Brand Name: MPIviropack Plus Tablet
Active Ingredients: Sofosbuvir 400 mg.
Ledipasvir 90 mg
When is MPIviropack Plus prescribed for?
MPIviropack Plus is indicated for the treatment of chronic hepatitis C (CHC) in adults.
How should you take MPIviropack Plus?
MPIviropack Plus treatment should be initiated and monitored by a physician experienced in the management of patients with CHC.
The recommended dose of MPIviropack Plus is one tablet once daily with or without food.
When you should not take MPIviropack Plus?
Hypersensitivity to the active substances or to any of the excipients.
Co-administration with Rosuvastatin or St. John's wort (Hypericum perforatum)
Special warning and precautions on using MPIviropack Plus:
- MPIviropack Plus should not be administered concomitantly with other medicinal products containing sofosbuvir.
- Concerning recommended regimens with different HCV genotypes and genotype-specific virological and clinical activity, see insert leaflet.
- Severe bradycardia and heart block have been observed when Ledipasvir+ Sofosbuvir is used with concomitant amiodarone with or without other drugs that lower heart rate.
The mechanism is not established.
Other Warning and Precaution concerning the following items are listed in the Insert Leaflet:
- Treatment of patients with prior exposure to HCV direct-acting antivirals
- Severe renal impairment
- Patients with decompensated cirrhosis and/or who are awaiting liver transplant or post liver transplant
- Use with potent P-gp inducers
- Use with certain HIV antiretroviral regimens
- Use with HMG-CoA reductase inhibitors
- HCV/HBV (hepatitis B virus) co-infection
- Paediatric population
Possible Drug interaction with MPIviropack Plus:
Potential for MPIviropack Plus to affect other medicinal products
Ledipasvir is an in vitro inhibitor of drug transporter P-gp and breast cancer resistance protein (BCRP) and may increase intestinal absorption of co-administered substrates for these transporters. In vitro data indicate that ledipasvir may be a weak inducer of metabolizing enzymes such as CYP3A4, CYP2C and UGT1A1. Compounds that are substrates of these enzymes may have decreased plasma concentrations when coadministered with ledipasvir/sofosbuvir. In vitro ledipasvir inhibits intestinal CYP3A4 and UGT1A1. Medicinal products that have a narrow therapeutic range and which are metabolized by these isoenzymes should be used with caution and carefully monitored.
Potential for other medicinal products to affect MPIviropack Plus
Ledipasvir and sofosbuvir are substrates of drug transporter P-gp and BCRP while GS- 331007 is not. Medicinal products that are potent P-gp inducers (e.g. rifampicin, St. John's wort, carbamazepine and phenytoin) may decrease ledipasvir and sofosbuvir plasma concentrations leading to reduced therapeutic effect of ledipasvir/sofosbuvir and should not be used with MPIviropack Plus. Co-administration with medicinal products that inhibit P-gp and/or BCRP may increase ledipasvir and sofosbuvir plasma concentrations without increasing GS-331007 plasma concentration; MPIviropack Plus may be co-administered with P-gp and/or BCRP inhibitors. Clinically significant medicinal product interactions with ledipasvir/sofosbuvir mediated by CYP450s or UGT1A1 enzymes are not expected.
Special information if you are pregnant or breastfeeding
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of ledipasvir, sofosbuvir or MPIviropack Plus in pregnant women.
Animal studies do not indicate direct harmful effects with respect to reproductive toxicity. No significant effects on foetal development have been observed with ledipasvir or sofosbuvir in rats and rabbits. However, it has not been possible to fully estimate exposure margins achieved for sofosbuvir in the rat relative to the exposure in humans at the recommended clinical dose.
As a precautionary measure, it is preferable to avoid the use of MPIviropack Plus during pregnancy.
It is unknown whether ledipasvir or sofosbuvir and its metabolites are excreted in human milk.
Available pharmacokinetic data in animals has shown excretion of ledipasvir and metabolites of sofosbuvir in milk.
A risk to the newborns/infants cannot be excluded. Therefore, MPIviropack Plus should not be used during breast-feeding.
Possible Side effects with MPIviropack Plus
In clinical studies, fatigue and headache were more common in patients treated with ledipasvir/sofosbuvir compared to placebo. When ledipasvir/sofosbuvir was studied with ribavirin, the most frequent adverse drug reactions to ledipasvir/sofosbuvir + ribavirin combination therapy were consistent with the known safety profile of ribavirin, without increasing the frequency or severity of the expected adverse drug reactions.