Buy Sebivo pills 600 mg, 28 pcs
  • Buy Sebivo pills 600 mg, 28 pcs

Telbivudine

Novartis
805 Items
2019-09-19
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$409.69
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Clinical Pharmacology

Sebivo is an antiviral drug active against the hepatitis B virus, a synthetic thymidine analogue of the nucleoside.

Sebivo blocks the activity of the DNA polymerase enzyme of the hepatitis B virus. Telbivudine is effectively phosphorylated by cellular kinases to the active form of triphosphate, which has a half-life in the cell for 14 hours. Telbivudine-5'-triphosphate competitively binds and inhibits DNA polymerase (reverse transcriptase) of hepatitis B virus, disrupting the interaction of the enzyme with its endogenous substrate, thymidine-5'-triphosphate. The inclusion of Telbivudine-5'-triphosphate in the structure of viral DNA causes the chain to break and suppress the replication of the hepatitis B virus. The drug more pronounced inhibits the synthesis of the second (EU + 0.12 - 0.24 μM) molecular chain of the hepatitis B virus than the first (EU 50 + 0.4 - 1.3 μM) Telbivudine-5'phosphate at concentrations up to 100 μM did not inhibit human DNA polymerase (α, β or γ). The drug in concentrations up to 10 μM did not have a significant toxic effect on the structure of mitochondria, as well as on the content and function of DNA and did not increase the formation of lactic acid in the human body.

Sebivo has a specific antiviral activity against the hepatitis B virus. The drug is not effective against other RNA and DNA viruses, including HIV

Indications

Chronic hepatitis B in adult patients with confirmed viral replication and active inflammation in the liver.

Composition

1 tablet contains Telbivudine 600 mg;
Excipients: microcrystalline cellulose, povidone (polyvinylpyrrolidone), sodium carboxymethyl starch type A, magnesium stearate, anhydrous colloidal silicon dioxide, titanium dioxide, macrogol (polyethylene glycol 400), talc, hypromellose.

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Telbivudine

Dosage and Administration

For the treatment of chronic hepatitis B The recommended dose of Sebivo is 600 mg (1 tablet) 1 time / oral, regardless of the meal.

Sebivo can be used to treat chronic hepatitis B in patients with impaired renal function.

In patients with impaired renal function with CC more than 50 ml / min, dose adjustment is not required. In patients with QA less than 50 ml / min, a correlation of the interval between doses is necessary.

Adverse reactions

From the side of the central nervous system and peripheral nervous system: often - slight dizziness (1.5%), headache; sometimes peripheral neuropathy.

From the digestive system: often - increased levels of amylase in the blood, diarrhea, increased levels of lipase, nausea.

From the hepatobiliary system: often - increased levels of ALT; sometimes - increased AST.

From the skin and subcutaneous tissue: often - rash.

From the musculoskeletal system: often - increased levels of CK in the blood; sometimes - myopathy, arthralgia, myalgia.

General violations: often - increased weakness of fatigue (4%); sometimes - moderate fatigue (0.3%), discomfort.

Some patients who stopped treatment with telbivudine experienced severe cases of acute exacerbation of hepatitis B. There is no data on the treatment of exacerbations of hepatitis B after discontinuation of therapy with telbivudine.

Contraindications

Hypersensitivity to telbivudine or any component of the drug.
The use of the drug in children and adolescents under the age of 18 years is not recommended due to insufficient data on efficacy and safety.

WITH caution:
patients after liver transplantation, patients aged 65 years and older.

Patients with QA

Drug interactions

Telbivudin is mainly excreted by the kidneys, therefore, when prescribing Sebivo with drugs that affect kidney function, it is possible to increase plasma concentrations of telbivudine and / or simultaneously used drugs.
In vitro telbivudine in concentrations 12 times higher than therapeutic, did not inhibit metabolic processes occurring with the participation of microsomal isoenzymes 1A2, 2C9, 2C19, 2D26, 2E1, and 3A4 cytochrome P450 in the liver. In animals, telbivudine does not induce cytochrome P450 isoenzymes. Given the above results and the known pathways for elimination of telbivudine, there is a low potential for Sebivo to interact with other drugs at the level of cytochrome P450.
The pharmacokinetic parameters of Telbivudine in the equilibrium state did not change after repeated use in combination with lamivudine, adefovir dipivoxil, cyclosporine or peginterferon-alpha 2a.
In a pilot clinical study on the combination of telbivudine 600 mg / day. and peginterferon alfa-2a (180 μg 1 time per week n / a), there was an increase in the risk of developing peripheral neuropathy. Care should be taken when prescribing Sebivo in combination with peginterferon alfa-2a.
It is not known whether the risk of myopathy increases with simultaneous use of telbivudine with drugs that cause myopathy. When prescribing Sebivo along with drugs that cause myopathy, the expected benefit of therapy and the potential risk of myopathy should be evaluated, and patients should be monitored to detect pain, muscle tension or muscle weakness of unknown etiology in a timely manner.
Cases of lactic acidosis and severe hepatomegaly with steatosis, including, were observed against the background of monotherapy with nucleoside / nucleotide analogues or their administration in combination with antiretroviral agents. fatal.

