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ENTECAVIR (entecavir)
- Chronic hepatitis B
- Lamivudine-refractory chronic hepatitis B
0.5 mg tablet
- 1 tablet (0.5 mg) by oral route once daily 1 hour before a meal or 2 hours after a meal
1 mg tablet
- 1 tablet (1 mg) by oral route once daily 1 hour before a meal or2 hours after a meal
0.5 mg tablet
- 1 tablet (0.5 mg) by oral route once daily 1 hour before a meal or 2 hours after a meal
1 mg tablet
- 1 tablet (1 mg) by oral route once daily 1 hour before a meal or2 hours after a meal
Chronic hepatitis B
- 1 tablet (0.5 mg) by oral route once daily 1 hour before a meal or 2 hours after a meal
- 2 tablets (1 mg) by oral route once daily 1 hour before a meal or 2 hours after a meal
- 1 tablet (1 mg) by oral route once daily 1 hour before a meal or2 hours after a meal
Lamivudine-refractory chronic hepatitis B
- 2 tablets (1 mg) by oral route once daily 1 hour before a meal or 2 hours after a meal
- 1 tablet (1 mg) by oral route once daily 1 hour before a meal or2 hours after a meal
- None
Contraindicated
- None
Severe
Moderate
- None
- None
Contraindicated
- Abnormal hepatic function tests
- Lactic acidosis
- Renal disease with moderate to severe impairment
- Steatosis of liver
Severe
Moderate
- Drug resistance to anti-retroviral therapy
ENTECAVIR (entecavir)
- Chronic hepatitis B
- Lamivudine-refractory chronic hepatitis B
- Abnormal hepatic function tests
- Hematuria
- Lactic acidosis
- Alopecia
- Dizziness
- Drowsy
- Fatigue
- Headache disorder
- Nausea
- Skin rash
More Frequent
Severe
Less Severe
- Glycosuria
- Hyperbilirubinemia
- Acute abdominal pain
- Diarrhea
- Dysgeusia
- Vomiting
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Anaphylaxis
- Hepatomegaly
- Hyperglycemia
- Steatosis of liver
- Thrombocytopenic disorder
Less Severe
- Dyspepsia
- Insomnia
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Entecavir
Safety and efficacy not established age < 2 years.
- 1 Day – 2 Years
- Safety and efficacy not established age < 2 years.
Entecavir
- Severity Level:
2
- Additional Notes: Insufficient human data available; animal data suggest no developmental toxicity
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Entecavir
Rat studies suggest excretion occurs; insufficient human data
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Unknown | Not known; no or inclusive data | Rat studies suggest excretion occurs; insufficient human data |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
Entecavir
Renal-Follow creatinine clearance. Decrease dose for CLCr <50 mL/minute.
| Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
| Increased Risk / Adverse Effects | Y | Y | N | N | N | N |
BEERS: N HEDIS: N STOPP: N
No Known Risk
None
- Rarely, entecavir may cause serious (possibly fatal) liver problems and lactic acid build-up in the blood (lactic acidosis). Get medical help right away if you have any of the following symptoms: nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine, unusual tiredness/weakness, deep/fast breathing, unusual drowsiness, unusual muscle pain, feeling cold in your arms/legs, fast/irregular heartbeat. These side effects may occur more often in women and obese patients.<br /><br /> Your hepatitis B infection may get worse if you stop taking entecavir. Do not stop this medication without talking to your doctor. Your doctor will do blood tests to check your liver for several months after you stop entecavir.<br /><br /> This medication is not recommended if you have both HIV and hepatitis B and are not receiving effective treatment for HIV. This drug does not treat HIV, and it can cause certain HIV medications to become ineffective. Get an HIV test before starting this medication, and get tested again anytime you may have become infected. Consult your doctor for more details.
| Chronic hepatitis B | |
| B18.0 | Chronic viral hepatitis B with delta-agent |
| B18.1 | Chronic viral hepatitis B without delta-agent |
| Lamivudine-refractory chronic hepatitis B | |
| B18.0 | Chronic viral hepatitis B with delta-agent |
| B18.1 | Chronic viral hepatitis B without delta-agent |
| 0-9 | A-Z |
|---|---|
| B18.0 | Chronic viral hepatitis B with delta-agent |
| B18.0 | Chronic viral hepatitis B with delta-agent |
| B18.1 | Chronic viral hepatitis B without delta-agent |
| B18.1 | Chronic viral hepatitis B without delta-agent |
Formulary Reference Tool