Exacerbation of Hepatitis

• Severe acute exacerbations of hepatitis have been reported in patients who have discontinued anti-Hepatitis B therapy including HEPSERA.  Hepatic function should be closely monitored with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-Hepatitis B therapy. If appropriate, resumption of anti-Hepatitis B therapy may be warranted.

Nephrotoxicity

• In patients at risk of or having underlying renal dysfunction, chronic administration of HEPSERA may result in nephrotoxicity.  These patients should be monitored closely for renal function and may require dose adjustment.

HIV Resistance

• HIV resistance may emerge in chronic hepatitis B patients with unrecognized or untreated Human Immunodeficiency Virus (HIV) infection treated with anti-hepatitis B therapies, such as therapy with HEPSERA, that may have activity against HIV.

Lactic Acidosis, Severe Hepatomegaly

• Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretrovirals.

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

• Closely monitor liver function after stopping therapy with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, resumption of anti-hepatitis B therapy may be warranted.
• Monitor renal function during therapy, particularly in those with pre-existing or other risk factors for renal impairment. Patients with renal insufficiency at baseline or during therapy may require dosage adjustments.
• Prior to initiating therapy, HIV antibody testing should be offered.
• Suspend treatment in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.

Patient Counseling Information

• Hepsera

Medication Guides

Patient Medication Guides

Package Inserts

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