Sovir Plus

Sovir Plus

sofosbuvir + ledipasvir

Manufacturer:

Zifam Pinnacle

Distributor:

Pinnacle House
Full Prescribing Info
Contents
Ledipasvir, sofosbuvir.
Description
Each film coated tablet contains: Sofosbuvir 400 mg, Ledipasvir 90 mg.
Excipients/Inactive Ingredients: Colour: Lake Sunset Yellow FCF.
Action
Pharmacotherapeutic Group: Antiviral drug.
Pharmacology:
Ledipasvir is a HCV inhibitor targeting the HCV NS5A protein, which is essential for both RNA replication and the assembly of HCV virions. Biochemical confirmation of NS5A inhibition by ledipasvir is not currently possible as NS5A has no enzymatic function. In vitro resistance selection and cross-resistance studies indicate ledipasvir targets NS5A as its mode of action.
Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication. Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analogue triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator. GS-461203 (the active metabolite of sofosbuvir) is neither an inhibitor of human DNA and RNA polymerases nor an inhibitor of mitochondrial RNA polymerase.
Indications/Uses
ZIFAM SOVIR PLUS is indicated for the treatment of chronic hepatitis C (CHC) with or without cirrhosis in adults and in adolescents aged 12 to < 18 years (weight >/= 35 kg).
Dosage/Direction for Use
Testing Prior to the Initiation of Therapy: Test all patients for HBV infection by measuring HBsAg and anti-HBc.
Recommended adult and pediatric dosage: One tablet (90 mg of ledipasvir and 400 mg of sofosbuvir) taken orally once daily with or without food.
HCV/HIV-1 coinfection: For adult and pediatric patients with HCV/HIV-1 coinfection, follow the dosage recommendations in the tables as follows, respectively.
If used in combination with ribavirin, follow the recommendations for ribavirin dosing and dosage modifications.
Recommended adult treatment regimen and duration: see Table 1.

Click on icon to see table/diagram/image

Recommended treatment duration for pediatric patients 12 years of age and older or weighing at least 35 kg. (See Table 2.)

