Tyzeka

Chronic Hepatitis B Infection

Treatment

1 FDA approval

9 Active Studies for Tyzeka

What is Tyzeka

Telbivudine

The Generic name of this drug

Treatment Summary

Telbivudine is a medication used to treat hepatitis B virus infections. It is taken by mouth and has few side effects and no dose-limiting issues. It is well tolerated and has no toxicity.

Tyzeka

is the brand name

image of different drug pills on a surface

Tyzeka Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Tyzeka

Telbivudine

2006

3

Approved as Treatment by the FDA

Telbivudine, also known as Tyzeka, is approved by the FDA for 1 uses including Chronic Hepatitis B Infection .

Chronic Hepatitis B Infection

Helps manage Hepatitis B Chronic Infection

Effectiveness

How Tyzeka Affects Patients

Telbivudine is a type of medicine used to treat hepatitis B. It is made from the same building blocks as a natural substance called thymidine. When telbivudine is taken, it is changed in the body by certain enzymes into an active form that works against the virus.

How Tyzeka works in the body

Telbivudine stops the hepatitis B virus from replicating. It does this by competing with another molecule, thymidine 5'–triphosphate, that the virus needs to make copies of itself. By taking the place of this molecule, telbivudine stops the virus from making new copies of itself, which stops it from spreading further.

When to interrupt dosage

The appropriate dosage of Tyzeka is contingent upon the diagnosed affliction. The amount of dosage also varies as per the administration technique (e.g. Tablet, film coated - Oral or Oral) recorded in the table below.

Condition

Dosage

Administration

Chronic Hepatitis B Infection

, 20.0 mg/mL, 600.0 mg

Solution, Oral, , Solution - Oral, Tablet, Tablet - Oral, Tablet, film coated - Oral, Tablet, film coated

Warnings

Tyzeka has two counter-indications. Under no circumstances should it be taken in combination with the conditions listed in the table below.

Tyzeka Contraindications

Condition

Risk Level

Notes

Pulse Frequency

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Telbivudine may interact with Pulse Frequency

There are 12 known major drug interactions with Tyzeka.

Common Tyzeka Drug Interactions

Drug Name

Risk Level

Description

Adenovirus type 7 vaccine live

Moderate

The therapeutic efficacy of Adenovirus type 7 vaccine live can be decreased when used in combination with Telbivudine.

Anthrax vaccine

Moderate

The therapeutic efficacy of Anthrax vaccine can be decreased when used in combination with Telbivudine.

BCG vaccine

Moderate

The therapeutic efficacy of BCG vaccine can be decreased when used in combination with Telbivudine.

Bacillus calmette-guerin substrain connaught live antigen

Moderate

The therapeutic efficacy of Bacillus calmette-guerin substrain connaught live antigen can be decreased when used in combination with Telbivudine.

Bacillus calmette-guerin substrain russian BCG-I live antigen

Moderate

The therapeutic efficacy of Bacillus calmette-guerin substrain russian BCG-I live antigen can be decreased when used in combination with Telbivudine.

Tyzeka Toxicity & Overdose Risk

There are no reports of intentional overdose on telbivudine, but one person experienced an unintentional and symptomless overdose. Healthy people who took up to 1800 mg of telbivudine per day for 4 days didn't have any extra or unexpected side effects. We don't know what the highest tolerated dose of telbivudine is.

image of a doctor in a lab doing drug, clinical research

Tyzeka Novel Uses: Which Conditions Have a Clinical Trial Featuring Tyzeka?

Three active clinical trials are assessing the potential of Tyzeka to alleviate Chronic Hepatitis B.

Condition

Clinical Trials

Trial Phases

Chronic Hepatitis B Infection

8 Actively Recruiting

Phase 3, Phase 2, Phase 1

Patient Q&A Section about tyzeka

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How long can hepatitis B be treated?

"Hepatitis b infection may be acute (short-lived) or chronic (long-lasting). Acute hepatitis B infection lasts less than six months and usually goes away on its own."

Answered by AI

Why was telbivudine discontinued?

"Telbivudine was approved by the United States in 2006 to be used as a therapy for chronic hepatitis b, either by itself or with other agents. It was withdrawn from the United States market in 2016 for mostly economic reasons. Telbivudine was previously accessible as 600 mg tablets under the brand name Tyzeka."

Answered by AI

What kind of drug is telbivudine?

"Telbivudine is used to treat chronic hepatitis b infection by reducing the amount of hepatitis B virus in the body. It is part of a class of medications called nucleoside analogues."

Answered by AI

What is tyzeka used for?

"Tyzeka is a medication used to treat an active, chronic hepatitis b infection. It is a nucleoside reverse transcriptase inhibitor (NRTI). NRTIs work by inserting themselves into the virus' DNA (genetic material)."

Answered by AI

Clinical Trials for Tyzeka

Image of National Institutes of Health Clinical Center in Bethesda, United States.

VIR-2218 + Peginterferon Alfa-2a for Chronic Hepatitis B

18 - 65
All Sexes
Bethesda, MD

Background: Chronic hepatitis B virus (HBV) infection affects 292 million people worldwide; 887,000 die each year from cirrhosis, liver cancer, and related issues. Treatment options are limited. Objective: To test 2 drugs (VIR-2218 and peginterferon) in people with mild or inactive HBV infection. Eligibility: People aged 18 to 65 years with mild or inactive HBV infection. Design: Participants will be screened. They will have blood tests and an eye exam. They will have imaging scans of the liver to check the health of the liver. Participants will be in the study for over 2 years. VIR-2218 is an injection given under the skin of the stomach, upper arm, or thigh. Participants will come to the clinic to receive this injection once a month for 6 months. Peginterferon is also injected under the skin. Participants will have this shot once a week for 6 months. They may either inject themselves at home or come to the clinic to get the injections. Participants will get just the VIR-2218 for 3 months, then both shots for 3 months, then just the peginterferon for 3 months. Participants will have two 3-day stays in the hospital. Tests will include: Liver biopsy. A sample of tissue will be taken from their liver. After the procedure, participants will lie on their right side for 2 hours and then on their back for 4 hours. Fine needle aspiration. A small needle will be used to collect cells from the liver. After the last injection of peginterferon, follow-up visits will continue in the outpatient clinic every 4 to 12 weeks.

Phase 2
Recruiting

National Institutes of Health Clinical Center

Marc G Ghany, M.D.

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Image of Institute of Human Virology, University of Maryland School of Medicine in Baltimore, United States.

HEPLISAV-B Vaccine for Chronic Hepatitis B

18+
All Sexes
Baltimore, MD

The goal of this clinical trial is to learn if HEPLISAV-B, a vaccine that is approved to prevent hepatitis B infection in people that are not already infected, is safe in people already chronically infected with hepatitis B. The main quiestions it aims to answer are: 1. Is HEPLISAV-B safe in people with chronic hepatitis B? 2. What side effects, if any, could HEPLISAV-B cause in people with chronic hepatitis B? 3. How does HEPLISAV-B affect the cells that fight chronic hepatitis B? Participants will: * Receive HEPLISAV-B as an injection in the muscle, one injection every 4 weeks, for a total of 2 injections. * Visit the clinic a total of 5 times, and have 3 phone follow ups over 14 months. * Be asked if they are having any side effects from HEPLISAV-B. * Have blood samples collected.

Phase 1
Recruiting

Institute of Human Virology, University of Maryland School of Medicine (+1 Sites)

Lydia Tang, MBChB