Dasabuvir And Ombitasvir And Paritaprevir And Ritonavir (Viekira Pak)

Trade Name : Viekira Pak

AbbVie Inc.

KIT

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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 Dasabuvir And Ombitasvir And Paritaprevir And Ritonavir (Viekira Pak) which is also known as Viekira Pak and Manufactured by AbbVie Inc.. It is available in strength of per ml. Read more

Dasabuvir And Ombitasvir And Paritaprevir And Ritonavir (Viekira Pak) 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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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with VIEKIRA PAK. 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
  • VIEKIRA PAK is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) :
  • VIEKIRA PAK is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV):
  • VIEKIRA PAK includes ombitasvir, a hepatitis C virus NS5A inhibitor, paritaprevir, a hepatitis C virus NS3/4A protease inhibitor, ritonavir, a CYP3A inhibitor and dasabuvir, a hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor. ()
  • genotype 1b without cirrhosis or with compensated cirrhosis
  • genotype 1a without cirrhosis or with compensated cirrhosis for use in combination with ribavirin.
  • Testing Prior to the Initiation of Therapy:
  • Recommended dosage: Two ombitasvir, paritaprevir, ritonavir 12.5/75/50 mg tablets once daily (in the morning) and one dasabuvir 250 mg tablet twice daily (morning and evening) with a meal without regard to fat or calorie content. ()
  • VIEKIRA PAK is ombitasvir, paritaprevir, ritonavir fixed dose combination tablets copackaged with dasabuvir tablets.
  • Tablets:
  • Ombitasvir, paritaprevir, ritonavir: 12.5/75/50 mg ()
  • Dasabuvir: 250 mg ()
  • No data
  • Patients with moderate to severe hepatic impairment. (, , , )
  • If VIEKIRA PAK is administered with ribavirin, the contraindications to ribavirin also apply to this combination regimen. ()
  • Co-administration with drugs that are: highly dependent on CYP3A for clearance; moderate or strong inducers of CYP3A and strong inducers of CYP2C8; and strong inhibitors of CYP2C8. ()
  • Known hypersensitivity to ritonavir (e.g. toxic epidermal necrolysis, Stevens-Johnson syndrome). ()
  • No data
  • Risk of Hepatitis B Virus Reactivation
  • Hepatic Decompensation and Hepatic Failure in Patient with Cirrhosis
  • ALT Elevations
  • Risks Associated With Ribavirin Combination Treatment
  • Drug Interactions
  • If VIEKIRA PAK is administered with ribavirin (RBV), refer to the prescribing information for ribavirin for a list of ribavirin-associated adverse reactions.
  • The following adverse reaction is described below and elsewhere in the labeling:
  • In subjects receiving VIEKIRA PAK with ribavirin, the most commonly reported adverse reactions (greater than 10% of subjects) were fatigue, nausea, pruritus, other skin reactions, insomnia and asthenia. In subjects receiving VIEKIRA PAK without ribavirin, the most commonly reported adverse reactions (greater than or equal to 5% of subjects) were nausea, pruritus and insomnia. ()n 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
  • Co-administration of VIEKIRA PAK can alter the plasma concentrations of some drugs and some drugs may alter the plasma concentrations of VIEKIRA PAK. The potential for drug interactions must be considered before and during treatment. Consult the full prescribing information prior to and during treatment for potential drug interactions. (, , , )
  • 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. n
  • No data
  • In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted immediately.
  • VIEKIRA PAK is ombitasvir, paritaprevir, ritonavir fixed dose combination tablets copackaged with dasabuvir tablets.
  • Ombitasvir, paritaprevir, ritonavir fixed dose combination tablet includes a hepatitis C virus NS5A inhibitor (ombitasvir), a hepatitis C virus NS3/4A protease inhibitor (paritaprevir), and a CYP3A inhibitor (ritonavir) that inhibits CYP3A mediated metabolism of paritaprevir, thereby providing increased plasma concentration of paritaprevir. Dasabuvir is a hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor, which is supplied as separate tablets in the copackage. Both tablets are for oral administration.
  • Ombitasvir
  • The chemical name of ombitasvir is Dimethyl ([(2,5)-1-(4--butylphenyl) pyrrolidine-2,5-diyl]bis{benzene-4,1-diylcarbamoyl(2)pyrrolidine-2,1-diyl[(2)-3-methyl-1-oxobutane-1,2-diyl]})biscarbamate hydrate. The molecular formula is CHNOu20224.5HO (hydrate) and the molecular weight for the drug substance is 975.20 (hydrate).u00a0 The drug substance is white to light yellow to light pink powder, and is practically insoluble in aqueous buffers but is soluble in ethanol. Ombitasvir has the following molecular structure:
  • Paritaprevir
