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Viekira
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).
