TORGABALIN 75
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INSTRUCTIONS for medical use of the medicinal product KYURLED
KYURLED is used in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients.
Composition
Active substance: sofosbuvir; 1 film-coated tablet contains 400 mg of sofosbuvir; excipients: mannitol 60 (E 421), microcrystalline cellulose, sodium croscarmellose, colloidal silicon dioxide, magnesium stearate; tablet coating: Opadry II Blue (85F505068).
Pharmaceutical form
Film-coated tablets.
Main physical and chemical properties
Blue, capsule-shaped, biconvex film-coated tablets with engraving "400" on one side and smooth on the other.
Pharmacotherapeutic group
Antiviral agents for systemic use. Direct-acting antiviral agents. Antiviral agents for the treatment of hepatitis C virus (HCV).
ATC code
J05A P08.
Pharmacological properties
Pharmacodynamics
Mechanism of action
Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA polymerase, which is essential for the replication of the virus. Sofosbuvir is a nucleotide prodrug that, after intracellular metabolism, forms the pharmacologically active uridine analog triphosphate (GS-461203), which can be incorporated into the HCV RNA by the NS5B polymerase and acts as a chain terminator.
Antiviral activity
In HCV replicon analyses, the effective concentrations (EC50) of sofosbuvir against full-length replicons of genotypes 1a, 1b, 2a, 3a, and 4a were 0.04, 0.11, 0.05, 0.05, and 0.04 μM, respectively, and the EC50 values of sofosbuvir against chimeric replicons of 1b, which encode NS5B from genotypes 2b, 5a, or 6a, were between 0.014 and 0.015 μM.
Resistance
Cell culture. HCV replicons with reduced susceptibility to sofosbuvir were selected in cell culture for multiple genotypes, including 1b, 2a, 2b, 3a, 4a, 5a, and 6a.
Pharmacokinetics
Sofosbuvir is a nucleotide prodrug that undergoes extensive metabolism. The active metabolite is formed in hepatocytes and is not detected in plasma.
Absorption
The pharmacokinetic properties of sofosbuvir and its main circulating metabolite GS-331007 were evaluated in healthy adult subjects and patients with chronic hepatitis C.
Distribution
Sofosbuvir is not a substrate for the uptake transporters OATP1B1 or OATP1B3, or the efflux transporters P-glycoprotein or BCRP.
Metabolism
Sofosbuvir is extensively metabolized in the liver to form the pharmacologically active nucleoside analog triphosphate GS-461203.
Elimination
Following a single oral dose of 400 mg [14C]-sofosbuvir, the mean total recovery of the dose was greater than 92%, consisting of approximately 80%, 14%, and 2.5% recovered in urine, feces, and expired air, respectively.
Clinical characteristics
Indications
KYURLED is used in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients.
Contraindications
Hypersensitivity to the active substances or to any of the excipients of the medicinal product.
Special warnings and precautions for use
Special precautions. KYURLED should not be used as monotherapy and should be used in combination with other medicinal products for the treatment of hepatitis C virus infection.
Severe bradycardia and heart block
When KYURLED is used in combination with other direct-acting antiviral agents (DAAs) (including daclatasvir, simeprevir, and ledipasvir) and concomitantly with amiodarone, cases of severe bradycardia and heart block have been reported.
Patient with HCV genotype 1, 4, 5, or 6 infection who have previously failed treatment
The efficacy of KYURLED in patients with HCV genotype 1, 4, 5, or 6 infection who have previously failed treatment has not been studied.
Patient with HCV genotype 5 or 6 infection who have previously failed treatment
Data on the use of KYURLED in patients with HCV genotype 5 or 6 infection who have previously failed treatment are very limited.
Concomitant use with other direct-acting antiviral agents against HCV
KYURLED can be used in combination with other direct-acting antiviral agents, only if the available data indicate that their efficacy outweighs the risks.
Pregnancy and concomitant use with ribavirin
When KYURLED is used in combination with ribavirin or peginterferon alfa-2/ribavirin, women of childbearing potential or their male partners should use effective contraception during treatment and for a period after treatment.
Use with moderate P-glycoprotein inducers
Medicinal products that are moderate inducers of P-glycoprotein in the intestine (such as oxcarbazepine and modafinil) may decrease the plasma concentration of sofosbuvir, leading to reduced therapeutic effect of KYURLED.
