Sebivo (Telbivudine)

Adult dose

Patients 16 years of age and older For patients with chronic hepatitis B, administer 600mg orally once daily, with or without food. When initiating treatment with this medicine, carefully consider the following: ①HBeAg-positive patients: Administer this medicine to patients with a baseline HBV DNA level below 9log10 copies/mL and a baseline ALT level at least 2 times the upper limit of normal (ULN). ②HBeAg-negative patients: Administer this medicine to patients with a baseline HBV DNA level below 7log10 copies/mL. The optimal duration of treatment has not been established. Patients with renal impairment/renal failure No dose adjustment is necessary in patients with creatinine clearance ≥50 mL/min. Creatinine clearance (mL/min) / Dose ≥50 / 600mg once daily 30-49 / 600mg once every 48 hours <30 (not receiving dialysis) / 600mg once every 72 hours End-stage renal disease / 600mg once every 96 hours In patients with end-stage renal disease, this medicine should be administered after hemodialysis. Patients with hepatic impairment No dose adjustment is necessary when administering this medicine to patients with hepatic impairment.

This drug can significantly impact liver function, particularly increasing the risk of hepatomegaly associated with lactic acidosis and steatosis. Women, obese individuals, and those taking this medication for a long time may be at higher risk. Patients with liver disease or risk factors should exercise caution while using this drug, and if liver dysfunction is suspected, they should immediately discontinue use. If this drug is suddenly stopped during the treatment of chronic hepatitis B, hepatitis may worsen rapidly; therefore, during the cessation of treatment, liver function should be closely monitored for at least several months, following the physician's instructions. This drug should not be used in children under the age of 16, individuals allergic to this drug or its components, or patients undergoing interferon-alpha therapy. Patients with decreased kidney function may experience delayed excretion of this drug, so the dosage or administration interval should be adjusted. Liver transplant patients, patients with nonalcoholic cirrhosis, and elderly patients should also use this drug with caution. This drug has a low potential for interactions with other medications; however, monitoring changes in blood concentration is necessary when taken with medications that affect kidney function. Pregnant women have a relatively low risk of fetal harm due to the use of this drug, but it should always be administered after consulting with a physician. It is advisable not to take this drug while breastfeeding. While taking this medication, symptoms such as muscle pain, muscle weakness, fatigue, headache, gastrointestinal disturbances may occur, and if these symptoms persist, report to a physician immediately for evaluation. In case of overdose, discontinue use immediately and seek necessary treatment; it is important to keep this medication out of the reach of children. This drug does not reduce the risk of hepatitis B virus infection; therefore, additional preventive measures should also be implemented.

• Lactic acidosis
• steatosis
• hepatomegaly
• rhabdomyolysis
• myopathy
• myositis
• peripheral neuropathy
• upper respiratory infection
• nasopharyngitis
• fatigue

This medication may be sensitive to air and moisture; therefore, it should be stored in a sealed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to preserve the drug's effectiveness for a long time.

Appearance

Slightly yellowish oval film-coated tablet with 'LDT' engraved on one side and beveled edges

Package unit

28 tablets (14 tablets/PTP packaging x 2)