Click on icon to see table/diagram/image

A dosage recommendation cannot be made for patients with severe renal impairment or end stage renal disease.
Paediatric Population aged < 12 years: The safety and effectiveness of ZIFAM SOVIR PLUS in paediatric patients aged < 12 years have not been established. No data on paediatric patients aged < 12 years are available.
Missed dose: Patients should be instructed that if vomiting occurs within 5 hours of dosing an additional tablet should be taken. If vomiting occurs more than 5 hours after dosing, no further dose is needed. If a dose is missed and it is within 18 hours of the normal time, patients should be instructed to take the tablet as soon as possible and then patients should take the next dose at the usual time. If it is after 18 hours then patients should be instructed to wait and take the next dose at the usual time. Patients should be instructed not to take a double dose.
Elderly: No dose adjustment is warranted for elderly patients.
Renal impairment: No dose adjustment of ZIFAM SOVIR PLUS is required for patients with mild or moderate renal impairment. The safety of ledipasvir/sofosbuvir has not been assessed in patients with severe renal impairment (estimated glomerular filtration rate [eGFR) < 30 mL/min/1.73 m2) or end stage renal disease (ESRD) requiring haemodialysis.
Hepatic impairment: No dose adjustment of ZIFAM SOVIR PLUS is required for patients with mild, moderate or severe hepatic impairment (Child-Pugh-Turcotte [CPT] class A, B or C). Safety and efficacy of ledipasvir/sofosbuvir have been established in patients with decompensated cirrhosis.
Method of administration: For oral use.
Patients should be instructed to swallow the tablet whole with or without food. Due to the bitter taste, it is recommended that the film-coated tablet is not chewed or crushed.
Overdosage
The highest documented doses of ledipasvir and sofosbuvir were 120 mg twice daily for 10 days and a single dose of 1,200 mg, respectively, with no untoward effects observed at these dose levels, and adverse reactions similar in frequency and severity to those reported in the placebo groups. The effects of higher doses are not known.
No specific antidote is available for overdose with ZIFAM SOVIR PLUS. If overdose occurs the patient must be monitored for evidence of toxicity. Treatment of overdose with ZIFAM SOVIR PLUS consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient. Haemodialysis is unlikely to result in significant removal of ledipasvir as ledipasvir is highly bound to plasma protein. Haemodialysis can efficiently remove the predominant circulating metabolite of sofosbuvir, GS-331007, with an extraction ratio of 53%.
Contraindications
ZIFAM SOVIR PLUS tablets are contraindicated in patients with known hypersensitivity to the active substance or to any other component of the tablets. ZIFAM SOVIR PLUS should not be coadministered with rosuvastatin or St. John's wort (Hypericum perforatum).
Special Precautions
Risk of Hepatitis B Virus Reactivation: Test all patients for evidence of current or prior HBV infection before initiation of HCV treatment. Monitor HCV/HBV coinfected patients for HBV reactivation and hepatitis flare during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
Bradycardia with amiodarone coadministration: Serious symptomatic bradycardia may occur in patients taking amiodarone, particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease.
Coadministration of amiodarone with ZIFAM SOVIR PLUS is not recommended. In patients without alternative, viable treatment options, cardiac monitoring is recommended.
Concomitant use of ZIFAM SOVIR PLUS and P-gp inducers (e.g., rifampin, St. John's wort) may significantly decrease ledipasvir and sofosbuvir plasma concentrations and may lead to a reduced therapeutic effect of ZIFAM SOVIR PLUS.
If ZIFAM SOVIR PLUS is administered with ribavirin regimen should be avoided in pregnancy.
Use in pregnancy: There are no adequate and well-controlled studies with ZIFAM SOVIR PLUS in pregnant women. Because animal reproduction studies are not always predictive of human response, ZIFAM SOVIR PLUS should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
If ZIFAM SOVIR PLUS is used in combination with ribavirin or peginterferon alfa/ribavirin, extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Women of childbearing potential and their male partners must use two forms of effective contraception during treatment and for a period of time after the treatment has concluded. As a precautionary measure, it is preferable to avoid the use of ZIFAM SOVIR PLUS during pregnancy.
Use in lactation: The development and health benefits of breastfeeding should be considered along with the mother's clinical need for ZIFAM SOVIR PLUS and any potential adverse effects on the breastfed child from ZIFAM SOVIR PLUS or from the underlying maternal condition.
Paediatric population: ZIFAM SOVIR PLUS is not recommended for use in paediatric patients aged < 12 years because the safety and efficacy have not been established in this population.
Use In Pregnancy & Lactation
Pregnancy: There are no adequate and well-controlled studies with ZIFAM SOVIR PLUS in pregnant women. Because animal reproduction studies are not always predictive of human response, ZIFAM SOVIR PLUS should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
If ZIFAM SOVIR PLUS is used in combination with ribavirin or peginterferon alfa/ribavirin, extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Women of childbearing potential and their male partners must use two forms of effective contraception during treatment and for a period of time after the treatment has concluded. As a precautionary measure, it is preferable to avoid the use of ZIFAM SOVIR PLUS during pregnancy.
Lactation: The development and health benefits of breastfeeding should be considered along with the mother's clinical need for ZIFAM SOVIR PLUS and any potential adverse effects on the breastfed child from ZIFAM SOVIR PLUS or from the underlying maternal condition.
Adverse Reactions
The most common adverse reactions (incidence greater than or equal to 10%, all grades) observed with treatment with ZIFAM SOVIR PLUS were fatigue, headache and asthenia. Adverse drug reactions to ZIFAM SOVIR PLUS + ribavirin combination therapy were consistent with the known safety profile of ribavirin, without increasing the frequency or severity of the expected adverse drug reactions. No new adverse drug reactions were detected among patients with decompensated cirrhosis and/or who were post-liver transplant and who received ledipasvir/sofosbuvir with ribavirin.
Drug Interactions
Coadministration with amiodarone may result in serious symptomatic bradycardia. Use of ZIFAM SOVIR PLUS with amiodarone is not recommended.
P-gp inducers (e.g., rifampin, St. John's wort): May alter concentrations of ledipasvir and sofosbuvir. Use of ZIFAM SOVIR PLUS with P-gp inducers is not recommended.
Frequent monitoring of international normalized ratio (INR) values is recommended in patients receiving warfarin.
Consult the full prescribing information prior to use for potential drug interactions.
Storage
Store in cool and dry place below 30°C, protected from light and moisture.
Shelf-Life: 24 months.
MIMS Class
ATC Classification
J05AP51 - sofosbuvir and ledipasvir ; Belongs to the class of antivirals for treatment of HCV infections. Used in the treatment of hepatitis C viral infections.
Presentation/Packing
FC tab 28's.
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