Tefostad T300

Rx

Indications

• Use in conjunction with other antiretroviral agents (should not be used alone) in the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults.
• Post-exposure prophylaxis of HIV infection (occupational exposure or nonoccupational exposure) in individuals associated with a risk for transmission of the virus.
• Treatment of chronic hepatitis B in adults.

Dosage

Adults

• Treatment of HIV infection: 1 tablet once daily, in conjunction with other antiretrovirals.
• Post-exposure prophylaxis following occupational exposure to HIV (preferably within hours rather than days and continued for 4 weeks, if tolerated): 1 tablet once daily in conjunction with other antiretrovirals (usually in conjunction with lamivudine or emtricitabine).
• Post-exposure prophylaxis following nonoccupational exposure to HIV (preferably within 72 hours and continued for 28 days): 1 tablet once daily in conjunction with at least 2 other antiretrovirals.
• Treatment of chronic hepatitis B: The recommended dosage is 1 tablet once daily past 48 weeks.

Hepatic impairment patients: Dosage adjustment is not required.

Renal impairment patients

Doses of tenofovir disoproxil fumarate should be modified by adjustment of the dosing interval in patients with renal impairment according to their creatinine clearance (Clcr):

• Clcr ≥ 50 mL/min: Usual once-daily dosage.
• Clcr 30 to 49 mL/minute: Every 48 hours.
• Clcr 10 to 29 mL/minute: Every 72 to 96 hours.
• Haemodialysis patients: A dose every 7 days or after a cumulative total of 12 hours of dialysis.

Usage

Tefostad T300 is administered orally once daily without regard to meals.

Known hypersensitivity to tenofovir disoproxil fumarate or to any of the ingredients.

• Mild gastrointestinal effects, particularly diarrhoea, nausea and vomiting, abdominal pain, flatulence, dyspepsia, and anorexia.
• Serum-amylase concentrations may be raised and pancreatitis has been reported.
• Hypophosphataemia.
• Skin rashes.
• Peripheral neuropathy, headache, dizziness, insomnia, depression, asthenia, sweating, and myalgia.
• Raised liver enzymes, hypertriglyceridaemia, hyperglycaemia, and neutropenia.
• Renal impairment, (including Fanconi syndrome).
• Lactic acidosis, severe hepatomegaly and steatosis.

• Adipogenic effects and bone effects has been reported with antiretroviral therapy.
• Discontinue using when hepatomegaly, raised quickly aminotransferase, lactic acidosis. Hepatic function should be closely monitored follow up for at least several months after tenofovir is discontinued.
• Tenofovir disoproxil fumarate should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. The use of tenofovir disoproxil fumarate in women of childbearing potential must be accompanied by the use of effective contraception. It is recommended that mothers being treated with tenofovir disoproxil fumarate do not breast-feed their infants. As a general rule, it is recommended that HIV infected women do not breast-feed their infants in order to avoid transmission of HIV to the infant.
• Patients should be aware of how they react to drug before driving or operating machinery.