cost effectively [172:<10 IU/mL] or >1 log increase in HBV DNA) should either be switched to an alternative antiviral monotherapy agent with a high genetic barrier to resistance or receive a second antiviral agent with a complementary resistance profile; consult current clinical practice guidelines for recommended agents (AASLD [Terrault 2016]). HBV reinfection prophylaxis, post liver transplant (with or without HBIG) (off-label use): Oral: 0.5 mg once daily (Fung, 2011) or 1 mg once daily (Perrillo 2012) HIV/HBV coinfection (off-label use): Oral: Nucleoside treatment naive: 0.5 mg once daily Lamivudine refractory or resistant: 1 mg once daily Note: Only recommended in patients who cannot take tenofovir; must be used in addition to a fully suppressive antiretroviral therapy regimen (DHHS, 2013). Dosing: Geriatric Refer to adult dosing. Dosing: Pediatric Hepatitis B virus (HBV) infection, treatment (nucleoside treatment naïve or lamivudine-refractory or -resistant viremia [or known lamivudine- or telbivudine-resistance mutations]): Children 2 years and Adolescents: Oral: Note: Oral solution should be used for patients weighing 30 kg. Treatment-naive: 10 to 11 kg: 0.15 mg once daily (oral solution) >11 to 14 kg: 0.2 mg once daily (oral solution) >14 to 17 kg: 0.25 mg once daily (oral solution) >17 to 20 kg: 0.3 mg once daily (oral solution) >20 to 23 kg: 0.35 mg once daily (oral solution) >23 to 26 kg: 0.4 mg once daily (oral solution) >26 to 30 kg: 0.45 mg once daily (oral solution) >30 kg: 0.5 mg once daily (oral solution or tablet) Lamivudine-experienced: 10 to 11 kg: 0.3 mg once daily (oral solution) >11 to 14 kg: 0.4 mg once daily (oral solution) >14 to 17 kg: 0.5 mg once daily (oral solution) >17 to 20 kg: 0.6 mg once daily (oral solution) >20 to 23 kg: 0.7 mg once daily (oral solution) >23 to 26 kg: 0.8 mg once daily (oral solution) >26 to 30 kg: 0.9 mg once daily (oral solution) >30 kg: 1 mg once daily (oral solution or tablet) Dosing: Renal Impairment Adults: Daily-dosage regimen preferred: CrCl 50 mL/minute: No dosage adjustment necessary. CrCl 30-49 mL/minute: Administer 50% of usual dose daily or administer the normal dose every 48 hours CrCl 10-29 mL/minute: Administer 30% of usual dose daily or administer the normal dose every 72 hours CrCl> <10 mL/minute (including hemodialysis and CAPD): Administer 10% of usual dose daily or administer the normal dose every 7 days; administer after hemodialysis Children >2 years and Adolescents: Insufficient data to recommend a specific dose adjustment in pediatric patients with renal impairment; consider a reduction in the dose or an increase in the dosing interval similar to adjustments for adults. Dosing: Hepatic Impairment Adults: No dosage adjustment necessary. Children >2 years and Adolescents: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). Administration Administer on an empty stomach (2 hours before or after a meal). Do not dilute or mix oral solution with water or other beverages; use calibrated oral dosing syringe. Oral solution and tablet are bioequivalent on a mg-to-mg basis. Dietary Considerations Take on an empty stomach (2 hours before or after a meal). Storage Store at 25 C (77 F); excursions permitted to 15 C to 30 C (59 F to 86 F). Protect from light. After opening, oral solution can be used up to expiration date on the bottle. Drug Interactions Orlistat: May decrease the serum concentration of Antiretroviral Agents. Monitor therapy Adverse Reactions Adverse reactions are generally similar in adult and pediatric patients. >10%: Cardiovascular: Peripheral edema (16% with decompensated liver disease) Hepatic: Ascites (15% with decompensated liver disease), increased serum ALT (>5 x ULN: 11% to 12%; post-treatment flare [lamivudine refractory]: >10 x ULN and >2 x baseline: 12%) Renal: Increased serum creatinine (11% with decompensated liver disease; 1% to 2% with compensated liver disease) Miscellaneous: Fever (14% with decompensated liver disease) 1% to 10%: Central nervous system: Headache (2% to 4%), fatigue (1% to 3%), dizziness Dermatologic: Skin rash Endocrine & metabolic: Glycosuria (4%), hyperglycemia (2% to 3%), decreased serum bicarbonate (2% with decompensated liver disease) Gastrointestinal: Increased serum lipase (7%), increased serum amylase (2% to 3%), abdominal pain (children and adolescents >1%), diarrhea (children and adolescents >1%; adults 1%), unpleasant taste (children and adolescents >1%), vomiting (children and adolescents >1%; adults> <1%), dyspepsia ( 1%), nausea Genitourinary: Hematuria (9%) Hematologic & oncologic: Hepatic carcinoma (6% with decompensated liver disease) Hepatic: Hepatic encephalopathy (10% with decompensated liver disease), increased serum bilirubin (2% to 3%), increased serum ALT (>10 x ULN and >2 x baseline: 2%; post-treatment flare [nucleoside-naive]: >10 x ULN and >2 x baseline: 2% to 8%) Respiratory: Upper respiratory tract infection (10% with decompensated liver disease)> <1% (Limited to important or life-threatening): Alopecia, anaphylactoid reaction, hepatomegaly, insomnia, lactic acidosis, macular edema (Muqit, 2011), renal failure, thrombocytopenia ALERT: U.S. Boxed Warning Severe acute exacerbations of hepatitis B: Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti hepatitis B therapy, including entecavir. Closely monitor hepatic function with clinical and laboratory follow-up for at least several months in patients who discontinue anti hepatitis B therapy. If appropriate, initiation of antihepatitis B therapy may be warranted. HIV and chronic hepatitis B virus coinfection: Limited clinical experience suggests there is a potential for the development of resistance to HIV nucleoside reverse transcriptase inhibitors if entecavir is used to treat chronic hepatitis B virus (HBV) infection in patients with HIV infection not being treated. Therapy with entecavir is not recommended for HIV/HBV coinfected