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| Mechanism of Action | Sofosbuvir is a nucleotide analog inhibitor of the HCV NS5B polymerase, an enzyme essential for viral RNA replication. |
| Drug Formulation | Velpanat is available as a fixed-dose combination tablet containing: Sofosbuvir 400 mg Velpatasvir 100 mg Inactive ingredients include: copovidone, croscarmellose sodium, microcrystalline cellulose, lactose monohydrate, magnesium stearate, and colloidal silicon dioxide. |
| PharmacoKinetics | Absorption: Both components are well absorbed orally. Peak plasma concentrations occur approximately 0.5–4 hours after dosing. Food does not significantly affect exposure. Distribution: Sofosbuvir has a moderate volume of distribution; Velpatasvir is highly protein-bound (>99%) and widely distributed. Metabolism: Sofosbuvir is metabolized in the liver to its active triphosphate form and by hydrolysis. Velpatasvir is primarily metabolized by CYP2B6, CYP2C8, and CYP3A4. Excretion: Sofosbuvir is mainly excreted in the urine as metabolites. Velpatasvir is excreted primarily in the feces. |
| Side Effects | The most commonly reported side effects include headache, fatigue, nausea, insomnia, irritability, diarrhea, and occasionally mild anemia or skin reactions. |
| Contraindications | Use of Sofosbuvir + Velpatasvir is contraindicated in patients with known hypersensitivity to either drug or to any component of the tablet. |
| Precautions | The medicine should be used with caution in patients with severe hepatic impairment, as dosage adjustments or additional therapy may be required. It should not be used with strong P-gp or CYP inducers because these can significantly lower drug levels and reduce effectiveness. Co-administration with amiodarone may result in serious bradycardia and should be avoided unless absolutely necessary under strict monitoring. |
| Pregnancy | There is limited information about the use of Sofosbuvir + Velpatasvir during pregnancy, and the drug should be used only when the potential benefits outweigh potential risks. If used together with ribavirin, additional precautions apply due to the known fetal risks associated with ribavirin. |
| Drug Interactions | Strong CYP inducers such as rifampin, carbamazepine, phenytoin, and St. John’s wort may reduce drug concentrations and should be avoided. Acid-reducing agents like proton pump inhibitors and H2 blockers can reduce Velpatasvir absorption. Co-use with amiodarone may cause severe bradycardia. Certain antiretroviral drugs may interact as well, and all concurrent medications should be reviewed with a physician. |
| Dosage | The recommended dosage is one tablet daily containing Sofosbuvir 400 mg and Velpatasvir 100 mg, taken with or without food. Treatment duration is usually 12 weeks and depends on genotype and the presence or absence of cirrhosis. Patients should follow the exact dosage and regimen prescribed by their physician. |
| Storage | Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). |
| Overdose | There is no specific antidote for overdose with Sofosbuvir + Velpatasvir. Management should be supportive, based on the symptoms observed, with appropriate clinical monitoring. |
Above mentioned information is for reference only and does not serve as medical advice. Please consult your physician and/or refer to original sources before treatment.
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