Uses of Sebivo: - HIV infection - Chronic hepatitis B virus (HBV) infection Chronic hepatitis B Hypersensitivity. Lactation. Concurrent use w/ peginterferon alfa-2a.

Hepatic viral infections (Hepatitis B)

Telbivudine is a synthetic thymidine nucleoside analogue with activity against hepatitis B virus (HBV). Telbivudine is the unmodified β–L enantiomer of the naturally occurring nucleoside, thymidine. It undergoes phosphorylation via interaction with cellular kinases to form the active metabolite, telbivudine 5'-triphosphate.Telbivudine 5'–triphosphate inhibits HBV DNA polymerase (reverse transcriptase) by competing with the natural substrate, thymidine 5'–triphosphate. This leads to the chain termination of DNA synthesis, thereby inhibiting viral replication. Incorporation of telbivudine 5'–triphosphate into viral DNA also causes DNA chain termination, resulting in inhibition of HBV replication. Telbivudine inhibits anticompliment or second-strand DNA.

How to use Telbivudine: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Telbivudine may be taken with or without food, but it is better to take it at a fixed time. Administration: May be taken with or without food. Adult Dose: Oral Chronic hepatitis B Adult: 600 mg once daily. Child Dose: Safety and efficacy not established Child: >16 yr: 600 mg once daily. Renal Dose: Renal impairment: ESRD: 600 mg 96 hrly, after dialysis session. CrCl (ml/min) Dosage Recommendation <30 (not requiring dialysis) 600 mg 72 hrly. 30-49 600 mg 48 hrly.

Increased risk of peripheral neuropathy when used with peginterferon alfa-2a.

Hypersensitivity. Lactation. Concurrent use w/ peginterferon alfa-2a.

Common - Fatigue - Headache - Nausea - Decreased appetite - Indigestion - Fever - Feeling of discomfort - Dizziness - Muscle pain - Joint pain - Abdominal distension - Insomnia (difficulty in sleeping) - Rash - Back pain - Liver damage >10% Fatigue (13%),Elevated serum creatinine kinase (11%); 1-10% Headache (10%),Cough (6%),Diarrhea (6%),Abdominal pain, upper (6%),Nausea (5%),Pharyngolaryngeal pain (5%),Arthralgia (4%),Pyrexia (4%),Rash (4%),Back pain (4%),Dizziness (4%),Abdominal pain (3%),Myalgia (3%),ALT increased (3%),Dyspepsia (3%),Insomnia (3%),Abdominal distension (3%),Pruritus (2%),Hepatitis B exacerbation (2%) <1% Peripheral neuropathy,Myopathy/myositis Potentially Fatal: Lactic acidosis and severe hepatomegaly.

Pregnancy Category B. Telbivudine is not teratogenic and has shown no adverse effects in developing embryos and fetuses in preclinical studies. Studies in pregnant rats and rabbits showed that telbivudine crosses the placenta. Developmental toxicity studies revealed no evidence of harm to the fetus in rats and rabbits at doses up to 1000 mg per kg per day, providing exposure levels 6- and 37-times higher, respectively, than those observed with the 600 mg per day dose in humans.There are no adequate and well-controlled trials of Tyzeka in pregnant women. Because animal reproductive toxicity studies are not always predictive of human response, Tyzeka should be used during pregnancy only if potential benefits outweigh the risks.

Precaution: Patient w/ cirrhosis, hepatomegaly or other risk factors for liver disease. Renal impairment. Pregnancy. Monitoring Parameters Monitor hepatic function (e.g. AST and ALT) periodically during therapy and for several mth following discontinuation of therapy; renal function; signs and symptoms of peripheral neuropathy or myopathy; serum creatine kinase; hepatitis B virus (HBV) DNA 3-6 mthly during therapy; HBeAg and anti-HBe signs/symptoms of HBV relapse/exacerbation after discontinuation of therapy. Lactation: not known if distributed in breast milk, do not nurse

Store Telbivudine Tablets and Oral Solution in the original bottle at room temperature (15° to 30°C)

Hepatic viral infections (Hepatitis B)

Telbivudine is a synthetic thymidine nucleoside analogue. It undergoes intracellular phosphorylation to form its active metabolite, telbivudine triphosphate. Telbivudine triphosphate inhibits hepatitis B viral DNA polymerase; enzyme inhibition blocks reverse transcriptase thus reducing viral DNA replication. It is used in the treatment of chronic hepatitis B infection.

Pregnancy Category B. Telbivudine is not teratogenic and has shown no adverse effects in developing embryos and fetuses in preclinical studies. Studies in pregnant rats and rabbits showed that telbivudine crosses the placenta. Developmental toxicity studies revealed no evidence of harm to the fetus in rats and rabbits at doses up to 1000 mg per kg per day, providing exposure levels 6- and 37-times higher, respectively, than those observed with the 600 mg per day dose in humans.There are no adequate and well-controlled trials of Tyzeka in pregnant women. Because animal reproductive toxicity studies are not always predictive of human response, Tyzeka should be used during pregnancy only if potential benefits outweigh the risks.