Forvic 300 Dosage/Direction for Use

Oral.
Therapy should be initiated by a physician experienced in the management of HIV infection and/or treatment of chronic Hepatitis B.
Posology: HIV-1 (Adult and Adolescents aged 12 to <18 years and weighing >35 Kg) and Chronic Hepatitis B (Adults): The recommended dose of Tenofovir disoproxil fumarate for the treatment of HIV or for the treatment of chronic Hepatitis B is 300 mg (one tablet) once daily taken orally with food.
Duration of therapy in adult 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. 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.
Pediatric population: The safety and efficacy of Tenofovir disoproxil fumarate in HIV-1 infected children or children with chronic hepatitis B under 2 years of age have not been established. No data are available.
Missed dose: If a patient misses a dose of Tenofovir disoproxil fumarate within 12 hours of the time it is usually taken, the patient should take Tenofovir disoproxil fumarate with food as soon as possible and resume their normal dosing schedule. If a patient misses a dose of Tenofovir disoproxil fumarate 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, another tablet should be taken. If the patient vomits more than 1 hour after taking Tenofovir disoproxil fumarate 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.
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 disoproxil fumarate 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 unable to take the granule formulation of Tenofovir disoproxil fumarate, 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 hemodialysis, but has not been confirmed in clinical studies. Therefore, clinical response to treatment and renal function should be closely monitored in these patients.
Severe renal impairment (creatinine clearance <30 mL/min) and hemodialysis patients: For patients unable to take the granule formulation of Tenofovir disoproxil fumarate and 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).
Hemodialysis patients: 300 mg Tenofovir disoproxil fumarate may be administered every 7 days following completion of a hemodialysis session*.
Simulations suggest that the prolonged dose interval using Tenofovir disoproxil fumarate 300 mg film coated tablets 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.
* Generally, once weekly dosing assuming three hemodialysis sessions per week, each of approximately 4 hours duration or after 12 hours cumulative hemodialysis.
No dosing recommendations can be given for non-hemodialysis patients with creatinine clearance <10 mL/min.
Pediatrics: The use of Tenofovir disoproxil fumarate is not recommended in pediatric patients.
Hepatic impairment: No dose adjustment is required in patients with hepatic impairment.
If Tenofovir disoproxil fumarate is discontinued in patients with or without HIV co-infection, these patients should be closely monitored for evidence of exacerbation of hepatitis.