Generic Name: telbivudine
Other Market Name: Sebivo (Europe)
Approval Status: Approved
Generic Version Available: No
FDA-approved for the treatment of chronic hepatitis B infection in persons who are 16 years and older.
- Tyzeka was approved by the U.S. Food and Drug Administration for use by adults with chronic hepatitis B in 2006.
- Novartis has discontinued production of Tyzeka; supplies available through 2016
- In clinical studies, 75 percent of participants had a therapeutic response after a year of treatment with Tyzeka.
Age 16 years and older: one 600 mg tablet daily, with or without food. Dosage may need to be adjusted for people with kidney disease.
Pediatric Dose: Not approved for children under age 16 years.
Dosing Info: Treatment length is indefinite and depends on clinical outcomes. Do not change your dose or stop taking Tyzeka without talking to your medical provider.
- The most common side effects are increased creatine kinase (CK), headache, cough, diarrhea, abdominal pain, nausea, throat pain, joint pain,fever, rash, back pain, dizziness, muscle aches, ALT increased, indigestion,insomnia and abdominal bloating.
- Tyzeka may cause severe liver problems or a serious condition called lactic acidosis (buildup of acid in the blood).
- Tyzeka may cause severe muscle problems (myopathy) or nerve problems (peripheral neuropathy). It may also cause your hepatitis B infection to worsen.
- Before taking this medication, tell your medical provider and pharmacist about any drugs, supplements and herbs you take, whether prescribed, over-the-counter or illicit.
- Do not take with Pegasys (peginterferon alfa-2a).
- Additional drug-drug interactions may occur; these are listed in Tyzeka’s full prescribing information. Potential interactions are listed at hep-druginteractions.org.
- There are no adequate, well-controlled studies in pregnant women who have taken Tyzeka. Tyzeka should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- The safety of breast feeding while taking Tyzeka has not been established, and it is recommended that Tyzeka be discontinued if breast-feeding.
Co-Pay Program Info: https://www.hepmag.com/basics/hepatitis-b-basics/paying-hepatitis-b-treatment
Patient Assistance Program Info: https://www.hepmag.com/basics/hepatitis-b-basics/paying-hepatitis-b-treatment
Last Reviewed: June 9, 2016