Tyzeka
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Questions & Answers
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
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 (14)].
- 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 (2.1) and Microbiology (12.4)].
- 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 (12.4)].
- The safety and efficacy of Tyzeka have not been evaluated in Black/African American or Hispanic patients [see Use in Specific Populations (8.9)].
History
There is currently no drug history available for this drug.
Other Information
Tyzeka is the trade name for telbivudine, a synthetic thymidine nucleoside analogue with activity against hepatitis B virus (HBV). The chemical name for telbivudine is 1-((2S,4R,5S)-4-hydroxy-5-hydroxymethyltetrahydrofuran-2-y1)-5-methyl-1H-pyrimidine-2,4-dione, or 1-(2-deoxy-β-L-ribofuranosyl)-5-methyluracil. Telbivudine is the unmodified β-L enantiomer of the naturally occurring nucleoside, thymidine. Its molecular formula is C10H14N2O5, which corresponds to a molecular weight of 242.23. Telbivudine has the following structural formula:
Telbivudine is a white to slightly yellowish powder. Telbivudine is sparingly soluble in water (greater than 20 mg per mL), and very slightly soluble in absolute ethanol (0.7 mg per mL) and n-octanol (0.1 mg per mL).
Tyzeka film-coated tablets are available for oral administration in 600 mg strength. Tyzeka 600 mg film-coated tablets contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. The tablet coating contains titanium dioxide, polyethylene glycol, talc, and hypromellose.
Tyzeka oral solution is available for oral administration in 100 mg per 5 mL strength. Tyzeka oral solution contains the following inactive ingredients: citric acid anhydrous, benzoic acid, passion fruit flavor, sodium saccharin, sodium hydroxide, and purified water. A 600 mg dose (30 mL) of Tyzeka oral solution contains approximately 47 mg of sodium.
Sources
Tyzeka Manufacturers
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Novartis Pharmaceuticals Corporation
![Tyzeka (Telbivudine) Tablet, Film Coated Tyzeka (Telbivudine) Solution [Novartis Pharmaceuticals Corporation]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Tyzeka | Novartis Pharmaceuticals Corporation
2.1 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.
2.2 Renal ImpairmentTyzeka 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 Creatinine Clearance
(mL/min) Tyzeka Oral Solution Dose
(5 mL = 100 mg) Tyzeka Tablet Dose
(1 tablet = 600 mg) greater than or equal to 50 30 mL once daily 1 tablet every 24 hrs 30-49 20 mL once daily 1 tablet every 48 hrs less than 30 (not requiring dialysis) 10 mL once daily 1 tablet every 72 hrs ESRD 6 mL once daily 1 tablet every 96 hrs1 1When administered on hemodialysis days, Tyzeka should be administered after hemodialysis. 2.3 Hepatic ImpairmentNo adjustment to the recommended dose of Tyzeka is necessary in patients with hepatic impairment.
2.4 Duration of TherapyFor 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.
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