Entecavir Side Effects

Some side effects of entecavir may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to entecavir: oral solution, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking entecavir: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as:

• muscle pain or weakness;

• numb or cold feeling in your arms and legs;

• trouble breathing;

• feeling dizzy, light-headed, tired, or very weak;

• stomach pain, nausea with vomiting; or

• slow or uneven heart rate.

Entecavir may also cause severe liver symptoms. Call your doctor at once if you have any of these liver symptoms:

• low fever;

• nausea, stomach pain, loss of appetite;

• dark urine, clay-colored stools; or

• jaundice (yellowing of the skin or eyes).

Less serious side effects of entecavir may include:

• mild nausea, vomiting, diarrhea, upset stomach;

• temporary hair loss;

• headache;

• skin rash; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to entecavir: oral solution, oral tablet

General

The most common side effects reported in patients with chronic hepatitis B virus (HBV) infection and compensated liver disease during clinical trials have included headache, fatigue, dizziness, and nausea. One percent of patients discontinued treatment due to side effects or laboratory abnormalities (compared to 4% of lamivudine-treated patients).

The most common side effects reported in patients with chronic HBV infection and evidence of hepatic decompensation (n=102) through Week 48 of a study have included peripheral edema, ascites, pyrexia, hepatic encephalopathy, and upper respiratory infection. Eighteen percent of patients treated with entecavir died during the first 48 weeks of therapy (compared to 20% of adefovir-treated patients). The majority of deaths (11 of 18 entecavir-treated patients and 16 of 18 adefovir-treated patients) were due to liver-related causes such as hepatic failure, hepatic encephalopathy, hepatorenal syndrome, and upper gastrointestinal hemorrhage. Five percent of patients discontinued entecavir or adefovir due to a side effect through 48 weeks of therapy.

Hepatic

Hepatic side effects have included elevated ALT (greater than 10 times ULN and greater than 2 times baseline: 2%; greater than 5 times ULN: up to 12%) and total bilirubin (greater than 2.5 times ULN; up to 3%). Elevated AST and ALT flares have also been reported. Hepatic encephalopathy (10%) and deaths due to liver-related causes (such as hepatic failure, hepatic encephalopathy, and hepatorenal syndrome) have been reported in entecavir-treated patients with hepatic decompensation. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside/nucleotide analogs alone or in combination with other antiretroviral agents. Severe acute exacerbations of hepatitis have been reported in patients with hepatitis B after discontinuation of entecavir. Increased transaminases have been reported during postmarketing experience.

Posttreatment exacerbations of hepatitis or ALT flare, as defined by ALT greater than 10 times ULN and greater than 2 times baseline, have been reported in patients who discontinued treatment at or after 52 weeks after achieving a defined treatment response (nucleoside-naive HBeAg-positive, 2%; nucleoside-naive HBeAg-negative, 8%; lamivudine-refractory, 12%). The median time to exacerbation was 23 to 24 weeks. The rate may be higher in patients who discontinue entecavir without regard to treatment response.

Other

Other side effects of moderate to severe intensity (Grade 2 to 4) have included fatigue (up to 3%). Fever, accidental injury, influenza, and back pain have also been reported. Peripheral edema (16%), ascites (15%), and pyrexia (14%) have been reported in entecavir-treated patients with hepatic decompensation.

Metabolic

Metabolic side effects have included elevated lipase (greater than or equal to 2.1 times ULN; 7%), fasting hyperglycemia (greater than 250 mg/dL; up to 3%), elevated alkaline phosphatase, and elevated amylase. Decreased blood bicarbonate has been reported in 2% of entecavir-treated patients with hepatic decompensation. Lactic acidosis has been reported during postmarketing experience.

Genitourinary

Genitourinary side effects have included hematuria (Grade 3 to 4; 9%), glycosuria (Grade 3 to 4; 4%), and dysuria.

Renal

Renal side effects have included confirmed creatinine increases of 0.5 mg/dL or more (up to 2%). A confirmed increase in serum creatinine of 0.5 mg/dL (11%) and renal failure (less than 1%) have been reported in entecavir-treated patients with hepatic decompensation.

Respiratory

Respiratory side effects have included upper respiratory tract infection, cough, nasopharyngitis, and rhinitis. Upper respiratory infection has been reported in 10% of entecavir-treated patients with hepatic decompensation.

Gastrointestinal

Gastrointestinal side effects of moderate to severe intensity (Grade 2 to 4) have included diarrhea (up to 1%), dyspepsia (up to 1%), nausea (less than 1%), and vomiting (less than 1%). Abdominal pain (unspecified) and upper abdominal pain have also been reported. Deaths due to gastrointestinal hemorrhage were reported in entecavir-treated patients with hepatic decompensation.

Oncologic

Oncologic side effects have included malignant neoplasms occurring at a rate of 8.4 per 1000 patient-years. Hepatocellular carcinoma has been reported in 6% of entecavir-treated patients with hepatic decompensation.

Nervous system

Nervous system side effects of moderate to severe intensity (Grade 2 to 4) have included headache (up to 4%), dizziness (less than 1%), and somnolence (less than 1%).

Hematologic

Hematologic side effects have included decreased albumin (less than 2.5 g/dL) and platelets (less than 50,000/mm3) in less than 1% of patients.

Immunologic

Immunologic side effects have included anaphylactoid reaction during postmarketing experience.

Psychiatric

Psychiatric side effects of moderate to severe intensity (Grade 2 to 4) have included insomnia (less than 1%).

Musculoskeletal

Musculoskeletal side effects have included arthralgia and myalgia.

Dermatologic

Dermatologic side effects have included erythema. Rash and alopecia have been reported during postmarketing experience.

Hypersensitivity

Hypersensitivity side effects have included photosensitivity with lethargy in at least one patient, which resolved after stopping entecavir.

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