Viread Patient Counseling 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 VIREAD. Advise patients not to discontinue VIREAD without first informing their healthcare provider. All patients should be tested for HBV infection before or when starting VIREAD and those who are infected with HBV need close medical follow-up for several months after stopping VIREAD to monitor for exacerbations of hepatitis [see Precautions].
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 VIREAD . Advise patients to avoid VIREAD with concurrent or recent use of a nephrotoxic agent (e.g., high-dose or multiple NSAIDs) [see Precautions]. The dosing interval of VIREAD 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 Precautions].
Bone Loss and Mineralization Defects: Inform patients that decreases in bone mineral density have been observed with the use of VIREAD. Consider bone monitoring in patients who have a history of pathologic bone fracture or at risk for osteopenia [see Precautions].
Lactic Acidosis and Severe Hepatomegaly: Inform patients that lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Treatment with VIREAD should be suspended in any patient who develops clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity [see Precautions].
Drug Interactions: Advise patients that VIREAD 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 Precautions and Interactions].
Dosing Recommendations: Inform patients that it is important to take VIREAD on a regular dosing schedule with or without food and to avoid missing doses as it can result in development of resistance [see Dosage & Administration].
Pregnancy Registry: Inform patients that there is an antiretroviral pregnancy registry to monitor fetal outcomes of pregnant women exposed to VIREAD [see Use in Pregnancy & Lactation].
Lactation: Instruct mothers not to breastfeed if they are taking VIREAD for the treatment of HIV-1 infection because of the risk of passing the HIV-1 virus to the baby [see Use in Pregnancy & Lactation].
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.