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Viekira

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Overview

What is Viekira?

VIEKIRA XR fixed dose combination, extended-release tablet includes a hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor (dasabuvir), 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. The tablets are for oral administration.

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). The molecular formula is CHNOS•Na•HO (salt, hydrate) and the molecular weight of the drug substance is 533.57 (salt, hydrate). The 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:

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 CHNO•4.5HO (hydrate) and the molecular weight for the drug substance is 975.20 (hydrate).  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 CHNOS•2HO (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:

Dasabuvir, Ombitasvir, Paritaprevir, Ritonavir Film-Coated Bilayer Tablets

Dasabuvir, ombitasvir, paritaprevir, and ritonavir film-coated bilayer tablets consist of an extended release (ER) layer and an immediate release (IR) layer. The ER layer contains 200 mg dasabuvir (equivalent to 216.2 mg of dasabuvir sodium monohydrate). The ER layer of the tablet also contains copovidone, K value 28, hypromellose 2208, 17,700 (mPa*s), colloidal silicon dioxide/colloidal anhydrous silica and magnesium stearate. The IR layer contains 8.33 mg ombitasvir, 50 mg paritaprevir and 33.33 mg ritonavir. Strength of ombitasvir and paritaprevir in the drug product are expressed on the anhydrous basis. The IR layer of the tablet also contains copovidone, K value 28, vitamin E polyethylene glycol succinate, propylene glycol monolaurate, sorbitan monolaurate, colloidal silicon dioxide/colloidal anhydrous silica. The tablet coating contains hypromellose (6 mPa*s), hypromellose (15 mPa*s), polyethylene glycol 400, hydroxypropyl cellulose, polysorbate 80, polyethylene glycol 3350/macrogol 4000, talc, titanium dioxide, colloidal silicon dioxide/colloidal anhydrous silica and iron oxide yellow.



What does Viekira look like?



What are the available doses of Viekira?

Extended-release tablets: 200 mg dasabuvir, 8.33 mg ombitasvir, 50 mg paritaprevir, and 33.33 mg ritonavir ()

What should I talk to my health care provider before I take Viekira?

How should I use Viekira?

VIEKIRA XR is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) :

Test all patients for HBV infection by measuring HBsAg and anti-HBc. ()

Assess for laboratory and clinical evidence of hepatic decompensation. ()


What interacts with Viekira?

Sorry No Records found


What are the warnings of Viekira?

Sorry No Records found


What are the precautions of Viekira?

Sorry No Records found


What are the side effects of Viekira?

Sorry No records found


What should I look out for while using Viekira?

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Table 2

[see Drug Interactions ()]

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Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with VIEKIRA XR. 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


What might happen if I take too much Viekira?

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.


How should I store and handle Viekira?

VIEKIRA XR 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 three tablets. The NDC number is 0074-0063-28.Dasabuvir, ombitasvir, paritaprevir, and ritonavir 200 mg/8.33 mg/50 mg/33.33 mg tablets are pale yellow-colored, film-coated, oblong shaped, debossed with “3QD” on one side.Store at or below 30°C (86°F).VIEKIRA XR 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 three tablets. The NDC number is 0074-0063-28.Dasabuvir, ombitasvir, paritaprevir, and ritonavir 200 mg/8.33 mg/50 mg/33.33 mg tablets are pale yellow-colored, film-coated, oblong shaped, debossed with “3QD” on one side.Store at or below 30°C (86°F).VIEKIRA XR 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 three tablets. The NDC number is 0074-0063-28.Dasabuvir, ombitasvir, paritaprevir, and ritonavir 200 mg/8.33 mg/50 mg/33.33 mg tablets are pale yellow-colored, film-coated, oblong shaped, debossed with “3QD” on one side.Store at or below 30°C (86°F).VIEKIRA XR 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 three tablets. The NDC number is 0074-0063-28.Dasabuvir, ombitasvir, paritaprevir, and ritonavir 200 mg/8.33 mg/50 mg/33.33 mg tablets are pale yellow-colored, film-coated, oblong shaped, debossed with “3QD” on one side.Store at or below 30°C (86°F).


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

VIEKIRA XR combines three direct-acting hepatitis C virus antiviral agents with distinct mechanisms of action .

Ritonavir is not active against HCV. Ritonavir is a potent CYP3A inhibitor that increases peak and trough plasma drug concentrations of paritaprevir and overall drug exposure (i.e., area under the curve).

Non-Clinical Toxicology
p009

Table 2

[see Drug Interactions ()]

p6122615291487687162

Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with VIEKIRA XR. 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

The results of a study of coadministration of ETHAMBUTOL HCl (50mg/kg) with an aluminum hydroxide containing antacid to 13 patients with tuberculosis showed a reduction of mean serum concentrations and urinary excretion of ethambutol of approximately 20% and 13%, respectively, suggesting that the oral absorption of ethambutol may be reduced by these antacid products. It is recommended to avoid concurrent administration of ethambutol with aluminum hydroxide containing antacids for at least 4 hours following ethambutol administration.

Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals, and who were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure and death. Cases have been reported in patients who are HBsAg positive and also in patients with serologic evidence of resolved HBV infection (i.e., HBsAg negative and anti-HBc positive). HBV reactivation has also been reported in patients receiving certain immunosuppressant or chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV direct-acting antivirals may be increased in these patients.

HBV reactivation is characterized as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level. In patients with resolved HBV infection reappearance of HBsAg can occur. Reactivation of HBV replication may be accompanied by hepatitis, i.e., increase in aminotransferase levels and, in severe cases, increases in bilirubin levels, liver failure, and death can occur.

Test all patients for evidence of current or prior HBV infection by measuring HBsAg and anti- HBc before initiating HCV treatment with VIEKIRA XR. In patients with serologic evidence of HBV infection, monitor for clinical and laboratory signs of hepatitis flare or HBV reactivation during HCV treatment with VIEKIRA XR and during post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.

The following adverse reaction is described below and elsewhere in the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

Tips

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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).