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Telbivudine Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Chronic Hepatitis B

600 mg orally once a day

Usual Pediatric Dose for Chronic Hepatitis B

16 years or older: 600 mg orally once a day

Renal Dose Adjustments

CrCl 30 to 49 mL/min:
Tablets: 600 mg orally every 48 hours
Oral solution: 400 mg orally once a day

CrCl less than 30 mL/min (not requiring dialysis):
Tablets: 600 mg orally every 72 hours
Oral solution: 200 mg orally once a day

Liver Dose Adjustments

No adjustment recommended.

Precautions

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with antiretrovirals. Risk factors for lactic acidosis may include female gender, obesity, and prolonged nucleoside exposure. Caution is recommended in patients with risk factors for liver disease; however, cases have also been reported in patients with no known risk factors. Treatment with telbivudine should be stopped in any patient who develops clinical and laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).

Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued antihepatitis B therapy, including therapy with telbivudine. Patients discontinuing telbivudine should be closely monitored with clinical and laboratory follow-up for at least several months. If appropriate, resumption of antihepatitis B therapy may be necessary.

Hepatic function should be monitored periodically in all patients during telbivudine therapy.

Coadministration of telbivudine with peginterferon alfa-2a is contraindicated due to increased risk of peripheral neuropathy.

Peripheral neuropathy has been reported with telbivudine alone or in combination with interferons. An increased risk and severity of peripheral neuropathy has been observed with concomitant telbivudine and peginterferon alfa-2a compared to telbivudine alone. The safety and effectiveness of telbivudine in combination with interferons for chronic hepatitis B has not been established. Patients should be advised to report any numbness, tingling, and/or burning sensations in the arms and/or legs, with or without gait disturbance. Telbivudine should be interrupted if peripheral neuropathy is suspected and discontinued if diagnosed.

Myopathy and myositis have been reported with telbivudine use several weeks to months following treatment initiation. Telbivudine treatment should be interrupted if myopathy is suspected and discontinued if diagnosed. When starting concurrent therapy with other drugs associated with myopathy, physicians should closely monitor patients for signs or symptoms of unexplained muscle pain, tenderness, or weakness.

Safety and efficacy have not been established in liver transplant patients, in patients with decompensated liver disease, or in patients coinfected with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus.

Renal function should be closely monitored before and during treatment in transplant recipients who are receiving immunosuppressants that can affect renal function.

Concurrent administration with drugs that affect renal function may alter serum levels of telbivudine and/or the other drugs. Close clinical and laboratory monitoring for adverse effects is recommended and appropriate dosage adjustments should be made if indicated.

Clinical studies of telbivudine did not contain sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. In general, dose selection for the elderly patient should be cautious, keeping in mind the greater frequency of decreased renal function due to concomitant disease or other drug therapy. Renal function should be closely monitored in this patient population.

Telbivudine oral solution contains about 47 mg sodium per 600 mg dose (30 mL).

Safety and efficacy have not been established in Black/African American or Hispanic patients.

Safety and efficacy have not been established in pediatric patients less than 16 years of age.

Dialysis

End-stage renal disease:
Tablets: 600 mg orally every 96 hours
Oral solution: 120 mg orally once a day

Telbivudine should be dosed after hemodialysis sessions when given on hemodialysis days.

Other Comments

Due to higher rates of resistance that may develop with longer term therapy among patients with incomplete viral suppression, therapy should only be started, if pretreatment HBV DNA and ALT measurements are known, in the following patients:

HBeAg-positive: HBV DNA should be less than 9 log10 copies/mL and ALT should be greater than or equal to 2 times upper limit of normal prior to therapy.
HBeAg-negative: HBV DNA should be less than 7 log10 copies/mL prior to therapy.

The optimal treatment duration has not been established. On-treatment response should guide continued therapy. Alternate treatment is recommended in patients with incomplete viral suppression (HBV DNA greater than or equal to 300 copies/mL) after 24 weeks of therapy. HBV DNA should be monitored every 6 months to assure continued response. Alternate treatment is recommended if patients test positive for HBV DNA at any time after their initial response. Optimal treatment should be guided by resistance testing.

Telbivudine may be taken with or without food. The oral solution may be considered for patients who have difficulty swallowing tablets.

Telbivudine oral solution should be discarded 2 months after opening the bottle.

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