  • The chemical name of paritaprevir is (2R,6S,12Z,13aS,14aR,16aS)-N-(cyclopropylsulfonyl)-6-{[(5-methylpyrazin-2-yl)carbonyl]amino}-5,16-dioxo-2-(phenanthridin-6-yloxy)-1,2,3,6,7,8,9,10,11,13a,14,15,16,16a-tetradecahydrocyclopropa[]pyrrolo[1,2-][1,4] diazacyclopentadecine-14a(5H)-carboxamide dihydrate. The molecular formula is CHNOSu20222HO (dihydrate) and the molecular weight for the drug substance is 801.91 (dihydrate). The drug substance is white to off-white powder with very low water solubility. Paritaprevir has the following molecular structure:
  • Ritonavir
  • The chemical name of ritonavir is [5S-(5R*,8R*,10R*,11R*)]10-Hydroxy-2-methyl-5-(1-methyethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12-tetraazatridecan-13-oic acid,5-thiazolylmethyl ester. The molecular formula is CHNOS and the molecular weight for the drug substance is 720.95. The drug substance is white to off white to light tan powder practically insoluble in water and freely soluble in methanol and ethanol. Ritonavir has the following molecular structure:
  • Ombitasvir, Paritaprevir, Ritonavir Fixed-Dose Combination Tablets
  • Ombitasvir, paritaprevir, and ritonavir film-coated tablets are co-formulated immediate release tablets. The tablet contains copovidone, K value 28, vitamin E polyethylene glycol succinate, propylene glycol monolaurate Type I, sorbitan monolaurate, colloidal silicon dioxide/colloidal anhydrous silica, sodium stearyl fumarate, polyvinyl alcohol, polyethylene glycol 3350/macrogol 3350, talc, titanium dioxide, and iron oxide red. The strength for the tablet is 12.5 mg ombitasvir, 75 mg paritaprevir, 50 mg ritonavir.
  • Dasabuvir
  • The chemical name of dasabuvir is Sodium 3-(3--butyl-4-methoxy-5-{6-[(methylsulfonyl)amino]naphthalene-2-yl}phenyl)-2,6-dioxo-3,6-dihydro-2H-pyrimidin-1-ide hydrate (1:1:1).u00a0The molecular formula is CHNOSu2022Nau2022HO (salt, hydrate) and the molecular weight of the drug substance is 533.57 (salt, hydrate).u00a0The drug substance is white to pale yellow to pink powder, slightly soluble in water and very slightly soluble in methanol and isopropyl alcohol. Dasabuvir has the following molecular structure:
  • Dasabuvir is formulated as a 250 mg film-coated, immediate release tablet containing microcrystalline cellulose (D50-100 um), microcrystalline cellulose (D50-50 um), lactose monohydrate, copovidone, croscarmellose sodium, colloidal silicon dioxide/anhydrous colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350/macrogol 3350, talc, and iron oxide yellow, iron oxide red and iron oxide black. Each tablet contains 270.3 mg dasabuvir sodium monohydrate equivalent to 250 mg dasabuvir.
  • No data
  • Carcinogenesis and Mutagenesis
  • Ombitasvir
  • Ombitasvir was not carcinogenic in a 6-month transgenic mouse study up to the highest dose tested (150 mg per kg per day). Similarly, ombitasvir was not carcinogenic in a 2-year rat study up to the highest dose tested (30 mg per kg per day), resulting in ombitasvir exposures approximately 16-fold higher than those in humans at 25 mg.
  • Ombitasvir and its major inactive human metabolites (M29, M36) were not genotoxic in a battery of or assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and mouse micronucleus assays.
  • Paritaprevir, ritonavir
  • Paritaprevir, ritonavir was not carcinogenic in a 6-month transgenic mouse study up to the highest dose tested (300/30 mg per kg per day). Similarly, paritaprevir, ritonavir was not carcinogenic in a 2-year rat study up to the highest dose tested (300/30 mg per kg per day), resulting in paritaprevir exposures approximately 9-fold higher than those in humans at 150 mg.
  • Paritaprevir was positive in an chromosome aberration test using human lymphocytes. Paritaprevir was negative in a bacterial mutation assay, and in two genetic toxicology assays (rat bone marrow micronucleus and rat liver Comet tests).
  • Dasabuvir
  • Dasabuvir was not carcinogenic in a 6-month transgenic mouse study up to the highest dose tested (2000 mg per kg per day). Similarly, dasabuvir was not carcinogenic in a 2-year rat study up to the highest dose tested (800 mg per kg per day), resulting in dasabuvir exposures approximately 19-fold higher than those in humans at 500 mg.
  • Dasabuvir was not genotoxic in a battery of or assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and rat micronucleus assays.
  • If VIEKIRA PAK is administered with ribavirin, refer to the prescribing information for ribavirin for information on carcinogenesis, and mutagenesis.
  • Impairment of Fertility
  • Ombitasvir
  • Ombitasvir had no effects on embryo-fetal viability or on fertility when evaluated in mice up to the highest dose of 200 mg per kg per day. Ombitasvir exposures at this dose were approximately 25-fold the exposure in humans at the recommended clinical dose.
  • Paritaprevir, ritonavir
