Sebivo

Indications

Telbivudine is an antiviral medicine used to treat long-term (chronic) hepatitis B infection in adults who have active liver inflammation. It reduces the amount of hepatitis B virus in the blood and helps limit liver damage. It does not cure hepatitis B.

How It Works

Telbivudine is a nucleoside analogue. Inside infected liver cells it is converted to an active form that blocks the hepatitis B virus DNA polymerase, the enzyme the virus needs to copy itself. This slows down the production of new virus.

Dosage and Administration

The usual adult dose is 600 mg by mouth once a day, with or without food, or as prescribed by a liver specialist. The dose interval is longer in people with reduced kidney function. Take it every day at about the same time and do not stop without medical advice.

Interactions

• Must not be used with Peginterferon alfa or other interferons, because this raises the risk of serious nerve damage (peripheral neuropathy).
• Medicines that can cause muscle problems (such as statins, Fibrates, Zidovudine or Chloroquine) may add to the risk of muscle damage.
• Medicines that affect kidney function may change Telbivudine levels.

Contraindications

• Allergy to Telbivudine.
• Use together with Peginterferon alfa or standard interferon.

Side Effects

Common effects include tiredness, headache, dizziness, cough, nausea, diarrhoea, stomach pain, rash and raised levels of the muscle enzyme creatine kinase (CK) in blood tests. Less often it causes muscle pain or weakness (myopathy) or numbness and tingling in the hands and feet (peripheral neuropathy). Lactic acidosis (a build-up of acid in the blood) is rare but serious.

Get urgent medical help if there is unexplained muscle pain or weakness, numbness or burning in the hands or feet, deep fast breathing, severe tiredness with stomach pain and vomiting, or yellowing of the skin or eyes and dark urine.

Pregnancy and Lactation

Animal studies have not shown harm, but human data are limited. It should be used in pregnancy only if a specialist judges it necessary. It is not known whether it passes into breast milk; breastfeeding is not recommended during treatment.

Precautions and Warnings

• Hepatitis can flare up severely after stopping treatment; liver tests are needed for several months afterwards.
• Resistance can develop; regular viral load tests are needed.
• Report any muscle or nerve symptoms promptly.
• It does not stop hepatitis B passing to others; use safe sex and do not share needles, razors or toothbrushes.
• Test for HIV before starting.

Overdose

Experience with overdose is limited. Seek medical help; treatment is supportive, and the medicine can be partly removed by dialysis.

Therapeutic Class

Antiviral, nucleoside analogue (hepatitis B).

Storage

Store below 30°C in a dry place, away from light. Keep out of the reach of children.