The generic name of Mavyret is glecaprevir and pibrentasvir. The product's dosage form is tablet, film coated and is administered via oral form. Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
The recommended oral dosage of MAVYRET in adults is 3 tablets taken at the same time once daily with food (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg) [see Clinical Pharmacology (12.3)]. 2.4 Recommended Dosage In Pediatric Patients 3 Years Of Age And Older
Adverse reactions observed in greater than or equal to 5% of subjects receiving MAVYRET in EXPEDITION-2 for 8 or 12 weeks were fatigue (10%), nausea (8%), and headache (5%).
The NDC numbers are: 4-Week Carton: 0074-2625-28 8-Week Carton: 0074-2625-56Bottle: 0074-2625-84Institutional-Use-Only Bottle: 0074-2625-80Store at or below 30°C (86°F). MAVYRET Oral PelletsMAVYRET oral pellets are dispensed in child-resistant unit-dose packets in cartons.
ICD-10-CM Diagnosis Code B18 B18.
2022 ICD-10-CM Diagnosis Code Z11. 59: Encounter for screening for other viral diseases.
ICD-10 code K75. 4 for Autoimmune hepatitis is a medical classification as listed by WHO under the range - Diseases of the digestive system .
Z23 is the ICD-10-CM code used when reporting an encounter for immunization for all vaccines given within the encounter.
ICD-10 code B18. 2 for Chronic viral hepatitis C is a medical classification as listed by WHO under the range - Certain infectious and parasitic diseases .
For asymptomatic individuals who are being screened for COVID-19 and have no known exposure to the virus, and the test results are either unknown or negative, assign code Z11. 59, Encounter for screening for other viral diseases.
ICD-10 code D89. 9 for Disorder involving the immune mechanism, unspecified is a medical classification as listed by WHO under the range - Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism .
ICD-10 Code for Atherosclerotic heart disease of native coronary artery without angina pectoris- I25. 10- Codify by AAPC.
ICD-10 code B15 for Acute hepatitis A is a medical classification as listed by WHO under the range - Certain infectious and parasitic diseases .
ICD-10 requires only one code (Z23) per vaccination, regardless if single or combination. Report Z23 for all vaccination diagnoses.
ICD-10-CM Code for Encounter for immunization Z23.
According to ICD-10-CM guidelines, clinicians may assign code Z28. 310, “Unvaccinated for COVID-19,” when the patient has not received a dose of any COVID-19 vaccine. Clinicians may assign code Z28.
The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.
The translation of the DosageForm Code submitted by the firm. The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”).
Proprietary Name: Mavyret What is the Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. Non-Proprietary Name: Glecaprevir And Pibrentasvir What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name.
Mavyret with NDC 0074-2625 is a a human prescription drug product labeled by Abbvie Inc.. The generic name of Mavyret is glecaprevir and pibrentasvir. The product's dosage form is tablet, film coated and is administered via oral form.
The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
MAVYRET is indicated for the treatment of adult patients 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 also indicated for the treatment of adult patients 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 [see Dosage and Administration (2.2) and Clinical Studies (14)].
Each MAVYRET tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir. The tablets are pink, oblong-shaped, film-coated, and debossed with “NXT” on one side.
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.
It is not known whether the components of MAVYRET are excreted in human breast milk, affect human milk production, or have effects on the breastfed infant. When administered to lactating rodents, the components of MAVYRET were present in milk, without effect on growth and development observed in the nursing pups[see Data].
No adequate human data are available to establish whether or not MAVYRET poses a risk to pregnancy outcomes. In animal reproduction studies, no adverse developmental effects were observed when the components of MAVYRET were administered separately during organogenesis at exposures up to 53 times (rats; glecaprevir) or 51 and 1.5 times (mice and rabbits, respectively; pibrentasvir) the human exposures at the recommended dose of MAVYRET [see Data]. No definitive conclusions regarding potential developmental effects of glecaprevir could be made in rabbits, since the highest achieved glecaprevir exposure in this species was only 7% (0.07 times) of the human exposure at the recommended dose. There were no effects with either compound in rodent pre/post-natal developmental studies in which maternal systemic exposures (AUC) to glecaprevir and pibrentasvir were approximately 47 and 74 times, respectively, the exposure in humans at the recommended dose[see Data].
Carbamazepine, efavirenz, and St. John’s wort may significantly decrease plasma concentrations of glecaprevir and pibrentasvir, leading to reduced therapeutic effect of MAVYRET. The use of these agents with MAVYRET is not recommended.
Glecaprevir and pibrentasvir are substrates of P-gp and/or BCRP. Glecaprevir is a substrate of OATP1B1/3. Coadministration of MAVYRET with drugs that inhibit hepatic P-gp, BCRP, or OATP1B1/3 may increase the plasma concentrations of glecaprevir and/or pibrentasvir.