patients who are not also receiving antiretroviral therapy. Lactic acidosis and hepatomegaly: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogue inhibitors alone or in combination with antiretrovirals. Warnings/Precautions Concerns related to adverse effects: Lactic acidosis/hepatomegaly: [US Boxed Warning]: Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with nucleoside analogue inhibitors; use with caution in patients with risk factors for liver disease (risk may be increased with female gender, decompensated liver disease, obesity, or prolonged nucleoside inhibitor exposure) and suspend treatment in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or hepatotoxicity (transaminase elevation may/may not accompany hepatomegaly and steatosis). Disease-related concerns: Chronic hepatitis B: [US Boxed Warning]: Severe, acute exacerbation of hepatitis B may occur upon discontinuation of antihepatitis B therapy, including entecavir. Monitor liver function for at least several months after stopping treatment; reinitiation of antihepatitis B therapy may be required. HIV: [US Boxed Warning]: May cause the development of HIV resistance in chronic hepatitis B patients with unrecognized or untreated HIV infection. Determine HIV status prior to initiating treatment with entecavir. Not recommended for HIV/HBV coinfected patients unless also receiving antiretroviral therapy. The manufacturer's labeling states that entecavir does not exhibit any clinically-relevant activity against human immunodeficiency virus (HIV type 1). However, a small number of case reports have indicated declines in virus levels during entecavir therapy. HIV resistance to a common HIV drug has been reported in an HIV/HBV-infected patient receiving entecavir as monotherapy for HBV. Hepatic impairment: Dose adjustment not required. Limited data supporting treatment of chronic hepatitis B in patients with decompensated liver disease; observe for increased adverse reactions, including hepatorenal dysfunction. Renal impairment: Use with caution in patients with renal impairment or patients receiving concomitant therapy which may reduce renal function; dose adjustment recommended for CrCl> <50 mL/minute. Special populations: Children: There are limited data available on the use of entecavir in lamivudine-experienced pediatric patients; use in these patients only if the potential benefit justifies the potential risk to the child. Dosage form specific issues: Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson, 2002; Lucente 2000; Shelley, 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade, 1986; CDC, 1984). See manufacturer s labeling. Other warnings/precautions: Resistance: Cross-resistance may develop in patients failing previous therapy with lamivudine. Monitoring Parameters Manufacturer s labeling: HIV status (prior to initiation of therapy); periodic monitoring of hepatic function is recommended during treatment and for at least several months after treatment in patients who discontinue anti-hepatitis B therapy. Monitor patients for signs and symptoms of lactic acidosis and hepatotoxicity. Alternate recommendations: Chronic Hepatitis B: HBV DNA and ALT (HBV DNA usually done every 3 months until undetectable and then every 3 to 6 months thereafter); HBeAg; anti-HBe (in patients who are HBeAg-positive to monitor for seroconversion); HBsAg; consider monitoring lactic acid levels (if clinical concern); following discontinuation, monitor for recurrent viremia, ALT flares, seroreversion, and clinical decompensation every 3 months for at least 1 year (AASLD [Terrault 2016]). As antivirals do not eliminate the risk of hepatocellular carcinoma, continued monitoring for this complication is recommended in at-risk patients. Pregnancy Risk Factor C Pregnancy Considerations Teratogenic effects have been observed in animal studies. Information related to use in pregnancy is limited; use only if other options are inappropriate (DHHS [OI], 2013). Pregnant women taking entecavir should enroll in the pregnancy registry by calling 1-800-258-4263. Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience headache, dizziness, nausea, or loss of strength and energy. Have patient report immediately to prescriber signs of lactic acidosis (fast breathing, tachycardia, abnormal heartbeat, vomiting, fatigue, shortness of breath, severe loss of strength and energy, severe dizziness, feeling cold, or muscle pain or cramps), or signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice) (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients. Next Interactions Print this page Add to My Med List More about entecavir Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Images Drug Interactions Support Group Pricing & Coupons En Español 1 Review Add your own review/rating Drug class: nucleoside reverse transcriptase inhibitors (NRTIs) Consumer resources Entecavir ... +3 more Professional resources Entecavir (AHFS Monograph) Entecavir (FDA) Other brands: Baraclude Related treatment guides Hepatitis B> ]} Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Entecavir Rating 1 User Review 10 /10 1 User Review 10 Rate it! Manufacturers Amneal Pharmaceuticals LLC Par Pharmaceutical, Inc. Teva Pharmaceuticals USA, Inc. Zydus Pharmaceuticals (USA) Inc. Aurobindo Pharma Limited Camber Pharmaceuticals, Inc. AvKare, Inc. More... Drug Class Nucleoside reverse transcriptase inhibitors (NRTIs) Related Drugs nucleoside reverse transcriptase inhibitors (NRTIs) Viread , lamivudine , abacavir , tenofovir , Baraclude , zidovudine Hepatitis B Viread , lamivudine , tenofovir , Baraclude , Epivir , Vemlidy , Pegasys , Intron A , adefovir , Hepsera , PegIntron , interferon alfa-2b , Epivir-HBV , Tyzeka , peginterferon alfa-2a , telbivudine , More... Entecavir Images Entecavir systemic 0.5 mg (TEVA 5786) View all images} } sizable of style
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