Bakavi 0.5 mg Tablet (Entacavir)

Adult dose

This medication should be administered orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). Administer entecavir 0.5mg orally once daily. Patients with lamivudine resistance, that is, patients aged 16 years or older who have experienced persistent hepatitis B virus replication despite lamivudine treatment or who have lamivudine-resistant mutations: entecavir 1mg once daily on an empty stomach Patients with renal impairment: In patients with renal impairment, the oral clearance of this medication decreases as creatinine clearance decreases. Adjust the dose as follows in patients with creatinine clearance below 50mL/min, including patients receiving hemodialysis or peritoneal dialysis (CAPD). Creatinine clearance (mL/min) ≥ 50: entecavir dose 0.5 mg once daily; entecavir dose in patients with lamivudine resistance 1 mg once daily Creatinine clearance (mL/min) 30 - <50: entecavir dose 0.25 mg a once daily or 0.5 mg every 48 hours; entecavir dose in patients with lamivudine resistance 0.5 mg once daily or 1 mg every 48 hours Creatinine clearance (mL/min) 10 - <30: entecavir dose 0.15 mg a once daily or 0.5 mg every 72 hours; entecavir dose in patients with lamivudine resistance 0.3 mg a once daily or 1 mg every 72 hours Creatinine clearance (mL/min) <10, hemodialysis b or CAPD: entecavir dose 0.05 mg a once daily or 0.5 mg every 7 days; entecavir dose in patients with lamivudine resistance 0.1 mg a once daily or 1 mg every 7 days a: For doses less than 0.5mg, use of the syrup formulation is recommended. b: If administered on a hemodialysis day, administer this medication after the hemodialysis session. (Pharmacokinetic properties in patients with renal impairment: See “8. Administration to patients with renal impairment” under Precautions for Use.)

Child dose

This document does not specify a separate dosage for children under 16 years of age.

Caution is particularly advised when administering this drug to patients with liver disease. When used alone or in combination with other antiretroviral agents, serious hepatic issues such as lactic acidosis and steatosis can occur, especially reported more frequently in women and obese patients. In patients with decreased liver function, the risk of lactic acidosis is increased, so if liver dysfunction is suspected, drug administration should be stopped immediately. Additionally, stopping this drug can lead to rapid worsening of hepatitis B; therefore, liver function should be carefully monitored for several months after discontinuation of treatment. This drug is not recommended for patients co-infected with HIV and hepatitis B who are not receiving treatment for HIV, and an HIV test should be conducted before administration. This drug should not be given to patients with allergies to this drug or its components, as well as those with genetic metabolic disorders such as lactose intolerance. Dose adjustments are necessary for patients with impaired renal function, particularly those receiving hemodialysis or peritoneal dialysis, and kidney function should be closely monitored in liver transplant recipients. Common side effects during treatment include headache, fatigue, dizziness, nausea, and gastrointestinal discomfort, and regular liver function tests should be conducted as abnormalities may arise. To enhance absorption, it is recommended to take this drug on an empty stomach (at least 2 hours after or at least 2 hours before meals). This drug is primarily excreted via the kidneys, so caution is needed when used in combination with other medications that may affect renal function. During pregnancy, there may be risks to the fetus, so administration must be under a physician's judgment, and during breastfeeding, it is advisable to either discontinue breastfeeding or stop medication. Use is only recommended for pediatric patients aged 2 years or older, as safety and efficacy have not been established in those under 2 years. There is no specific antidote for overdose; therefore, appropriate supportive measures should be taken according to symptoms, and some drugs may be removed by hemodialysis. This drug should be stored out of the reach of children, away from direct sunlight, and kept at room temperature between 15-30 degrees Celsius.

• Lactic acidosis
• steatosis
• severe liver enlargement
• liver metabolic dysfunction
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• dyspepsia

This drug should be stored in a tightly closed container to prevent air and moisture from entering. The recommended storage temperature is between 15 and 30 degrees Celsius to maintain the drug's effectiveness and safety for a longer period.

Appearance

White to off-white triangular film-coated tablets

Package unit

30 tablets (10 tablets/PTP*3)