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Entecavir (Entecavir)

Trade Name : Entecavir

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED

Strength 0.5 mg/1

ENTECAVIR Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Entecavir (Entecavir) which is also known as Entecavir and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 0.5 mg/1 per ml. Read more

Entecavir (Entecavir) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted [].
  • Limited clinical experience suggests there is a potential for the development of resistance to HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitors if entecavir tablets are used to treat chronic hepatitis B virus (HBV) infection in patients with HIV infection that is not being treated. Therapy with entecavir tablets are not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART) [].
  • 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 [].
  • WARNING: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED WITH HIV AND HBV, and LACTIC ACIDOSIS AND HEPATOMEGALY
  • See full prescribing information for complete boxed warning
  • Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely for at least several months after discontinuation. Initiation of anti-hepatitis B therapy may be warranted. ()
  • Entecavir tablets are not recommended for patients co-infected with human immunodeficiency virus (HIV) and hepatitis B virus (HBV) who are not also receiving highly active antiretroviral therapy (HAART), because of the potential for the development of resistance to HIV nucleoside reverse transcriptase inhibitors. ()
  • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogue inhibitors. ()
  • Entecavir tablets are indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
  • Entecavir tablets are a hepatitis B virus nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults and children at least 2 years of age with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. ()
  • No data
  • Nucleoside-inhibitor-treatment-nau00efve with compensated liver disease (greater than or equal to 16 years old): 0.5 mg once daily. ()
  • Nucleoside-inhibitor-treatment-nau00efve and lamivudine-experienced pediatric patients at least 2 years of age and weighing at least 10 kg: dosing is based on weight. ()
  • Lamivudine-refractory or known lamivudine or telbivudine resistance substitutions (greater than or equal to 16 years old): 1 mg once daily. ()
  • Decompensated liver disease (adults): 1 mg once daily. ()
  • Renal impairment: Dosage adjustment is recommended if creatinine clearance is less than 50 mL/min. ()
  • Entecavir tablets should be administered on an empty stomach. ()
  • No data
  • Tablets: 0.5 mg and 1 mg (, )
  • None.
  • None. ()
  • No data
  • Severe acute exacerbations of hepatitis B virus infection after discontinuation: Monitor hepatic function closely for at least several months. (, )
  • Co-infection with HIV: Entecavir is not recommended unless the patient is also receiving HAART. ()
  • Lactic acidosis and severe hepatomegaly with steatosis: If suspected, treatment should be suspended. ()
  • The following adverse reactions are discussed in other sections of the labeling:
  • To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • In adults, the most common adverse reactions (u22653%, all severity grades) are headache, fatigue, dizziness, and nausea. The adverse reactions observed in pediatric patients were consistent with those observed in adults. ()
  • Since entecavir is primarily eliminated by the kidneys [], coadministration of entecavir with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. Coadministration of entecavir with lamivudine, adefovir dipivoxil, or tenofovir disoproxil fumarate did not result in significant drug interactions. The effects of coadministration of entecavir with other drugs that are renally eliminated or are known to affect renal function have not been evaluated, and patients should be monitored closely for adverse events when entecavir is coadministered with such drugs.
  • No data
  • Liver transplant recipients: Limited data on safety and efficacy are available. ()
  • There is limited experience of entecavir overdosage reported in patients. Healthy subjects who received single entecavir doses up to 40 mg or multiple doses up to 20 mg/day for up to 14 days had no increase in or unexpected adverse events. If overdose occurs, the patient must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary.
  • Following a single 1 mg dose of entecavir, a 4-hour hemodialysis session removed approximately 13% of the entecavir dose.
  • Entecavir, USPu00a0is a guanosine nucleoside analogue with selective activity against HBV. The chemical name for entecavir is 2-amino-1,9-dihydro-9-[()-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6-purin-6-one, monohydrate. Entecavir has the following structural formula:
  • CHNOu2022HO M.W. 295.3
  • Entecavir monohydrate, USP is a white to off-white crystalline powder. It is slightly soluble in water (2.4 mg/mL), and the pH of the saturated solution in water is 7.9 at 25u00b0 C u00b1 0.5u00b0 C.