Renal impairment
The safety of KYURLED has not been assessed in patients with severe renal impairment (eGFR <30 mL/min/1.73 m2) or in patients with chronic kidney disease requiring hemodialysis.
HCV/HBV co-infection (hepatitis B virus)
During or after treatment with direct-acting antiviral agents, cases of hepatitis B virus (HBV) reactivation have been reported, some of which were fatal.
Pediatric population
KYURLED is not recommended for use in children (under 18 years of age), as the safety and efficacy have not been established in this population.
Interaction with other medicinal products and other forms of interaction
Sofosbuvir is a nucleotide prodrug that undergoes extensive metabolism. After administration of KYURLED, sofosbuvir is rapidly absorbed and undergoes intensive first-pass metabolism in the liver and stomach.
Interaction table
| Medicinal product by therapeutic group | Effect on the medicinal product. Mean ratio (90% confidence interval) for AUC, Cmax, Cmin.a,b | Recommendations for use with KYURLED |
|---|---|---|
| ANALEPTICS | Interaction not studied. Expected: ↓ Sofosbuvir ↔ GS-331007 | It is expected that concomitant use of KYURLED with modafinil will decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of KYURLED. Such concomitant use is not recommended. |
| ANTIARRHYTHMIC AGENTS | Interaction not studied. | Use only when there are no alternative treatments. When used with KYURLED and another DAA (see "Special warnings and precautions for use" and "Adverse reactions"), close monitoring is recommended. |
| ANTICOAGULANTS | Interaction not studied. | When using all vitamin K antagonists, it is recommended to closely monitor INR. This is due to changes in liver function during treatment with KYURLED. |
Special instructions
Women of childbearing potential/contraception for men and women
When KYURLED is used in combination with ribavirin or peginterferon alfa-2/ribavirin, special attention should be paid to preventing pregnancy in female patients and their male partners.
Use during pregnancy or breastfeeding
There are no or limited data (less than 300 pregnancy outcomes) on the use of sofosbuvir in pregnant women.
Ability to influence the speed of reaction when driving vehicles or operating other mechanisms
KYURLED has a moderate influence on the ability to drive vehicles and work with complex mechanisms.
Method of administration and dosage
Adults
Recommended dose - 400 mg in the form of a tablet, which should be taken orally once a day during meals.
Table of recommendations for concomitant use of medicinal products and duration of comprehensive therapy with KYURLED
| Patient population* | Therapy | Duration of treatment |
|---|---|---|
| Patients with genotype 1, 4, 5, or 6 CHC | KYURLED + ribavirin + peginterferon alfa-2 | 12 weeksa,b |
| KYURLED + ribavirin | 24 weeks |
Dose adjustment
Dose reduction of KYURLED is not recommended.
Elderly patients
Dose adjustment for elderly patients is not required.
Renal impairment
No dose adjustment of KYURLED is required for patients with mild or moderate renal impairment.
Hepatic impairment
No dose adjustment of KYURLED is required for patients with mild, moderate, or severe hepatic impairment.
Overdose
The maximum reported dose of sofosbuvir is a single dose of 1200 mg, which was administered to 59 healthy subjects.
Adverse reactions
Brief overview of the safety profile. During treatment with sofosbuvir in combination with ribavirin or with peginterferon alfa-2 and ribavirin, the most common adverse reactions were those expected based on the safety profiles of sofosbuvir and peginterferon alfa-2.
Table of adverse reactions
| Frequency | SOFa+ RBVb | SOF + PEGc+ RBV |
|---|---|---|
| often | rhinopharyngitis |
Shelf life
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 30 °C.
Packaging
White high-density polyethylene bottle with an aluminum foil and a polypropylene child-resistant cap.
Release category
Prescription only.
Manufacturer
Strides Pharma Science Limited.
Manufacturer's location and address
No. 36/7, Suragajakkanahalli, Indlawadi Cross, Anekal Taluk, Bangalore, Karnataka 562106, India.
Applicant
Strides Pharma Science Limited.
Applicant's location
201, Devawrata Sector 17, Vashi, Navi Mumbai – 400 703, India.
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