Entaliv containing Entecavir exhibits its anti-viral activity by prohibiting three steps in viral production; Entaliv is an anti-viral medicine, which is guanosine nucleoside analogue effective against HBV infection. Entaliv is encounters with natural substrate deoxyguanosine triphosphate. Entaliv interferes with three activities of HBV polymerase; Base priming from pregenomic messenger RNA, Reverse transcription of negative strand occurs Integration of positive strand of HBV DNA. A Entaliv tablet has Entecavir, which is inserting into viral DNA has extreme effect of prohibiting the HBV polymerase activity.
Entaliv tablet, after an oral administration it may undergo ADME properties. The peak plasma concentration time of Entaliv is occurs within 0.5 & 1.5 hours. The steady state of Entaliv is reaches after 6 to 10 days of single dose administration. Entaliv 0.5mg Cmax value is 4.2ng/ml and trough plasma concentration is 0.3ng/ml
The critical points take into consideration, while starting the therapy with Entaliv tablets; Indication of Entaliv is established by clinical trial data in nucleoside inhibitor-therapy naïve and lamivudine resistant patients with HBeAg positive and HBeAg negative HBV infection and compensated liver cirrhosis & decompensated cirrhosis. Entaliv is used in pediatric patients with 2 years of age or older, with treatment naïve, lamivudine resistant with HBeAg positive HBV infection & compensated liver cirrhosis. Main indication: Entaliv tablets are used to treat chronic hepatitis B viral infection commonly in adolescent patients with the sign of viral multiplication and other information of lasting elevation of serum aminotransferase or active disease.
Brand : Entaliv
Ingredients : Entecavir
Strength : 0.5mg
Manufactured : Dr. Reddy’s
Package : 30 tablets
Entaliv tablets should be taken on an empty stomach (partially 2 hours after a meal or two hours earlier to the next meal). The usual prescribed dosage of Entaliv tablets;In compensated cirrhosis
In adults In this condition, the prescribed dosage of Entaliv is 0.5mg should be administered orally as a single dose for the chronic hepatitis B viral infected patients who have newly started with Entaliv. In past hepatitis B viremia, since taking lamivudine therapy or known lamivudine or telbivudine resistant alteration; the advised dosage of Entaliv tablets is 1mg should be administered orally as a single dose.In pediatric
The safety and efficacy of Entaliv in children with the age of <2 years has not been established. In nucleoside naïve patients: 2 years or older with >30kg: 0.5mg of Entaliv should be recommended as single dose. In lamivudine resistant patients: 2 years and older with >30kg: 1mg (2 tablet of 0.5mg Entaliv) of Entaliv should be recommended as a single dose.
In decompensated condition, the suggested dosage is 1mg of Entaliv should be taken as once a day.In renal damaged patients
If creatinine clearance decreased, then the apparent oral clearance of Entaliv is also decreased. The dosage recommendation for the patients; With creatinine clearance of less than 50ml/min, Hemodialysis patients and For Continuous ambulatory peritoneal dialysis patients (CAPD) CrCl ≥50ml/min: 0.5mg of Entaliv should be recommended; in lamivudine resistant or decompensated condition 1mg of Entaliv is recommend. In 30 to <50ml/min: 0.5mg of Entaliv is taken for every 48 hours; in lamivudine resistant or decompensated condition 0.5mg of Entaliv as single dose or 1mg of Entaliv taken for every 48 hours. In 10 to <30ml/min: 0.5mg of Entaliv should be given for every 72 hours; in lamivudine resistant or decompensated condition 1mg of Entaliv is recommended for every 72 hours. <10ml/min: & hemodialysis or CAPD: 0.5mg of Entaliv is recommended for every 7 days; in lamivudine resistant or decompensated condition 1mg of Entaliv should be given for every 7 days. In hepatic impairment patients, dosage adjustment of Entaliv should not be recommended.
The most common adverse reaction occurs during or after the treatment; Severe aggravation of hepatitis B infection Lactic acidosis Hepatomegaly with steatosis The common side effects like Dyspepsia Alopecia Rash Elevation of transaminase Headache Fatigue Anaphylactic reactions Dizziness Diarrhea Nausea Vomiting Somnolence Insomnia Hepatic failure Gastrointestinal hemorrhage Hepatocellular carcinoma
Some precautions should be taken while starting therapy with EntalivIn severe acute aggravation of hepatitis B:
This adverse may occur after discontinuation of anti-hepatitis B therapy. In this condition patient should be monitored frequently with liver functions and other laboratory follow ups. Continue the anti-hepatitis B therapy, if required.In HBV/HIV-1 co infected patients
Entecavir has not assessed in HIV/HBV co infected patients who are not concurrently taking effective anti-retroviral therapy. Entaliv tablet used for HBV infection in patients who are infected with HIV, produce resistant to HIV nucleoside reverse transcriptase inhibitors, not exist to treat. Entaliv should not be suggested to HBV/HIV co infected patients, also not receiving HAART. To overcome this type of condition, patient should be examine with HIV antibody testing before the therapy.In lactic acidosis & hepatomegaly with steatosis
This condition may occur due to the combination of nucleoside analog with anti-retroviral agents, this may happen mostly in women. The major fatal cases of this condition is obesity and extended nucleoside exposure. Lactic acidosis frequently occurs in decompensated liver cirrhosis patients, the only way to reduce this adverse is discontinuing the treatment with Entaliv .
Entaliv is not a CYP 450 enzyme substrate, inhibitor or inducers. Since Entaliv is majorly eliminated through kidneys, co administration of Entaliv tablets with drugs which reduce the renal functions causes increasing the serum concentration of Entecavir and other combined drugs leads to adverse effects of Entaliv. Drug interaction may occur during combination of Entaliv with the drugs which metabolized, inhibit or induce by CYP450 enzyme may have chance to alter pharmacokinetic properties of Entecavir. Co administration of Entaliv with lamivudine, Adefovir or tenofovir disoproxil fumarate not expels any drug interaction.