Advise the patient to read the FDA-approved patient labeling (Patient Information).
Severe Acute Exacerbation of Hepatitis B in Patients Infected with HBV
Inform patients that severe acute exacerbations of hepatitis B have been reported in patients infected with hepatitis B virus (HBV) and have discontinued tenofovir disoproxil fumarate. Advise patients not to discontinue tenofovir disoproxil fumarate without first informing their healthcare provider. All patients should be tested for HBV infection before or when starting tenofovir disoproxil fumarate and those who are infected with HBV need close medical follow-up for several months after stopping tenofovir disoproxil fumarate to monitor for exacerbations of hepatitis [ see Warnings and Precautions (5.1)].
New Onset or Worsening Renal Impairment
Inform patients that renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported in association with the use of tenofovir disoproxil fumarate. Advise patients to avoid tenofovir disoproxil fumarate with concurrent or recent use of a nephrotoxic agent (e.g., high-dose or multiple NSAIDs) [ see Warnings and Precautions (5.2)]. The dosing interval of tenofovir disoproxil fumarate may need adjustment in HIV-1 infected patients with renal impairment.
Immune Reconstitution Syndrome
Inform patients that in some patients with advanced HIV infection (AIDS) signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms. Advise patients to inform their healthcare provider immediately of any symptoms of infection [ see Warnings and Precautions (5.4)].
Bone Loss and Mineralization Defects
Inform patients that decreases in bone mineral density have been observed with the use of tenofovir disoproxil fumarate. Consider bone monitoring in patients who have a history of pathologic bone fracture or at risk for osteopenia [ see Warnings and Precautions (5.5)].
Lactic Acidosis and Severe Hepatomegaly
Inform patients that lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Treatment with tenofovir disoproxil fumarate should be suspended in any patient who develops clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity [ see Warnings and Precautions (5.6)].
Drug Interactions
Advise patients that tenofovir disoproxil fumarate may interact with many drugs; therefore, advise patients to report to their healthcare provider the use of any other medication, including other HIV drugs and drugs for treatment of hepatitis C virus [ see Warnings and Precautions (5.7) and Drug Interactions (7)].
Dosing Recommendations
Inform patients that it is important to take tenofovir disoproxil fumarate on a regular dosing schedule with or without food and to avoid missing doses as it can result in development of resistance [ see Dosage and Administration (2)].
Pregnancy Registry
Inform patients that there is an antiretroviral pregnancy registry to monitor fetal outcomes of pregnant women exposed to tenofovir disoproxil fumarate [ see Use in Specific Populations (8.1)].
Lactation
Instruct mothers not to breastfeed if they are taking tenofovir disoproxil fumarate for the treatment of HIV-1 infection because of the risk of passing the HIV-1 virus to the baby [ see Use in Specific Populations (8.2)].
Treatment Duration
Advise patients that in the treatment of chronic hepatitis B, the optimal duration of treatment is unknown. The relationship between response and long-term prevention of outcomes such as hepatocellular carcinoma is not known.
Revised: February 2025
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Qilu Pharmaceutical Co., Ltd..