Adult Dosing
Management of chronic hepatitis B
- TABS: 600 mg PO qd
- SOLN: 600 mg (30 mL of 100 mg/5 mL soln) PO qd
Pediatric Dosing
Management of chronic hepatitis B
Adolescents (
16 yrs)
- TABS: 600 mg PO qd
- SOLN: 600 mg (30 mL of 100 mg/5 mL soln) PO qd
[Outline]
Renal Dose Adjustment (Based on CrCl)
- 50 mL/min
- TABS: 600 mg PO qd
- SOLN: 600 mg (30 mL of 100 mg/5 mL soln) PO qd
- 30-49 mL/min
- TABS: 600 mg PO q48 hrs
- SOLN: 400mg (20 mL of 100mg/5ml soln) PO qd
- <30 mL/min
- TABS: 600 mg PO q72 hrs
- SOLN: 200mg (10 mL of 100mg/5ml soln) PO qd
- End stage renal disease (ESRD): 600 mg PO q96 hrs
- Hemodialysis (HD): 600 mg PO q96 hrs after hemodialysis
Hepatic Dose Adjustment
- Hepatic impairment: No dose adjustments
See Supplemental Patient Information
- Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have occurred with the use of nucleoside analogues alone or in combination with other antiretrovirals [US Black Box Warning]. Female gender, obesity and prolonged nucleoside exposure are risk factors
- Exercise caution while administering to any patient with known risk factors for liver disease
- Consider suspension of therapy if clinical or laboratory findings suggest symptomatic hyperlactatemia, lactic acidosis, or pronounced hepatotoxicity (may include hepatomegaly and steatosis even in the absence of marked transaminase elevations). Permanently discontinue therapy for patients with confirmed lactic acidosis
- Severe acute exacerbations of hepatitis B have occurred in patients following the discontinuation of anti-hepatitis B therapy. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months after a patient discontinues therapy. Anti-hepatitis B therapy may be resumed if warranted [US Black Box Warning]
- Myopathy/myositis has occurred after several weeks to months after starting therapy. Rhabdomyolysis has been reported during postmarketing surveillance. Hold treatment if myopathy is suspected and discontinue on confirmation of myopathy. Closely monitor patients who are taking other medications that are known to cause myopathy for any signs or symptoms of unexplained muscle pain, tenderness or weakness
- Peripheral neuropathy has been reported with telbivudine alone or when used in combination with pegylated interferon alfa-2a. Safety and efficacy of telbivudine in combination with pegylated interferons or other interferons for the treatment of chronic hepatitis B has not been established. Suspend therapy if peripheral neuropathy is suspected and discontinue on confirmation of peripheral neuropathy
Cautions: Use cautiously in:
- Renal impairment
- Concomitant nephrotoxic agents
Supplemental Patient Information
- Advise patients to promptly report unexplained muscle aches, pain, tenderness or weakness
- Advise patients to report their clinician any numbness, tingling, and/or burning sensations in the arms and/or legs, with or without gait disturbance
Pregnancy Category:B
Breastfeeding: Possibly unsafe; Telbivudine has not been evaluated in nursing mothers treated for hepatitis B infection. Survey conducted in US suggests 31% of clinicians recommend breastfeeding for their patients with hepatitis B who are taking antiviral therapy, 44% state that they do not recommend breastfeeding during antiviral therapy and 25% state that they are unsure. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 1 February 2011). Manufacturer advises to instruct mothers not to breast-feed if they are receiving this drug.
Pricing data from www.DrugStore.com in U.S.A.
- Tyzeka 600 MG TABS [Bottle] (NOVARTIS)
30 mg = $816.03
90 mg = $2208.88
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
Drug Name: Tyzeka 600 MG Oral Tablet
Ingredient(s): Telbivudine
Imprint: LDT
Color(s): White
Shape: Oval
Size (mm): 18.00
Score: 1
Inactive Ingredient(s): silicon dioxide / hypromellose / polyethylene glycol / magnesium stearate / cellulose, microcrystalline / povidone / sodium starch glycolate type a potato / talc / titanium dioxide
Drug Label Author:
Novartis Pharmaceuticals Corporation
DEA Schedule:
Non-Scheduled
