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All price changes →Indications & Uses
Telbivudine is used to treat chronic hepatitis B in adults who show evidence of viral replication and who also have either persistently raised serum aminotransferases (ALT or AST) or histologically active disease. Some points need to be considered before starting Telbivudine. This use is based on virologic, serologic, biochemical and histologic responses in adults with HBeAg positive and HBeAg negative chronic hepatitis B and compensated liver disease, who had not been treated with a nucleoside before. For HBeAg-positive patients, Telbivudine should only be started when HBV DNA is less than 9 log10 copies per mL and ALT is greater than or equal to 2x Upper Limit of Normal (ULN) before treatment. For HBeAg-negative patients, it should only be started when HBV DNA is less than 7 log10 copies per mL before treatment. The response during treatment should guide whether therapy continues. Telbivudine has not been evaluated in patients co-infected with HIV, HCV or HDV, nor in liver transplant recipients or patients with decompensated liver disease. It has also not been studied in well-controlled trials in patients with established nucleoside analog reverse transcriptase inhibitor-resistant hepatitis B virus infection, but it is expected to be cross-resistant to lamivudine. The safety and efficacy of Telbivudine have not been evaluated in Black/African American or Hispanic patients.
Pharmacology
Telbivudine is a synthetic thymidine nucleoside analogue that works against hepatitis B virus (HBV). It is the unmodified β-L enantiomer of thymidine, the nucleoside that occurs naturally. Cellular kinases phosphorylate it, and this forms the active metabolite, telbivudine 5'-triphosphate. That active form inhibits HBV DNA polymerase (reverse transcriptase) by competing with the natural substrate, thymidine 5'-triphosphate. The competition ends in chain termination of DNA synthesis, so viral replication is held back. When telbivudine 5'-triphosphate is incorporated into viral DNA, it also causes DNA chain termination and stops HBV replication. Telbivudine also inhibits anticompliment or second-strand DNA.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
For adults and adolescents (16 years of age and older), higher rates of resistance may develop with longer treatment in patients whose virus is not fully suppressed. Because of this, treatment should only be started if the HBV DNA and ALT measurements before treatment are known, and only in the following patients. For HBeAg-positive patients, HBV DNA should be less than 9 log10 copies per mL and ALT should be greater than or equal to 2x ULN before treatment with Telbivudine. For HBeAg-negative patients, HBV DNA should be less than 7 log10 copies per mL before treatment with Telbivudine.
HBV DNA levels should be monitored at 24 weeks of treatment to confirm complete viral suppression (HBV DNA less than 300 copies per mL). Patients who still have detectable HBV DNA after 24 weeks should be started on alternate therapy. Further resistance testing should guide the best choice of therapy.
The recommended dose of Telbivudine for chronic hepatitis B is 600 mg once daily, taken orally, with or without food. Telbivudine Oral Solution (30 mL) may be considered for patients who have difficulty swallowing tablets.
Side Effects
Telbivudine can cause cough, dizziness, fatigue, headache and trouble sleeping (insomnia). Some people get stomach and bowel effects such as abdominal pain, diarrhoea, nausea, vomiting and dyspepsia. Rash, joint pain (arthralgia), muscle pain (myalgia), myopathy, malaise and back pain have also been reported, along with nasopharyngitis and flu or flu-like symptoms. Blood tests may show raised serum amylase, lipase, creatine phosphokinase and alanine aminotransferase levels. More serious effects are peripheral neuropathy and rhabdomyolysis.
Cautions & Contraindications
Warnings & Precautions
Severe acute exacerbations (flare-ups) of hepatitis B can occur with telbivudine, so hepatic function should be monitored when therapy is discontinued. Other cautions are lactic acidosis, severe hepatomegaly with steatosis, myopathy, rhabdomyolysis and uncomplicated myalgia. If myopathy is diagnosed, stop the medicine. The risk of peripheral neuropathy is higher when telbivudine is combined with pegylated interferon α-2a. Take extra care in people with decompensated cirrhosis, renal impairment or those on hemodialysis, and in liver transplant recipients or people on immunosuppressant therapy. Telbivudine may impair the ability to drive or operate machinery. Caution is also needed in pregnancy, in children under 16 years, and in the elderly.
Contraindications
Telbivudine must not be used in people who are hypersensitive to it. It must also not be given together with pegylated interferon alfa-2a, because that combination raises the risk of peripheral neuropathy.
Pregnancy & Breastfeeding
Telbivudine is Pregnancy Category B. It is not teratogenic, and preclinical studies showed no adverse effects on developing embryos and fetuses. Studies in pregnant rats and rabbits showed that telbivudine crosses the placenta. Developmental toxicity studies found no evidence of harm to the fetus in rats and rabbits at doses up to 1000 mg per kg per day. These doses gave exposure levels 6 times and 37 times higher, respectively, than those seen with the 600 mg per day dose in humans.
There are no adequate and well-controlled trials of Tyzeka in pregnant women. Animal reproductive toxicity studies don't always predict how humans will respond, so Tyzeka should be used during pregnancy only if the potential benefits outweigh the risks.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Storage
Keep Telbivudine tablets and oral solution in their original bottle, at room temperature (15° to 30°C).
Drug Interactions
Common questions about Sebivo 600 mg
What is Sebivo 600 mg Tablet?
Sebivo 600 mg Tablet is a medicine that contains Telbivudine. It is made by Nevian Lifescience PLC. It belongs to the Hepatic viral infections (Hepatitis B) group of medicines.
What is Sebivo used for?
Telbivudine is used to treat chronic hepatitis B in adults who show evidence of viral replication and who also have either persistently raised serum aminotransferases (ALT or AST) or histologically active disease. Some points need to be considered before starting Telbivudine.
What are the side effects of Sebivo?
Telbivudine can cause cough, dizziness, fatigue, headache and trouble sleeping (insomnia). Some people get stomach and bowel effects such as abdominal pain, diarrhoea, nausea, vomiting and dyspepsia.
Can I take Sebivo during pregnancy or while breastfeeding?
Telbivudine is Pregnancy Category B. It is not teratogenic, and preclinical studies showed no adverse effects on developing embryos and fetuses. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Sebivo?
Keep Telbivudine tablets and oral solution in their original bottle, at room temperature (15° to 30°C).
Can I take other medicines with Sebivo?
Some medicines can interact with Telbivudine, for example: Erythromycin, Zidovudine, Vancomycin, Amphotericin B, Penicillamine, Cyclosporine. Tell your doctor or pharmacist about every medicine you take.
Is there a cheaper medicine with the same ingredient?
Sebivo is already among the lowest-priced brands of Telbivudine at this strength.
Do I need a prescription for Sebivo?
Sebivo is a prescription (Rx) medicine. Take it as your doctor advises.