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MyHep ALL Drug Interactions

sofosbuvir + velpatasvir

Manufacturer:

Mylan Healthcare

Distributor:

Antah Pharma
Full Prescribing Info
Drug Interactions
As Sofosbuvir and Velpatasvir tablet contains sofosbuvir and velpatasvir, any interactions that have been identified with these active substances individually may occur with Sofosbuvir and Velpatasvir tablet.
Potential for Sofosbuvir and Velpatasvir tablet to affect other medicinal products: Velpatasvir is an inhibitor of drug transporter P-gp, breast cancer resistance protein (BCRP), organic anion-transporting polypeptide (OATP) 1B1 and OATP1B3. Co-administration of Sofosbuvir and Velpatasvir tablet with medicinal products that are substrates of these transporters may increase the exposure of such medicinal products. See Table 17 for examples of interactions with sensitive substrates of P-gp (digoxin), BCRP (rosuvastatin), and OATP (pravastatin).
Potential for other medicinal products to affect Sofosbuvir and Velpatasvir tablet: Sofosbuvir and velpatasvir are substrates of drug transporters P-gp and BCRP. Velpatasvir is also a substrate of drug transporter OATP1B. In vitro, slow metabolic turnover of velpatasvir by CYP2B6, CYP2C8 and CYP3A4 was observed. Medicinal products that are potent inducers of P-gp or potent inducers of CYP2B6, CYP2C8, or CYP3A4 (e.g. rifampicin, rifabutin, St. John's wort, carbamazepine, phenobarbital and phenytoin) may decrease plasma concentrations of sofosbuvir or velpatasvir leading to reduced therapeutic effect of Sofosbuvir and Velpatasvir. The use of such medicinal products with Sofosbuvir and Velpatasvir tablet is contraindicated (see Contraindications). Medicinal products that are moderate P-gp inducers or moderate CYP inducers (e.g. oxcarbazepine, modafinil , efavirenz or rifapentine) may decrease sofosbuvir or velpatasvir plasma concentration leading to reduced therapeutic effect of Sofosbuvir and Velpatasvir tablet. Co-administration with such medicinal products is not recommended with Sofosbuvir and Velpatasvir tablet (see Precautions). Co-administration with medicinal products that inhibit P-gp or BCRP may increase sofosbuvir or velpatasvir plasma concentrations. Medicinal products that inhibit OATP, CYP2B6, CYP2C8, or CYP3A4 may increase plasma concentration of velpatasvir. Clinically significant medicinal product interactions with Sofosbuvir and Velpatasvir tablet mediated by P-gp, BCRP, OATP, or CYP450 inhibitors are not expected; Sofosbuvir and Velpatasvir tablet may be co-administered with P-gp, BCRP, OATP and CYP inhibitors.
Patients treated with vitamin K antagonists: As liver function may change during treatment with Sofosbuvir and Velpatasvir, a close monitoring of International Normalised Ratio (INR) values is recommended.
Impact of DAA therapy on drugs metabolized by the liver: The pharmacokinetics of drugs that are metabolized by the liver (e.g. immunosuppressive agents such as calcineurin inhibitors) may be impacted by changes in liver function during DAA therapy, related to clearance of HCV.
Interactions between Sofosbuvir and Velpatasvir tablet and other medicinal products: Table 17 provides a listing of established or potentially clinically significant medicinal product interactions. The medicinal product interactions described are based on studies conducted with either Sofosbuvir and Velpatasvir or velpatasvir and sofosbuvir as individual agents, or are predicted medicinal product interactions that may occur with Sofosbuvir OR Velpatasvir. The table is not all-inclusive. (See Tables 17A, 17B and 17C.)

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