  • Each film-coated tablet, for oral administration, contains either 0.533 mg or 1.065 mg of entecavir monohydrate, USP equivalent to 0.5 mg or 1 mg of entecavir. In addition, each film-coated tablet contains the following inactive ingredients: crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized corn starch, talc, and titanium dioxide. In addition, the 1 mg contains FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, and iron oxide yellow.
  • No data
  • Carcinogenesis
  • Long-term oral carcinogenicity studies of entecavir in mice and rats were carried out at exposures up to approximately 42 times (mice) and 35 times (rats) those observed in humans at the highest recommended dose of 1 mg/day. In mouse and rat studies, entecavir was positive for carcinogenic findings. It is not known how predictive the results of rodent carcinogenicity studies may be for humans .
  • In mice, lung adenomas were increased in males and females at exposures 3 and 40 times those in humans. Lung carcinomas in both male and female mice were increased at exposures 40 times those in humans. Combined lung adenomas and carcinomas were increased in male mice at exposures 3 times and in female mice at exposures 40 times those in humans. Tumor development was preceded by pneumocyte proliferation in the lung, which was not observed in rats, dogs, or monkeys administered entecavir, supporting the conclusion that lung tumors in mice may be a species-specific event. Hepatocellular carcinomas were increased in males and combined liver adenomas and carcinomas were also increased at exposures 42 times those in humans. Vascular tumors in female mice (hemangiomas of ovaries and uterus and hemangiosarcomas of spleen) were increased at exposures 40 times those in humans. In rats, hepatocellular adenomas were increased in females at exposures 24 times those in humans; combined adenomas and carcinomas were also increased in females at exposures 24 times those in humans. Brain gliomas were induced in both males and females at exposures 35 and 24 times those in humans. Skin fibromas were induced in females at exposures 4 times those in humans.
  • Mutagenesis
  • Entecavir was clastogenic to human lymphocyte cultures. Entecavir was not mutagenic in the Ames bacterial reverse mutation assay using and strains in the presence or absence of metabolic activation, a mammalian-cell gene mutation assay, and a transformation assay with Syrian hamster embryo cells. Entecavir was also negative in an oral micronucleus study and an oral DNA repair study in rats.
  • Impairment of Fertility
  • In reproductive toxicology studies, in which animals were administered entecavir at up to 30 mg/kg for up to 4 weeks, no evidence of impaired fertility was seen in male or female rats at systemic exposures greater than 90 times those achieved in humans at the highest recommended dose of 1 mg/day. In rodent and dog toxicology studies, seminiferous tubular degeneration was observed at exposures 35 times or greater than those achieved in humans. No testicular changes were evident in monkeys.
  • No data
  • Entecavir Tablets USP, 0.5 mg are available as white to off-white, round, unscored, film-coated tablets, debossed with u201cTEVAu201d on one side and u201c5786u201d on the other side packaged in bottles of 30 (NDC 0093-5786-56) and 90 (NDC 0093-5786-98) tablets.
  • Entecavir Tablets USP, 1 mg are available as light-pink to pink, round, unscored, film-coated tablets, debossed with u201cTEVAu201d on one side and u201c5787u201d on the other side packaged in bottles of 30 (NDC 0093-5787-56) tablets.
  • Storage
  • Entecavir Tablets USP should be stored in a tightly closed container at 20u00b0 to 25u00b0 C (68u00b0 to 77u00b0 F) [See USP Controlled Room Temperature].
  • See FDA-approved patient labeling (Patient Information).
  • Severe Acute Exacerbation of Hepatitis after Discontinuation of Treatment
  • Inform patients that discontinuation of anti-hepatitis B therapy, including entecavir, may result in severe acute exacerbations of hepatitis B. Advise the patient to not discontinue entecavir without first informing their healthcare provider .
  • Risk of Development of HIV-1 Resistance in Patients with HIV-1 Coinfection
  • Inform patients that if they have or develop HIV infection and are not receiving effective HIV treatment, entecavir may increase the risk of development of resistance to HIV medication .
  • Lactic Acidosis and Severe Hepatomegaly
  • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with use of drugs similar to entecavir. Advise patients to contact their healthcare provider immediately and stop entecavir if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity n
  • Missed Dosage
  • Inform patients that it is important to take entecavir on a regular dosing schedule on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal) and to avoid missing doses as it can result in development of resistance n
