Active Ingredient: Tenofovir disoproxil
Tenofovir disoproxil is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults.
In adults, the demonstration of the benefit of tenofovir disoproxil in HIV-1 infection is based on results of one study in treatment-naïve patients, including patients with a high viral load (>100,000 copies/ml) and studies in which tenofovir disoproxil was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (<10,000 copies/ml, with the majority of patients having <5,000 copies/ml).
Tenofovir disoproxil is also indicated for the treatment of HIV-1 infected paediatric patients and adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to <18 years.
The choice of tenofovir disoproxil to treat antiretroviral-experienced patients with HIV-1 infection should be based on individual viral resistance testing and/or treatment history of patients.
For this indication, competent medicine agencies globally authorize below treatments:
For:
In case that patient weight is ≥ 35 kg, oral, 245 milligrams tenofovir disoproxil, once daily to meals.
The recommended dose of tenofovir disoproxil for the treatment of HIV is 245 mg once daily taken orally with food.
The decision to treat adolescent patients should be based on careful consideration of individual patient needs and with reference to current paediatric treatment guidelines including the value of baseline histological information. The benefits of long-term virologic suppression with continued therapy must be weighed against the risk of prolonged treatment, including the uncertainties as regards the long term impact of bone and renal toxicity.
If a patient misses a dose of tenofovir within 12 hours of the time it is usually taken, the patient should take Viread with food as soon as possible and resume their normal dosing schedule. If a patient misses a dose of tenofovir 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, another dose should be taken. If the patient vomits more than 1 hour after taking tenofovir they do not need to take another dose.
Should be taken once daily, orally with food.
For:
Regimen A: In case that patient age in years is ≥ 6 and patient weight is ≥ 17 kg and patient weight is ≤ 22 kg, oral, 123 milligrams tenofovir disoproxil, once daily to meals.
Regimen B: In case that patient age in years is ≥ 6 and patient weight is ≥ 22 kg and patient weight is ≤ 28 kg, oral, 163 milligrams tenofovir disoproxil, once daily to meals.
Regimen C: In case that patient age in years is ≥ 6 and patient weight is ≥ 28 kg and patient weight is ≤ 35 kg, oral, 204 milligrams tenofovir disoproxil, once daily to meals.
Regimen D: In case that patient age in years is ≥ 2, granule oral, 6.5 milligrams tenofovir disoproxil per kilogram of body weight, once daily to meals.
The recommended dose for the treatment of HIV-1 infection in paediatric patients aged 6 to <12 years weighing 17 kg to <22 kg is 123 mg once daily taken orally with food.
For patients weighing 22 kg to <28 kg the recommended dose is 163 mg once daily and for patients weighing 28 kg to <35 kg the recommended dose is 204 mg once daily taken orally with food.
Tenofovir disoproxil granules are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, from 2 to <6 years of age, and above 6 years of age for whom a solid dosage form is not appropriate. The recommended dose is 6.5 mg per kilogram of body weight once daily taken with food.
The decision to treat paediatric patients should be based on careful consideration of individual patient needs and with reference to current paediatric treatment guidelines including the value of baseline histological information. The benefits of long-term virologic suppression with continued therapy must be weighed against the risk of prolonged treatment, including the uncertainties as regards the long term impact of bone and renal toxicity.
Serum ALT should be persistently elevated for at least 6 months prior to treatment of paediatric patients with compensated liver disease due to HBeAg positive chronic hepatitis B; and for at least 12 months in patients with HBeAg negative disease.
If a patient misses a dose of tenofovir within 12 hours of the time it is usually taken, the patient should take tenofovir with food as soon as possible and resume their normal dosing schedule. If a patient misses a dose of tenofovir 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, another tablet should be taken. If the patient vomits more than 1 hour after taking tenofovir they do not need to take another dose.
Should be taken orally with food.
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