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Overview

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This medicine contains an important and useful components, as it consists of
Crisaboroleis available in the market in concentration

Name

Telbivudine

Precaution

Before starting **Telbivudine**, it is essential for patients to consult their healthcare provider to ensure the medication is suitable for them. The following precautions should be considered: - **Liver Disease**: Telbivudine should be used with caution in patients with **liver impairment** as it is metabolized in the liver. Close monitoring of liver function is advised, particularly in patients with **chronic hepatitis** or those with a history of **cirrhosis**. - **Renal Impairment**: Since telbivudine is primarily excreted through the kidneys, dosage adjustments are required in patients with **renal impairment** to avoid drug accumulation and potential toxicity. **Creatinine clearance** (CrCl) should be regularly monitored in these patients. - **Co-infection with Hepatitis B and C**: Patients with **chronic hepatitis B** and **Hepatitis C virus** co-infection should be carefully monitored. Telbivudine does not treat **Hepatitis C**, and monotherapy may lead to **HCV resistance**. - **Pregnancy and Lactation**: Telbivudine falls under **Category C** for pregnancy, meaning there is insufficient data on its safety. It should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Telbivudine is also excreted in breast milk, so breastfeeding mothers should consult their healthcare provider before using this medication. - **Resistance Development**: There is a risk of developing resistance to telbivudine in patients with **chronic hepatitis B**. Monitoring of the **viral load** and the emergence of mutations is important during treatment. Telbivudine should not be used in patients with **lamivudine-resistant** hepatitis B. - **Muscle Weakness or Pain**: Rare side effects like **myopathy** (muscle weakness or pain) have been associated with telbivudine. Patients should report any unexplained muscle pain, tenderness, or weakness.

Indication

Telbivudine is an antiviral medication used primarily for the treatment of **chronic hepatitis B virus (HBV) infection** in adults and children aged **16 years and older**. It is used for the following indications: - **Chronic Hepatitis B**: Telbivudine is used to treat adults with **chronic HBV infection** who have evidence of active viral replication and liver damage. It helps to reduce the levels of HBV in the blood, improve liver function, and prevent further liver damage. - **Viral Suppression**: Telbivudine aids in achieving **viral suppression** by inhibiting the replication of the hepatitis B virus in the body, leading to lower viral loads and reducing the risk of **liver cirrhosis** and **hepatocellular carcinoma** (liver cancer). - **HBV DNA Levels Reduction**: It is used in patients with elevated **HBV DNA levels** (viral replication), to help reduce the risk of **liver failure** and other HBV-related complications. - **In Combination**: Sometimes, telbivudine is used alongside other **hepatitis B treatments**, though it is typically used as a standalone therapy in most cases.

Contra indication

Telbivudine is contraindicated in the following situations: - **Hypersensitivity**: It is contraindicated in patients with known hypersensitivity to **telbivudine** or any of its components. - **Severe Renal Impairment**: Telbivudine is contraindicated in patients with **severe renal impairment** (CrCl <50 mL/min) unless a dose adjustment is made. - **Co-infection with Hepatitis C or HIV**: Telbivudine should not be used as monotherapy in patients co-infected with **HCV** or **HIV**, as it does not provide effective treatment for these infections and may contribute to viral resistance. - **Severe Liver Disease**: Patients with **severe liver disease** (e.g., cirrhosis) may have impaired drug metabolism and should avoid telbivudine unless otherwise advised by a healthcare provider. - **Pregnancy**: Telbivudine should not be used during pregnancy unless absolutely necessary, as its safety in pregnant women has not been adequately studied.

