Caution:

PRECAUTIONS General

– Patients receiving tenofovir disoproxil fumarate or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.

– Patients should be advised that antiretroviral therapies, including Getino-B, have not been proven to prevent the risk of transmission of HIV or HBV to others through sexual contact or blood contamination. Appropriate precautions must continue to be used.

– Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

– Tenofovir disoproxil fumarate may be associated with reduction in bone density and patients should be observed for evidence of bone abnormalities. Geriatric Patients Dose selection for the elderly patients should be done with caution, keeping in mind the greaterfrequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. Renal Insufficiency It is recommended that creatinine clearance is calculated in all patients prior to initiating therapy and as clinically appropriate, during tenofovir disoproxil fumarate therapy.

Patients at risk for, or with a history of, renal dysfunction should be routinely monitored for changes in serum creatinine and phosphorus. Hepatic Insufficiency

– Patients with cirrhosis may be at a higher risk for hepatic decompensation following hepatitis exacerbation and therefore should be monitored closely during therapy.

– Co-infected patients with HIV and hepatitis B: Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice. If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.

Liposystrophy (lipoatrophy/lipomatosis) Consideration should be given to the measurement of fasting serum lipids and blood glucose. Lipid disorders should be managed as clinically appropriate. Immune Reactivation Syndrome Any inflammatory symptoms should be evaluated and treatment instituted when necessary.

Osteonecrosis Patients are advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.