Bakavi Tablet 1.0 mg (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

There is no separate pediatric dosage as the dosage for patients aged 16 and older with lamivudine resistance is specified.

This medicine may cause hepatomegaly, including lactic acidosis and steatosis, especially in severely ill liver patients, particularly females, so caution is required in patients with liver function problems. Discontinuation of treatment may lead to acute exacerbation of hepatitis B, therefore liver function should be continuously monitored even after treatment discontinuation and re-treatment should commence if necessary. The use of this medication is not recommended for patients co-infected with HIV and hepatitis B who are not receiving HIV treatment, and testing for HIV infection is necessary before starting treatment. Patients who have hypersensitivity to this medication or genetic issues such as lactose intolerance should not take this medication. Patients with renal impairment need to adjust their dosages according to renal function, and patients undergoing hemodialysis or peritoneal dialysis should be particularly cautious. Liver transplant patients or those taking medications that may affect renal function, such as cyclosporine or tacrolimus, should closely monitor their renal function. Absorption decreases when taken with food, so it is recommended to take it on an empty stomach. While taking this medication, symptoms such as headache, fatigue, dizziness, and nausea may occur; if adverse reactions are severe, consult a doctor. During pregnancy, it should be used cautiously considering potential risks to the fetus versus the benefits of this medication, and during breastfeeding, it is advisable to discontinue breastfeeding or stop taking the medication. For children, it is recommended for use in patients 2 years and older; the safety and effectiveness in children under 2 years old have not been established. In the event of overdose, serious side effects may occur, so consult medical staff immediately and seek appropriate treatment if necessary. This medication is excreted through the kidneys, so when used in conjunction with other medications that affect renal function, careful observation for adverse reactions is required. Store out of reach of children, keep tablets in a tightly sealed container at room temperature, and store syrup formulations protected from light.

• Hyperuricemia
• lipidosis
• hepatomegaly
• impaired hepatic metabolism
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• indigestion

This medication should be stored in a tightly sealed container to prevent air and moisture from entering. Additionally, it is important to keep the medicine in a cool place, specifically at a temperature between 15 and 30 degrees Celsius, to maintain its effectiveness.

Appearance

Pink triangular film-coated tablet

Package unit

30 tablets (10 tablets/PTP*3)