Ricovir Special Precautions

General: Tenofovir Disoproxil Fumarate has not been studied in patients under the age of 12 years or in patients over the age of 65 years. Elderly patients are more likely to have decreased renal function, therefore caution should be exercised when treating elderly patients with tenofovir Disoproxil Fumarate (see as follows).
HIV antibody testing should be offered to all HBV infected patients before initiating tenofovir therapy (see as follows Co-infection with HIV-1 and hepatitis B). In turn, HBV antibody testing should be offered to all HIV infected patients before initiating tenofovir therapy.
In the treatment of chronic hepatitis B, limited data are currently available in immunosuppressed patients or those receiving immuno-suppressive regimens, orthotropic liver transplant patients and patients coinfected with the hepatitis C or D virus. As clinical studies have not included sufficient numbers of subjects to determine whether these patients respond differently to Tenofovir Disoproxil Fumarate 300 mg Tablets chronic hepatitis B therapy, such patients should be closely monitored.
Lactic Acidosis/Severe Hepatomegaly with Steatosis: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of antiretroviral nucleoside analogues alone or in combination, including tenofovir disoproxil fumarate, in the treatment of HIV infection. A majority of these cases have been reported in women. The preclinical and clinical data suggest that the risk of occurrence of lactic acidosis, a class effect of nucleoside analogues is low for tenofovir disoproxil fumarate. However, as tenofovir is structurally related to nucleoside analogues, this risk cannot be excluded. Caution should be exercised when administering Tenofovir Disoproxil Fumarate 300 mg Tablets to any patient, and particularly to those with known risk factors for liver disease. Treatment with Tenofovir Disoproxil Fumarate 300 mg Tablets should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or hepatotoxicity.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed. However, patients should be informed that dizziness has been reported during treatment with tenofovir disoproxil fumarate.
Impaired renal function: Dosing interval adjustment is required in all patients with creatinine clearance <50 ml/min (See Dosage & Administration). The proposed dose interval modifications are based on limited data and may not be optimal. Therefore, clinical response to treatment and renal function should be closely monitored in these patients.
Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphataemia), has been reported in association with the use of Tenofovir Disoproxil Fumarate 300 mg Tablets.
Tenofovir Disoproxil Fumarate 300 mg Tablets should be avoided with concurrent or recent use of a nephrotoxic agent.
It is recommended that creatinine clearance is calculated in all patients prior to initiating therapy and, as clinically appropriate, during Tenofovir Disoproxil Fumarate 300 mg Tablets therapy. Patients at risk for, or with a history of, renal dysfunction, including patients who have previously experienced renal events while receiving adefovir dipivoxil, should be routinely monitored for changes in serum creatinine and phosphorus.
Use in Children: The safety and efficacy of Tenofovir Disoproxil Fumarate 300 mg Tablets has not been established in children less than 12 years of age.
The clinical relevance of the long term effects of tenofovir disoproxil fumarate treatment on BMD are unknown, and at present the data on the reversibility of renal toxicity effects is limited. Therefore, a multidisciplinary approach is recommended to consider the benefit/risk balance of treatment.
As hepatitis B is a chronic disease of the liver, ongoing clinical monitoring is recommended.
Use in the Elderly: In general, dose selection for the elderly patient should be cautious, keeping in mind the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.