Glecaprevir And Pibrentasvir (Mavyret)

Trade Name : Mavyret

AbbVie Inc.

TABLET, FILM COATED

Strength 40100 mg/1mg/1

PIBRENTASVIR; GLECAPREVIR Hepatitis C Virus NS5A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],UGT1A1 Inhibitors [MoA],Hepatitis C Virus NS3/4A Protease Inhibitor [EPC],HCV NS3/4A Protease Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],UGT1A1 Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Glecaprevir And Pibrentasvir (Mavyret) which is also known as Mavyret and Manufactured by AbbVie Inc.. It is available in strength of 40; 100 mg/1; mg/1 per ml. Read more

Glecaprevir And Pibrentasvir (Mavyret) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with MAVYRET. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV
See full prescribing information for complete boxed warning.
Hepatitis B virus (HBV) reactivation has been reported, in some cases resulting in fulminant hepatitis, hepatic failure, and death. ()

No data

MAVYRET is indicated for the treatment of adult with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A).
MAVYRET is indicated for the treatment of adult with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both .

MAVYRET is a fixed-dose combination of glecaprevir, a hepatitis C virus (HCV) NS3/4A protease inhibitor, and pibrentasvir, an HCV NS5A inhibitor, and is indicated for the treatment of adult and pediatric patients 12 years and older or weighing at least 45 kg with chronic HCV genotype (GT) 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A).
MAVYRET is indicated for the treatment of adult and pediatric patients 12 years and older or weighing at least 45 kg with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both. ()

No data

Each MAVYRET tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir. The tablets are pink, oblong-shaped, film-coated, and debossed with u201cNXTu201d on one side.
Tablets: 100 mg glecaprevir and 40 mg pibrentasvir. n

No data

Patients with moderate or severe hepatic impairment (Child-Pugh B or C) or those with any history of prior hepatic decompensation. (, )
Coadministration with atazanavir and rifampin. n

No data

Risk of Hepatitis B Virus Reactivation
Risk of Hepatic Decompensation/Failure in Patients with Evidence of Advanced Liver Disease

In subjects receiving MAVYRET, the most commonly reported adverse reactions (greater than 10%) are headache and fatigue. n
To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

No data

Carbamazepine, efavirenz, and St. Johnu2019s wort may decrease concentrations of glecaprevir and pibrentasvir. Coadministration of carbamazepine, efavirenz containing regimens, and St. Johnu2019s wort with MAVYRET is not recommended. ()
Clearance of HCV infection with direct-acting antivirals may lead to changes in hepatic function, which may impact safe and effective use of concomitant medications. Frequent monitoring of relevant laboratory parameters (INR or blood glucose) and dose adjustments of certain concomitant medications may be necessary. ()
Medication- Assisted Treatment (MAT) for Opioid Use Disorder. ()
Consult the full prescribing information prior to and during treatment for potential drug interactions. (n , )

No data

In case of overdose, the patient should be monitored for any signs and symptoms of toxicities. Appropriate symptomatic treatment should be instituted immediately. Glecaprevir and pibrentasvir are not significantly removed by hemodialysis.

MAVYRET is a fixed-dose combination tablet containing glecaprevir and pibrentasvir for oral administration. Glecaprevir is a HCV NS3/4A PI, and pibrentasvir is a HCV NS5A inhibitor.
Glecaprevir/Pibrentasvir Film-Coated Immediate Release Tablets
Each tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir. Glecaprevir and pibrentasvir are presented as a co-formulated, fixed-dose combination, immediate release bilayer tablet.
The tablet contains the following inactive ingredients: colloidal silicon dioxide, copovidone (type K 28), croscarmellose sodium, hypromellose 2910, iron oxide red, lactose monohydrate, polyethylene glycol 3350, propylene glycol monocaprylate (type II), sodium stearyl fumarate, titanium dioxide, and vitamin E (tocopherol) polyethylene glycol succinate.
The tablets do not contain gluten.
Glecaprevir drug substance:
The chemical name of glecaprevir is (3a,7,10,12,21,24a)-7--butyl--{(1,2)-2-(difluoromethyl)-1-[(1-methylcyclopropane-1-sulfonyl)carbamoyl]cyclopropyl}-20,20-difluoro-5,8-dioxo-2,3,3a,5,6,7,8,11,12,20,23,24a-dodecahydro-1,10-9,12-methanocyclopenta[18,19][1,10,17,3,6]trioxadiazacyclononadecino[11,12-]quinoxaline-10-carboxamide hydrate.
The molecular formula is CHFNOS (anhydrate) and the molecular weight for the drug substance is 838.87 g/mol (anhydrate). The strength of glecaprevir is based on anhydrous glecaprevir. Glecaprevir is a white to off-white crystalline powder with a solubility of less than 0.1 to 0.3 mg/mL across a pH range of 2u20137 at 37u00b0C and is practically insoluble in water, but is sparingly soluble in ethanol. Glecaprevir has the following molecular structure:
Pibrentasvir drug substance:
The chemical name of pibrentasvir is Methyl {(2,3)-1-[(2)-2-{5-[(2,5)-1-{3,5-difluoro-4-[4-(4-fluorophenyl)piperidin-1-yl]phenyl}-5-(6-fluoro-2-{(2)-1-[-(methoxycarbonyl)--methyl-L-threonyl]pyrrolidin-2-yl}-1-benzimidazol-5-yl)pyrrolidin-2-yl]-6-fluoro-1-benzimidazol-2-yl}pyrrolidin-1-yl]-3-methoxy-1-oxobutan-2-yl}carbamate.
The molecular formula is CHFNOand the molecular weight for the drug substance is 1113.18 g/mol. Pibrentasvir is a white to off-white to light yellow crystalline powder with a solubility of less than 0.1u00a0mg/mL across a pH range of 1u20137 at 37u00b0C and is practically insoluble in water, but is freely soluble in ethanol. Pibrentasvir has the following molecular structure:

No data

Carcinogenesis and Mutagenesis
Glecaprevir and pibrentasvir were not genotoxic in a battery of or assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and rodent micronucleus assays.
Carcinogenicity studies with glecaprevir and pibrentasvir have not been conducted.
Impairment of Fertility
No effects on mating, female or male fertility, or early embryonic development were observed in rodents at up to the highest dose tested. Systemic exposures (AUC) to glecaprevir and pibrentasvir were approximately 63 and 102 times higher, respectively, than the exposure in humans at the recommended dose.

No data

MAVYRET is dispensed in a 4-week (monthly) carton, 8-week carton, or institutional-use-only bottle. Each weekly carton contains seven daily dose wallets. Each monthly carton contains four weekly cartons. Each 8-week carton contains 2 monthly cartons. Each child resistant daily dose wallet contains three 100 mg/40 mg glecaprevir/pibrentasvir tablets. Each institutional-use-only bottle contains eighty-four 100 mg/40 mg glecaprevir/pibrentasvir tablets. MAVYRET tablets are pink-colored, film-coated, oblong biconvex shaped, debossed with u201cNXTu201d on one side.
The NDC numbers are:
Store at or below 30u00b0C (86u00b0F).

Advise the patient to read the FDA-approved patient labeling (Patient Information).
Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV
Inform patients that HBV reactivation can occur in patients coinfected with HBV during or after treatment of HCV infection. Advise patients to tell their healthcare provider if they have a history of hepatitis B virus infection .
Risk of Hepatic Decompensation/Failure in Patients with Evidence of Advanced Liver Disease
Advise patients to seek medical evaluation immediately for symptoms of worsening liver problems such as nausea, tiredness, yellowing of the skin or white part of the eyes, bleeding or bruising more easily than normal, confusion, loss of appetite, diarrhea, dark or brown urine, dark or bloody stool, swelling of the stomach area (abdomen) or pain in the upper right side of the stomach area, sleepiness, or vomiting of blood .
Drug Interactions
Inform patients that MAVYRET may interact with some drugs; therefore, patients should be advised to report to their healthcare provider the use of any prescription, non-prescription medication or herbal products .
Administration
Inform patients it is important to take all three tablets at the same time once daily with food as directed. Inform patients that it is important not to miss or skip doses and to take MAVYRET for the duration that is recommended by the physician .
If a dose is missed and it is:
Manufactured by AbbVie Inc., North Chicago, IL 60064
MAVYRET is a trademark of AbbVie Inc.
u00a9 2020 AbbVie Inc. All rights reserved.
03-C386

No data

NDC 0074-2625-28
Rx only
Mavyretn
(glecaprevir and pibrentasvir)
100mg / 40mg
Each tablet contains glecaprevir and pibrentasvir 100mg / 40mg
This carton contains 21 tablets packaged as follows:
7 wallets for 1 week of treatment.
Each wallet contains 3 tablets.
Do not use if seal on top of carton is broken or missing
Keep out of reach of children
Store at or below 30u00b0C (86u00b0F)
See Package Insert for full Prescribing Information
AbbVie Inc.
North Chicago, IL 60064
u00a92017 AbbVie Inc.
NDC 0074-2625-01
Rx only
Mavyretn
(glecaprevir and pibrentasvir)
100mg / 40mg
Each tablet contains glecaprevir and pibrentasvir 100mg / 40mg
Please see accompanying full Prescribing Information
Each box contains: 1 wallet of 3 tablets each
Keep out of reach of children
Store at or below 30u00b0C (86u00b0F)
See Package Insert for full Prescribing Information
AbbVie Inc.
North Chicago, IL 60064
Product of Ireland
u00a92017 AbbVie Inc.
NDC 0074-2625-28
Rx only
4-WEEK SUPPLY
Mavyretu2122
(glecaprevir and pibrentasvir)
100mg / 40mg
Each tablet contains glecaprevir and pibrentasvir 100mg / 40mg
NDC 0074-2625-80
Rx only
MAVYRETn
glecaprevir/pibrentasvir
100 mg/40 mg
84 Tablets
For Institutional Use Only
abbvie
Do not accept if seal over bottle opening is broken or missing.
Each tablet contains glecaprevir and pibrentasvir 100 mg/40 mg.
Store at or below 30u00b0C (86u00b0F).
See package insert for full Prescribing Information.
AbbVie Inc.
North Chicago, IL 60064 USA
See opposite side of label for Customs Country of Origin.
u00a92019 AbbVie Inc.

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Glecaprevir And Pibrentasvir (Mavyret)

Trade Name : Mavyret

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Glecaprevir And Pibrentasvir (Mavyret)

Trade Name : Mavyret

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

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US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

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