 2x Upper Limit of Normal (ULN) prior to treatment.
• For HBeAg-negative patients, Tyzeka should only be initiated in patients with HBV DNA less than 7 log₁₀ copies per mL prior to treatment.
• On-treatment response should guide continued therapy [see DOSAGE AND ADMINISTRATION and Microbiology].
• Tyzeka has not been evaluated in patients co-infected with HIV, HCV or HDV.
• Tyzeka has not been evaluated in liver transplant recipients or in patients with decompensated liver disease.
• Tyzeka has not been studied in well-controlled trials for the treatment of patients with established nucleoside analog reverse transcriptase inhibitor-resistant hepatitis B virus infection, but is expected to be cross-resistant to lamivudine [see Microbiology].
• The safety and efficacy of Tyzeka have not been evaluated in Black/African American or Hispanic patients [see Use in Specific Populations].

Adults and Adolescents (16 years of age and older)

Due to higher rates of resistance that may develop with longer term treatment among patients with incomplete viral suppression, treatment should only be initiated, if pre-treatment HBV DNA and ALT measurements are known, in the following patient populations:

For HBeAg-positive patients, HBV DNA should be less than 9 log₁₀ copies per mL and ALT should be greater than or equal to 2x ULN prior to treatment with Tyzeka.

For HBeAg-negative patients, HBV DNA should be less than 7 log₁₀ copies per mL prior to treatment with Tyzeka.

HBV DNA levels should be monitored at 24 weeks of treatment to assure complete viral suppression (HBV DNA less than 300 copies per mL). Alternate therapy should be initiated for patients who have detectable HBV DNA after 24 weeks of treatment. Optimal therapy should be guided by further resistance testing.

The recommended dose of Tyzeka for the treatment of chronic hepatitis B is 600 mg once daily, taken orally, with or without food.

Tyzeka Oral Solution (30 mL) may be considered for patients who have difficulty with swallowing tablets.

Renal Impairment

Tyzeka may be used for the treatment of chronic hepatitis B in patients with impaired renal function. No adjustment to the recommended dose of Tyzeka is necessary in patients whose creatinine clearance is greater than or equal to 50 mL per min. Adjustment of the total daily dose of Tyzeka Oral Solution or of the interval for administration of Tyzeka tablets is required in patients with creatinine clearance less than 50 mL per min including those with ESRD on hemodialysis (Table 1).

Table 1 : Dose Adjustment of Tyzeka in Patients with Renal Impairment

Hepatic Impairment

No adjustment to the recommended dose of Tyzeka is necessary in patients with hepatic impairment.

Duration of Therapy

For patients with incomplete viral suppression (HBV DNA greater than or equal to 300 copies per mL) after 24 weeks of treatment, alternate therapy should be instituted. 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, alternate treatment should be instituted. Optimal therapy should be guided by resistance testing.

The optimal duration of therapy with Tyzeka for patients with chronic hepatitis B is unknown.

Dosage Forms And Strengths

Tablets

Tyzeka (telbivudine) 600 mg Tablets are white to slightly yellowish film-coated, ovaloid-shaped tablets, imprinted with “LDT” on one side.

Oral Solution

Tyzeka (telbivudine) Oral Solution is a clear, colorless to pale yellow, passion fruit flavored liquid. Tyzeka Oral Solution contains 100 mg of telbivudine per 5 milliliters. Therefore, 30 mL of the oral solution provides a 600 mg dose of telbivudine.

Storage And Handling

Tablets

Tyzeka 600 mg Tablets are white to slightly yellowish film-coated, ovaloid-shaped tablets, imprinted with “LDT” on one side.

Bottle of 30 tablets (NDC 0078-0538-15) with child-resistant closure.

Store Tyzeka Tablets in original container at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Oral Solution

Tyzeka (telbivudine) Oral Solution is a clear, colorless to pale yellow, passion fruit flavored liquid. Tyzeka Oral Solution contains 100 mg of telbivudine per 5 milliliters.

Bottle containing 300 mL oral solution (NDC 0078-0539-85) with child-resistant closure and embossed dosing cup. The dosing cup is intended for measurement of Tyzeka Oral Solution only.

Store Tyzeka Oral Solution in original container at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Use within two months after opening the bottle. Do not freeze.

For all medical inquiries call: 1-877-8-Tyzeka (1-877-889-9352).

Keep this and all drugs out of the reach of children.

Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936. Revised: January 2013

Last reviewed on RxList: 2/19/2013
This monograph has been modified to include the generic and brand name in many instances.