TENOBERG
TENOFOVIR DISOPROXIL · by JSK MEDICA
Composition
Tab 300 mg: Tenofovir Disoproxil (as fumarate) 300 mg
Indications & Dosage
HIV infection in combination with other antiretroviral drugs, Chronic hepatitis B infection with compensated liver disease (with evidence of viral replication, and histologically documented active liver inflammation or fibrosis), Chronic hepatitis B infection with decompensated liver disease: Adult: 245 mg once daily
Precautions
When treating chronic hepatitis B with tenofovir, monitor liver function tests every 3 months and viral markers for hepatitis B every 3-6 months during treatment (continue monitoring for at least 1 year after discontinuation; recurrent hepatitis may occur on discontinuation), renal or hepatic impairment, hyperphosphataemia. Monitor renal function before treatment, every 4 weeks during first year, then every 3 months; reduce dose or interrupt therapy if serum phosphate or creatinine clearance is decreased. Risk of immune reactivation syndrome in patients with severe immune deficiency within first few weeks or months or starting combination antiretroviral therapy, Risk of osteonecrosis; monitor for signs of joint pain or immobility. Reduced bone mineral density, elderly, Cirrhosis; monitor for hepatic decompensation. Caution in patients (particularly obese women) with hepatomegaly, hepatitis or other risk factors for liver disease and hepatic steatosis; monitor for lactic acidosis, discontinue therapy if occurs. Risk of lipodystrophy and metabolic abnormalities; monitor for physical signs of fat redistribution, measure fasting serum lipids and blood glucose.
Interactions
Nephrotoxic drugs, drugs eliminated by active tubular secretion, nucleoside analogues, atazanavir, didanosine, adefovir, tacrolimus. Triple therapy with lamivudine, plus abacavir, or lamivudine plus didanosine.
Pregnancy
Caution advised, avoid
Lactation
Caution advised, avoid
Side Effects
Hypophosphataemia, reduced bonedensity, hyperphosphataemia, dizziness, headache, raised ALT fatigue, pancreatitis, rash, renal abnormalities lactic acidosis, GI disturbance. Rare: Nephrogenic diabetes insipidus, proximal renal tubulopathy, renal failure