Side Effect

The most common side effects of **telbivudine** include: - **Common Side Effects**: - **Fatigue** - **Headache** - **Nausea** - **Diarrhea** - **Abdominal pain** - **Cough** - **Serious Side Effects**: - **Myopathy** (muscle pain or weakness): Telbivudine can cause muscle-related side effects, and patients should report any muscle pain or tenderness immediately. This can progress to **rhabdomyolysis** in severe cases. - **Lactic Acidosis**: Rarely, telbivudine can cause **lactic acidosis**, a serious and potentially life-threatening condition. Symptoms may include deep or rapid breathing, weakness, stomach discomfort, and nausea. - **Hepatotoxicity**: In some cases, patients may experience liver enzyme abnormalities or **hepatitis flare** upon discontinuation of therapy. Close monitoring of liver function is important. - **Renal Impairment**: Telbivudine may cause **renal toxicity** in certain individuals, especially those with pre-existing renal disease. - **Peripheral Neuropathy**: Though rare, **numbness** or **tingling** in the hands or feet may occur. Patients should contact their healthcare provider immediately if they experience symptoms like unexplained **muscle pain**, **tenderness**, or weakness, **breathing difficulties**, or persistent **abdominal discomfort**.

Pregnancy Category ID

2

Mode of Action

Telbivudine is an **antiviral** medication that specifically inhibits the **hepatitis B virus (HBV)**. Its mechanism of action involves the following: - **Inhibition of HBV DNA Polymerase**: Telbivudine works by selectively inhibiting the **HBV DNA polymerase**, an enzyme critical for the replication of the hepatitis B virus. By inhibiting this enzyme, telbivudine prevents the virus from making new copies of itself, thus reducing the viral load in the body. - **Nucleoside Analogue**: Telbivudine is a **nucleoside analogue** that mimics the natural building blocks of **DNA**. Once incorporated into the viral DNA chain, it causes premature termination of the growing DNA strand, thereby halting further viral replication. - **Selective Action**: Telbivudine selectively targets **HBV** over human DNA, making it effective in reducing HBV replication without causing significant damage to host cells.

Interaction

Telbivudine has several known drug interactions that should be carefully managed: - **Adefovir**: Concomitant use of **telbivudine** and **adefovir** can increase the risk of **lactic acidosis**, **hepatic steatosis**, and **renal toxicity**. These two drugs should generally not be used together. - **Lamivudine**: Telbivudine should not be used concurrently with **lamivudine**, as both drugs have similar mechanisms of action, and using them together may increase the risk of developing drug-resistant HBV strains. - **Rifampin**: Rifampin, an antibiotic, may reduce the effectiveness of telbivudine by increasing its metabolism. If both drugs are necessary, monitoring of viral load is required. - **Other Hepatitis Drugs**: Careful consideration should be given when using telbivudine with other **hepatitis** medications, such as **entecavir** or **tenofovir**, due to the potential for **overlapping antiviral effects** and the risk of resistance development.

Pregnancy Category Note

Information not available

Adult Dose

The typical **adult dose** for **telbivudine** in treating chronic hepatitis B is: - **Standard Dose**: 600 mg once daily, taken with or without food. - **Renal Impairment Dose Adjustment**: For patients with **renal impairment**, the dose must be adjusted based on creatinine clearance (CrCl). The dosing schedule may need to be modified if **CrCl** is reduced to avoid the risk of drug accumulation and toxicity.

Child Dose

Telbivudine is not approved for use in children under the age of 16 years. The safety and efficacy in pediatric populations have not been established. Therefore, it is critical to consult with a healthcare provider for any treatment considerations in younger patients. As always, it is important for patients to consult their healthcare provider before starting telbivudine to determine the most appropriate dose based on their medical history, renal function, and specific needs.

Renal Dose

For patients with **renal impairment**, telbivudine dosing must be adjusted based on the level of kidney function. The recommended dose adjustments are: - **CrCl >50 mL/min**: 600 mg once daily (standard dosing). - **CrCl 30–50 mL/min**: 400 mg once daily. - **CrCl <30 mL/min**: 200 mg once daily. In cases of **severe renal impairment** (CrCl <10 mL/min) or **end-stage renal disease**, telbivudine should be avoided or used with caution under close medical supervision.

Administration

Information not available