TenoBoston

POSOLOGY AND METHOD OF ADMINISTRATION 

Method of administration: Oral use, should be taken with meals at a certain time.

Posology:

- Treatment of HIV infection: 1 tablet x 1 time/day, in combination with other antiretroviral medicinal products.

- Prevention of HIV infection after occupational exposure: 1 tablet x 1 time/day in combination with other antiretroviral medicinal products (usually in combination with lamivudine or emtricitabine). Prevention should begin as soon as possible after occupational exposure (best within hours rather than days) and continue for the next 4 weeks if tolerated.

- Prevention of HIV infection after non-occupational exposure: 1 tablet x 1 time/day in combination with at least 2 other antiretroviral medicinal products.

Prevention should begin as soon as possible after non-occupational exposure (best within 72 hours) and continue for 28 days.

- Treatment of chronic hepatitis B: the recommended dose is 1 tablet x 1 time /day for more than 48 weeks.

- Renal impairment:

The dose of Tenofovir disoproxil fumarate should be reduced by dosage interval adjustment for patients with renal impairment based on creatinine clearance (CC):

  CC 50 ml/min or greater: usual dose 1 time /day.

  CC 30 to 49 ml/min: every 48 hours.

  CC 10 to 29 ml/min: every 72 to 96 hours.

- Hemodialysis patients: Every 7 days or after a total of approximately 12 hours of dialysis.

The safety and efficacy of these doses have not been clinically evaluated, clinical response to therapy and renal function should be closely monitored.

Since the safety and efficacy of these doses have not been clinically evaluated, clinical response to therapy and renal function should be closely monitored.

- Hepatic impairment: No dose adjustment is required in patients with hepatic impairment.

CONTRAINDICATIONS

Patients with hypersensitivity to Tenofovir disoproxil fumarate or any ingredient of the drug.

WARNINGS AND PRECAUTIONS 

 - Discontinue the drug immediately when aminotransferase levels increase or in the condition of advanced hepatomegaly, fatty degeneration, metabolic disease, lactic acidosis of unknown cause.

 - Caution in patients with hepatomegaly or risk factors for liver disease, hepatitis C patients treated with α -interferon and ribavirin.

 - For patients with renal impairment, it is necessary to monitoring of renal function and plasma phosphate before starting treatment with tenofovir disoproxil fumarate (the first year 4 weeks/time then reduce to 3 months/time in the following years). Patients at risk for, or with a history of renal dysfunction should be routinely monitored for renal function. Evaluation of renal function weekly and adjustment of dose or discontinue use when serum phosphate levels decrease significantly or creatinine clearance is less than 50 ml/min.

 - Tenofovir disoproxil fumarate may cause a reduced bone density, bone density should be monitored in patients with a history of pathologic bone fracture or bone loss, although the effect of supplementation with calcium and vitamin D was not studied, such supplementation may be beneficial. If bone abnormalities are suspected, it is necessary to consult a doctor.

 - Severe acute exacerbations of hepatitis have been reported in patients who are infected with HBV. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months after discontinuation of tenofovir in patients with concomitant HBV and HIV infection. If appropriate, treatment for HBV infection should be initiated

 - Immune-activated syndrome: In HIV-infected patients who are severely immunocompromised at the time of initiation of combination antiretroviral therapy (CART), asymptomatic inflammatory reactions may develop. or opportunistic infections and cause serious clinical conditions or worsening of symptoms. Reactions are seen within the first few weeks of initiation of combination antiretroviral therapy.

 - Caution in patients with renal impairment, renal function should be monitored before initiating treatment with Tenofovir

SHELF LIFE: 36 months from the manufacturing date. Do not use after the expiry use.