  • Paritaprevir, ritonavir had no effects on embryo-fetal viability or on fertility when evaluated in rats up to the highest dose of 300/30 mg per kg per day. Paritaprevir exposures at this dose were approximately 2- to 5-fold the exposure in humans at the recommended clinical dose.
  • Dasabuvir
  • Dasabuvir had no effects on embryo-fetal viability or on fertility when evaluated in rats up to the highest dose of 800 mg per kg per day. Dasabuvir exposures at this dose were approximately 16-fold the exposure in humans at the recommended clinical dose.
  • If VIEKIRA PAK is administered with ribavirin, refer to the prescribing information for ribavirin for information on Impairment of Fertility.
  • No data
  • VIEKIRA PAK is dispensed in a monthly carton for a total of 28 days of therapy. Each monthly carton contains four weekly cartons. Each weekly carton contains seven daily dose packs.
  • Each child resistant daily dose pack contains four tablets: two 12.5/75/50 mg ombitasvir, paritaprevir, ritonavir tablets and two 250 mg dasabuvir tablets, and indicates which tablets need to be taken in the morning and evening. The NDC number is 0074-3093-28.
  • Ombitasvir, paritaprevir, ritonavir 12.5/75/50 mg tablets are pink-colored, film-coated, oblong biconvex shaped, debossed with u201cAV1u201d on one side. Dasabuvir 250 mg tablets are beige-colored, film-coated, oval-shaped, debossed with u201cAV2u201d on one side.
  • Store at or below 30u00b0C (86u00b0F).
  • Advise the patient to read the FDA-approved patient labeling ().
  • Inform patients to review the Medication Guide for ribavirin .
  • 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 ALT Elevations or Hepatic Decompensation and Failure
  • Inform patients to watch for early warning signs of liver inflammation or failure, such as fatigue, weakness, lack of appetite, nausea and vomiting, as well as later signs such as jaundice, onset of confusion, abdominal swelling, and discolored feces, and to consult their health care professional without delay if such symptoms occur .
  • Pregnancy
  • Advise patients that extreme care must be taken to avoid pregnancy during treatment with VIEKIRA PAK with ribavirin and within 6 months of stopping ribavirin in both female patients and in female partners of male patients. Inform patients to notify their health care provider immediately in the event of a pregnancy .
  • Drug Interactions
  • Inform patients that VIEKIRA PAK 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 .
  • Inform patients that contraceptives containing ethinyl estradiol are contraindicated with VIEKIRA PAK .
  • Administration
  • Advise patients to take VIEKIRA PAK every day at the regularly scheduled time with a meal without regard to fat or calorie content .
  • Inform patients that it is important not to miss or skip doses and to take VIEKIRA PAK for the duration that is recommended by the healthcare provider.
  • Advise patients not to remove tablets from the daily dose pack until they are ready to take them.
  • Manufactured by AbbVie Inc., North Chicago, IL 60064.
  • VIEKIRA PAK and NORVIR are trademarks of AbbVie Inc.
  • u00a9 2019 AbbVie Inc. All rights reserved.03-C075
  • No data
  • NDC 0074-3093-28
  • Rx only
  • viekira pakn
  • ombitasvir, paritaprevir, ritonavir tablets 12.5 mg / 75 mg / 50 mg
  • Copackaged with
  • dasabuvir tablets 250 mg
  • Do not use if seal on top of carton is broken or missing
  • Keep out of reach of children
  • Store at or below 30C (86F)
  • See Package Insert for full Prescribing Information
  • AbbVie Inc.
  • North Chicago, IL 60064
  • u00a92016 AbbVie Inc.
  • Each tablet contains ombitsavir, paritaprevir, ritonavir 12.5 mg / 75 mg / 50 mg
  • Each tablet contains 270.3 mg dasabuvir sodium monohydrate equivalent to 250 mg dasabuvir
  • Each carton contains 28 tablets in 7 wallets for 1 week of treatment.
  • Each wallet contains 4 tablets:
  • 2 ombitasvir, paritaprevir, ritonavir tablets and 2 dasabuvir tablets.
  • NDC 0074-3093-01
  • Rx only
  • viekira pakn
  • ombitasvir, paritaprevir, ritonavir tablets 12.5 mg / 75 mg / 50 mg
  • Copackaged with
  • dasabuvir tablets 250 mg
  • Keep out of reach of children
  • Each box contains: 1 wallet of 4 tablets each
  • 2 ombitasvir, paritaprevir, ritonavir tablets and 2 dasabuvir tablets
  • Store at or below 30u00b0C (86u00b0F)
  • See Package Insert for full Prescribing Information
  • AbbVie Inc.
  • North Chicago, IL 60064
  • u00a92014 AbbVie Inc.
  • Each tablet contains ombitsavir, paritaprevir, ritonavir 12.5 mg / 75 mg / 50 mg
  • Each tablet contains 270.3 mg dasabuvir sodium monohydrate equivalent to 250 mg dasabuvir
  • NDC 0074-3093-28
  • Rx only
  • viekira pakn
  • ombitasvir, paritaprevir, ritonavir tablets 12.5 mg / 75 mg / 50 mg
  • Copackaged with
  • dasabuvir tablets 250 mg
  • Each tablet contains ombitsavir, paritaprevir, ritonavir 12.5 mg / 75 mg / 50 mg
  • Each tablet contains 270.3 mg dasabuvir sodium monohydrate equivalent to 250 mg dasabuvir

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