SMOFKABIVEN Price

Overview

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

Name

Ledipasvir + Sofosbuvir

Precaution

Before initiating treatment with **Ledipasvir** and **Sofosbuvir**, it is crucial for patients to consult with their healthcare provider, especially those with pre-existing conditions or taking other medications. This combination therapy is primarily used for treating **chronic hepatitis C virus (HCV)** infections, but there are specific precautions to consider: - **Liver Function**: Although effective for HCV, ledipasvir and sofosbuvir may not be appropriate for individuals with **severe liver impairment** or **decompensated cirrhosis**. These patients may require careful monitoring or alternative treatments. - **Renal Impairment**: Patients with significant **renal impairment** (eGFR <30 mL/min/1.73 m²) should exercise caution, as the safety and effectiveness of this combination in severe renal dysfunction have not been fully established. Adjustments or alternative therapies may be necessary. - **Drug Interactions**: Both ledipasvir and sofosbuvir can interact with various medications, such as **antacids**, **HIV medications**, **antifungal drugs**, and **certain anti-seizure drugs**. Patients must inform their healthcare provider about all medications, including over-the-counter drugs and herbal supplements, to avoid potentially harmful interactions. - **Pregnancy and Breastfeeding**: The safety of ledipasvir and sofosbuvir during pregnancy and breastfeeding has not been fully established. Women who are pregnant or planning pregnancy should discuss potential risks with their healthcare provider, as alternative therapies may be safer during pregnancy. Additionally, it is recommended that women avoid breastfeeding while on this treatment. - **Cardiovascular Risk**: There is a potential for heart-related issues in patients taking ledipasvir and sofosbuvir, particularly if they have underlying cardiovascular conditions. Close monitoring is essential for these patients.

Indication

**Ledipasvir and Sofosbuvir** is a combination antiviral therapy used to treat **chronic hepatitis C virus (HCV)** infection in adults. It is effective for patients with **genotype 1** and **genotype 4** HCV infections, and it is also used for other HCV genotypes in some cases. This therapy is prescribed for patients who have **no cirrhosis** or **compensated cirrhosis** and is highly effective in achieving a **sustained virologic response (SVR)**, which means the virus remains undetectable in the blood after completing treatment. - This combination treatment helps to stop the replication of the virus by inhibiting **NS5A** (ledipasvir) and **NS5B** (sofosbuvir) proteins, essential for the HCV replication process. - **Ledipasvir + Sofosbuvir** is typically used for **treatment-naïve** patients and those who have failed previous therapies. It is commonly used in combination with **ribavirin** or other direct-acting antiviral agents depending on the HCV genotype and treatment history.

Contra indication

**Ledipasvir and Sofosbuvir** is contraindicated in certain situations: - **Hypersensitivity**: Patients who are allergic to either ledipasvir, sofosbuvir, or any other ingredients in the medication should avoid using it. An allergic reaction can lead to severe symptoms such as swelling, rash, or breathing difficulties. - **Co-administration with Rifampin**: Rifampin, a potent **CYP3A inducer**, should not be used in combination with ledipasvir and sofosbuvir as it can significantly reduce the effectiveness of the antiviral therapy by decreasing the plasma levels of both drugs. - **Severe Renal Impairment**: Patients with **severe renal impairment** (eGFR <30 mL/min/1.73 m²) should not use this combination therapy without careful consideration and adjustment by a healthcare provider. In these patients, the effectiveness and safety of the combination have not been well established. - **Pregnancy and Lactation**: The use of ledipasvir and sofosbuvir during pregnancy and breastfeeding should only occur if the potential benefit outweighs the potential risks. It is crucial to consult with a healthcare provider to assess the risks to the fetus or infant. - **Active Hepatitis B Infection**: Patients with active **hepatitis B** co-infection may require additional monitoring and therapy, as reactivation of hepatitis B can occur during or after treatment with sofosbuvir or ledipasvir.

