Tenofovir Disoproxil Fumarate Teva Dosage/Direction for Use

Therapy should be initiated by a physician experienced in the management of HIV infection and/or treatment of chronic hepatitis B.
Posology: HIV-1 and Chronic hepatitis B: Adults: The recommended dose of tenofovir disoproxil fumarate for the treatment of HIV or fot the treatment of chronic hepatitis B is 300 mg (one tablet) once daily taken orally with food.
Duration of therapy in adult patients with chronic hepatitis B: The optimal duration of treatment is unknown. Treatment discontinuation may be considered as follows: In HBeAg positive patients without cirrhosis, treatment should be administered for at least 12 months after HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection on two consecutive serum samples at least 3-6 months apart) is confirmed or until HBs seroconversion or there is loss of efficacy (see Precautions). Serum ALT and HBV DNA levels should be followed regularly after treatment discontinuation to detect any late virological relapse.
In HBeAg negative patients without cirrhosis, treatment should be administered at least until HBs seroconversion or there is evidence of loss of efficacy. Treatment discontinuation may also be considered after stable virological suppression is achieved (i.e. for at least 3 years) provided serum ALT and HBV DNA levels are followed regularly after treatment discontinuation to detect any late virological relapse. With prolonged treatment for more than 2 years, regular reassessment is recommended to confirm that continuing the selected therapy remains appropriate for the patient.
In adult patients with decompensated liver disease or cirrhosis, treatment cessation is not recommended.
Missed dose: If a patient misses a dose of Tenofovir Disoproxil Fumarate Teva Tablet within 12 hours of the time it is usually taken, the patient should take Tenofovir Disoproxil Fumarate Teva Tablet with food as soon as possible and resume their normal dosing schedule.
If a patient misses a dose of Tenofovir Disoproxil Fumarate Teva Tablet by more than 12 hours and it is almost time for their next dose, the patient should not take the missed dose and simply resume the usual dosing schedule.
If the patient vomits within 1 hour of taking Tenofovir Disoproxil Fumarate Teva Tablet, another tablet should be taken. If the patient vomits more than 1 hour after taking Tenofovir Disoproxil Fumarate Teva Tablet they do not need to take another dose.
Special populations: Elderly: No data are available on which to make a dose recommendation for patients over the age of 65 years (see Precautions).
Renal impairment: Tenofovir is eliminated by renal excretion and the exposure to tenofovir increases in patients with renal dysfunction.
Adults: There are limited data on the safety and efficacy of tenofovir disoproxi1fumarate in adult patients with moderate and severe renal impairment (creatinine clearance <50 ml/min) and long-term safety data has not been evaluated for mild renal impairment (creatinine clearance 50-80 ml/min). Therefore, in adult patients with renal impairment tenofovir disoproxil fumarate should only be used if the potential benefits of treatment are considered to outweigh the potential risks.
Mild renal impairment (creatinine clearance 50-80 ml/min): Limited data from clinical studies support once daily dosing of 300 mg tenofovir disoproxil fumarate in patients with mild renal impairment.
Moderate renal impairment (creatinine clearance 30-49 ml/min): For patients with no alternative treatment available, prolonged dose intervals using the 300 mg film-coated tablets may be used. Administration of 300 mg tenofovir disoproxil fumarate every 48 hours can be used based on modelling of single-dose pharmacokinetic data in HIV negative and non-HBV infected subjects with varying degrees of renal impairment. including end-stage renal disease requiring haemodialysis, but has not been confirmed in clinical studies. Therefore, clinical response to treatment and renal function should be closely monitored in these patients (see Precautions).
Severe renal impairment (creatinine clearance <30 ml/min) and haemodialysis patients: For patients with no alternative treatment available, prolonged dose intervals using the 300 mg film-coated tablets may be used as follows: Severe renal impairment: 300 mg tenofovir disoproxil fumarate may be administered every 72-96 hours (dosing twice a week); Haemodialysis patients: 300 mg tenofovir disoproxil fumarate may be administered every 7 days following completion of a haemodialysis session*.
These dose interval adjustments have not been confirmed in clinical studies. Simulations suggest that the prolonged dose interval using tenofovir disoproxil fumarate is not optimal and could result in increased toxicity and possibly inadequate response. Therefore, clinical response to treatment and renal function should be closely monitored (see Precautions).
*Generally, once weekly dosing assuming three haemodialysis sessions per week, each of approximately 4 hours duration or after 12 hours cumulative haemodialysis.
No dosing recommendations can be given for non-haemodialysis patients with creatinine clearance <10 ml/min.
Paediatrics: The use of tenofovir disoproxil fumarate is not recommended in paediatric patients.
Hepatic impairment: No dose adjustment is required in patients with hepatic impairment (see Precautions). If Tenofovir Disoproxil Fumarate Teva Tablet is discontinued in patients with chronic hepatitis B with or without HIV co-infection, these patients should be closely monitored for evidence of exacerbation of hepatitis (see Precautions).
Method of administration: Tenofovir Disoproxil Fumarate Teva Tablets should be taken once daily, orally with food.