SEBIVO TABLETS 600MG

Indications

• Chronic hepatitis B virus infection

Dosage

Children: For children aged 2 years and older, the dosage varies based on body weight and must be determined based on clinical guidelines; refer to the BNF for Children for specific dosing recommendations.

Adults: The recommended dose for adults is 600 mg once daily.

Mechanism of action

Telbivudine 5'–triphosphate inhibits HBV DNA polymerase (reverse transcriptase) by competing with the natural substrate, thymidine 5'–triphosphate. This leads to chain termination of DNA synthesis, inhibiting viral replication. Its incorporation into viral DNA also causes DNA chain termination, further inhibiting HBV replication.

Pharmacodynamics

Telbivudine exhibits antiviral activity specifically against hepatitis B virus (HBV). It is a synthetic thymidine nucleoside analogue that is phosphorylated by cellular kinases to produce the active form, telbivudine 5'-triphosphate. This active metabolite is crucial for its action against HBV, as it directly interferes with viral DNA synthesis.

Pharmacokinetics

Telbivudine is well absorbed following oral administration, with its bioavailability being significantly high. It is metabolized intracellularly to its active form and has a long half-life, allowing for once-daily dosing. The drug is primarily eliminated via renal excretion, necessitating dosage adjustments in patients with renal impairment.

Contra-indications

• Hypersensitivity to telbivudine or any of its excipients
• Severe renal impairment (creatinine clearance less than 50 mL/min)

Adverse effects

• Fatigue
• Headache
• Nausea
• Diarrhea
• Elevated liver enzymes
• Myopathy
• Peripheral neuropathy

Interactions

• Other antiviral agents may have additive effects on liver toxicity
• Caution is advised when co-administering with drugs that affect renal function

Precautions

• Monitor liver function tests regularly during treatment
• Assess renal function prior to initiating therapy
• Patients with a history of myopathy or neuropathy should be closely monitored

Pregnancy

Telbivudine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

It is not known whether telbivudine is excreted in human milk. Caution is advised when administering to nursing mothers.

Storage

Store in a cool, dry place, protected from light. Keep out of reach of children.

Formulations

• Oral tablets
• Oral solution

Mechanism of action

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.

Pharmacodynamics

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.