Side Effect

Common side effects of **Ledipasvir and Sofosbuvir** are generally mild and well-tolerated, but some individuals may experience: - **Fatigue**: Many patients report feeling tired or weak while on treatment, which may affect daily activities. - **Headache**: A common side effect, typically mild and temporary. - **Nausea**: Some patients experience mild gastrointestinal symptoms, including nausea or stomach discomfort, especially during the initial phase of treatment. - **Anemia**: While less common, some patients may experience **anemia**, particularly if they are on **ribavirin** in combination with ledipasvir and sofosbuvir. - **Insomnia**: Difficulty sleeping or disturbed sleep patterns can occur in some individuals during treatment. - **Liver Enzyme Elevations**: In rare cases, liver enzymes may become elevated, signaling potential liver irritation. This is generally reversible once the therapy is discontinued. - **Rash**: A mild rash may develop in some patients, especially if the medication is used in combination with other antivirals or medications. Serious side effects are rare but may include **heart-related issues** (such as slow heart rate) and **severe liver injury** (particularly in patients with co-infection with **hepatitis B**). If any severe reactions occur, immediate medical consultation is necessary.

Pregnancy Category ID

2

Mode of Action

**Ledipasvir** and **Sofosbuvir** work together to inhibit the replication of the **hepatitis C virus (HCV)** by targeting different components of the virus's lifecycle: - **Sofosbuvir**: This is a **nucleoside analog** that inhibits the **NS5B RNA-dependent RNA polymerase**, an enzyme essential for HCV replication. By inhibiting this polymerase, sofosbuvir prevents the virus from copying its genetic material, effectively halting the replication process. - **Ledipasvir**: This is a **NS5A inhibitor** that prevents the formation of the HCV replication complex and the assembly of new viral particles. NS5A is a protein that plays a critical role in viral RNA replication and viral assembly. By inhibiting this protein, ledipasvir disrupts the virus's ability to reproduce and spread. Together, these two drugs provide a powerful combination that can eliminate the virus from the body when used for a specified duration.

Interaction

**Ledipasvir and Sofosbuvir** can interact with various medications, potentially reducing the effectiveness or increasing the risk of adverse effects: - **CYP3A Inhibitors and Inducers**: The combination of ledipasvir and sofosbuvir is affected by drugs that influence the **CYP3A** enzyme pathway. For instance, **CYP3A inhibitors** (e.g., **ketoconazole**) can increase the levels of ledipasvir and sofosbuvir, leading to an increased risk of side effects. On the other hand, **CYP3A inducers** (e.g., **rifampin**, **St. John's Wort**) can reduce the drug effectiveness by lowering its plasma levels. - **Antacids and Proton Pump Inhibitors**: Antacids and proton pump inhibitors (PPIs) that reduce stomach acid may interfere with the absorption of ledipasvir. It is advised to space out the administration of these medications by several hours to ensure proper absorption. - **HIV Medications**: Some **antiretroviral** drugs, especially those containing **protease inhibitors** or **NNRTIs**, may interact with ledipasvir and sofosbuvir. For example, **atazanavir** or **ritonavir** can lead to an increased concentration of sofosbuvir, increasing the risk of adverse effects. - **Other Antiviral Medications**: Combining ledipasvir and sofosbuvir with other antiviral agents, such as **ribavirin**, may be appropriate in certain cases, but the combination must be monitored for any potential additive effects or risks.

Pregnancy Category Note

Information not available

Adult Dose

The typical dose for **Ledipasvir + Sofosbuvir** for adults with **chronic hepatitis C (HCV)** is one tablet taken once daily, which contains 90 mg of ledipasvir and 400 mg of sofosbuvir. Treatment duration varies based on the patient's HCV genotype and other factors: - **For Genotype 1**: The recommended treatment duration is typically **12 weeks**. - **For Genotype 4**: The standard duration is **12 weeks** as well, though this may vary based on additional factors such as liver function and treatment history. For patients with **compensated cirrhosis**, the duration may be extended, and a combination with **ribavirin** may be recommended.

Child Dose

The use of **Ledipasvir + Sofosbuvir** is not recommended for pediatric patients under 18 years of age, as safety and efficacy have not been established in this population. The treatment is not typically prescribed for children and adolescents. For pediatric patients with chronic hepatitis C, alternative therapies and treatment regimens should be considered and tailored by a healthcare provider based on the patient’s age, liver function, and HCV genotype.

Renal Dose

For patients with **renal impairment** (eGFR <30 mL/min/1.73 m²), the use of **Ledipasvir and Sofosbuvir** should be approached with caution. While no specific dose adjustments are recommended for mild to moderate renal impairment, the combination may not be recommended for individuals with severe renal dysfunction. In patients with renal issues, a healthcare provider may recommend **alternative therapies** or adjust the treatment regimen. Continuous monitoring of renal function is advised during treatment.

Administration

Information not available