Medication info
Maviret Tablets

Maviret Tablets

Prescription medicationTabletOral
Ingredient · strength
Glecaprevir›100mg / 1 tabletPibrentasvir›40mg / 1 tablet
Manufacturer / importer
AbbVie Korea Ltd.
Appearance
Pink, biconvex, rectangular film-coated tablet
Packaging
(84 tablets/PTP) box
Approval status
Active

MFDS item code 201800200 · Approved 2018.01.12 · Insurance code 624900290

Summary

Main use
Treatment of chronic hepatitis C (genotypes 1, 2, 3, etc.)
Who takes it
Adults
Adult dose
The recommended oral dose of this drug is 3 tablets once daily at the same time each day, taken with food. Swallow the tablets whole; do not chew, crush, or cut them. Table 1. Recommended treatment duration for treatment-naive patients Genotypes 1, 2, 3, 4, 5, 6: Without cirrhosis, 8 weeks; with compensated cirrhosis, 8 weeks Table 2. Recommended treatment duration for treatment-experienced patients Genotypes 1,2,4,5,6; prior treatment with interferon, peginterferon, ribavirin and/or sofosbuvir: Without cirrhosis, 8 weeks; with compensated cirrhosis, 12 weeks Genotype 1, with no prior NS5A inhibitor treatment and prior NS3/4A protease inhibitor1 treatment: 12 weeks Genotype 1, with no prior NS3/4A protease inhibitor treatment and prior NS5A inhibitor2 treatment: 16 weeks Genotype 3; prior treatment with interferon, peginterferon, ribavirin and/or sofosbuvir: 16 weeks 1. In clinical trials, received treatment with simeprevir and sofosbuvir, or combination therapy of simeprevir, boceprevir, or telaprevir with peginterferon and ribavirin 2. In clinical trials, received treatment with ledipasvir and sofosbuvir, or combination therapy of daclatasvir with peginterferon and ribavirin Administration in patients with hepatic impairment No dose adjustment of this drug is required for patients with mild hepatic impairment (Child-Pugh A). This drug is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C) or a history of hepatic decompensation. Administration in patients with renal impairment No dose adjustment of this drug is required in patients with mild, moderate, or severe renal impairment, including patients receiving dialysis. Administration in liver or kidney transplant recipients This drug may be administered to liver or kidney transplant recipients for 12 weeks. A 16-week treatment duration should be considered in genotype 1 transplant recipients with no prior NS3/4A protease inhibitor treatment and prior NS5A inhibitor treatment, and genotype 3 transplant recipients with prior treatment with interferon, peginterferon, ribavirin and/or sofosbuvir. Missed dose If a dose is missed: • If 18 hours or less have elapsed from the usual time of taking this drug, advise the patient to take the missed dose immediately and take the next dose at the usual time. • If more than 18 hours have elapsed from the usual time of taking this drug, advise the patient to skip the missed dose and take the next dose at the usual time.

Ingredients

Importer
AbbVie Korea Ltd.

Efficacy & effects

Treatment of chronic hepatitis C (genotypes 1, 2, 3, etc.)

  • Chronic hepatitis C virus infection
View approved original text

This medication is used for the treatment of adult and adolescent patients aged 12 and over infected with various genotypes of the chronic hepatitis C virus (HCV), including types 1, 2, 3, 4, 5, or 6. It helps to improve the viral infection status and protect liver function.

How to take

Adult dose

The recommended oral dose of this drug is 3 tablets once daily at the same time each day, taken with food. Swallow the tablets whole; do not chew, crush, or cut them. Table 1. Recommended treatment duration for treatment-naive patients Genotypes 1, 2, 3, 4, 5, 6: Without cirrhosis, 8 weeks; with compensated cirrhosis, 8 weeks Table 2. Recommended treatment duration for treatment-experienced patients Genotypes 1,2,4,5,6; prior treatment with interferon, peginterferon, ribavirin and/or sofosbuvir: Without cirrhosis, 8 weeks; with compensated cirrhosis, 12 weeks Genotype 1, with no prior NS5A inhibitor treatment and prior NS3/4A protease inhibitor1 treatment: 12 weeks Genotype 1, with no prior NS3/4A protease inhibitor treatment and prior NS5A inhibitor2 treatment: 16 weeks Genotype 3; prior treatment with interferon, peginterferon, ribavirin and/or sofosbuvir: 16 weeks 1. In clinical trials, received treatment with simeprevir and sofosbuvir, or combination therapy of simeprevir, boceprevir, or telaprevir with peginterferon and ribavirin 2. In clinical trials, received treatment with ledipasvir and sofosbuvir, or combination therapy of daclatasvir with peginterferon and ribavirin Administration in patients with hepatic impairment No dose adjustment of this drug is required for patients with mild hepatic impairment (Child-Pugh A). This drug is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C) or a history of hepatic decompensation. Administration in patients with renal impairment No dose adjustment of this drug is required in patients with mild, moderate, or severe renal impairment, including patients receiving dialysis. Administration in liver or kidney transplant recipients This drug may be administered to liver or kidney transplant recipients for 12 weeks. A 16-week treatment duration should be considered in genotype 1 transplant recipients with no prior NS3/4A protease inhibitor treatment and prior NS5A inhibitor treatment, and genotype 3 transplant recipients with prior treatment with interferon, peginterferon, ribavirin and/or sofosbuvir. Missed dose If a dose is missed: • If 18 hours or less have elapsed from the usual time of taking this drug, advise the patient to take the missed dose immediately and take the next dose at the usual time. • If more than 18 hours have elapsed from the usual time of taking this drug, advise the patient to skip the missed dose and take the next dose at the usual time.

Precautions

This drug may carry the risk of reactivation of hepatitis B virus, so it is essential to check for hepatitis B infection before treatment. Patients with a history of hepatitis B may still experience liver function deterioration during or after treatment, making regular monitoring necessary. Diabetic patients should pay careful attention to their blood sugar levels, as this drug may cause sudden control changes leading to hypoglycemic symptoms within 3 months of starting treatment. Severely impaired liver function or advanced cirrhosis patients should not use this drug. If a cirrhosis patient is treated, they should closely monitor symptoms related to liver function during treatment. Patients allergic to this drug or with specific liver diseases should not take it, and it may interact with several specific medications. This drug primarily causes mild side effects such as headaches, fatigue, and nausea, but can also rarely lead to severe side effects like skin rashes or liver function abnormalities. It can be relatively safely used in patients with severely impaired kidney function, post-liver transplant or kidney transplant patients, adolescents, and elderly individuals, but must be taken under a doctor's guidance. There is a potential for drug interactions, so all medications being taken should be communicated to doctors or pharmacists, and if adjustments are needed, consult a professional. Pregnant or breastfeeding women should avoid using this drug, and women planning to become pregnant should consult a professional before use. In cases of overdose, since there is no specific antidote, symptoms should be reported immediately to medical staff for proper treatment. This drug should be stored in a tightly sealed container to avoid exposure to air or moisture, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius for optimal effectiveness. There is minimal impact on driving or machine operation, but variations may occur in individuals, requiring caution.

Side effects

headache

Not everyone experiences these, and they can vary from person to person.

Storage

This drug must be stored in a tightly sealed container away from air and moisture, ideally at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness.

Appearance and packaging

Appearance

Pink, biconvex, rectangular film-coated tablet

Package unit

(84 tablets/PTP) box

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.