  • Treatment Duration
  • Advise patients that in the treatment of chronic hepatitis B, the optimal duration of treatment is unknown. The relationship between response and long-term prevention of outcomes such as hepatocellular carcinoma is not known.
  • Pregnancy Registry
  • Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to entecavir during pregnancy .
  • All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.
  • Manufactured In Israel By:
  • Teva Pharmaceutical Ind. Ltd.
  • Jerusalem, 9777402, Israel
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev.u00a0J 11/2019
  • Entecavir (en-TEK-a-vir) Tabletsu00a0
  • Read this Patient Information before you start taking entecavir tablets and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
  • What is the most important information I should know about entecavir tablets?
  • 1. Your hepatitis B virus (HBV) infection may get worse if you stop taking entecavir tablets.
  • 2. If you have or get HIV that is not being treated with medicines while taking entecavir tablets, the HIV virus may develop resistance to certain HIV medicines and become harder to treat.
  • Entecavir tablets can cause serious side effects including:
  • 3. Lactic acidosis (buildup of acid in the blood). Some people who have taken entecavir tablets or medicines like entecavir tablets (a nucleoside analogue) have developed a serious condition called lactic acidosis.
  • Call your healthcare provider right away if you get any of the following signs or symptoms of lactic acidosis:
  • 4. Serious liver problems. Some people who have taken medicines like entecavir tablets have developed serious liver problems called hepatotoxicity, with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Hepatomegaly with steatosis is a serious medical emergency that can cause death.
  • Call your healthcare provider right away if you get any of the following signs or symptoms of liver problems:
  • You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight, or have been taking nucleoside analogue medicines, like entecavir tablets, for a long time.
  • What are entecavir tablets?
  • Entecavir tablets are a prescription medicine used to treat chronic hepatitis B virus (HBV) in adults and children 2 years of age and older who have active liver disease.
  • What should I tell my healthcare provider before taking entecavir tablets?
  • Before you take entecavir tablets, tell your healthcare provider if you:
  • Antiretroviral Pregnancy Registry.
  • Tell your healthcare provider about all the medicines you take,
  • Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist when you get a new medicine.
  • How should I take entecavir tablets?
  • What are the possible side effects of entecavir tablets?
  • Entecavir tablets may cause serious side effects. n- u201cWhat is the most important information I should know about entecavir tablets?u201d
  • The most common side effects of entecavir tablets include:
  • Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
  • These are not all the possible side effects of entecavir tablets. For more information, ask your healthcare provider or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
  • How should I store entecavir tablets?
  • Keep entecavir tablets and all medicines out of the reach of children.
  • General information about the safe and effective use of entecavir tablets
  • Entecavir tablets do not stop you from spreading the hepatitis B virus (HBV) to others by sex, sharing needles, or being exposed to your blood. Talk with your healthcare provider about safe sexual practices that protect your partner. Never share needles. Do not share personal items that can have blood or body fluids on them, like toothbrushes or razor blades. A shot (vaccine) is available to protect people at risk from becoming infected with HBV.
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use entecavir tablets for a condition for which they were not prescribed. Do not give entecavir tablets to other people, even if they have the same symptoms you have. They may harm them.
  • This Patient Information leaflet summarizes the most important information about entecavir tablets. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about entecavir tablets that is written for health professionals.
  • For more information, call 1-888-838-2872.
  • What are the ingredients in entecavir tablets?
  • Active ingredient:u00a0entecavir monohydrate
  • Inactive ingredients:u00a0crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized corn starch, talc, and titanium dioxide. In addition, the 1 mg contains FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, and iron oxide yellow.
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • Manufactured In Israel By:
  • Teva Pharmaceutical Ind. Ltd.
  • Jerusalem, 9777402, Israel
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. E 3/2019
  • No data
  • No data

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