Pregnancy and Lactation

Sebivo can be used during pregnancy if the expected benefit to the mother outweighs the potential risk to the fetus.

There are no data on the effects of telbivudine on transmission of hepatitis B virus from the mother to the fetus. Care should be taken to prevent neonatal infection with the hepatitis B virus.

It is not known whether telbivudine is excreted in human breast milk. Women taking Sebivo should stop breastfeeding.

Special instructions

Patients who have discontinued treatment for hepatitis B with Sebivo have experienced severe cases of exacerbation of hepatitis B. It is recommended that careful clinical and laboratory monitoring of liver function be performed for at least several months after discontinuation of treatment of hepatitis B. If necessary, hepatitis B therapy should be resumed.

By the 52nd week of drug treatment, an increase in the level of CPK (grade 3/4) was noted in 7.5% of patients taking telbivudine and in 3.1% of patients taking lamivudine. The average level of CPK was higher in patients taking telbivudine. However, from 53 weeks of treatment with telbivudine, an increase in the level of CPK was not observed. In most cases, an increase in the level of CPK was asymptomatic. Usually, with continuous drug therapy, there was a decrease in the concentration of CPK.

For several weeks, months after the start of drug treatment, cases of uncomplicated myopathy were observed (constant diffuse pain and tension in the muscles and / or muscle weakness of unclear ethology, regardless of the degree and time of elevation of CPK levels). Myopathy was also observed when taking other synthetic thymidine nucleoside analogues.

The factors provoking the development of myopathy in patients receiving treatment with telbivudine are unknown.

Patients should immediately report to the doctor about any cases of persistent pain, muscle tension or muscle weakness. When confirming myopathy, drug treatment should be discontinued.

Overdosage

Cases of overdose Sebivo not reported. Telbivudin is well tolerated in doses up to 1800 mg / day, 3 times the recommended daily doses. The maximum tolerated dose of telbivudine has not been determined.
Treatment: in case of overdose, Telbivudine should be discontinued and, if necessary, appropriate general supportive therapy should be prescribed.

  • Brand name: Sebivo
  • Active ingredient: Telbivudine
  • Dosage form: Pills.
  • Manufacturer: Novartis
  • Country of Origin: Switzerland

Studies and clinical trials of Telbivudine (Click to expand)

  1. A dose-finding study of once-daily oral telbivudine in HBeAg-positive patients with chronic hepatitis B virus infection
  2. Hepatitis B goes globe: Telbivudine as a new treatment option
  3. Kinetics of hepatitis B surface antigen decline during 3 years of telbivudine treatment in hepatitis B e antigen–positive patients
  4. Efficacy and safety of therapy of chronic hepatitis B with telbivudine (LdT) in patients with HIV-infection without HAART
  5. Telbivudine in the treatment of chronic hepatitis B
  6. Telbivudine preserves T-helper 1 cytokine production and downregulates programmed death ligand 1 in a mouse model of viral hepatitis
  7. Clinical features and risk factors of creatine kinase elevations and myopathy associated with telbivudine
  8. Efficacy of switching to telbivudine in chronic hepatitis B patients treated previously with lamivudine
  9. Treatment of chronic hepatitis B with telbivudine: wise hepatologists needed in hepatitis B endemic countries where treatment options are limited
  10. Efficacy and safety of prolonged 3-year telbivudine treatment in patients with chronic hepatitis B
  11. Novel anti-hepatitis B agents: a focus on telbivudine
  12. Telbivudine
  13. Effects of antiviral therapy with Telbivudine on peripheral iNKT cells in HBeAg(+) chronic hepatitis B patients
  14. Telbivudine myopathy in a patient with chronic hepatitis B
  15. Telbivudine, a nucleoside analog inhibitor of HBV polymerase, has a different in vitro cross-resistance profile than the nucleotide analog inhibitors adefovir and tenofovir
  16. Effect of telbivudine therapy on the cellular immune response in chronic hepatitis B
  17. A 24-week, parallel-group, open-label, randomized clinical trial comparing the early antiviral efficacy of telbivudine and entecavir in the treatment of hepatitis B e antigen-positive chronic hepatitis B virus infection in adult Chinese patients
  18. CO 8-Étude de phase III comparant la telbivudine A la lamivudine chez des malades ayant une hépatite B chronique AgHBe positifs : efficacité, tolérance et facteurs prédictifs de réponse A 1 an
  19. CA 52-Éude randomisée comparant l’efficacité de la telbivudine (LDT) à l’adéfovir (ADV) dans l’hépatite chronique B AgHBe positif: résultats 24 semaines
  20. Telbivudine versus Lamivudine in Patients with Chronic Hepatitis B
  21. Telbivudine for the management of chronic hepatitis B virus infection
  22. On-treatment serum HBsAg level is predictive of sustained off-treatment virologic response to telbivudine in HBeAg-positive chronic hepatitis B patients
  23. Telbivudine: Taking into account baseline and on-therapy predictors
  24. Baseline characteristics and early on-treatment response predict the outcomes of 2 years of telbivudine treatment of chronic hepatitis B

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