Tecavir Tablet (Tenofovir Disoproxil)

Adult dose

Adults and pediatric patients aged 12 years and older (35kg or more) For the treatment of HIV-1 or chronic hepatitis B, take 1 tablet once daily (equivalent to 245mg of tenofovir disoproxil). It may be taken with or without food. The optimal duration of treatment for chronic hepatitis B is unknown. Drug exposure increased significantly when this medicine was administered to patients with moderate to severe renal impairment. Therefore, for patients with a baseline creatinine clearance of <50mL/min, adjust the dosing interval of this medicine with reference to Table 1. These dose interval adjustment recommendations are based on pharmacokinetic modeling of single-dose data from patients with varying degrees of renal impairment who were not infected with HIV or HBV, including patients with end-stage renal disease requiring hemodialysis. The safety and efficacy of these dose interval adjustment recommendations have not been clinically evaluated in patients with moderate or severe renal impairment; therefore, closely monitor renal function and clinical response to treatment in these patients (see Warning 3). In patients with mild renal impairment, no dose interval adjustment is necessary (creatinine clearance 50-80mL/min). Regularly monitor the estimated creatinine clearance and serum phosphate (see Warning 3). Creatinine clearance (mL/min)a ≥50: Take 1 tablet every 24 hours Creatinine clearance (mL/min)a 30-49: Take 1 tablet every 48 hours Creatinine clearance (mL/min)a 10-29: Take 1 tablet every 72-96 hours Patients on hemodialysis: Take 1 tablet every 7 days or approximately 12 hours after hemodialysisb a. Calculated using ideal (lean) body weight. b. Assuming 3 hemodialysis sessions per week, each lasting approximately 4 hours, administer once weekly. This medicine should be administered after hemodialysis is completed. The pharmacokinetics of tenofovir have not been evaluated in patients with creatinine clearance <10mL/min who are not receiving hemodialysis; therefore, no dosage recommendations are available for these patients.

Child dose

Pediatric patients aged 12 years and older (35kg or more): For the treatment of HIV-1 or chronic hepatitis B, take 1 tablet once daily (equivalent to 245mg of tenofovir disoproxil). It may be taken with or without food. Pediatric patients with chronic hepatitis B who weigh less than 35kg: Safety and efficacy have not been established. Pediatric patients with renal impairment: There are no data to provide dosage recommendations.

This medication is an antiviral drug used for the treatment of hepatitis B virus infection. Stopping treatment may lead to a rapid deterioration of hepatitis symptoms, so regular monitoring for several months after stopping is necessary. Individuals with an allergy to this medication or certain genetic disorders should not take it. It should not be taken with other medications that contain the same ingredient and certain other antiviral drugs are also contraindicated. Patients with impaired kidney function may be affected by this medication, so kidney function tests are required before and during treatment. In cases of severe renal impairment, dosage intervals should be adjusted, and it should not be used with drugs that may cause nephrotoxicity. It may affect bone health, so bone density tests and calcium and vitamin D supplementation may be beneficial. It contains sulfite, so those with sulfite allergies should take caution. During use, side effects such as diarrhea, headache, nausea, fatigue, etc. may occur, and in rare cases, serious kidney and musculoskeletal disorders may appear. This medication has not been reported to pose significant risks to the fetus during pregnancy, but pregnant women should consult a physician before taking it. Nursing mothers should avoid breastfeeding as this medication may be excreted in breast milk. Safety and efficacy for children under 12 years or weighing less than 35 kg have not been established. Elderly patients over 65 years should take it with caution considering potential deterioration in kidney and liver function. In case of overdose, contact a medical institution immediately for appropriate treatment, and some may be removed by dialysis. This medication should be stored at room temperature and kept out of reach of children.

• Worsening of hepatitis
• acute renal failure
• Fanconi syndrome
• hypophosphatemia
• tubular injury
• bone pain
• limb pain
• fractures
• muscle pain
• proximal tubular dysfunction

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is recommended to maintain storage temperature between 1 to 30 degrees Celsius to preserve the medication's efficacy and safety for an extended period.

Appearance

Light blue almond-shaped film-coated tablets

Package unit

30 tablets/bottle